NASA Procedural Requirements

NPR 7100.1 Effective Date: March 28, 2003 Expiration Date: September 07, 2013

Subject: Protection of Human Research Subjects (Revalidated 7/7/08)

Responsible Office: Office of the Chief Health & Medical Officer

CHAPTER 5. NASA IRB Records

5.1 Preparation and Maintenance of Records

The IRB shall prepare and maintain documentation of its activities including the following:

5.1.1 Copies of all research proposals reviewed; scientific evaluations, if any, that accompany the proposals approved; final consent documents; progress reports submitted by PI's; and reports of illness or injuries to subjects.

5.1.2 Minutes of IRB meetings shall include members, alternates, and visitors in attendance at the meetings; actions taken by the IRB; the vote on these actions, including the number voting for, against, and abstaining; the basis for requiring changes in or disapproving research; a written summary of the discussion of controversial issues and resolutions of same; and a statement for each approved proposal that the proposal is approved and all IRB concerns have been addressed. Minority reports shall be filed in all cases in which there is no consensus.

5.1.3 Records of continuing review and monitoring activities.

5.1.4 Copies of all correspondence between the IRB, the investigators, and between other NASA Centers, including NASA HQ.

5.1.5 A list of IRB members identified by name, earned degrees, representative capacity, areas of proficiency such as board certification and licenses, and any current or previous employment or other relationship between each member and NASA or NASA contractors. A copy of this list and changes including IRB members' continuing education thereto shall be forwarded to the ANO yearly or as updated.

5.1.6 Written procedures for the operation of the IRB.

5.1.7 Statements of significant new findings provided to subjects, as required below by section 8.5.5 of this NPR.

5.1.8 Written procedures for assuring prompt reporting to the IRB and the ANO of any problems, whether anticipated or not, involving risks to subjects or to others; serious noncompliance or continuing noncompliance with NASA research policy, with the PI's protocol, or with the requirements of the IRB; or suspension or termination of IRB approval.

5.1.9 An annual report of IRB activities based on the minutes.

5.2 Record-Retention Requirement

IRB records relating to research conducted by an investigator shall be retained for at least 3 years beyond the last action of the IRB on that protocol or specific issue. The IRB shall retain records that shall then be dispositioned in accordance with NPR 1441.1, NASA Records Retention Schedules. All records shall be entered into a secure database, under the management of the Recording Secretary of the IRB, and accessible for inspection and copying by authorized representatives of NASA at reasonable times and in a reasonable manner. The information contained in the records and the database shall be maintained in conformity with prescribed NASA policies, guidelines, and procedures.

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