Use of human participants for research or certain instructional purposes is subject to prior review and approval of the Institutional Review Board (IRB) for the Protection of Human Subjects, a standing committee with members appointed by the Vice President for Research Development and Support and Federal Relations and approved by the President. The IRB published a set of guidelines in compliance with applicable federal statutes which must be followed whenever use of human participants is involved. Copies of theses guidelines may be obtained from the Division of Graduate Studies or the Research Compliance IRB Office on the 6^th floor of the Administration Tower or downloaded from the Research web page at http://ccaix.jsums.edu/~ordsfr/.

Faculty, staff, and students (undergraduate and graduate) of Jackson State University are governed by these Policies and Procedures in any research that involves human participants conducted by or in any way under the sponsorship of JSU, including thesis and dissertation research.

Researchers are reminded that adherence to full compliance to these Policies and Procedures is the authority of the IRB, not the researcher.

A. Purpose

JSU, under its basic charter, is dedicated to education, research, and service. This Policy, and the procedures used to carry out this Policy, is designed to aid in expanding research while protecting human research participants to the full degree required both legally and morally.

Investigations who use human research participants require concern by all member of the University for protecting the rights and welfare of the individuals involved. Many specific criteria, including state and federal regulations, must be considered before approval can be authorized. The University much be sensitive to the ethical issues and community laws relevant to the specific area of research under consideration. These principles apply to all investigations involving human research participants in the biomedical, behavioral, and social sciences. Finally, it is the responsibility of the University, through staff, faculty, and the IRB to ensure that the rights of human research participants are protected.

B. Policy

The policies and procedures relating to human research participants, as detailed in this handbook, comprise the basic minimum procedures that the JSU IRB for the Protection of Human Research Participants in Research uses in its review processes. These guidelines are written in accordance with the basic requirements of the Department of Health and Human Services (DHHS) (45 CFR 46) along with those of 16 (currently) other federal agencies and departments, as defined in the Common Rule, and also are in compliance with the principles of the 1948 Nuremberg Code, the 1964 Declaration of Helsinki, and the 1979 Belmont Report, which laid out the ethical principle for the protection of human participants.

Both the membership of the IRB and any prospective researchers who intend to use human participants in their research projects are reminded that this document constitutes a basic minimum Policies and Procedures and does not include every possibility for variation of protocols utilizing human research participants

The JSU IRB has many responsibilities including: (1) protecting human research participants, (2) educating and informing university members and the community about human participants issues, (3) assisting in the application process, (4) reviewing protocols, and (5) maintaining familiarity with federal and state policies and regulations.

Since the responsibilities of the IRB have increased over time, it is important for members to use the policies and procedures as a framework and guide to meet the minimum requirements. The IRB will apply with the policies in this manual for all research involving human participants that is conducted at, by, or under the auspices of the University, no matter the source (or absence) of funding.

The methodology of application, review, monitoring, and approving human participant-related research has been reduced to the levels of effort consistent with maintaining positive control over such research, yet avoiding unnecessary paperwork and time by researchers and IRB members.

The IRB Research Associate or Administrative Assistant will be glad to answer your questions regarding the application process for human participants research. Please call (601) 979-4197.

C. Governing Principles

University researchers and the IRB will be governed by the following principles:

1. Research projects will use the minimum number of human research participants for obtaining reasonable results.

2. Illegal, immoral, or significantly harmful research with human participants is prohibited.

3. Research projects involving human research participants must conform to moral and scientific principles that justify such research and should be based on scientifically established facts.

4. Research projects involving human research participants must be conducted by qualified scientists or under the supervision of a qualified scientist.

5. Research projects should not be conducted unless benefits outweigh the inherent risks.

6. Personality or self-concept testing where the participant may be altered or disturbed must be conducted with extreme caution.

7. Research projects conducted by students (undergraduate or graduate) require an advisor.

8. The research investigator has a duty to protect the life, health, and welfare of the human participants within the context of the research situation.

9. The nature, purpose, and risk of the research must be explained to the human participants by the investigator, and the participants’ consent must be obtained. If the nature and purpose of the research cannot be explained to the participants, the investigator must justify his/her reasons to the IRB and obtain a waiver by submitting the IRB application for a full board review as required under 45 CFR 46.116(d).

9. Informed Consent MUST be documented by the use of a written consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative. A waiver of this requirement can only be granted by the JSU IRB for the Protection of Human Participants in Research, in accordance with 45 CFR 46. The oral consent process may be used only when approved in writing by the IRB. The researcher must insure that each signer, whether participant or representative, is given a copy of the consent form for his/her retention. In addition to authorized representative or parent consent, assent forms are required for minors. (A model assent form is found in Appendix IV)

10. Research investigators much respect the integrity of every human research participant, especially if the participant is in a dependent relationship to the investigator (e.g., instructors and student, physicians and patients).

11. Human research participants must be informed that they are free to withdraw consent at any time without prejudice or penalty.

12. Research investigator(s) must discontinue any research project if, in his/her or their judgment or the judgment of the IRB, the research could be harmful to the participant if continued.

13. The University assumes responsibility for human research participants at risk. As such, the University will determine whether or not research projects require IRB approval, will assure that appropriate research methods are used, will review any human research project as necessary, and will be informed of any changes in procedures or any anticipated dilemmas involving human participants.

14. The use of deceit by a researcher is generally frowned upon by the IRB, and must be justified fully by the researcher prior to IRB approval.

15. The research investigator must make adequate provisions to protect the privacy of participants and the confidentiality of the data collected.

16. Additional safeguards must be included to protect the rights and welfare of participants who are likely to be vulnerable to coercion or undue influence or who belong to potentially vulnerable populations.

17. The Board will not grant retroactive approval once data have been collected from human participants

D. Jurisdiction of the Board

The JSU IRB for the Protection of Human Participants in Research is an administrative body established to protect the rights and welfare of human research participants recruited to participate in research activities conducted under the auspices of JSU. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by the IRB may be subject to further review and disapproval by officials of the institution. However, those officials may not approve research if it has disapproved by the IRB, according to Federal Policy §46.112. Furthermore, any approved research is subject to continuing JSU IRB review and must be reevaluated at least annually (and more frequently, as specified by the IRB) [Federal Policy §46.109(e)]. The IRB may suspend or terminate a study, impose restrictions or require modifications to a study as a condition for continuation.

The IRB also functions independently of other committees and makes its independent determination whether to approve or disapprove the protocol based upon whether or not human participants are adequately protected. The IRB has jurisdiction over all human participants research, thereby providing broader protection for participants than required by the regulations. No University administrator, faculty, or staff can override the IRB decisions. However, the investigator may go through the appeal processes set forth in. (INCOMPLETE)

Several professional organizations and societies have formulated their own guidelines for research involving human participants. Such guidelines may supplement but do not supercede or diminish the protections and requirements outlined in this document.

E. Responsibilities of Investigators

The qualifications of the principal investigator will be considered when the IRB reviews proposals. The investigator’s professional development will be taken into account and related to the degree of protocol complexity and risk to human participants. Less experienced research investigators may be required to be sponsored by seasoned researchers, and all students will be required to have a sponsor. Proposals that require skills beyond those held by the principal investigator can be modified to meet the investigator’s skills, have additional qualified personnel added, or be disapproved.

Research investigators shall prepare protocols giving complete descriptions of the proposed research. The research plan must include provisions for the adequate protection of the rights and welfare of prospective participants and ensure that pertinent laws and regulations are observed. Copies of questionnaires, surveys, letters of permission, etc. are required upon submission of the IRB application. Samples of informed consent documents must be included with protocols. Research investigators are responsible for obtaining informed consent and ensuring that no human participant will be involved in the research prior to obtaining the consent.

Researchers are responsible for complying with all IRB decisions, conditions, and requirements. Research investigators are responsible for reporting the progress of the research to the IRB and/or appropriate institutional officials as often as and in the manner prescribed by the IRB, but no less than once per year [Federal Policy § 46.109(e)].

The IRB has approved a policy that protocols involving human participants will not be approved until all “key personnel” listed on the protocol application have satisfactorily completed human research ethics training and have received a certificate. The term key personnel includes the Primary Investigator (PI) and other individuals who contribute to the scientific development, execution of a project in an substantive, measurable way, or any personnel who has direct contact with the prospective participant.

Note: This includes all personnel who have direct contact with the participant, not only the PI.

Investigators must receive written and signed approval from the IRB prior to making any changes to a protocol. Changes include:

- modifications or advertisements, surveys or questionnaires, consent forms or assent forms

Investigators must immediately notify the IRB of any adverse reactions, unforeseen events, terminations of human participant involvement, and completion of the study.

Protocols are subject to random internal quality assurance audits. It is the responsibility of the PI to keep records in order and to assist the IRB and the auditor in conducting any audits. All IRB records relating to a research study shall be retained for at least three (3) years after the completion of the research. All records shall be accessible for inspection and copying by all representatives of Office for Human Protections (OHRP) or any federal/state funding agency at reasonable times and in a reasonable manner.

Failure to comply with IRB policies can be policies can be serious and can involve the institution losing all federal funding for a period. Also, researchers should be aware of the possibility of litigation, both against the institution and against them as individuals.

Chapter II

Levels of Review

There are three different levels of review, based on the human participant involvement and potential risk. They are:

The IRB has designated the IRB Research Associate as the primary individual to receive all IRB applications and review the packet to ensure that all required documentation is present and that all signatures are affixed. The Research Associate also reviews the proposed project to determine the level of review required.

Note: To see if your research meets the criteria for exempt status, you may view the decision charts found at the OHRP website.

Exempt research is research that does not require expedited of full Board review but does require submission of an application protocol for exempt status from the IRB.

If the Research Associate determines that the proposed research falls wholly within the scope of the one or more of the seven categories of research defined by §46.101(b) of the Common Rule, that participant recruitment and informed consent conform to requirements, that adequate provisions have been made to ensure participant confidentiality and that other requirements have been fulfilled, the application can receive Level 1 Expedited review.

A project is exempt if all the research activities belong in one or more of the following categories:

1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:

b. research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), surveys or interviews, or observation of public behavior unless:

a. information obtained is recorded in such a manner that human participants can be identified directly or through identifiers linked to the participants;

b. any disclosure of the human participants’ responses (or conduct) outside the research may place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability or reputation. (If this is suspected, the protocol will be subject to full Board review.)

i. Research involving the use of educational tests (cognitive, diagnostic, attitude, achievement) may not be exempt if the investigator’s own current students are participants.

3. Research involving the collection or study of existing data-including documents, records, pathological specimens or diagnostic specimens-if:

b. the information is recorded by the investigator in such a manner that human participants cannot be identified directly or through identifiers linked to the participants.

4. Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads and which are designed to study, evaluate or otherwise examine:

d. possible changes in methods or levels of payment for benefits or services under these programs.

5. Research involving only taste and food quality evaluations and consumer acceptance studies if:

b. a food is consumed that contains a food ingredient at or below the level and use found to be safe or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

If the IRB Research Associate has a protocol meeting the requirements for a Level 1 review but it is written as a grant, she may contact the IRB Chair to assign another Board member to review the protocol as a second check for requirements. All IRB members are notified of the specifics of the application and its approval. The IRB members will be given a copy of the database each month as part of the business meeting. Should any member not agree with an action taken, he/she has the right to call the application before the full Board review. Note: In 45 CFR 46 and the Common Rule, these categories of research are termed “Exempt”; this has caused confusion among researchers. These categories of research are exempt from mandatory Board review. The IRB reserves the right to review a proposed project and determine if it indeed is exempt from Board review. Also, several of the exemptions listed by DHHS (i.e., several categories of research using children) are not exempted under U.S. Department of Education Regulations).

Note: To see if your research meets the criteria for exempt status, you may view the decision charts found at the OHRP website.

Level II Expedited review is appropriate when the proposed research deals with one (or several) of the following categories of research as published by the Director, DHHS, in 63 FR 60364-60367, November 9, 1998.

Applicability

1. Research activities that (a) present no more than minimal risk to human participants and (b) involve only procedures listed in one or more of the following categories may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human participants.

2. The categories in this list apply regardless of the age of participants, except as noted.

3. The expedited review procedure may not be used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

4. The expedited review procedure may not be used for classified research involving human participants.

5. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review—expedited or full Board—utilized by the IRB.

6. Categories a through g pertain to both initial and continuing IRB review. They are:

(i) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increase the risks or decrease the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(ii) Research on medical devices for which an investigational device exemption application (21 CFR Part 812) is not required, or (it) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

(i) from healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(ii) from other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3ml per kg in an 8 week period, and collection may not occur more frequently than 2 times per week.

exempt from the DHHS regulations for the protection of human participants. 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.

7. Continuing review of research previously approved by the convened IRB as follows:

8. Continuing review of research, not conducted under an investigational new drug

application or investigational device exemption where categories (b) through seven (7) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk an no additional risks have been identified.

A Level II expedited review procedure consists of a review of research involving human participants by the IRB Chair or by one or more experienced reviewers designated by the Chair from among members of the IRB in accordance with the requirement set forth in 45 CFR 46.110.

Children are defined in the DHHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 46.402(a).

Expedited review shall be conducted by the IRB Chair or by two of the experienced IRB members designated by the Chair. The IRB members conducting the expedited review may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. The reviewers shall refer any research project which the reviewer would have disapproved to the full IRB for review. The reviewer may also refer other research projects to the full IRB whenever the reviewer believes that full IRB review is warranted.

When the expedited review procedures are used, the IRB Chair or members(s) conducting the review shall inform the IRB membership of research projects that have been approved under the procedure. At a convened IRB meeting, any member may request that an activity that has been approved under either the administrative or the expedited procedure be reviewed by the IRB in accordance with nonexpedited procedures. A vote of members shall be taken concerning the request and the majority will decide the issue.

C. Full Board Review

Full Board review is review of proposed research at a convened meeting at which a quorum of the membership of the IRB is present, including at least one member whose primary concerns are in non-scientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting, in accordance with Federal Policy §46.108.

Protocols requiring full Board review will be reviewed at regularly scheduled IRB meetings. These occur on the 2^nd Thursday of each month. (See Appendix VI)

Before a protocol can be placed on the agenda, the IRB Research Associate screens it for compliance with the required format, necessary signatures, inclusion of consent and/or assent forms, letter(s) of permission (if necessary), and research training certificate. If protected health information will be collected, appropriate HIPAA documents must be submitted. For information on preparing a protocol, see Chapter III.

Investigators must have an official, written approval letter from the IRB chair before enrolling participants in the study. All consent forms, letters, HIPAA forms (if required) and recruitment ads must have an official, signed IRB approval stamp.

The initial approval is valid for a maximum of one year. If the protocol is not reapproved by the anniversary date, the protocol will be closed. Note that approval of an addendum does not constitute reapproval for another year. The Board may decide (on a case-by-case basis based primarily on the risk/benefit analysis of the study) that a protocol requires reapproval more often than once a year. If the Board disapproves a protocol, any resubmitted must be accompanied by a new protocol application including all appropriate signatures.

Investigators whose protocols are disapproved may invoke the appeal procedures. (LINK TO APPEAL PROCEDURES IN APPENDIX WHEN ADDED)

A. Protocol Submission

2. Letter requesting permission to designated agent of cooperating institution or

3. Letter from designated agent of cooperating institution or agency (if required)

6. Certificate of research training from all persons associated with the research

All submissions must be typed, legible and suitable for photocopying on the official IRB application form. The IRB Research Associate will request additional information or a resubmission if materials are not sufficiently legible, if sections are incomplete, or if required documentation is missing.

B. Risk/Benefit Analysis

Risks to research participants posed by participation in research should be justified by the anticipated benefits to the participants or society. This requirement is clearly stated in all codes of research ethics and is central to the federal regulations. One of the major responsibilities of the IRB, therefore, is to assess the risks and benefits of proposed research.

Level I Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routing physical or psychological examinations or tests (Federal Policy, DHHS Subpart A and FDA) [Federal Policy §46.102(i); and 21 CFR 50.3(k) and 56.102(j)].

Level II Minimal Risk: The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives or in the routine medical, dental, or psychological examination of healthy persons (DHHS Subpart C-prisoners)[45 CFR 46.303 (d)].

Risk: The probability of harm or injury occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

The IRB’s assessment of risks and anticipated benefits involves a series of steps. The IRB must consider the following:

(1) identification of the risks associated with the research as distinguished from

(2) determination that the risks will be minimized to the fullest extent possible,

(5) assurance that potential participants will be provided with an accurate and fair

C. Informed Consent

Informed consent is one of the primary ethical requirements underpinning research with human participants. It reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper of a discrete moment in time. Informed consent assures that prospective human participants will understand that nature of the research and can knowledgeably and voluntarily decide whether or not to participate. This assurance protects all parties – both the participant, whose autonomy is respected, and the investigator, who otherwise faces legal hazards.

The “proxy consent” of someone other than the participant is not the same as the participant’s own consent, although it may be an acceptable substitute when a participant is unable to give informed consent.

Though the elements of informed consent are easy to enumerate, various empirical studies suggest they are not so easy to achieve. Even the best intentions do not ensure against failures of communication, information that is poorly conveyed or participants who may forget (if indeed they ever understood) that they are involved in a research project. Enhancing the likelihood that informed consent will take place is a challenge to which the IRB will respond with imagination and good judgment. When the proposed research will involve vulnerable participants or the research design involves incomplete disclosure or deception, the challenges to the IRB are even greater. Certain populations may not be able to understand the required information, whereas other populations are so situated that the voluntariness of their consent may be in doubt. Hospitalized patients, particularly those who are seriously ill or undergoing emergency treatment, may also need special protection.

The issues discussed in this section are general IRB considerations regarding informed consent, and they apply to the review of research that involves human participants.

The federal regulations require that certain information must be provided to each participant [Federal Policy §46.116(a)]:

(1) A statement that the study involves research, an explanation of the purposes of

(4) A disclosure of appropriate alternative procedures or courses of treatment, if

(5) A statement describing the extent, if any, to which confidentiality of records

(8) A statement that participation is voluntary, refusal to participate will involve

The regulations further provide that the following additional treatment be provided to participants, where appropriate (Federal Policy §46.116(b)].

(1) A statement that the particular treatment or procedure may involve risks to the

(2) Anticipated circumstances under which the participant’s participation may be

(3) Any additional costs to the participant that may result from participation in the

(4) The consequences of a participant’s decision to withdraw from the research

(5) A statement that significant new findings developed during the course of the

Investigators may seek consent only under circumstances that provide the prospective participant or his or her representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. Furthermore, the information must be written in language that is understandable to the participant or representative. The consent process may not involve the use of exculpatory language through which the participant or representative is made to waive or appear to waive any of the participant’s legal rights or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence [Federal Policy §46.116]. A child’s assent form must be written in language appropriate to the age and grade level of the child.

It is essential that IRB members and researchers think of informed consent, not as a form that must be signed, but as an educational process that takes place between the investigator and the prospective participant. No one can guarantee that another person has understood the information presented; one can only inform prospective participants as clearly as possible. No one can guarantee that another’s choice is voluntary; one can only attempt to remove obvious impediments to free choice by being alert to coercive aspects of the consent procedure. A model consent is given in Appendix II.

D. Documentation of Informed Consent

In most cases, the federal regulations require that informed consent be documented, but they also provide for some exceptions. Documentation usually involves the use of a written consent form containing all the information to be disclosed and signed by the participant or the participant’s legal representative. Is should be reiterated, however, that these documents are not substitutes for discussion. The person who signed the consent form must be given a copy as a reference and reminded of the information conveyed. A “short form” may sometimes be used. The use of a short form means that the information is presented without benefit of a written version of the consent document. Before a short form can be used, the IRB must first review and approve a written summary of all related procedures. Typically, an oral presentation must be witnessed by a third person, who must sign both the consent form and a copy of the written summary of the presentation. A copy of the summary must be provided to those who sign the consent form so that they have the information available for future reference.

The IRB will consider the use of a short-form consent under two types of research. One is when the principle risk to the participant is a breach of confidentiality, where the consent document would be the only link between the participant and the research (e.g., on highly confidential or sensitive topics) and when the consent document is the only link between the participant and the research. The other type is for projects that present only minimal risk and involve procedures that do not require written consent if they are performed outside the research context.

E. Selection of Participants

Defining the appropriate group of participants for a research project involves a variety of factors – requirements of scientific design, susceptibility to risk, likelihood of benefit, practicability, and considerations of fairness. The IRB is required to make a specific determination that the selection of participants is equitable. The requirement for an equitable selection of participants helps ensure that the burdens and benefits of research will be fairly distributed. The National Commission for the Protection of Human Subjects recommended that, as a matter of social justice, there should be an order of preference in the selection of classes of participants: adults before children, competent individuals before incompetent individuals, and noninstitutionalized persons before institutionalized persons. In addition, The National Commission believes that those who are already burdened (e.g., by disabilities or institutionalization) should not be asked to accept the burdens of research unless other appropriate participants cannot be found (i.e., if the research concerns their particular disability or circumstance). The IRB will consider the extent to which a proposed participant population is already burdened by poverty, illness, poor education, or chronic disabilities in deciding whether they are a suitable participant population.

F. Privacy and Confidentiality

In reviewing some protocols, the IRB may have to consider whether an invasion of privacy in involved. The IRB will base decisions on its sense of propriety and the particular circumstances of the study. Among the several relevant factors are: the private nature of the information sought, the likelihood that the participants would regard the release of information as an invasion of privacy, the importance of the research, and the availability of alternative ways to do the study.

Investigators sometimes want access to existing records to identify people suitable for inclusion in a study. If the participants’ names will be recorded by the investigator for follow-up, either for further record review or for personal contact, this research requires IRB review. The IRB will determine whether the consent of participants should be sought (e.g., by the institution holding the records) before the researcher gains access to the records. Factors used in deciding if consent must be sought include the sensitivity of the information reviewed, the vulnerability of the participant population, and the purpose for which the investigator wants access to the information. The Buckley Amendment [the General Education Provisions Act (20 USC 1232)], also known as FERPA (Family Education and Privacy Act)], requires PARENTAL CONSENT for release of records or identifiable information about children in public schools. Instructional material to be used in connection with any research or experimental program must be open to inspection by the parents or guardians of the children to be involved.

Research on certain archival data sets does not require prior IRB review and approval. See Figure 1, following, for a flowchart to assist the researcher in determining if his/her proposed p

In most research, ensuring confidentiality is only a matter of following some routine practices: substituting codes for identifiers, removing face sheets (containing such items as names and addresses) from survey instruments containing data, properly disposing of computer sheets and other papers, limiting access to identified data, impressing on the research staff the importance of routine precautions that should be taken to maintain the confidentiality of data. More elaborate procedures may be needed in some studies, either to give participants the confidence they need to participate and answer questions honestly or to enable researchers to offer strong, truthful assurances of confidentiality. Such elaborate procedure may be particularly necessary for studies in which data are collected on sensitive matters such as sexual behavior or criminal activities. When information linked to individuals will be recorded as part of the research design, the IRB will make sure that adequate protections will be taken to safeguard the confidentiality of the information. Sensitive information is sometimes obtained in the course of behavioral studies, research with the cognitively impaired, AIDS research, and research dealing with drug and alcohol abuse. There is a regulatory provision for waiving documentation of consent when a signed consent form would itself constitute risk to the participants [Federal Policy §46.117(c)(1)].

Researchers must be aware that promising participants anonymity is misleading. Neither the researcher nor the institution can promise anonymity, except when a Certificate of Confidentiality has been obtained from a federal agency (usually OHRP). Otherwise, research records can be subpoenaed.

G. Monitoring and Observation

One of the areas to be reviewed in proposed research is the researcher’s plan for collection, storage, and analysis of data. Monitoring of the research by the research is important because preliminary data may signal the need to change the research design, change the information presented to participants, or even to terminate the project before the scheduled ending date.

Both the timing and adequacy of the plan for analysis are important. If the data are not analyzed until the project is terminated, the chance for making mid-course corrections is lost. If the data are not properly analyzed, the research itself is not valid, and incorrect conclusions may not result. For the IRB to approve proposed research, the protocol must, when appropriate, include plans for monitoring the data

Investigators sometimes misinterpret this requirement as calling for annual reports so the IRB can monitor the project. However, it does, in fact, require, when appropriate, that researchers provide the IRB with a description of their plans for analyzing the data during the collection process. Concurrent collection and analysis enable the researcher to identify flaws in the study design early in the project. At this point, researchers are able to reevaluate the risks to human participants to assure they are no greater than initially predicted. Like other considerations, the level of monitoring in the research plan should be related to the degree of risk posed by the research.

2. Confidentiality

G. Monitoring and Observation

collected to ensure the safety of participants [Federal Policy §46.111(a)(6)].

H. Additional Safeguards

The protection of human participants is the paramount consideration of the IRB. Each project will be reviewd to determine whether some or all of the participants are likely to be vulnerable to coercion or undue influence to participate. The vulnerabilities may be subtle but may limit the ability of certain participants to refuse to participate or to continue to participate in the research. The IRV must assure that due consideration of this issue is addressed in the research plan. Additional safeguards may need to be included in the study to protect the rights and welfare of these participants. The federal regulations provide that additional safeguards to protect participants’ rights and welfare must be included in any study where “some or all of the participants are likely to vulnerable to coercion or undue influence” [Federal Policy §46.111(b)]. Examples of such vulnerable participants are children, prisoners, pregnant women, mentally disabled persons, and persons who are economically or educationally disadvantaged.

The consent process must be conducted only under circumstances that provide the prospective participant sufficient opportunity to consider whether or not to participate. Research conditions must also minimize the possibility of coercion or undue influence to give consent. Persons with acute and/or severe physical or mental illness may be overly compliant with requests to participate in research due to the effects of their illness or due to the prospect of relief from suffering. Occasionally, the institutional setting in which the consent is sought will pose the possibility of coercion. Conducting research at institutions that provide services to participants may be perceived as implying that continued service is dependent upon participation in the research. Students in the educational setting may be concerned that refusal to participate will affect their grades. These institutional pressures should be addressed in the research design. The protocol must adequately preserve the right to refuse participation. The requirement to obtain informed consent should be seen as not only a legal obligation, but also a moral obligation. The research design must adequately address how informed consent will be obtained and what information will be given to prospective participants.

Researchers should be aware that the various laws and rules that govern human participants research are subject to change. Thus, it is most important that the researcher work closely with the IRB to be informed of such changes.

I. Incentives

Federal regulations governing research with human participants contain little specific guidance for IRB review of payment practices. However, the IRB will make sure that prospective participants realize that their participation is voluntary and that choosing not to participate will not adversely affect their relationship with the institution or its staff in any way. To make this determination, the IRB will know whom the participants will be, what incentives are being offered, and the conditions under which the offer will be made. Informed consent documents must contain a detailed account of the terms of payment, including a description of the conditions under which a participant would receive partial or no payment.

Determining the appropriateness of the incentive is another matter. For research that requires participants to undergo only minor inconvenience or discomfort, a modest payment will usually be adequate. Reimbursement for travel, babysitting, and so forth may also be provided. In more complex research projects, IRBs tend to base their assessment on the prevailing payment practices within their institution or general locale. Volunteers are often compensated for their participation according to an established fee schedule, based upon the complexity of the study, the type and number of procedures to be performed, the time involved, and the anticipated discomfort or inconvenience. Extra payments are usually provided for a variety of additional inconveniences (e.g., the imposition of dietary restrictions). Payments may vary according to a number of factors, and, therefore, the IRB will be familiar with accepted standards within the community as well as the anticipated discomforts and inconveniences involved in a particular study to judge the appropriateness of payments.

It should be noted that providing participants with monetary awards through the University can create a problem of maintaining strict confidentiality. If the award is made through funding from a contract or grant, usually participants receive a check for the predetermined (and approved) order to issue the check. Such payroll records are not available to the public, but do constitute a link between the participant and the research.

J. Continuing Review

It would be a mistake to see the IRB approval process as a one-time step in the life of a research project. IRB approval is a temporary authority that may be withdrawn at any time if warranted by the conduct of the research. The regulations authorize the IRB to establish procedures for the concurrent monitoring of research activities [Federal Policy §46.109(e)]. The initial IRB review is based on the researcher’s best assessment about anticipated results, risk, and procedures. The IRB uses its expertise to judge whether this estimate is reasonable and supportable. The responsibility for continued monitoring of approved research is as important as the initial review and approval. It is only after the research has begun that the real risks can be evaluated and the preliminary results used to compute the actual risk/benefit ratio; the IRB can then determine the correctness of the initial judgment. The risk/benefit ratio may change over time. Not only unexpected results and effects of the research project itself, but new knowledge resulting from other research may affect the balance. After reassessment, the IRB may require that the research be modified or halted altogether. The IRB may need to impose special precautions or relax special requirements it had previously imposed on the research protocol.

Federal policy requires that investigators inform participants of any important new information that might affect their willingness to continue participating in the research [Federal Policy §46.116(b)(5)]. The IRB has the authority to observe, or have a third party observe, the consent process and the research itself [Federal Policy §46.109(e)]. The researcher is obligated to keep the IRB informed of unexpected findings involving risks and to report any occurrence of serious harm to participants [Federal Policy §46.103(b)(5)]. The IRB has the authority and responsibility to suspend or terminate approval of research that is not being conducted in accordance with JSU policies and procedures or that has been associated with unexpected serious harm to participants [Federal Policy §46.113]. If the IRB decides to suspend or terminate its approval of a research project, the IRB shall report its decision promptly to the investigator(s), the Vice President for Research, and the department or agency head (or designated office. The IRB’s report will include a statement of the reasons for the suspension or termination.

The various rules, laws, and regulations that govern human participant research are subject to change. These changes may be from new or modifies regulations, the results of litigation, or other sources. Thus, it is important that the researcher work closely with the local IRB to remain informed of any changes.

Chapter IV

Preparing the Protocol for Review

The applicant should answer all questions thoroughly. If questions are not answered that are pertinent to the proposed research or if a copy of the research instrumentation, procedures, etc., are not attached, the application will be returned to the applicant or held for receipt of all necessary documentation.

Questions

1. Name, department, etc.: Who are you? In what department do you work or study? At what phone number can you be reached? Indicate your local address. Where do you receive your campus mail? If you are faculty or staff, indicate your title. If you are a student, indicate your level of study (i.e., masters student, doctoral student, etc.) and expected date of graduation.

2. Title of project: List title of project.

3. Project period: Give approximate time period of participant involvement. This is important if your project is a long-term one. The IRB must review ongoing projects every twelve months. The interest here is in the period of participant involvement.

4. Funding source(s): If your project is supported, totally or partially, by external funding, the IRB wants to know. (We keep track of sponsored human subject research.) If you are self-funded, enter "N/A*. If the proposal has not been funded, but has been submitted, enter the proposed funding source.

5. Site(s) of research

6. a. Research Project: Present an overview of your study. It is not necessary to include your thesis or dissertation proposal. Provide adequate information so that

a reviewer could understand what you intend to do and accomplish.

d. Cooperating Institution: If data are being collected at another site (school, hospital, prison, etc.), then prior written permission must be obtained and the IRB must have the original letter.

e. Number of observations: Are the participants completing the forms on one occasion or are they repeatedly asked to return for follow-up? Are you asking them to report their diet three times a week for six weeks and take blood samples weekly for six weeks? How much of the participant’s time will you need to complete the data collection?

f. Procedures: What are you asking them to do? Attach all questionnaires or test instruments and complete description of what tasks they will be doing in your study.

g. Voluntariness: You must state that their participation is completely voluntary. Does your informed consent form make this clear to the participants? Is it written in language they can understand?

h. Withdrawal: You must state that they may withdraw from participation in the

study at any time without penalty.

i. Refusal: Does your consent form state that they may refuse to answer any

question or participate in any section of the study?

j. Experience: Faculty, please provide a brief description of your research

experience. Students, please indicate you are under the direction of your advisor and briefly list their experience.

8. Informed Consent: How do you intend to obtain the subjects’ informed consent? If in writing, attach a copy of the consent form. If not in writing, include a written summary of what is to be said to the participant(s), and justify the reason that oral, rather than written, consent is being used (in this case, the researcher and his or her assistant must sign a form indicating that they witnessed the person provide verbal approval). The consent and/or assent in the case of a minor child much include the following information:

a. They are being asked to participate in a research project (the word

"research" will be used);

b. The title of the project is stated;

c. State who is conducting the research and under whose auspices;

d. Explain what they are being asked to do or what will be done to them;

e. Tell them how much of their time will be involved in the study;

f. Explain that participation is fully voluntary; they may stop participation

at any time; and they may refuse to answer any question(s).

g. State how their confidentiality and privacy will be maintained.

h. Provide name of person who would furnish participants with additional

information about the research project; and

i. Offer to answer any questions the participants might have about the study.

j. Provide the name and phone number of the Vice President for Research Development Support and Federal Relations, Dr. Felix Okojie, to answer questions about their rights as research subjects.

9. Justify:

a. Why is human subjects' participation in this research necessary? Can your research question be answered with secondary data analysis? Has the topic already been exhausted?

10. a. What are the benefits gained by the individual for participation in your

e. Social risks? Could your subject lose status if they participate? Could their privacy be jeopardized? Could their reputation be changed?

11. Do you deceive them in any way? If deception is part of your study, then you much include procedures or debriefing them and provide the name and number of someone who could assist with their distress.

12. Confidentiality: By Federal law, data must by kept for a period of three years in a locked file cabinet. Also, include who will be responsible for the data and where it will be located.

13. Student Applications: If this is a thesis or dissertation, has your committed reviewed the application?

14. Student Applications: If this is a research project, has someone in your department reviewed the application and are the assisting you with the process?

15. RESEARCH CERTIFICATION: All applicants and advisors must have a certificate from the Office of Human Protection Risks or the National Institutes of Health to certify that they have reviewed information regarding the protections of research participants. This certificate must be renewed every 2 years.

16. Consent Form Approval: As of January 16, 2003, all research must have an officially approved consent letter or assent form that has a date of approval and expiration on the form.

17. THE APPLICATION MUST BE SIGNED BY ALL RESEARCHERS AND ADVISORS. Contact numbers and email addresses should be provided. In most cases, the applicant will first be contacted by email to be informed of the status of their application.

Chapter V

Waiver or Alteration of the Consent/Assent Process

A. Consent Process

Written informed consent is required, and copies of the most recent stamped, approved consent form must be used to enroll participants in a study. No consent may be assumed; so called “passive consent” is not legally valid consent.

In exceptional cases, the IRB may give permission to depart from the usual consent procedures. A consent procedure may be waived provided the IRB finds and documents that:

- The waiver or alteration will not adversely affect the rights and welfare of the participants.

- The research could not practicably be carried out without the waiver or alteration.

- Whenever appropriate, the participants will be provided with additional pertinent information after participation.

All four criteria must be met in order to alter some or all of the consent process [45 CFR 46.116(d)].

Protocols requesting waiver of both consent and assent must undergo full Board review.

In rare instances, such as studies of participants in emergency situations, the IRB may approve the use of a narrative coupled with a short-form consent. The investigator must adhere to the following procedures:

a. The investigator must provide a written version of the narrative that contains all the information and elements of the standard consent form. This narrative may be read to the participant verbatim or may be paraphrased.

b. The participant (or the participant’s authorized representative) signs only a short-form consent which states that the participant willingly agrees to participate in the research described in the narrative.

c. A witness must be present when the narrative is read to the participant. The witness signs the narrative and the short-form consent to verify that the narrative and written information were the same.

e. The investigator gives the participant signed copies of the narrative and the short-form consent.

In rare instances, such as with impaired (e.g., blind or dyslexic) or illiterate participants who are fully capable of consenting but are not capable of reading or signing a consent form, the IRB may approve the use of an oral consent.

In such cases, the investigator reads a narrative to the participant in the presence of a witness. The witness must sign a form to verify the participant’s oral consent. The investigator must adhere to the following procedures:

a. The narrative must be read or paraphrased from a document that contains all elements of the standard consent form.

c. A witness must be present when the narrative is read to the participant. The witness signs the narrative and a “Verification of Oral Consent” form to verify that the narrative was presented essentially as written and that the participant consented. The investigator signs the narrative and verification form.

d. The investigator gives the participant a signed copy of the narrative and the verification form.

For the investigator to use the oral consent process, the IRB requires three items:

- the verification of oral consent form that will be signed by the witness and the investigator

In some instances – especially in research involving only the use of educational tests, questionnaires, surveys, interviews or observation – the principal risk to the participant would be a breach of confidentiality. When data are recorded so that the participants cannot be identified, the only record linking the participant and the research would be the consent document. In such cases, the IRB may waive the requirement of a signed consent from if it finds the risks resulting from a breach of confidentiality warrant such action. In these cases, after the participant has read a narrative that contains all elements of the standard consent form, he/she may provide explicit oral consent or implicit consent by means of voluntarily participating in the research. The investigator must adhere to the following procedures:

a. All participants must receive an information sheet signed by the investigator and containing all elements of the standard consent form.

b. The information sheet must be in the form of a cover letter and must include all elements required in a consent form.

c. Participants must have an opportunity to read it before deciding whether to participate.

For an investigator to obtain a waiver of signed consent, the IRB requires 2 items:

The IRB may approve substantial alterations to or waive any element of written informed consent only if all of the following conditions apply:

b. The waiver or alteration will not adversely affect the rights and/or welfare of the participants.

c. The research could not practicably be carried out without the waiver or alteration

d. Whenever appropriate, the participants will receive additional pertinent information after participation.

Protocols in which the investigator seeks a waiver or alteration of the consent process under this provision may be eligible for expedited review by three Board members.

B. Assent Process

Assent is an agreement by an individual who is unable to give legally valid informed consent to participate in research. Written informed assent is required unless the IRB approves a waiver or alteration. When potential research participants are not competent to give legally valid informed consent, respect for a person’s autonomy mandates that the investigator obtain their voluntary asses to participate in addition to obtaining the informed consent of a parent, guardian or other legally authorized representative.

- participants are children below the age of consent as legislated by the state and

- intellectually or emotionally impaired participants are not legally competent to give their informed consent.

When an intervention or procedure involved in the research may directly benefit the participant and is available only through participation in the research, the consent of the participant’s parent(s) or guardian(s) is sufficient, and the participant’s assent is not required. The assent of the participant should, nevertheless, be solicited. In such cases, a short-form assent document may be used. The participant should be given signed copy of the consent form or narrative and a signed copy of the short-form assent document.

- justification in item 8 of the protocol and explanation of why it is appropriate

- The narrative that will be read to the participant, if different from the consent form to be signed by the participant’s parent(s), guardian(s) or legally authorized representative

The mere existence of laws authorizing minors to consent to specific medical treatments (e.g., treatment of sexually transmitted diseases) should not be broadly interpreted to authorize minors to consent to research regarding that treatment, unless so stated in the law. This interpretation should not unduly restrict otherwise ethical research. IRBs may waive the requirement for parental permission in accordance with the procedures set forth in 46.116 or 46.408(c) if appropriate measures are taken to protect the interests of minors.

Chapter VI

Special (Vulnerable) Populations as Participants of Research

Whenever participants in a study may be vulnerable to injury, coercion or undue influence, the study must include additional safeguards to protect their rights and welfare. The IRB requires that special consideration be given by all researchers to protect the welfare of particularly vulnerable participants, such at pregnant women, prisoners, children, decisionally impaired persons, elderly/aged persons, students, employees, and healthy volunteers [Federal Policy §46.111]. The U.S. DHHS regulations set forth specific provisions on research involving fetuses, pregnant women and human in vitro fertilization, prisoners, and children. The special classes in human research requiring additional safeguards are:

- employees of institutions associated with the study or subordinates of the investigator

Special regulatory requirements govern the participation of pregnant women in research. Research involving women who are or may become pregnant receives special attention from the IRB because of women’s additional health concerns during pregnancy and because of the need to avoid unnecessary risks to the fetus. Further, in the case of a pregnant woman, the IRB will determine when the informed consent of the father to the research is required. Special attention is justified because of the involvement of a third party (the fetus) who may be affected and because of the need to prevent harm or injury to future members of society.

The National Institutes of Health (NIH) policy requires the inclusion of women and minorities in research study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Principal investigators of NIH funded grants and cooperative agreements falling under the scope of the NIH policy must report annually on the number of participants planned and enrolled to date by ethnic origin and gender. This information should also be available for IRB review, both for its initial review and for its annual review for continuation of projects.

Pregnancy emcompasses the period of time from the confirmation of implantation by biochemical or biophysical means until intended or unintended passage or removal of the embryo or fetus. The state of pregnancy is defined by the presence of the embryo of fetus, whether alive, not alive or of uncertain or unknown status.

Embryo describes the developing human during organogenesis, generally spanning the first three months after conception.

Fetus refers to the growing human after the first three months. It is the product of conception from the time of implantation until birth by expulsion or extraction and until it is determined to be viable.

Viable refers to the ability of the fetus, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration.

Nonviable fetus means a fetus ex utero (outside the body) which, although living, is not viable.

Dead fetus refers to a fetus ex utero which exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord (if still attached).

In vitro fertilization means any fertilization of human ova which occurs outside the body of a female, either through admixture of donor human sperm and ova or by any other means.

Pregnant women may be involved in several categories of research. The primary objective of the IRB is to assess (a) whether the research is directed toward the mother’s health or toward the fetus and (b) the risks to the woman and to the fetus. For research activities directed toward pregnant women as participants, the federal regulations provide that no pregnant woman may be involved as a participant unless either: (a) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs or (b) the risk to the fetus is minimal.

The IRB will approve research involving pregnant women and fetuses only if all of the following conditions are met:

a. Appropriate studies on animals and nonpregnant participants have been completed.

b. The risk to the fetus is minimal, except where the purpose of the activity is to meet the health needs of the mother or the fetus.

c. The risk to the fetus is the least possible risk for achieving the objectives of the research.

d. Investigators involved in the study will have no role in any decisions regarding the timing, method or procedure used to terminate the pregnancy or the viability of the fetus.

e. When termination of a pregnancy is involved, no changes from standard procedures that may cause more than minimal risk to the fetus or the pregnant woman may be introduced solely for the purpose of the research.

f. No monetary or other inducements may be offered to terminate a pregnancy for purposes of the research.

a. The fetus in utero may be involved as a research participant only if the purpose of the research is to meet the health needs of the particular fetus and the fetus will be placed at the minimum risk necessary to meet such ends. The other condition allowable is that the risk to the fetus is minimal and the purpose of the research is to obtain important biomedical knowledge that cannot be obtained by any other means.

b. Until it has been ascertained whether or not a fetus in viable, a fetus ex utero may be involved as a research participant only if there will be added risk to the fetus and the purpose of the study is to develop important biomedical knowledge that cannot be obtained bay any other means or the purpose of the research is to enhance the possibility of survival of the fetus to the point of viability.

c. A nonviable fetus may be involved as a research participant only if vital functions will not be maintained solely for the purposes of research, experimental procedures which would of themselves terminate heartbeat or respiration are not used, and the purpose of the research is to develop important biomedical knowledge which cannot be obtained by other means.

The mother of the fetus must be legally competent and have given her informed consent for any research involving her or the fetus. The mother’s consent alone is sufficient if the purpose of the activity is to meet the health needs of the mother, the father’s identity or whereabouts cannot be reasonably determined, the father is not reasonably available or the pregnancy resulted from rape. In all other circumstances, informed consent must also be obtained from the father of the fetus.

The ethical mandate of the IRB is to protect the rights and welfare of human research participants. The IRB is obligated to ensure that research studies do not endanger the safety or well being of human participants or undermine public confidence in the conduct of research. The special vulnerability of children makes consideration of involving them as research participants particularly important. In order to safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children Research that is contrary to the rights and welfare of child-participants is prohibited.

Researchers should be aware that other federal regulations are applicable in any research involving children, including both U.S. Department of Education regulations and the Buckley Amendment [FERPA (Family Education and Privacy Act)]. The IRB makes a practice of giving full Board review to any research project involving children and requires the researcher to obtain the consent of the parent/guardian and assent of the child.

The following definitions are important to an understanding of the issues relating to approval of research involving children [45 CFR 46.102]:

Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. Legal age in Mississippi is 18 years.

Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Permission means the agreement of parent(s) or guardian(s) to the participation of their child or ward in research.

Guardian means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.

When reviewing research with children, the IRB will consider the benefits, risks, and discomforts inherent in the proposed research and assess their justification in light of the expected benefits to the child-participant or to society as a whole. In calculating the degree of risk and benefit, the IRB will weigh the circumstances of the participants under study, the magnitude of risks that may accrue from the research procedures, and the potential benefits the research may provide the participants or class of participants.

NIH regulations require the IRB to classify research with children into one of four categories and to document the discussion of the risks and benefits of the research study. The four categories of research involving children that may be approved by the IRB, based on degree of risk and benefit to individual participants, are as follows:

a. The research involves no more than minimal risk [45 CFR 46.404]. This requires the consent of one parent or guardians.

b. The research involves greater than minimal risk, but presents the prospect of direct benefit to individual participants. Research in this category is opposable provided: the risk is justified by the anticipated benefit to the participant; and the relationship of risk to benefit is at least as favorable as any available alternative approach [45 CFR 46.405]. This requires the consent of one parent or guardian.

c. The research involves greater than minimal risk with no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the participant’s disorder or condition. Research in this category is opposable provided: (i) the risk represents a minor increase over minimal risk; (ii) the intervention or procedure presents experiences to participants that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational settings; and (iii) the intervention or procedure is likely to yield generalizable knowledge about he participant’s disorder or conditions that is of vita importance for the understanding or amelioration of the participant’s disorder or condition [45 CFR 46.406]. This requires the consent of both parents.

d. The research is not otherwise approvable, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. This requires the consent of both parents.

In all cases, the IRB will determine that adequate provisions have been made for soliciting the assent of children and the permission of their parents or guardians. NOTE: The lack of active objection shall not be considered to be either consent or assent; both require a positive action by the potential participant and, when appropriate, the parent/guardian.

Below is a diagram of the DHHS requirement in 45 CFR Part 46, Subpart D, for research involving children found in the “NIH Policy and Guidelines on the Inclusion of Children as Participants in Research”:

When children or minors are involved in research, the regulations require that assent (a child’s affirmative agreement to participate in research) of the child or minor and the permission (the agreement of parent(s) or guardian(s) to the participation of their child or ward in research) of the parent(s) or guardian(s) in place of the consent of the participants.

Given that children have not reached their full intellectual and emotional capacities and are legally unable to give valid consent, involving children in research requires the permission of their parents or legally authorized representatives. In addition, the IRB will determine that adequate provisions have been made for soliciting the assent of the children, when in the judgment of the IRB, the children are capable of providing assent.

While children may be legally incapable of giving informed consent, they neverless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research does not involve interventions likely to be of benefits to the participants and the children can comprehend and appreciate what it means to be a volunteer for the benefit of others.

A prisoner is an individual involuntarily confined in penal institution, including persons (a) sentenced under a criminal or civil statute, (b) detained pending arraignment, trial or sentencing and (c) detained in other facilities (e.g., drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing alternatives to criminal prosecution or incarceration in a penal institution.

Protocols utilizing prisoners as research participants require full Board review.

When the IRB receives a protocol proposing the use of prison inmates as a study population, it must determine whether that population was chosen simply out of convenience to the investigator. Because the population is relatively stable and the life is routing, prisons have in the past seemed to be ideal environments in many ways for the conduction of certain types of research. Some procedures that would inconvenience free participants are not a burden to prisoners. Since prison pay scales are notably lower than those in the free world, the cost of using prisoners as participants may be less than using those who are not prisoners.

The primary issue surrounding the participation of prisoners in research has always been whether prisoners have a real choice regarding their participation in research or whether their situation prohibits the exercise of free choice. A secondary issue is whether confidentiality of participation and of data can be adequately maintained in the prison.

In addition to problems of coercion and undue inducement, the involvement of prisoners in research raises questions of burden and benefit. Prisoners should neither bear an unfair share of the burden of participating in research, nor should they be excluded from its benefits to the extent that voluntary participation is possible. Prisoners’ rights to self-determination (autonomy) should not be circumscribed more than required by applicable regulations.

Finally, confidentiality is extremely difficult to maintain in an environment such as prisons in which there is no privacy. In prisons, people do not move about freely; the movements of prisoners are carefully tracked. When inmates are moved around, everyone will know about it. Prison records, including medical records, are accessible to persons who in others settings would not have access to such personal information. To protect prisoners from the exploitive conditions presented by these situations, DHHS issued regulations governing research with prisoners, limiting it to studies with an independent and valid reason for involving these particular populations. These limitations were imposed in response to, but are more restrictive than, the National Commission for the Protection of Human Subjects.

If a protocol involves the use of prisoners as participants, both the general DR14S regulations governing research with human participants and the special ones dealing specifically with prisoners apply (see §46.306), in addition to requirements established by the prison administration.

association with the prison(s) involved, apart from their membership on the Board

(b) At least one member of the Board shall be a prisoner or a prison representative

with appropriate background and experience to serve in that capacity, except when a particular research project is reviewed by more than one board. In that case, only one board need satisfy this requirement.

Also, in research supported by DHHS that involves prisoners, the IRB is required to consider the seven points listed in §46.305 and, furthermore, determine that the proposed research falls within one or more of the specific provisos of §46.305.

possible causes, effects, and processed of incarceration and criminal behavior; studies (involving no more than minimal risk or inconvenience) of prisons as institutional structures or of prisoners as incarcerated persons;

(b) Research on particular conditions affecting prisoners as a class (providing the Secretary of DHHS has consulted with appropriate experts and the intent to support such research in the Federal Register); and

(c) Research involving practices that have the intent and reasonable probability of benefiting the prisoner participant. If the research involves possible assignment to a control group that may not benefit from the research, the Secretary of DHHS must also consult with appropriate experts and publish the intent to support the research in the Federal Register [45 CFR 46.306].

The following additional determinations must be made by the IRB before research involving prisoners goes forward [45 CFR 46.305]:

(b) Any possible advantages accruing to the prisoner through his or her participation in the research, when compared with the general living conditions, medical care, quality of food, amenities and opportunity for earning in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;

(d) Procedures for selecting participants within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control participants must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;

(e) The information is presented in language that is understandable to the participant population;

(f) Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and

(g) Where the Board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoner’s sentences, and for informing participants of this fact.

(1) The Board shall carry out such other duties as may be assigned by the Secretary; and

(2) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that the duties of the Board under this section have been fulfilled.

D. Decisionally Impaired Persons

A decisionally impaired person is someone with an intellectual or impairment whose cognitive or emotional functions are affected or whose capacity for judgment and reasoning is significantly diminished, either by a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorder), a developmental disorder (e.g., mental retardation), or a neurological disorder.

These individuals may be vulnerable to coercion or may not be able to give legally valid informed consent. Protocols using these persons as research participants require full Board review.

The predominant ethical concern in research involving individuals with psychiatric, cognitive, or developmental disorders or who are substance abusers is that their disorders may compromise their capacity to understand the information presented and their ability to make a reasoned decision about participation. Many individuals with disabilities affecting their reasoning powers may be residents of institutions responsible for their total care and treatment. The impact of institutionalization may further compromise their ability to exercise free choice (voluntariness). These concerns apply both toe voluntary patients and those committed involuntarily. It is important to protect the privacy of all participants and the confidentiality of information gathered in research exploring emotionally sensitive topics.

It is now generally accepted that research involving persons whose autonomy is compromised by disability or restraints on their personal freedom should bear some direct relationship to their condition or circumstances. Persons who are institutionalized, particularly if disable, should not be chosen for studies that bear no relations to their situation just because it would be convenient for the researcher.

Consent to research involving cognitively impaired participants through any of the intramural programs of the NIH is guided by NIH policy on consent to research with impaired human participants. This policy sets out, in matrix, form, conditions under which cognitively impaired participants may participate in research of varying risk.

As a general rule, the IRB requires that all adults, regardless of their diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability that would impair reasoning or judgment. Even those who do have a diagnosed mental disorder may be perfectly able to understand the matter of being a research volunteer and quite capable of consenting to or refusing participation. Mental disability alone should not disqualify a person from consenting to participate in research. Rather, there should be specific evidence of individuals’ incapacity to understand and to make a choice before they are deemed unable to consent.

Decision should be made with the utmost deference to the ethical principles underlying human participant’s research as set forth in the Belmont Report. It should be understood that competency should be evaluated on an individual basis in order to avoid incorrect assumptions as to an individual’s capacity to consent. In cases where research involving cognitively impaired individuals is approved, IRBs should require additional safeguards (e.g., involvement of participant advocated, independent monitoring, formal capacity assessment, waiting periods) as part of the research plan to protect participants.

Persons formally adjusted incompetent have a court-appointed guardian who must be consulted and who can give consent on their behalf. Officials of the institution in which incompetent patients reside are not generally considered appropriate, since their supervisory duties may give rise to conflicting interest and loyalties. Family members or others financially responsible for the patient may also be subject to conflicting interests because of financial pressures, emotional distancing, or other ambivalent feelings common in such circumstances.

E. Elderly/Aged Persons

As the American population ages, research on the aging process and conditions and diseases that disproportionately affect the elderly has become increasingly import. The inclusion of other participants in research poses several issues for the IRB. Primary among them is the question of whether and when the elderly need special protections. The IRB must maintain the balance between the need for protection and the need to proved respect for persons.

There is no age at which prospective participant should become ineligible to be included in research. Most older people are neither cognitively impaired nor live in institutional settings. The inclusion of older persons in the research enterprise is important. The use of age as the criterion of ability to consent and therefore to participate in research is not valid. Studies have shown that education, health status, and inadequate communication about he research rather than age contribute to lack of comprehension and recall. The IRB should ensure that, where they are excluded or treated specially, older participants are in need of protection and are not the object of disdain, stereotyping, or paternalism. Together, researchers and the IRB should enable older persons to share in the benefits and burdens of research.

F. Students or Trainees

Universities, and the association of investigators with them, provide investigators with a ready pool of research participants: students. The problem with student participation in research conducted at the university is that their agreement to participate may not be freely given. Students may volunteer to participate out of a belief that doing so will place them in good favor with faculty (e.g., that participating will result in receiving better grades, recommendations, employment, or the like) or that failure to participate will negatively affect their relationship with the investigator of faculty in general (i.e., by seeming “uncooperative”, not part of the scientific community). Prohibiting all student participation in research, however, would clearly be an overprotective reaction. An alternative way to protect against coercion is to advertise for individual students directly. As with any research involving a potentially vulnerable population, the IRB will pay special attention to the potential for coercion or undue influence and consider ways in which the possibility of exploitation can be reduced or eliminated.

Requiring participation in research for course credit (or extra credit) is also controversial, though common in the social and behavioral sciences. Students in beginning psychology courses, for instance, might be required to serve as participants for a given number of hours of research or in a given number of research projects. They might be given the option of participating for additional grade credit. In either case, students should be afforded a non-research alternative to complete course requirements or earn extra credit. This alternative should be no less attractive (e.g., in time or effort) than the research opportunity. Another concern raised by the involvement of student as participants is confidentiality. As with research involving human participants generally, the IRB must be made aware that research involving the collection of data on sensitive subjects such as mental health, sexual activity, or the use of illicit drugs or alcohol present risks to participants of which they should be made aware and from which they should be protected, to the greatest extent possible. The close environment of the university amplifies this problem.

Except in special circumstances, the Board will approve a protocol involving the investigator’s current students or trainees as participants only if the study is designed to assure anonymity, including whether or not any particular individual elected to participate. One method of assuring anonymity is for all contact with participants to be made by persons other than the investigator.

G. Employees

The issues with respect to employees as research participants are essentially identical to those involving students as research participants: coercion or undue influence and confidentiality. As student participation raises questions of the ability to exercise free choice because of the possibility that grades or other important factors will be affected by decisions to participate, employee research programs raise the possibility that the decision will affect performance evaluation or job advancement. It may also be difficult to maintain the confidentiality of personal medical information or research data when the participants are also employees.

If prospective participants are employees of JSU or any institution associated with the study, the consent form must state that job standing will not be affected by refusal to participate or by withdrawal from the study nor will job standing be enhanced by participation in the study.

Chapter VII

Research investigators are the most frequent source on noncompliance with human participants regulations. The most common lapses in investigator compliance include unreported changes in protocols, misuses or non-use of the informed consent document, and failure to submit protocols to the IRB in a timely fashion. Problems such as these are often caused by communication difficulties. Occasionally, an investigator will either avoid or ignore the IRB. Such cases present a more serious challenge to the IRB and to JSU. Regardless of investigator intent, unapproved research involving human participants places those participants at an unacceptable risk. When unapproved research is discovered, the IRB will act promptly to halt the research, assure remedial action regarding any breach of regulatory or institutional human participant protection requirement, and address the question of the investigator’s fitness to conduct human participant research. Beyond the obvious need to protect the rights and welfare of research participants, the credibility of the IRB is clearly at stake. In addition, any serious or continuing noncompliance with DHHS human participants regulations or the determinations of the IRB must be promptly reported to the Vice President for Research and the University Compliance Officer.

Whenever questions arise concerning possible noncompliance with IRB guidelines and other applicable regulations, the Chair and the Board have the authority to investigate and take appropriate action to ensure compliance or to terminate the research.

A. Action by the Chair

The Chair has the discretion and authority to temporarily suspend research is there exists:

- information suggesting that the research involves substantially greater risk than

3. Place the matter on the agenda for the next monthly IRB meeting, at which time the Board may confirm or rescind the suspension, convert the suspension to a termination or take any other action consistent with its authority and obligations.

B. Action by the Board

If the Board finds research has been conducted in violation of IRB guidelines or other applicable regulations, it may:

1. disallow the publication of data collected during periods of noncompliance including theses and dissertation.

Questions or concerns regarding noncompliance should be directed to the University’s Compliance Officer who will report preliminary findings to the Board. The Board may also involve the University’s legal counsel if necessary.

If the Board believes further action may be appropriate, it will investigate the matter in question. The Board may suspend the research during this investigation.

The Board will notify the investigator(s) of the nature of the concerns that have been raised and the time, date and place of the meeting to discuss them. The investigator will have an opportunity to attend and explain. It is the duty and responsibility of the principal investigator to cooperate with the IRB and to provide any documentation the Board my request.

Appendix I

NOTE: No research involving human subjects is to be conducted without the prior written approval of the IRB.

Each question should be thoroughly completed. Attachments should be used when appropriate and not in place of completing the application. Please read the instructions and questions prior to completing the application.

3. Research Project Period: from ____________ to ____________ (Do not predate your research. It must be a date after you would receive IRB approval.)

7. Describe in detail the research procedure related to subjects’ participation; minimally, the following information must be included:

a) How will the subject(s) be selected and/or recruited? (Append copy of letter and/or transcript of verbal announcement).

d) If a cooperating institution (school, hospital, prison, etc.) is involved, prior written permission must be obtained. (Append approval letter.)

f) What do the subject’s do, or what is done to them, in the study? (You must append a copy of questionnaires or test instruments and description of procedure to be conducted on the participant.)

g) How is it made clear to the subject that their participation is fully voluntary?

j) Cite your experience with this type of research. If you are a student, what is your advisor’s experience?

8. How do you intend to obtain the subjects’ informed consent? If in writing, attach a copy of the consent form. If not in writing, include a summary of what is said to the participant(s) and justify the reason that oral rather than written consent is being used. Also explain how you will ascertain that the subjects understand what they are agreeing to.

a. Why is human subject participation in this research necessary? (Consider if your research could be completed with secondary data.)

10. a. What are the benefits gained by the individual for participation in your

d. Psychological risks? (Might a subject feel demeaned or embarrassed or worried or upset? All research has some psychological risk.)

11. Do you deceive them in any way? If yes, explain why deception is justified and provide information about how the participants will be debriefed about your project.

12. How do you ensure confidentiality of the information collected? (By Federal Law, you must state where and who will be responsible for maintaining your data for a period of 3 years.)

13. STUDENT APPLICATIONS ONLY: Has your committee reviewed and approved your proposal prior to submitting your IRB application? Yes No

14. STUDENT APPLICATIONS ONLY: If no, have you reviewed the approval process with your department? Yes No. If you answered no, please see your advisor or chair of your committee for their approval process.

15. Due to recent changes in the Federal Regulations, the IRB is requiring that students, faculty, and researchers obtain a certificate from a tutorial regarding research with human subjects. This may be obtained online.

This requires 30-40 minutes and allows you to start and stop until all sections are completed.

b. At the recommendation of OHRP, the Board is requiring that students, faculty, and researchers read “The Belmont Report.” This may be found at http://ohrp.osophs.dhhs.gov/educmat.htm. Go to (1) Policy Guidance, and scroll down (2) under Guidance Materials to the link.

c. The final recommendation for the IRB is a requirement that all students, faculty, and researchers read the ethical principals for research with human subjects from their respective disciplines.

Please sign the following, I ____________________________________________________ and my

Advisor ______________________________________ have completed all three requirements as of

16. As of January 16, 2003, the researcher must use a consent form that has been stamped with an approval date and expiration date. This will be mailed to you along with your approval letter. Failure to use the stamped consent form may result in suspension of data collection until the proper form is utilized. Please notify the IRB when your data collection has been completed.

Appendix II

PURPOSE OF STUDY: Your child is being asked to take part in a research study to determine juvenile competence for understanding the court and legal system. The goal of the research project is to determine the relationship (if any) between certain background information and competence. He or she will be asked several questions and complete an interview based on a story that will be read to them.

METHODS AND PROCEDURES: The entire procedure should take one and one-half hours. If you agree to allow your child to participate, they will first be asked several questions about personal and background information such as their age, race, education level, and prior juvenile offences (if any). After completing these questions, they will be given a brief form of an intelligence measure. The intelligence measure provides only an estimate of intelligence; therefore, results will be provided only to your child’s therapist from Jackson Mental Health/Jackson Public Schools. Your child will then be read a story about a person and asked to answer several questions based on the information they are given in the story. Finally, they will be asked to complete two brief self-report forms.

You or your child may ask questions at any time during the study and you are free to contact Vicki L. Prosser, M.S., (601) 362-4522 or W. Criss Lott, Ph.D., at (601) 364-3108 should you have any questions that should arise about the research project.

RISKS AND DISCOMFORTS: We expect no risks or discomforts for people in this study. However, it is possible that they may feel somewhat uneasy answering the questions involved.

BENEFITS: The information obtained in this study will not directly benefit the adolescent. However, the results may provide needed information about juveniles’ competence to understand the court and legal system and other information which may be related to competence.

CONFIDENTIALITY OF RECORDS: All information obtained during this study is private. That is, we protect the privacy of people by withholding their names and other personal information from all persons not connected to this study. Each adolescent will be identified using a three digit code number rather than his or her name. Raw data will be kept in locked file cabinet. Although the information in this study is private, it may be revealed in certain rare circumstances. Confidentiality will be broken if the information obtained reveals that the adolescent intends to harm himself/herself, or another person, or if the court requests the information.

Your child’s response will be hand written during portions of this study to insure accuracy of the study procedures. The material will be kept in a locked room for a period of three years and only research personnel involved in the study will review the information.

LIABILITY STATEMENT: Adolescents are told to notify the researcher immediately if they experience any discomfort or feel bad during the study. If, by chance, your child experiences emotional distress as a result of their taking part in the study, you may want to consult with their assigned mental health professional from Jackson Mental Health.

VOLUNTARY PARTICIPATION: Taking part in this study is completely voluntary. Participants may withdraw at any time without penalty or prejudice.

PARTICIPANTS CONSENT: I have had the purposes and procedures of this study explained to me and have had the opportunity to ask questions. My signature shows my willingness to allow my child to take part in the study under the conditions stated.

This study has been reviewed by the Institutional Review Board of Jackson State University, which ensures that research projects involving human subjects follow federal regulations. Any questions or concerns about your rights as a research participant should be directed to Dr. Felix Okojie, Vice President for Research Development Support and Federal Relations, Jackson State University, P. O. Box 17095, Jackson, Mississippi, 39217, or (601) 979-2931.

Appendix III

Verification of Oral Consent

I certify that I have explained the nature and purpose of this research study to the [above-named individual(s)], and I have discussed the potential benefits and the possible risks of study participation. Any questions the individual has about this study have been answered, and I (or the researchers involved) will always be available to address any future questions.