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Past Interpretations of the TCPS

Subject Record Retention: Departmental Reviews of Student Projects
Keywords departmental versus other levels of review, archiving, record retention in the TCPS, record retention in other norms and jurisdictions, parameters and considerations, undergraduate research
TCPS Articles 1.3, 1.8
Date February 2004

PDF Record Retention_Departmental Reviews of Student Projects_February 2004.pdf

1. Thank you for your question about the retention and archiving of records related to ethics approval of undergraduate research granted at the department level within your institution. Your inquiry has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for their advice1..

Departmental Versus Other Levels of Review

2. Your question focuses on record retention of reviews at the department level. While the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) has specified three levels of review (full review by the institutional Research Ethics Board [REB], expedited review, and department level review for undergraduate course based research), the intent is to consistently apply the same set of TCPS guidelines, including record keeping requirements and accountability, to all three levels. Our response therefore applies to all levels of review for the ethical conduct of research involving humans.

Record Keeping Under the TCPS

3. The TCPS does not set a specific period for the retention of records; rather, it outlines more requirements. Article 1.8 of the TCPS refers to taking and maintaining minutes of REB meetings, and indicates the need to have the minutes readily accessible for various administrative, documentary and legal purposes. The explanatory notes to the article also refer to the need to ensure accurate and fair administration and the integrity of the research process, by noting that the maintenance of satisfactory records and documentation is essential.

Record Keeping Under Other Norms and Institutions

4. In response to a similar request, and to understand record retention in a broader context, we consulted informally with organizations such as the National Archives of Canada2., federal privacy law sources, and a granting agency. The responses revealed retention policy standards of 2 to 10 years. (We emphasize that our inquiries were informal and not comprehensive.)

5. In addition, we are aware that laws sometimes affect the length of the retention period. For instance, Canadian federal law requires maintenance of records for 25 years under Division 5 of the Health Canada Food and Drug Regulations, which are specific to clinical-trial studies used in support of licensing a drug or device. In the United States, federal Department of Health regulations require (1) that research ethics committee records be retained for at least three years, and (2) that records relating to research conducted be retained for at least three years after completion of the research.3. The three-year benchmark in the US is echoed in the new standards for research ethics committees from the Department of Health in the UK.4.

Parameters and Considerations

6. This context suggests some parameters. In the absence of uniform Canadian standards, institutions are likely to base their archiving and retention policies on their operational needs and on the kind of research being conducted, as well as on financial, administrative and legal requirements. Institutions should define what constitutes “essential” records and documentation to meet those requirements. For instance, applications to an REB containing personal information that are subject to privacy and access-to-information laws may require the retention of information long enough to ensure that the individual to whom it relates has a reasonable opportunity to access it.

7. Furthermore, in making decisions on the archiving and retention of applications to an REB, it seems prudent to keep in mind other dimensions of research applications. Some applications, for instance, contain sensitive information. It may also be important to differentiate between files that receive a positive versus a negative decision. For negative decisions, the duration to retain files should allow time for possible appeals and reconsideration. Researchers who initially receive negative decisions may wish to resubmit an application to the REB at a later stage, and the REB may need to refer to previous applications. Consistent with the logic of article 1.8 of the TCPS, these different purposes may help define the particulars of retention policies.

8. As a first step, we suggest that you consult your institution’s records retention policy. In the absence of such a policy, or if the one you have does not apply to REB review documents, we encourage your institution to create a policy with records retention periods that follow regulatory and provincial requirements, yet respond to the institution’s operational needs. REB members with a legal background,5. or the legal counsel of the institution, may help research administrators and institutions identify the issues or expertise essential for developing a policy.

9. In view of the considerations embodied in the TCPS and based on emerging international norms and guidelines in other jurisdictions, we find it reasonable for institutions to adopt record retention periods for a minimum of three years after a research project concludes—subject, of course, to special circumstances and such factors as applicable laws and provincial regulations, type of research, and institutional requirements. We also advise keeping a log of what has not been retained. Please note that operational issues for REBs, which include keeping of records, is under consideration for potential development by PRE.

Summary

10. The TCPS applies consistently to all levels of review of ethical conduct of research involving humans within an institution. There is no explicit mention in the TCPS of a period of retention of records and documentation related to such a review, or to the details of what to archive. While uniform Canadian standards on the subject do not exist, there are models that can inform the development of standard operating procedures that meet the administrative, operational and legal requirements of the institution. Other elements need to be taken into consideration, such as the status of applications and the sensitivity of information in the applications. Your institutional records retention policy should be your first guide. In the absence of such a policy, or if the one you have does not address records of REB review, we encourage your institution to create a policy. We suggest that the minimum three-year period after the conclusion of the research adopted by other jurisdictions for similar purposes is a reasonable starting point in keeping with the spirit of the TCPS.

We hope you find this information useful in your deliberation of research ethics.

Sincerely,

Secretariat on Research Ethics,
on behalf of
The Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.
  2. Now Library and Archives Canada
  3. See 45 CFR 46.115.b, at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.115
  4. UK, Department of Health, Governance Arrangements for NHS Research Ethics Committees, July 2001, paragraph 7.8, at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/ PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/
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  5. See TCPS, article 1.3.c and Context of an Ethics Framework, E. (Ethics and Law) p. i.8.