Institutional Review Board

About the IRB  |  Member Information

A.Member Responsibilities

The membership must have at least five members with varying backgrounds and with the competence required to review the research proposals, including:

Chairperson (Chair)

Alternate Chairperson (Alternate Chair)

Biomedical life scientist

Flight surgeon/ Physician

Attorney

Representative from the Safety & Mission Assurance Office (S&MA)

Astronaut

A non-scientist

A non-NASA employee from the bioethics or health profession community

The JSC Center Director appoints the members of the Committee yearly.

The member position filled by a non-life-sciences employee may be rotated among the Center directorates and offices.

One member must not be affiliated with JSC and must not be a member of a immediate family of a person who is affiliated with NASA.

The Protocol Compliance Officer (PCO) is a physician who serves as medical monitor for the Committee and ensures that all experiments are conducted in accordance with IRB requirements. The PCO routinely monitors tests as a representative of the IRB and is a voting member of the Committee. In this role, the PCO is fully authorized to halt any research or test activity that is judged to be in violation of IRB recommendations, accepted medical practice, or accepted safety guidelines.

The Secretary provides administrative support for the Committee. The secretary prepares the official minutes of the IRB meetings, and distributes agendas, proceedings, and action items.

The Chair may designate a Committee member as acting Chairperson for meetings or portions thereof.

The IRB may invite individuals 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 on the IRB.

All members of the IRB are voting members and are expected to attend the regularly scheduled meetings. A majority vote of the members present is required for protocol approval. The Chair will vote only in the event of a tie.

The IRB is autonomous and impartial. Committee members may not be added or deleted to alter membership for the purpose of influencing a decision. Individual members must feel free to express opinions and concerns without fear of career repercussions.

No IRB member may participate in the initial or continuing review of any protocol in which that member has a conflicting interest, except to provide information requested by the Committee. Conflicts of interest include role as a principal investigator (PI), co-investigator (Co-I), immediate supervisor, or relative of the investigator(s).

Members may abstain from voting if they are not technically familiar with aspects of a protocol.

Members may participate in formal, announced visits to facilities conducting IRB-approved investigations. At the direction of the Chair, Committee members may make an unannounced visit to observe tests in progress, to ensure that IRB recommendations are being followed.

B.Quorum

IRB meetings are open meetings and require a quorum of 50% of the members to vote on the proposals. A simple majority vote of the members present is required for approval.

Abstention: to refrain from participating or voting by one's own choice.

The member may choose to not participate but is not required to do so.

A member who abstains is part of the quorum.

An abstention should be recorded in the vote totals to show presence of a quorum.

Recusal: to disqualify oneself as judge in a particular case or, more broadly, to remove oneself from participation to avoid a conflict of interest.

The member may not participate, and he or she has no choice in the matter.

A member who is recused is no longer a part of the quorum.

An IRB member who has a conflict of interest in a research project must recuse himself or herself from voting.

C.Memorandum of Understanding (MOU) – JSC IRB and Payload Safety Review Panel (PSRP)

To define and clarify the joint responsibilities of the JSC Institutional Review Board (IRB) and the NASA Payload Safety Review Panel (PSRP) in reviewing NASA-sponsored experiments involving human research subjects. The IRB shall combine their biomedical expertise with the technical expertise and engineering capability of the PSRP in an effort to ensure that NASA-sponsored experiments involving human subjects (i.e., human physiology experiments) are safe.

Memorandum of Understanding

D.Meeting Details

Overview

Full Committee review is used for:

All protocols of more than minimal risk, both initial and renewal;

Action item responses to previously reviewed proposals;

Major modifications to protocols of more than minimal risk;

Selected expedited protocols;

Adverse events and incident reports.

Subcommittees may review:

Expedited review protocols, initial and renewals,

Minor modifications of reasonable risk or minimal risk protocols,

Selected adverse event reports.

Studies involving no greater than minimal risk

Studies which fall into specific categories, including blood sampling by finger stick or venipuncture from healthy individuals, collection of data through noninvasive procedures routinely employed in clinical practice (not involving sedation), low risk behavioral research, and hardware evaluations.

Full committee meeting minutes include:

Minutes of previous IRB meeting

Expedited and subcommittee review summaries,

Permanent records of all Committee actions

Distribution list, including NASA Headquarters, JSC management, IRB members, meeting attendees, and action assignees.

Unattributed individual Committee member comments and votes.

The IRB Chair meets with the Institutional Official on a regular basis to summarize the protocol reviews and actions.