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IRB Guidelines and Policies
Chapter I: Introduction
A. Purpose
B. Policy
E. Responsibilities of Investigators
Chapter II: Levels of Review
A. Exempt Research (Level I Expedited)
B. Expedited Research (Level II)
Chapter III: Basic IRB Review
D. Documentation of Informed Consent
F. Privacy and Confidentiality
1. Privacy
I. Incentives
Chapter IV: Preparing the Protocol for Review
Chapter V: Waiver or Alteration of the Consent/Assent Process
1. Narrative with Short-Form Consent for Emergency Situations
2. Oral Consent and Waiver of Signed Consent Form for Impaired or Illiterate Participants
3. Waiver of Signed Consent Form to Preserve Participant Anonymity
4. Other Waivers or Alterations
Chapter VI: Special (Vulnerable) Populations as Participants of Research
1. Definitions
1. Definitions
C. Prisoners
1. Definition
D. Decisionally Impaired Persons
1. Definition
G. Employees
Chapter VII: Noncompliance
C. Procedure
Appendix I: IRB Application
Appendix II: Model Consent Form
Appendix III: Example of Verification of Oral Consent
Appendix IV: Model Assent Form
Appendix V: Appeal Procedures
Appendix VI: Spring 2005 IRB Schedule of Deadlines and Meetings
INSTITUTIONAL REVIEW BOARD HANDBOOK
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 6th 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.
Chapter I
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 review and be familiar with Health Insurance Portability and Accountability Act (HIPAA) requirements if the protocol involves the creation, access to, use or disclosure of protected health information.
Investigators must receive written and signed approval from the IRB prior to making any changes to a protocol. Changes include:
- change in investigator(s) who will have contact with participants or records
- additions or deletions to data collection sites
- modifications or advertisements, surveys or questionnaires, consent forms or assent forms
- changes to procedures or methods
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:
-Exempt from Board Review (Level 1 Expedited)
-Expedited Review (Level II)
-Full Board Review
Protected (vulnerable) populations have additional requirements.
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.
A. Exempt Research (Level 1 Expedited)
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:
a. research on regular and special educational instructional strategies, or
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.)
c. additional restrictions which apply:
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.
ii. Research involving observation of public behavior will be
exempt only if the participant’s responses do not deal with
sensitive aspects of personal behavior (e.g., illegal conduct,
drug use, sexual behavior or alcohol use) and the investigator
does not participate in the activities being observed.
iii. Research involving surveys or interviews will be exempt only if
the participant’s responses do not deal with sensitive aspects of
personal behavior (e.g., illegal conduct, drug use, sexual
behavior, or alcohol use).
3. Research involving the collection or study of existing data-including documents, records, pathological specimens or diagnostic specimens-if:
a. these sources are publicly available, or
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:
a. public benefit or service programs;
b. procedures for obtaining benefits or services under these programs;
c. possible changes in or alternatives to these programs or procedures; or
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:
a. wholesome foods without additives are consumed or
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.
Notes:
-If a consent form is used, the protocol cannot qualify for exemption.
-Any research in which the participants are filmed or videotaped
cannot qualify as exempt and must undergo expedited or full Board
review.
-Focus group studies are not exempt.
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).
B. Expedited Review (Level II)
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.
*This document can be viewed at:
http://www.hhs.gov/ohrp/humansubjects/guidance/63fr60364.htm
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:
(a) Clinical studies of drugs and medical devices only when condition (i)
or (ii) is met.
(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.
(b) Collection of blood samples by finger stick, heel stick, ear stick, or
venipuncture as follows:
(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.
(c) Prospective collection of biological specimens for research purposes
by noninvasive means.
Examples: (i) hair and nail clippings in a nondisfiguring manner; (ii)
deciduous teeth at time of exfoliation or if routing patient care indicated a
need for extraction; (iii) permanent teeth permanent teeth if routine patient
care indicates a need for extraction; (iv) excreta and external secretions
(including sweat); (v) uncannulated saliva collected either in an
unstimulated fashion or stimulated by chewing gumbase or wax; or by
applying a dilute citric solution to the tongue; (vi) placenta removed at
delivery; (vii) amniotic fluid obtained at the time of rupture of the
membrane prior to or during labor; (viii) supra- and subgigival dental
plaque and calculus, provided the collection procedure is not more
invasive that routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques; (ix)
mucosal and skin cells collected by buccal scraping or swab, skin swab, or
mouth washings; sputum collected after saline mist nebulization.
(d) Collection of data through noninvasive procedures (not involving
general anesthesia or sedation) routinely employed in clinical practice,
excluding procedures involving x-rays or microwaves. Where medical
devices are employed, they must be cleared/approved fro marketing.
(Studies intended to evaluate the safety and effectiveness of the medical
device are not generally eligible for expedited review, including studies of
cleared medical devices for new indications.)
Examples: (i) physical sensors that are applied either to the surface of the
body or at a distance and do not involve input of significant amounts of
energy into the participant or an invasion of the participant’s privacy; (ii)
weighing or testing sensory acuity; (iii) magnetic resonance imaging; (iv)
electrocardiography; electroencephalography, themiography, detection of
naturally occurring radioactivity, electroretinography, ultrasound,
diagnostic infrared imaging, Doppler blood flow, and echocardiography;
(v) moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the age,
weight, and health of the individual.
(e) Research involving materials (data, documents, records, or specimens)
that have been collected or will be collected solely for nonresearch
purposes (such as medical treatment or diagnosis). (Note: Some research
in this category may be exempt from the DHHS regulations for the
protection of human participants. 45 CFR 46.101 (b)(4). This listing refers
only to research that is not exempt.)
(f) Collection of data from voice, video, digital, or image recordings made
for research purposes.
(g) Research on individual or group characteristics or behavior (including,
but not limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral history, focus
group, program evaluation, human factors evaluation, or quality assurance
methodologies. (Note: Some research in this category may be
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:
(a) where (i) the research is permanently closed to the enrollment of new
participants; (ii) all participants have completed all research-
related interventions; and (ii) the research remains active only for
long-term follow-up of participants; or
(b) where no participants have been enrolled and no additional risks have
been identified; or
(c) where the remaining research activities are limited to data analysis
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 2nd 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.
At its convened meeting, the Board may:
-Approve the protocol as submitted.
-Require modifications or request additional information (must be
received within 60 calendar days) to be submitted to the Chair for
approval.
-Table the protocol until the next regularly scheduled meeting, and invite
the investigator(s) to attend that next meeting to address concerns.
-Disapprove the protocol. If disapproved, all signatories will receive a
copy of the disapproval letter.
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)
Chapter III
A. Protocol Submission
An IRB protocol application submitted for review consists of the following
submitted in the order given here:
1. Protocol Application with signatures
2. Letter requesting permission to designated agent of cooperating institution or
agency (if required)
3. Letter from designated agent of cooperating institution or agency (if required)
4. Consent forms, assent forms, recruitment ads,
HIPAA forms (as
necessary)
5. Research instrument
6. Certificate of research training from all persons associated with the research
project
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.
The following definitions apply to risk/benefit analysis:
Benefit: A valued or desired outcome; an advantage.
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
the risks the participants would receive even if not participating in the
research,
(2) determination that the risks will be minimized to the fullest extent possible,
(3) identification of the probable benefits to be derived from the research,
(4) determination that the risks are reasonable in relation to the benefits to
participants, if any, and the importance of the knowledge to be gained,
(5) assurance that potential participants will be provided with an accurate and fair
description of the risks or discomforts and the anticipated benefits,
(6) determination of intervals of periodic review and, where appropriate,
determination that adequate provisions are in place for monitoring the data
collected.
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.
A model consent form is given in Appendix II.
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
the research, the expected duration of the participant’s participation, a
description of the procedures to be followed, and identification of any
procedures which are experimental,
(2) A description of any reasonably foreseeable risks or discomforts to the
participant,
(3) A description of any benefits to the participants or to others which may
reasonably be expected from the research,
(4) A disclosure of appropriate alternative procedures or courses of treatment, if
any, that might be advantageous to the participant,
(5) A statement describing the extent, if any, to which confidentiality of records
identifying the participant will be maintained,
(6) For research involving more than minimal risk, an explanation as to whether
any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist of or
where further information can be obtained,
(7) An explanation of whom to contact for answers to pertinent questions about
the research and research participants rights and whom to contact in the
event of a research related injury to the participant,
(8) A statement that participation is voluntary, refusal to participate will involve
no penalty or loss of benefits to which the participant is otherwise entitled,
and the participant may discontinue participation at any time without
penalty or loss of benefits to which the participant is otherwise entitled.
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
participant (or to the embryo or fetus, if the participant is or may become
pregnant) which are currently unforeseeable,
(2) Anticipated circumstances under which the participant’s participation may be
terminated by the investigator without regard to the participant’s consent,
(3) Any additional costs to the participant that may result from participation in the
research,
(4) The consequences of a participant’s decision to withdraw from the research
and procedures for orderly termination of participation by the participant,
(5) A statement that significant new findings developed during the course of the
research which may be related to the participant’s willingness to continue
participation will be provided to the participant,
(6) The approximate number of participants involved in the study.
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
oject falls within this category.