New Member Orientation Checklist

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IRB Member Manual

New Member Orientation Checklist

New Member Manual

CITI Training Requirement

Belmont Report

Common Rule (45 CFR 46 subpart A)

• Subparts B,C,D – protected populations
• B – Pregnant women and human fetuses, and neonates
• C – Prisoners
• D – Children

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IRB MemberManual

Contents

1.0 IRB Membership

2.0 Training requirement

2.1 CITI Course

2.2 New Member Orientation

3.0 Meeting expectations

3.1 Attendance

3.2 Meeting Preparation

3.3 Input

5.0Research Review

5.1 Is the activity research?

5.2 Does it involve human subjects?

5.3 Is the research minimal risk?

5.4 Is the research greater than minimal risk?

6.0Opposing Views

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1.0 IRB Membership

Each member contributes to the diversity of the committee and experience necessary to make informed decisions on proposed research. The intended purpose of an IRB is to evaluate a proposed study’s Respect for Persons, Beneficence, and Justice as outlined in the Belmont Report. These principals translate to a study’s informed consent procedures, inclusion and exclusion criteria, and risk to benefit ratio for participants.

Given the three principles in the Belmont Report, which is recommended to be read annually, the federal regulations describe the authority of an IRB as follows:

• An IRB has authority to approve, require modifications in (to secure approval), or disapprove research covered by 45 CFR 46.
• An IRB must ensure regulatory requirements are met for informed consent for regulated research, unless the IRB approves a waiver of documentation or, in rare cases, consent.
• An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
• An IRB shall conduct continuing review of research covered by 45 CFR 46 at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

2.0 Training requirement

IRB members participate in initial and continuing education by reviewing relevant materials on issues, regulations and guidance concerning human subjects protections.

2.1 CITI Course

All members of the IRB must complete the required Collaborative Institutional Training Initiative (CITI) course that is appropriate for their field of study. The optional modules at the end of the course that relate to IRB membership must be completed as well. Please see the Training webpage for learner groups and instructions. Certification is valid for three years. An abbreviated course is required in years three and six for individuals continuing service on the IRB or conducting human subjects research. The cycle restarts after nine years with the full length course.

2.2 New Member Orientation

In addition to the CITI course, IRB members should become familiar with:

• The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (
• Code of Federal Regulations (45 CFR 46) (
• The Human Research Protection Program Guidance Manual (
• Office for Human Research Protections - Policy and Guidance (
• U.S. Food and Drug Administration (FDA) INFORMATION SHEETS Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update (
• Office of Research Integrity(

IRB members are also periodically notified of events such as lectures, workshops and conferences related to human research protections occurring nationally and locally. IRB members are strongly encouraged to attend relevant lectures, conferences and associated events.

3.0 Meetingexpectations

Official business can only be conducted with a full quorum of the Board. One more than half of the committee members and one member whose interests are in non-scientific areas must be present to conduct official business. A majority vote of present members is needed to approve studies.

3.1 Attendance

Members are expected to attend all scheduled full board meetings. Meeting dates and times are scheduled during the spring or summer prior to the next academic year and usually follow the pattern of every third Monday of the month. Times may vary, but usually occur from 2:30-4:30pm in the University Enterprises, Inc. Boardroom. Adjustments to the meeting schedule are made to avoid holidays and final examination weeks. Once the academic meeting dates are scheduled, they are posted on the Review Categories website with submission deadlines for greater than minimal risk studies.

3.2 Meeting Preparation

At least one week prior to a full board meeting, the Analyst will send via email the following information: agenda, last month’s meeting minutes, new protocols for full board review, protocols requesting modifications or continuation needing full board review. It is expected that all material will be reviewed prior to the meeting so little explanation is needed and the committee can focus on the risk/benefit evaluation.

Documents are reviewed at the meeting using a projector. Each member is responsible for making their own copies if they prefer to have paper copies at the meeting for review.

3.3 Input

As an IRB member who was selectively chosen to participate on the committee, each voice is important to the balance of the committee and integrity of research conducted on campus. The objective of full board meetings is to facilitate a professional environment for ethical review.

Protocols and policy or procedure requiring a vote of a full quorum are passed by a majority vote. Every vote allows for an opposing or abstaining vote. Those votes opposing or abstaining will be followed by an explanation for the vote in the meeting minutes as required by federal regulation. In many cases, a vote will not be called until all member’s concerns are met, facilitating collaboration.

5.0 Research Review

An IRB review is required when a study meets the criteria as defined by the federal regulations as human subjects research.

5.1 Is the activity research?

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

5.2 Does it involve human subjects?

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1)Data through intervention or interaction with the individual, or

(2)Identifiable private information.

If the activity is human subjects research, continue the review as outlined below. In most cases, the Officer will ensure only human subjects research makes it to the review stage of the IRB process.

5.3 Is the research minimal risk?

Minimalrisk 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 examinations or tests.

All minimal risk protocols are categorized as exempt or expedited and are not reviewed by the full board at a convened meeting.

If the activity is minimal risk:

Is it Exempt?

Does the research fall within one or more exemption category? Please see 45.101(b)(1)-(6) for exempt categories.

Is it Expedited?

If the research does not fall within one or more exempt categories, but remains minimal risk to participants, the study will be reviewed as expedited. The regulations outline studies which can be considered expedited. Most studies conducted on campus that are expedited fall under category 7.

5.3.1 Exempt reviews

Exempt reviews are conducted by the Research Integrity and Compliance Officer, the IRB Chair, an authorized third party who has received appropriate training and certification for making exemption determinations, or an IRB member assigned by the Officer. The reviewer acts on behalf of the IRB in making an exemption determination.

If the IRB Chair assigns a protocol to a member for exempt review, the member is expected to review the study and identify the exemption category. If the study does not apply to an exemption, the study should be recommended for expedited or full board review. The member’s comments or requested revisions are sent to the IRB Chair within two weeks and are disseminated to the investigator in aggregate.

5.3.2 Expedited reviews

Expedited reviews are conducted by two IRB members assigned by the Research Integrity and Compliance Officer. Members are expected to review the study in accordance with federal regulation by using the checklist available in the application. The member’s comments or requested revisions are sent to the Officer within two weeks and are disseminated by the Officer to the investigator.

It is not anticipated that reviewers will be from the same field of study when reviewing applications. Studies are, as often as possible, assigned to a member from the same or similar field and someone from outside the field of the proposed research. This ensures a robust review that will touch on sound design and a fresh perspective on risks and benefits.

Expedited reviewers act on behalf of the IRB when conducting expedited reviews. While expedited reviewers can approve or require modifications to research, they cannot disapprove research. In instances when a reviewer does not feel comfortable approving research on behalf of the IRB, it can be recommended for full board review.

5.4 Is the research greater than minimal risk?

5.4.1 Full Board Review

If the study involves any kind of risk that is greater than minimal, it will be reviewed by the full board at a convened meeting. Please view section 3.0 Meeting expectations for more information.

6.0 Opposing Views

If a reviewer receives an application for review and feels the study has been inaccurately categorized, it is a reviewer’s right to question the determination. This helps all members continuously learn and improve the review process as well as assist in maintaining accurate records which follow federal regulation.