IRB Member Handbook

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Section 1: General Information

Section 2: Introduction to the HRPP and IRB

Section 3: Types of Review

Section 4: Quick Guide for IRB Member Review of Human Research Studies

Section 5: IRB Member Review Responsibilities and Guidance

Section 6: Review Outcomes

Section 7: Policy, Guidelines, Regulations, and Ethical Principles

 

Section 1: General Information

1.1 Current Member and Staff Lists

Committee Member Lists: Current committee member lists are available on the IRB Rosters & Meeting Dates page.

Staff Member List:

1.2 IRB Meeting Locations

Each committee meets at the campus for which it is named. The e-mailed PDF meeting agenda will announce the location of the meeting. Contact the IRB Coordinator or Assistant Coordinator for additional information or directions.

1.3 IRB Resources

The following informational resources are available for members:

HRPP WebsiteThis website is the primary source of communication between the IRB and campus investigators and staff. IRB news and policy decisions are posted on the web site. The site also includes links to various ethical codes, federal agencies, research ethics organizations, and other IRBs as well as a comprehensive list of Federal Regulations, State Statutes and Other Guidance.

Member Checklists and GuidesSeveral checklists are available to assist member in their reviews. While members are not required to fill out these checklists, they should be familiar with the information in these checklists and be referred to as needed when reviewing studies. Click here for these checklists.

Handouts Distributed at Regular Meetings or Via Email: The HRPP regularly distributes materials of interest to IRB members, such as newspaper articles, editorials from professional journals, and publications, such as IRB: Ethics & Human Research. These handouts are included for information and general discussion.

Institutional Review Board: Member Handbook: Each new member receives a copy of Institutional Review Board: Member Handbook by Robert Amdur and Elizabeth A. Bankert. This book provides members with important information needed in order to help them in the collaborative effort to protect the rights and welfare of research subjects. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during committee meetings.

HRPP BulletinsThe HRPP announces major changes or updates via the HRPP bulletin. For example, bulletins may include information on updates to application forms, revised policy and guidance that impacts human subject research, and educational opportunities. In addition to being posted on our website, this bulletin also is distributed by email to all active iRIS users.

Section 2: Introduction to the HRPP and IRB

2.1 What are the HRPP, IRB and QIU?

The UCSF Human Research Protection Program (HRPP) is a unit within the Office of Ethics and Compliance. The HRPP unit is responsible for reviewing and monitoring research involving human subjects at UCSF and several affiliate institutions to safeguard the rights and welfare of human subjects in research. UCSF has established policies and procedures to assure compliance with all federal regulations, state laws, and University of California policies governing the use of human subjects in research and it provides education, training, and assistance to the UCSF research community conducting human research.

The following groups make up the HRPP:

  • The UCSF IRB, which is currently comprised of four panels, reviews and approves (or disapproves) research projects involving human subjects at UCSF and several affiliate institutions. The UCSF IRB operates in compliance with relevant state and federal regulations. The UCSF IRB also serves as the Privacy Board for research that falls under the jurisdiction of federal HIPAA regulations.

All three of these units provide education and training to the campus community. See the following sections of the HRPP website for additional information:

2.2 Brief History of the Development of Federal Regulations and IRBs

Key Historical Events Leading to the Establishment of the IRBs in the USA

Below you will find links to key events in the development of human subjects research regulations. The IRB Member Handbook you received has additional information.

  • The Nuremberg Code (1948): The Nuremberg Code was established a result of the trials against Nazi physicians and administrators for their willing crimes against humanity. The non-binding Nuremberg Code included such basic ethical principles as the requirement that subjects freely consent to participate in research.
  • World Medical Association’s “Declaration of Helsinki” (1964): The declaration established recommendations guiding doctors in biomedical research involving human participants.
  • Henry Beecher’s article “Ethics and Clinical Research” in the New England Journal of Medicine (1966): In his article, Beecher provided 22 examples of medical research in the United States in which researchers had not told research subjects about the nature of their participation, had not obtained their informed consent, and put their health at risk.
  • Tuskegee Syphilis Study (1932-1972): Conducted with Public Health Service funding, this study included 400 rural black men in Alabama with syphilis who were deliberately left untreated – even after effective antibiotics became available – so that the natural progression of syphilis could be studied. It has been cited as one of the most infamous studies in U.S. history.
  • The National Commission of 1974: Legislation was enacted that established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission’s principal charge was to review the practices and problems associated with the protection of the human subjects in research sponsored by the federal government.
  • The Belmont Report (1979): Issued by the National Commission, the Belmont Report outlines “basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.” Two years later, the U.S. Department of Health and Human Services (45 CFR 46) and the Food and Drug Administration (21 CFR, parts50 and 56) issued regulations requiring the establishment of IRBs to ensure compliance with the ethical principles outlined in the Belmont Report.
  • National Bioethics Commissions (1974-present) and Secretary's Advisory Committee on Human Research Protections (2001-present): These groups helped shape bioethics policy in the United States.
  • Research Scandals in the 1990s and 2000s: As a result of two research-related deaths of healthy subjects and a highly publicized death of a research subject in a gene therapy program, the national press and the government again began to scrutinize human research at the major research institutions. Several institutions had all of their human research approvals suspended – some for several months – until they could bring their human subjects protection programs up to federal standards.

History of the UCSF Institutional Review Board
Since 1966 the United States Public Health Service (PHS) has required prior review and approval of all PHS-funded research using human subjects. Review boards known as Institutional Review Boards (IRBs) were established to fulfill this function.

As early as 1970, the President of the University of California required that PHS regulations be applied to “all investigations involving human subjects for which the University is responsible” – that is, all research, regardless of source of funding or even when no funds are involved.

The UCSF Committee on Human Research (CHR) was created in 1966, and re-structured in 1971 as the Institutional Review Board (IRB). Although the name CHR has been in widespread use since then, it was officially changed to IRB in 2015. Please review the Review Info section of our website for additional information on the creation of the UCSF IRB.

Additional Resources

2.3 Ethical Principles for the IRB

The IRB’s primary responsibility is the protection of subjects from undue risk and from deprivation of personal rights and dignity. The Committee considers research in the light of three ethical principles summarized in “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 1979). The three principles are as follows:

  • Respect for persons – voluntary participation by the subjects, indicated by free and informed consent, must be assured;
  • Beneficence – an appropriate balance must exist between potential benefits of the research to the subject or to society and the risks assumed by the subject; and
  • Justice – there are fair procedures and outcomes in the selection of research subjects.

Respect for Persons: The Voluntary Participation of Experimental Subjects
Research subjects should understand as completely as possible what is to be done to them, what information will be gathered about them, and what the potential risks and benefits are. The person must give his/her consent freely, without pressure or inappropriate inducement. The IRB attempts to ensure free and informed consent of subjects through careful review of the recruitment and consent process, including the consent form or information sheet to be used with subjects. The Committee's concern is to verify that the consent process and document are likely to assist prospective subjects to make an informed decision that will be in their own interests.

For studies in which subjects are not able to give personal consent for themselves, the consent document is addressed to those who have been designated responsible for the subject's well-being. For example, parents must give consent for children, as minors are not legally authorized to give consent (except in special circumstances). Federal regulations also require, however, that capable minors be asked to assent to being in a study.

The Committee exercises special care when considering subjects whose ability to give free and informed consent may be compromised in any way. Prisoners, for example, have limited choices in their lives and are vulnerable to coercive pressures. Demented or mentally ill subjects may have impaired ability to act in their own interests, so a guardian often must be consulted.

Beneficence: The Risk-Benefit Ratio
The IRB must decide whether risks to a study subject are outweighed by the combination of potential benefits to the individual subject and the importance of the knowledge to be gained from the study (the study’s societal benefits).

Risks of injury or discomfort to individuals can be physical, psychological, and/or social. There can be potential benefits to the individual, to a group to which the individual belongs, and/or to society. In reviewing applications, the Committee assesses the types and degrees of both risks and benefits for a given subject population, as well as the investigator's communication of these risks and benefits in the consent process and form.

Justice: The Fair Selection of Research Subjects
Both the risks and the potential benefits of research should be spread fairly among potential individual subjects and subject groups. Study design and selection of subjects should avoid bias for or against particular social, racial, sexual, or ethnic groups.

Sharing Research Risks: The guiding principle in the ethical selection of subject groups is that any risks of the research should fall upon the groups who might benefit from the research. If the results of a risky protocol might benefit the general population, it would be unethical to focus subject recruitment on vulnerable or disadvantaged groups (institutionalized people or prisoners; patients at free clinics primarily patronized by people unable to afford other care) simply because they are easily accessible or can be persuaded to participate. When research involves persons whose autonomy is compromised, it is expected that the research bear some direct relationship to the conditions or circumstances of the subject population.

In addition, groups fully able to consider research risks and informed consent should be asked to face research risks before more vulnerable populations are asked. Investigational drugs usually are tested in adults before they are tested in children. Consenting adults are preferred as subjects before adults for whom a guardian must consent.

Sharing Research Benefits: In recent years, increasing attention has been paid to the rights of various groups to be included in research. As individuals and through advocacy groups, many patients have come to insist on having access to experimental treatments as these experimental treatments may potentially provide the best medical care available. In addition, researchers, ethicists, and public officials have recognized that because many clinical trials focused primarily on white male middle-class subject groups, the results of some trials were of questionable value for members of other social, racial, sexual, and ethnic groups.

As a result, both the Food and Drug Administration and the National Institutes of Health now require that study design include as broad a range of subjects as feasible and ask that data be analyzed to uncover responses that differ between groups. For example, where women of child-bearing potential and pregnant or nursing women previously were routinely excluded from new drug trials, it is now required that whenever possible these women be asked to make their own choices after being fully informed of the risks of the research.

2.4 Make-Up the IRB

Each committee is sufficiently qualified through the experience, expertise, and diversity of its members – including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes – to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. With a few exceptions, IRB members must hold appointments of Associate Professor or higher, as this helps to promote respect for the IRBs.

The membership of each IRB committee typically includes, at a minimum:

  • At least five (though typically 12-18) members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
  • At least one member whose primary concerns is in scientific areas and at least one member whose primary concerns is in non-scientific areas.
  • At least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. These members will be designated as “non-affiliated” on committee rosters.
  • Members from affiliated institutions served by the UCSF IRB, and members from a wide enough variety of disciplines to review the vast majority of research submitted to the IRB. Expertise may vary by panel, and studies are assigned to an IRB panel with appropriate expertise.
  • Individuals who are knowledgeable about and experienced in working with vulnerable populations, such as children, prisoners, pregnant women, or individuals with cognitive impairments. The necessity and number of members with sufficient knowledge and experience working with these vulnerable populations will be determined by the amount of applications received that propose to enroll vulnerable populations and through the review of membership.

A member may satisfy more than one of the above criteria. Although the HRPP strives to keep each committee equivalent in terms of membership and able to review both medical and social/behavioral research, practical considerations will dictate whether an institution, discipline, or other specialty or area of experience or expertise is represented on one, two, three or four IRBs. This means that some research may be directed toward a particular IRB.

An IRB may, in its discretion, invite individual consultants with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

2.5 Visitors

On a case-by-case basis visitors may attend IRB meetings. Visitors are usually students observing an IRB meeting as an assignment for courses on human research or guests of IRB members. Visitors attend at the members’ convenience, must sign a confidentiality agreement, and must agree to attend a brief introduction to before or debriefing after the meeting.

A request for a visitor to attend an IRB meeting must be submitted in writing to the HRPP and include the name of the guest(s), the purpose of the visit and the preferred date of attendance. The request will be reviewed and approved by the appropriate IRB chair or the HRPP Director.

Section 3: Types of Review

3.1 Submissions Requiring Review

Below are the major categories of submissions that require review by the IRB. The Submissions section of the HRPP website has more detail, including when these types of submissions are needed and what information should be included.

  • New Studies (Initial Submissions): All new studies requiring review must receive IRB approval before they can begin.
  • Modifications: All changes to a study, even minor ones, must be approved by the IRB before they are implemented. For example, changes in screening criteria, procedures, recruitment materials, consent forms, questionnaires and other study materials all require IRB review and approval.

Note: The only exception to the requirement for prior IRB review and approval is when the changes are “necessary to eliminate apparent immediate hazards to the subject” (45 CFR 46.103.b.4, 21 CFR 56.108.a). Investigators must still notify the IRB when such changes are made.

3.2. Levels of Review

Submissions receive various levels of review based upon an assessment of the study risks. The levels of review are based on the level of risk of the overall study compared to minimal risk as defined below and are as follows: full committee, expedited and exempt.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i) and 21 CFR 56.110). See UCSF HRPP Tip Sheet: Minimal Risk for examples of minimal risk studies.

Additional information is available on the Levels of Review page, but is summarized below:.

Full Committee ReviewThe following submissions are reviewed by the full committee at a convened meeting.

  • New studies involving greater than minimal risk to subjects or minimal risk studies that do not qualify for expedited review;
  • Responses/revised applications that the committee asked to be re-reviewed at a convened meeting (review outcome of “Returned for Additional Information”);
  • Continuing review applications for studies that require full committee review;
  • Major modifications to approved full committee studies; and
  • Post-approval events such as adverse events or protocol violations – that require full committee determinations.

Expedited ReviewThe following submissions when they involve procedures that are no more than minimal risks can be reviewed via expedited review. An expedited review procedure consists of review by a committee member (usually an HRPP staff member) and/or one or more experienced IRB reviewers as needed.

  • New studies that involve no more than minimal risk to subjects and fit into one of nine specific categories, as defined by the federal government
  • Responses/revised applications that do not require re-review by the full committee (review outcome of “Revisions Requested”);
  • Continuing reviewapplications that qualify for expedited review;
  • Minor or administrative modifications of approved studies; and
  • Post-approval events that do not require full committee review.

Exempt CertificationThe following types of submissions do not require IRB review involve no more than minimal risks and are exempted from 45CFR46.101(b). The HRPP is responsible for reviewing the preliminary determinations of exemption by investigators and for mfit aking the final determination and certification.

Additional information about what materials are required for each type of review on the HRPP website under the Submissions section for each type of review.

3.3 Overview of IRB Review Process

Below you will find information on the basic IRB review process. For more detailed information, review Section 4 below as well as IRB Review Process page.

Screening: The IRB assigns an analyst to follow each individual submission from initial submission to final approval. This analyst conducts an administrative pre-review screening to ensure the submission is complete before forwarding it to IRB reviewers. When the submission is complete and meets basic submission standards (inclusion of funding protocol, drug brochure, recruitment and consent documents and correct sections of the application completed), the assigned analyst will assign the submission to IRB reviewer(s). Although the analyst may try to clarify major issues with the PI before the meeting, the analyst does not conduct an initial review.

IRB Member Review Process: Review assigned studies in depth according to information in the IRB Reviewer's Checklist and the IRB Member Reviewer's Guide. Specifically, members should:

  • Apply the criteria required by federal regulations for IRB approval of a human research study and the appropriate regulatory determinations (i.e., for inclusion of children in research, the inclusion of pregnant women, neonates and fetuses in research, the inclusion of prisoners in research, criteria for waiving and/or altering consent, criteria for making nonsignificant risk determinations for devices). These are included in iRIS in the Member Comment section.
  • Be familiar with the funding agency documents (sponsor protocol, NIH grant, drug brochure) to assist in answering questions and to affirm consistency between and among documents.
  • If possible, contact investigator before a meeting to clarify major issues that could result in a return if left unanswered.
  • Put comments in iRIS Member Comment Section. See below for details about this process.

When reviewing the study, the IRB reviewers will be asked to identify any outstanding issues that must be addressed by the PI prior to approval. IRB requests for changes or additional information should be clearly related to one or more of the federal criteria for approval of human research studies or to achieve compliance with State regulations and/or University policies. If there are no outstanding issues, the reviewers should indicate that the submission can be approved.

Post-Review Stipulations: If the IRB reviewers identify issues that need to be addressed prior to approval, the HRPP staff will draft post-review stipulations and send them to the PI. (Note: The staff may forward the stipulations to the IRB Chair or other reviewer(s) before sending them to the PI to ensure accuracy.)

After the PI responds and the response is complete, the HRPP staff will forward the response to either the full committee or the designated IRB reviewer(s), as applicable. If the reviewer(s) find the response acceptable, and the study meets the federal criteria required for IRB approval of a human research study, the IRB will approve the submission. If the response is not adequate, the HRPP staff will send additional stipulations to the PI and approve the submission only after the response is deemed acceptable by the reviewer(s).

3.4 Basic IRB Review Flowchart

IRB Review Process Infographic

Section 4: Quick Guide for IRB Member Review of Human Research Studies

4.1 Quick Guide for IRB Member Review of Human Research Studies

This is a brief but important guide for your IRB reviews. Your following this guidance will help ensure an effective and efficient discussion of the studies on the IRB agenda and is based on many years of experience and feedback from other members, Chairs and HRPP staff. Sections 3, 4 and 5 of the IRB Member Handbook below provide more detailed information and guidance.

Attendance

  • Attend IRB meetings on a regular basis (at least 75% of scheduled meetings).
  • Arrive on time and stay for the entire session whenever possible.
  • Update attendance records in iRIS in a timely fashion and before agendas are assigned.
  • Communicate well in advance if you’re going to miss two or more meetings in row so submissions being held for your expertise can be assigned to a different review committee.

Review and Meeting Preparation

  • Before the meeting, read and review the studies assigned to you thoroughly and be familiar with all the items on the agenda so that you may participate in the discussions..
  • Evaluate assigned protocols to ensure they meet the criteria for IRB approval of research found in 45 CFR 46.111 and 321 CFR 56.111 (see below). IMPORTANT NOTE: The Committee’s requests for changes or additional information should be clearly related to one or more of the criteria for approval, or to achieve compliance with State regulations and/or University policies.
  • When reviewing a protocol, use the attachments including the sponsor’s protocols and investigators’ brochures to answer questions you may have.
  • If you need additional information that is not provided in the study application or submission attachments, contact the HRPP analyst to request the missing information prior to the meeting so the review can proceed.
  • Be familiar with HRPP guidelines and template consent documents. If a consent form fulfills the requirements for informed consent as described in 45 CFR 46.116, please refrain from requesting editorial changes to improve it or fix minor typographical errors.
  • Complete your reviews as early as possible. The HRPP staff screen IRB reviewers comments prior to the meeting, looking for issues that could be resolved with additional clarification or concerns that may lead to the study being Returned for Additional Information.
  • Enter review comments and questions in iRIS at least 24 hours prior to the IRB meeting, Write comments in such a manner that HRPP analysts can quickly and easily relay any significant concerns to the PI and study team—either in advance of the meeting, if it seems like doing so could result in a more productive review or after the meeting in a letter.
  • Whenever possible, the HRPP encourages IRB reviewers to discuss major concerns directly with the study PI prior to the meeting to facilitate review of new protocols and prevent unnecessary returns.

Meeting Participation

  • Review Section 5.2 Primary Reviewer System and Meeting Review Process below for details about how to lead the discussion at the meeting.
  • Please stay focused with your review comments. Questions raised at the meeting should be relevant to subject safety and ethics. Questions raised out of curiosity can derail or extend the discussion unnecessarily and are not conveyed to the investigator unless related to safety.
  • Please contribute to committee discussions by sharing any knowledge and expertise you have that could address the concerns and questions of other members even if you are not an assigned reviewer.

For members assigned to Expedited Review submissions, please:

  • Complete review assignments within 7 days of receipt. If you receive an assignment and you are not available or otherwise unable to do reviews, promptly contact the analyst who assigned it to you to allow for timely reassignment to an alternate reviewer.
  • Evaluate assigned protocols that may be reviewed under an expedited review procedure according to the criteria for IRB approval of research found in 45 CFR 46.110 and 321 CFR 56.111 (see below).

4.2 Federal Criteria for IRB Approval of Research (45 CFR 46.111 and 321 CFR 46.111)

All conditions must be satisfied:

  • Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
  • Selection of subjects is equitable. Inclusion/exclusion criteria are adequate. Research purpose and setting are appropriate. Recruitment process is fair.
  • Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116, and 21 CFR 50.25 for FDA-regulated research.
  • Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117, and 21 CFR 50.27 for FDA-regulated research.
  • When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.
  • Provisions to protect the privacy of subjects and to maintain the confidentiality of data are adequate.
  • When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Section 5: IRB Member Review Responsibilities and Guidance

5.1. IRB Meeting Attendance and Agendas

Meeting Attendance:
A list of meeting dates is available on both the HRPP website and in iRIS.

You will need to specify whether you can attend each meeting using the attendance calendar in the “Meeting Availability” section of iRIS. Please update your attendance at least 2 weeks prior to the next meeting.

You will be asked a) whether you can attend the meeting and b) if you are available to review submissions (whether or not you are attending). Note: If you do not update your attendance, you will be automatically marked as available to review submissions.

Late Cancellations:
If you must cancel attendance after having been assigned as a reviewer, contact the committee Coordinator immediately so your protocols can be reassigned.

Meeting Agendas:
The HRPP staff finalizes the agenda at least one week before the upcoming meeting. You will be notified by email when the agenda is finalized, and a PDF copy of the agenda will be attached to the email. You can access an electronic copy of the agenda and all of the submissions on it by going to the “Meeting Agenda” section in iRIS.

The full committee meeting agenda may include the following types of submissions:

The agenda also may include miscellaneous items for discussion, and members may be asked to approve the minutes from previous meetings.

The electronic agenda in iRIS also displays submissions that have been reviewed under an expedited procedure. These submissions are listed for reporting purposes only and will not be discussed at the IRB meeting, unless the members have questions or comments.

Reviewer Assignments:
You will receive an email notification and see a “Reviewer Assignment” task in iRIS for each of your reviewer assignments. For technical help on how to complete your reviewer assignments, review the “IRB Member Quick Guide” in the Help section in iRIS.

The staff does its best to assign studies according to member interests and expertise. However, to balance the number of reviews, members may be assigned to review studies not within their immediate area of expertise. In addition, a member may find a study of particular interest and decide to comment. If members notice they are not being assigned the type of studies they are particularly interested in, they should let the Coordinator know.

5.2 Primary Reviewer System and Meeting Review Process

At the meeting, submissions generally are discussed in the order in which they appear on the meeting agendas. UCSF uses a primary reviewer system, in which up to three or four members will be assigned as reviewers of a particular submission. However, all members in attendance at a IRB meeting are expected to be familiar enough with each study so that he or she can either follow or contribute to the discussion.

The number of assigned reviewers depends on the type of submission, and the roles of the reviewers vary, as described below.

New Full Committee Studies and Studies Returned for Additional Information

First Reviewer: The first reviewer presents a brief overview of the study so the other members will be able to have a sense of the subject population, purpose, and design of the study. This presentation should be no more than a minute or so and should not go into great detail. (This is not the sort of presentation one would give at an NIH review.) Then the reviewer should:

  • Identify the funding source(s), if any.
  • Describe the major risk/s.
  • Follow with the most salient concerns or comments about the study protocol with a focus on the risk/benefit ratio, other risks and/or procedures to minimize risks.
  • Consider all criteria required by federal regulations for IRB approval [link to separate document which should be first linked on front page of IRB Information [separate document], although discussion should be limited to questions, problems, or concerns with: 
    • Subject selection,
    • Informed consent documents,
    • Data safety monitoring provisions,
    • Protection of privacy and confidentiality, and/or
    • Adequate protections of vulnerable populations.
  • Initiate discussion about
    • Any needed clarifications, justifications and/or additional information in the protocol,
    • Requested revisions and/or stipulations in the protocol;
    • Major problems or concerns with consent documents.
      • NOTE: Minor issues are noted as comments within iRIS and need not be discussed Staff will include in letters as appropriate.
      • NOTE: Easily correctable consent form should list be listed in the Reviewer’s Checklist (see below) or member notes rather than discussed at the meeting.

Second Reviewer: The second reviewer may either concur with the first reviewer or make additional comments or raise additional concerns, first with respect to the protocol, then the consent form. The second reviewer is also back up for the first reviewer if the first reviewer has to cancel unexpectedly. Thus, the second reviewer should be prepared to present the protocol.

Third Reviewer: The third reviewer serves as back up to the second reviewer, in case either the first or second reviewer has to cancel unexpectedly. The third reviewer should review the consent form, but need not be prepared to present the protocol in depth unless informed in advance of the meeting of a reviewer cancellation. Also, new members are assigned as third or even fourth reviewers. The third or fourth reviewer is not expected to make comments about the study but may do so, of course.

All Members: All members are expected to be familiar enough with all studies in order to follow and/or contribute to the discussion.

Full Committee Major Modifications, Continuing Reviews (Renewals), and Post-Approval Events

First Reviewer: The first reviewer does not need to present an overview of the study, though he or she could provide a very brief summary of changes (not the details, unless they are a matter of safety). The discussion should begin with if and how the risks and benefits of the study have changed. Comments or concerns should be addressed, first with respect to the protocol and study status, then the consent form. Confirm regulatory determinations.

Unless serious oversights occurred at initial review, avoid asking for changes in design or the consent unless related to changes in the actual study.

Second Reviewer: The second reviewer either concurs with the first review or presents his or her additional comments or questions.

All Members: All members should be familiar enough with the the materials in order to follow or contribute to the discussion.

Chairs and Policy Analysts:

Chairs: Although chairs are sometimes assigned as primary reviewers, they generally review all the studies and so may comment on studies as well, and provide back up if needed.

Policy Analysts or Coordinators: A committee coordinator or policy analyst (also a member) at the meeting also reviews the new studies and may comment at the time of review. The Assistant Coordinators also provide backup.

Expedited Review by IRB Full Committee Members

Normally studies reviewed by full committee are studies involving more than minimal risk, though there may, of course, be minimal risk components within a full committee study. Minimal Risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests” (45 CFR 46.102). Studies in which all procedures are no more than minimal risks and which fit into one of the nine expedited review categories may be reviewed using the expedited process, that is, reviews by one or more designated IRB members.

Expedited Initial Reviews
Designated IRB members who are also HRPP staff review the majority of the minimal risk, expedited studies. However, the HRPP staff members sometimes assign minimal risk studies to IRB Chairs or Vice Chairs or other full committee members for expedited review. This is done to take advantage of member expertise when reviewing studies that are minimal risk. For example, members with relevant expertise may be assigned to review minimal risk studies involving vulnerable populations, controversial subject matter, foreign study sites, or extensive interaction with patients.

The expedited review process for these types of studies is as follows:

  • Expedited review assignments will appear in the member’s iRIS task list just as full board reviews do. The reviewer also will receive an e-mail notification from the iRIS system.
  • The reviewer should use the Reviewer Checklist to make comments.
  • Reviewers are asked to complete these reviews within a week. If a more rapid turnaround is needed, staff will check with the reviewer before assigning.

Reviewing Responses via Expedited Review
After the IRB meeting, the HRPP staff will forward the committee’s comments to the researcher. Unless the response needs to be returned to the full committee for re-review, a designated IRB member will review the response or forward the response to a Chair, Vice Chair, or a member who raised concerns or has particular expertise to decide if the response is sufficient. This will be done using Internal Routing in the iRIS system, described in the “IRB Member Quick Guide.” If the response is adequate, the reviewer should inform the staff by writing “OK” in the IRB Member’s Comments block at the bottom of the Internal Submission Routing section. If additional changes are needed, the reviewer should include that information in the comments.

5.3 Member Review Tools

The Reviewer’s Checklist: This checklist is viewable in in iRIS when you open the study. Section 2 of the checklist contains the 9 required federal criteria for IRB approval of human research (also included above in Section 4), which reviewers should use to guide their presentation of the study (as discussed above). It also contains study-specific regulatory determinations about the inclusion of women, prisoners, pregnant women, neonates and prisoners in research as well as information about waivers and alterations of consent, non-significant risk determinations for devices and HIPAA that the IRB must make during its review.

Reviewers should consider these regulatory determinations, but are not required to mark any final determinations in the checklist. However, member comments should be clearly related to one or more of the criteria for approval, or to achieve compliance with State regulations an/or University policies.

The completed checklists can be displayed during the IRB meeting to help guide the presentation of the protocol. In addition, the HRPP staff members often use the checklists to supplement their own notes of the meeting deliberations. NOTE: The HRPP does not consider the completed checklists to be a record of the committee’s deliberations and actions – only individual members’ thoughts recorded before the meeting.

For assistance completing a Reviewer’s Checklist, reviewers should consult the “IRB Member Quick Guide” (available in the Help section of iRIS) or contact the HRPP staff.

The Reviewer’s Guide: This guide is in paper form available on the website. Reviewers should be familiar with and consult this as needed when conducting their reviews. This guide contains regulatory information and other issues that reviewers should take into consideration when reviewing protocol. For example, the guide asks if screening procedures are acceptable and whether study resources are adequate.

5.4 Putting Comments in iRIS

Reviewers should enter their review comments in iRIS before the meeting. The comments may be projected during the meeting for other members to review during the discussion and may be used by HRPP staff to help prepare the letters to investigators after the meeting.

There are two ways to putt reviewer comments into iRIS:

  • You can add comments while reviewing the application by clicking on the green plus sign in the right column.
  • You can also write your comments in a Word doc while doing your review, then cut-and-paste them into the final page of your Submission Review Form by clicking the “Add new comment” green plus sign.

For assistance completing a Reviewer’s Checklist, reviewers should consult the “IRB Member Quick Guide” (available in the Help section of iRIS) or contact the HRPP staff.

Note that for consent form comments reviewers can print the consent documents and hand mark typographical errors, grammatical changes, or other easily correctable items directly on the consent forms themselves so meeting time does not have to be spent discussing these issues. Reviewers are asked to turn in the marked up consent documents and any other relevant handwritten notes to the HRPP staff at the meeting.

Important Stylistic Comments for Putting Member Comments into iRIS

  • Begin comment with the name of the section (or section number):
    • Exclusion criteria: Exclude pregnant or lactating women.
    • Procedures: Specify the frequency of the blood draws.
    • Risks: Add the consequences of increased amylase.
  • When comments should be included in the letter to PI:
    • Write as a stipulation that the IRB Analyst can paste into letter.
    • Be directive.
    • Write to the investigator, not to the analyst.
  • Examples of stipulations:
    • In the Recruitment section of the application, please clarify how subjects will be recruited from the UCSF Pediatric Specialty Clinic.
    • Please revise the study application and consent form to describe the timeline and frequency of tissue biopsies that will be done in the study. Also, include the risks associated with this procedure.

5.5 IRB Member or Consultant Potential Conflict of Interest

Member or Consultant Conflict of Interest

Guiding Principle: It is important that the members of the Committee on Human Research, including alternate members, or expert consultants, regardless of voting privilege, do not have or appear to have a conflict of interest, including a significant financial interest, related to any of the studies in which they participate in the review process. The term “conflict of interest in research” refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a member’s professional judgment in reviewing or evaluating a research project. The goal in adhering to this principle is to prevent conflicting interests from interfering with the review process either by competing with an IRB member’s or consultant’s obligation to protect participants or by compromising the credibility of the review process. A conflict of interest depends on the situation, and not on the character or actions of the individual member.

Policy: It is the policy of the UCSF IRB that all conflicting interests of an IRB committee member, including alternates, or consultants, regardless of voting privileges, be declared before review of any research under IRB jurisdiction. IRB committee members, alternates, and consultants with a conflicting interest may not participate in any portion of the review of research activities except to provide information requested by the IRB and must absent themselves from the meeting during the IRB’s deliberative discussion and vote on the affected research.

Considerations: As an IRB panel member or consultant, you should consider the following conflicts of interest and determine whether a particular role or relationship could affect your objectivity before reviewing, participating in the panel discussion or deliberation, and voting on a protocol.

IMPORTANT NOTE: Affirmative responses to questions one through five below indicate a conflict of interest requiring recusal of a member from reviewing or voting on a particular protocol (see Procedures below).

1. Are you an investigator listed on the protocol or a member of the research team?

2. Are you a direct supervisor of an investigator or a faculty sponsor of the protocol director?

3. Do you have a familiar or close personal relationship with an investigator on the protocol, e.g., a spouse, a child, a registered domestic partner, a significant other?

4. Do you (or your spouse, child, registered domestic partner, or significant other) have a significant financial interest (see definition below) in the drug, device, assay or product being tested?

5. Are you an executive or director of the agency or company sponsoring the research?

NOTE: An affirmative answer to questions six and/or seven below does not automatically disqualify a panel member or consultant from reviewing and voting, but does require careful consideration. If a panel member or consultant answers “yes” to these questions and believes the situation poses a conflict of interest, he or she should adhere to the policy and procedures outlined in this guidance.

6. Do you have a competing interest with the protocol being reviewed?

7. Do you have other concerns that in your judgment warrant abstaining from review, deliberation, and voting on a protocol? Examples of other concerns may be a commitment to a particular research approach or objections to a particular type of research.

Definition of Significant Financial Interest: Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria): equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from cash rights).

For example, the following meet the UCSF IRB criteria for having a Significant Financial Interest that needs to be reported to the IRB and which requires that the member recuse him or herself from voting on an IRB application:

  • An equity interest that when aggregated for you, your spouse and dependent children meets the following tests:
    • Exceeds $10,000 in value as determined through reference to public prices or other reasonable measures or fair market value, and
    • Represents more than a five percent set ownership in a single entity.
  • Salary, royalties or other payments what when aggregated for you and your spouse and dependent children over the next twelve months are expected to exceed $10,000.
  • Executive or director positions (compensated or uncompensated related to the research).
  • Compensation of any amount that could be affected by the outcome of the research.

This term does not include:

  • Any ownership interest in the institution if the institution is an application under the SBIR Program.
  • Income from seminars, lectures or teaching engagements sponsored by public or nonprofit entities.

Procedures for Protocol Review and Attendance at the IRB Meeting

Please be aware of the following procedures as part of your membership or consulting responsibilities:

  • Please inform the Committee Coordinator at the beginning of your service of any existing conflicts of interest, as discussed above. The Coordinator will track these conflicts and not assign you studies to review if you have indicated you would have a conflict of interest.
  • If at any time during the period of IRB service new conflicts of interest arise, please alert the Committee Coordinator. You should not participate in the review of a study for which you have a significant financial interest. If you indicate at any point during your service of any significant financial interests, the IRB office will not assign you as a reviewer on the study. If you are inadvertently assigned, please notify your IRB Coordinator immediately so that the study may be reassigned.
  • You are not allowed to be in the room during the deliberations or the vote on the outcome of a study for which you have a significant financial interest, but you may answer questions about the study.
  • At the top of every agenda is a printed reminder that anyone attending the meeting who has a conflict of interest, including a significant financial interest, related to a study on the agenda must leave the room during the deliberations and voting on that protocol. The Chair will remind members of this requirement at the beginning of the meeting.
  • At the IRB meeting, the panel member or consultant with the conflict must inform the panel that he or she cannot act as a reviewer, participate in the discussion, or vote on the protocol. It is not required that the member or consultant state what the conflict is, only that there is a conflict. The fact that the member or consultant was disqualified as a reviewer at the meeting due to a conflict of interest will be noted in the minutes.
  • The IRB panel member will not be counted as part of the quorum for the protocol. If quorum is not present as a result of this absence, then the IRB panel may not take further action or vote on this protocol. It will have to be re-reviewed at a meeting for which there is quorum.

Coordination of Review between the IRB and the Conflict of Interest Advisory Committee (COIAC) for Investigator Conflict of Interest

Guiding Principle: The goal of coordinating the reviews of the COIAC and the IRB is first and foremost to prevent financial interests from adversely affecting the protection of participants and secondly to protect the credibility of UCSF and the Human Research Protection Program. Detailed information about investigator conflict of interest is included on both the HRPP and COICAC websites. See the reference section below.

Procedures are in place for coordinating reviews of potential conflicts of interest between the IRB and the COIAC. Once financial interests are disclosed, they are evaluated by the COIAC and a management plan is put in place or the interests are eliminated.

Important Notes:

  • The IRB has final authority to decide whether the financial interest and its management, if any, is acceptable and will adequately protect the safety and rights of the participants.
  • The IRB will be advised if the COIAC recommends that the study not be funded and/or conducted at UCSF. In that case, the study will be withdrawn and not reviwed any further by the IRB.

References

  • UCSF HRPP Website: Investigator Conflicts of Interest
  • UCSF Conflict of Interest Advisory Committee
  • DHHS Guidance on Financial Relationships and Interest in Research Involving Human Subjects: On May 5, 2004, DHHS issued revised Guidance for Human Subjects Protection. This guidance proposed the establishment of an Institutional Conflict of Interest Committee, a committee UCSF has had in place for several years, and it also includes recommendations for the IRB. This guidance is in partial response to the DHHS guidance as it addresses the need to develop policies and procedures for addressing conflicts of interest for IRB members.
  • UCSF Policies Regarding Conflict of Interest: Detailed information about UCSF policies with respect to conflict of interest are posted on the UCSF Conflict of Interest Advisory Committee website. The threshold for conflict of interest for a UCSF researcher is more stringent and not the same as that of a IRB member

Small Business Innovation Research (SBIR) Program means the extramural research program for small business that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Pub. L. 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program includes the Small Business Technology Transfer (STTR) Program, which was established by Pub. L. 102-564.

5.6 Member Appointment, Evaluation and Accelerated Advancement

Appointments: Members are nominated by various sources including but not limited to the Department Chairs, Division Chiefs, the HRPP Director or Assistant Directors, IRB Chairs, Vice Chairs, and other IRB Members. Members are chosen to represent the types of research being reviewed by each IRB.

Appointments are typically for two years and renewable by mutual agreement, depending on the needs of the IRBs and the results of the yearly member evaluations. The Associate Vice Chancellor for Ethics and Compliance gives final approval to an appointment or the decision to rotate a member off the IRB.

Member Evaluations: The HRPP conducts annual member evaluations in order to provide feedback to members on the quality of their reviews. The evaluation is based primarily on the points described in the Quick Guide in Section 4 above.

Accelerated Advancement: The evaluation includes information on how your service with the IRB can qualify as exceptional performance when you are considered for advancement (see below and page 10 of the Academic Senate’s Handbook for more information).

IRB Members:
Attached to this message is your individual evaluation of performance as an IRB member. The evaluation was completed by the Chair of your IRB panel in collaboration with the staff Coordinator and the HRPP Director.

For attendance we adopted an arbitrary standard of 80% or more attendance at your scheduled meetings being “Good to Outstanding,” and 50% to 79% as Satisfactory. We know there are good reasons for missing meetings, and we need to average better than 50% attendance to maintain quorum. The other measures clearly are more subjective If you have questions, please contact your IRB chair or coordinator. Accelerated Advancement: As an aside, please be aware that your service with the IRB can qualify as exceptional performance when you are considered for advancement, per guidelines from the Office of Academic Affairs. Among Examples of Exceptional Performance are: Sustained (3 years) and dedicated University service on a major campus committee such as CAP, IRB, CAR; or on a School's admissions committee as appropriate. For more on Accelerated Advancement, see page 10 of the Academic Senate’s Handbook.

Thank you for your continued efforts at protecting research participants and facilitating ethical research at UCSF.

Section 6: Review Outcomes

6.1 IRB Review Outcomes

One of two general outcomes are possible following review: a) the investigators can begin the study without submitting additional information to the IRB or b) the investigators may not begin the study until additional information is provided and the IRB approves the response. A third but very rare outcome is that the study is disapproved and cannot be conducted. The IRB will apply one of the following outcomes to each submission based on the discussion during the review process.

The IRB Review Process section of the HRPP website contains more information.

  • Straight Approval or Approval with Comments: Study can begin.
  • Approved with Comments that Must Be Addressed: Study can begin.
  • Revisions Requested : Study approved in concept but directed changes or concurrences requested.before study can begin.
  • Returned for Additional Information: To be reviewed again by Full Committee.
  • Disapproved : Study cannot be conducted under aegis of UCSF.

Tabled is another rare but possible outcome. This occurs when the criteria for a convened full board meeting are not met (e.g., loss of quorum, or a required member, such as the VA representative or the nonscientist, are not present) and/or appropriate expertise for a particular study (e.g., pediatrician) is not available at the meeting. The study will be reviewed at the next available full board meeting.

6.2 IRB Full Committee Votes on Review Outcomes

A vote is taken for all submissions requiring approval by the full committee. The number of members voting for or against the outcome is recorded in the minutes. The names of those voting one way or the other are not recorded, except in the case of abstentions. Members may request that a secret ballot be used, though typically a vote is indicated orally or by raising hands. Dissenting members may write a minority report to be included in the minutes.

Any member may abstain from voting if he or she desires and this decision will be recorded in the minutes. A member must abstain and leave the room before the final discussion and vote if he or she is listed as an investigator on a study or has another conflict of interest.

6.3 Post-Approval Event Determinations

The committee occasionally is asked to make determinations on post-approval events, including internal adverse events or protocol violations and incidents. Here are the specific determinations (and accompanying definitions) the committee must make about these events:

  • An unanticipated problem involving risk to participants or others is defined as: an unexpected, research-related event where the risk exceeds the nature, severity, or frequency described in the protocol, study consent form, Investigator’s Brochure or other study information previously reviewed and approved by the IRB.
  • Noncompliance is defined as: failure to follow state or federal regulation, or the University policies, or the requirements of the VHA Handbook 1200.5, or determinations of the IRB for the protections of the rights and welfare of study participants.
  • Serious Noncompliance is defined as: failure to follow state or federal regulations or University policies or determinations of the IRB for the protection of the rights and welfare of study participants and that, in the judgment of the IRB, results in, or indicates a potential for a) a significant risk to enrolled or potential participants or others, or b) compromises the integrity of the UCSF HRPP or the University.
  • Continuing Noncompliance is defined as: a pattern of noncompliance that continues to occur after a report of noncompliance and a corrective action plan have been reviewed and approved by the IRB.

The Committee may request additional corrective action plans or request that the Quality Improvement Unit conduct a directed site visit. The Committee may also suspend or terminate IRB approval.

6.4 Minutes

Minutes of the IRB meetings are prepared by HRPP staff after all of the stipulations and comments from the meeting have been sent. The minutes record the attendance and list the outcomes, regulatory determinations, and stipulations and comments for each submission reviewed. The minutes also summarize discussions of any controverted issues and/or other discussions as appropriate. The minutes also include a report of submissions that were reviewed under an expedited procedure.

Minutes are distributed via email to all members of that committee who attended the meeting. Only those members in attendance at the convened meeting may vote on the minutes. Members may request that changes be made in the minutes or they may request additional information about a study that was discussed.

Approved minutes are maintained in iRIS and are available for review by auditors.

Section 7: Policy, Guidelines, Regulations, and Ethical Principles

7.1 UCSF Policy and Guidelines

All of the IRB forms and guidance can be found on the UCSF HRPP website.

Almost all IRB policy is based on UCSF interpretation of federal regulations and state law and is included in the HRPP website. Another source of IRB policy is the University of California Office of the President (UCOP). UCSF, of course, must also adhere to UCOP policy. New UCSF guidelines and policy typically are developed by UCSF’s Human Research Policy Group and then distributed to IRB members for comments and suggestions. The UCSF Institutional Official approves policy changes.

While UCSF policy may be more restrictive than federal or state regulation or UCOP policy, it may not be less restrictive. During the nearly 40 years of the UCSF IRB’s existence, UCSF has tended to develop and distribute guidelines and recommendations and institute procedures that help investigators comply with regulations rather than go beyond the regulations. However, because UCSF is often on the cutting edge of research, the HRPP in consultation as appropriate sometimes develops guidance before regulations are in place.

7.2 Regulations and Ethical Principles

7.3 Abbreviated Recruitment and Informed Consent Considerations for Members

As discussed above, the first Belmont principle is that of respect for persons. This principle requires that subjects give their free and informed consent to participate in research. As such, during its review of a study, the Committee must examine the study’s recruitment and consent process – including recruitment materials and the consent form or information sheet to be used at the time of consent.

Below are some points to consider when reviewing the recruitment and consent process. Please also utilize the IRB Reviewers’ Checklist, which includes regulatory issues related to these processes. The Recruitment, Consent and HIPAA section of the HRPP website has additional information on acceptable recruitment strategies, consent guidance, and considerations for unique situations or when vulnerable populations are involved.

Recruitment Considerations

  • How will subjects first be contacted? Does the recruitment strategy emphasize the voluntary nature of participation? The application form should discuss how, where, when, and by whom prospective subjects will be contacted. In addition, the recruitment strategy should make clear that subjects are free to refuse to participate.

For studies where contact information on potential subjects is obtained from medical or other private records, the IRB generally recommends initial contact by letter rather than telephone. In addition, the IRB strongly suggests that subjects be approached by someone already involved in their care.

For telephone recruitment or surveys, the IRB expects that subjects will have the study explained and will be asked explicitly whether they are willing to participate in the research study. The investigator should submit scripts or guides that will be used for recruitment interviews.

Advertisements and other recruitment materials also must be submitted (see below) and meet UCSF requirements.

  • How will the privacy of prospective subjects be respected? The study team should make efforts to respect the privacy of possible subjects. If a study is first explained to subjects in a group, the IRB usually asks that the actual consent process be done in private.
  • Is the person obtaining informed consent qualified to do so? It is important that the person obtaining the subject’s consent be knowledgeable and appropriate.

General Considerations of Informed Consent (summarized from the federal regulations):

  • Consent must obtained from subjects or representatives before enrollment (there are very rare exceptions).
  • Consent must be obtained under circumstances that provide the subject or the representative sufficient opportunity to consider whether or not to participate. The possibility of coercion or undue influence must be minimized.
  • Prospective subjects must be able to understand the information provided to them. Subjects or representatives who do not speak English must receive information in their own language. Review guidance on consenting Consenting Non-English Speakers for details.
  • No language may be used that makes subjects waive or appear to waive any rights.
  • We will soon post a checklist of criteria required by federal regulation to approve informed consent. In the meantime, please review the criteria here.

Additional Forms: HIPAA Authorization and Experimental Subject’s Bill of Rights

In addition to the consent form, subjects at UCSF may receive up to two additional documents during the consent process. These documents do not need to be submitted to the IRB for review. However, the “Consent” section of the consent document should specify that subjects will receive the additional documents.

1. HIPAA Authorization Form:

HIPAA applies to a research study if researchers access, use, create, or disclose the individual's protected health information (PHI) for research purposes. For example, HIPAA applies to a research study if researchers …

  • Add research results to the subject’s medical record.
  • Abstract data (e.g. medical history, clinical test results, etc.) from the subject’s health record for research purposes.
  • Share/disclose the subject’s PHI with the outside groups, such as the study sponsor.
  • Create a medical record because subjects enroll in a study.

At UCSF, the IRB is the HIPAA Privacy Board, which means the IRB makes HIPAA determinations for research projects. If HIPAA regulations apply to a research study, the IRB must determine the following:

The IRB also can grant a waiver of authorization for recruitment purposes only. For example, researchers often want to screen medical records to identify potential subjects, but only obtain written authorization from subjects who enroll in the study. In such cases, the IRB can grant a waiver of authorization for recruitment purposes only.

More information is available in the HIPAA section of the HRPP website.

2. The State of California Experimental Subject’s Bill of Rights

California law requires that subjects in “medical experiments” be provided a copy of the Experimental Subject’s Bill of Rights. The IRB has interpreted the term “medical experiment” to include almost all studies involving biomedical procedures, placebo controls, innovative therapy, and/or normal volunteer subjects. It is required when the standard UCSF Treatment and Compensation for Injury statement is included in the protocol and the consent form, that is, when there is a real or foreseeable risk of biomedical harm.

Subjects must be provided with a UCSF Bill of Rights written in their own language. About two dozen translations are available on the HRPP website. If an additional translation is needed, please contact the IRB office. A copy of these Bill of Rights is also available in Braille by calling the office.

Recruitment and Consent Materials to Review

The following items must be submitted as part of the initial application for IRB review. Any additions or changes to these documents must be submitted as formal modifications:

  • Letters to Subjects: All letters to subjects or their representatives, regardless of who signs the letters, including the PI, a primary care provider, or an organization the subject has joined.
  • Advertisements: All advertisements in all media, including flyers, posters, newspaper ads, radio or television announcements, and informational videos. The content of these ads must meet certain criteria.
  • Recruitment Scripts: All scripts or guides that will be used for in-person or telephone recruitment interviews.
  • Web Postings or Pages: Investigators should describe content and/or submit printouts of postings or pages used for direct recruitment. Informational descriptions posted on websites that have policies insuring that study descriptions are accurate and balanced (e.g. ClinicalTrials.gov) do not need to be submitted for review.
  • Consent Documents:
    • Consent forms, including any parental consent forms
    • Assent forms
    • Information sheets and/or scripts
    • VA-specific consent form
    • Investigators do not need to submit a copy of the HIPAA authorization form or the Experimental Subject’s Bill of Rights.

UCSF Consent Form Templates: The HRPP has prepared several consent and assent form templates that investigators should use as models. Consent forms that follow these templates comply with all federal regulations, state laws, and UCSF institutional requirements. Therefore, investigators are strongly encouraged to use the formats, although it is not absolutely required. If another template is used, please refer to the Consent Form Checklist for Using a Non-UCSF Consent Form.