6. CUHS Records

6 CUHS Records

6.1 Minutes of CUHS Meetings

6.2 Membership Rosters

6.3 Records Retention Requirements

6.4 Written Procedures and Guidelines

6 CUHS Records 

The staff of the CUHS must prepare and maintain adequate documentation of the Committee’s activities and copies of all items reviewed, including but not limited to any of the following: 

• applications for approval of research; 

• protocols; 

• investigators’ brochures and recruitment materials; 

• scientific evaluations that accompany the proposals; 

• approved consent documents; 

• DHHS-approved sample consent documents and protocols; 

• approved HIPAA Authorization documents, if separate from the informed consent documents; 

• proposed amendments and the CUHS’s action on each amendment; 

• progress reports submitted by investigators; 

• reports of injuries to subjects and serious and unexpected adverse events; 

• documentation of protocol violations and actions taken by the CUHS in response; 

• documentation of non-compliance with applicable regulations. 

• For initial and continuing review of research by the expedited procedure: 

o The specific permissible category. 

o Description of action taken by the reviewer. 

o Any findings required under the regulations. 

• For exemption determinations cited the specific category of exemption. 

• Determinations required by the regulations and protocol-specific findings supporting those determinations for. 

o Waiver or alteration of the consent process. 

o Research involving pregnant women, fetuses, and neonates. 

o Research involving prisoners. 

o Research involving children. 

• For each protocol’s initial and continuing review, the frequency for the next continuing review 

CUHS records must also include continuing review activities and copies of all relevant correspondence between the CUHS and investigators. If there are significant new findings relevant to subjects’ participation in the research, they will be provided to subjects, maintained with the related research proposal and, when reviewed at a CUHS meeting, documented in the minutes. 

6.1 Minutes of CUHS Meetings 

Proceedings must be written and available for review by the members in advance of a subsequent scheduled CUHS meeting date. Once approved by the members at a subsequent CUHS meeting, the minutes may not be altered by anyone at the University. Minutes of CUHS meetings must contain sufficient detail to show: 

1. The presence of a quorum throughout the meeting, including the presence of one member whose primary concerns are in a non-scientific area; 

2. Attendance at the meetings, including those members or alternate members participating through videoconference or teleconference, and documentation that those attending through videoconferencing or teleconferencing received all pertinent material prior to the meeting and were able to actively and equally participate in all discussions; 

3. Alternate members attending the meeting and for whom they are substituting; 

4. Actions taken by the CUHS, including those involving full review; 

5. Separate deliberations, actions, and votes for each protocol undergoing continuing review by the convened CUHS; 

6. Documentation that the research meets the required criteria [45 CFR 46.116(d)] when approving a consent procedure that does not include or that alters some or all of the required elements of informed consent, or when waiving the requirement to obtain an informed consent, along with protocol-specific findings justifying each of those determinations; 

7. Documentation that the research meets the required criteria [45 CFR 46.117(c)] when the requirements for documentation of consent are waived, along with protocol-specific findings justifying each of those determinations 

8. When approving research that involves populations covered by Subparts B, C, or D of 45 CFR 46, the minutes will document the CUHS’s findings regarding the determinations stated in the Subparts along with protocol-specific findings justifying each of those determinations, or the CUHS’s agreement with the findings and justifications as presented by the investigator on CUHS forms. 

9. The vote on actions, including the number of members voting for, against, and abstaining; changes in the number of members if they join, leave or rejoin the meeting shall be noted, along with the effect on the quorum, if any. 

10. A note indicating that when a CUHS member has a real or potential conflict of interest (see Section 7.5.7.) relative to the proposal under consideration, that the CUHS member was not present during the deliberations (except to answer questions from other CUHS members) or voting on the proposal (and that the quorum was maintained); 

11. The basis for requiring changes in or disapproving research and documentation of resolution of these issues when resolution occurs; 

12. A written summary of the discussion of controverted issues and their resolution; 

13. Review of additional safeguards to protect vulnerable populations if entered as study subjects when this is not otherwise documented in CUHS records; 

14. The determination of the level of risk, if not recorded elsewhere in CUHS records; 

15. The frequency of continuing review of each proposal, as determined by the CUHS, if not recorded elsewhere in CUHS records; 

16. Documentation, as required by 45 CFR 164(i)(2), indicating the approval of a waiver or alteration of the HIPAA Authorization; 

17. Key information provided by consultants (unless separately documented in a report provided by the consultant). 

18. Justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in a DHHS-approved sample consent document. 

6.2 Membership Rosters 

A membership list of CUHS members must be maintained and must identify members sufficiently to describe each member's chief anticipated contributions to CUHS deliberations. The list must contain information including a member’s name, earned degrees, status as scientist (physician-scientist, other scientist, social/behavioral scientist, or non-scientist); voting status, status as chairperson; representative capacities in terms of whether the member is knowledgeable or experienced in working with specific vulnerable populations; affiliated or non-affiliated status (whether the member or an immediate family member of the member was affiliated with the organization); indications of experience sufficient to describe each member’s chief anticipated contributions; employment or other relationship between each member and the organization; alternate status; the primary members or class of primary members for whom each alternate member could substitute. 

The CUHS Office must keep the membership list current. 

The CUHS Office must provide an updated CUHS membership list to the Office for Human Research Protections, Department of Health and Human Services, and to its Institutional Official, when there is a membership change. 

6.3 Records Retention Requirements 

The records described in this section will be stored securely in the CUHS Office and will be retained for at least three years; records relating to research that is conducted, shall be retained for at least three years after completion of the research. If a protocol is cancelled without subject enrollment, CUHS records are maintained for at least three years after cancellation. Permanent records of CUHS actions, including agendas and minutes, are retained according to the University’s General Records Schedule. 

All records must be accessible for inspection and copying by authorized representatives of the federal OHRP, the FDA, and other authorized entities at reasonable times and in a reasonable manner. 

Any destruction of CUHS records will be carried out in a manner that ensures their security to the point of destruction. 

6.4 Written Procedures and Guidelines 

The University Area Policies and Procedures for Human Research Protection detail the policies and regulations governing research with human subjects and the requirements for submitting research proposals for review by the CUHS. 

These policies and procedures also detail: 

1. Written procedures that the CUHS must follow for: conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous CUHS review; ensuring prompt reporting to the CUHS of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which CUHS approval has already been given, may not be initiated without CUHS review and approval except when necessary to eliminate apparent immediate hazards to the subject. 

2. Written procedures for ensuring prompt reporting to the CUHS, appropriate institutional officials, and the federal Department or Agency head of any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance with 45 CFR 46 or the requirements or determinations of the CUHS suspension or termination of CUHS approval. 

These policies and procedures contain the most current information for reference by investigators and their staff as they plan and carry out research; however, this is not a static document, and it should be read in conjunction with the University’s September 22, 2003 Vote. These policies and procedures are subject to annual review and revision by the CUHS, in consultation with the Associate Provost for Research Policy and Institutional Compliance and University counsel. 

The CUHS Office keeps the University Area research community apprised of new information that may affect the human research protection program (including laws, regulations, policies, procedures, and emerging ethical and scientific issues), on its website, through campus electronic mailing lists, and through in-person training, education, and forum sessions. All relevant policies and procedures are available on the CUHS website and paper copies are made available upon request. See http://www.fas.harvard.edu/~research/hum_sub/