2010-23517. Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues

AGENCY:

Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

The Office for Human Research Protections (OHRP), within the Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled, “Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues.” The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on the OHRP Web site at http://www.hhs.gov/​ohrp/​policy/​subjectwithdrawal.html or http://www.hhs.gov/​ohrp/​policy/​subjectwithdrawal.pdf,, is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance entitled, “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,” that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and organizations, and those comments were considered as the guidance was finalized.

DATES:

Comments on OHRP guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for a single copy of the guidance document entitled, “Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues,” to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document.

Submit written comments to COMMENTS ON SUBJECT WITHDRAWAL GUIDANCE, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to [e-mail] or via facsimile at 240-402-2071.

FOR FURTHER INFORMATION CONTACT:

Irene Stith-Coleman, PhD, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

OHRP, Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled, “Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues.” The guidance document provides OHRP's first formal guidance on this topic. The document is intended primarily for IRBs, investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by HHS.

The guidance document applies to non-exempt human subjects research conducted or supported by HHS. The guidance addresses the following six topics:

(1) What does it mean when a subject withdraws from a research study?

(2) May an investigator retain and analyze already collected data about a subject who withdraws from the research or whose participation is terminated by the investigator?

(3) Can investigators honor subjects' requests to have their data destroyed or excluded from any analysis?

(4) Should the withdrawal of a subject from a research study be documented?

(5) What is the relationship of this guidance to FDA's guidance on this issue and to the HIPAA Privacy Rule?

(6) When seeking the informed consent of subjects, what should investigators tell subjects about data retention in the event the subjects withdraw?

Of particular importance, the guidance document clarifies that when a subject chooses to withdraw from (i.e., discontinue his or her participation in) an ongoing research study, or when an investigator terminates a subject's participation in such a research study without regard to the subject's consent, the investigator may retain and analyze already collected data relating to that subject, even if that data includes identifiable private information about the subject.

The guidance document announced in this notice finalizes the draft guidance entitled, “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,” that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and organizations, and those comments were considered as the guidance was finalized.

In addition to the change in the title, the final guidance document differs from the draft guidance document that was made available for public comment in the following three key ways:

(1) All content regarding biospecimens that was included in the draft guidance document has been removed from the final guidance document. This change makes the final guidance document more harmonious with the Food and Drug Administration's (FDA's) corresponding guidance entitled, “Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,” which also focuses on data retention when subjects withdraw from research and is silent on issues related to biospecimens. Furthermore, research involving the banking and use of biospecimens for research purposes is a complex, evolving area of research. OHRP believes that guidance on the use of biospecimens obtained from subjects who subsequently withdraw from research should be addressed in the future by a more comprehensive guidance document that addresses more broadly research involving biospecimens. In the meantime, individuals with questions regarding how to handle biospecimens obtained from subjects who subsequently withdraw from a research study should contact OHRP by telephone at 240-453-6900 or 866-447-4777 or by e-mail at [e-mail].

(2) The final guidance document includes more examples of social and behavioral research activities in order to emphasize that the guidance applies to such research, in addition to its applicability to biomedical research.

(3) The final guidance includes a recommendation that investigators plan for the possibility that subjects will withdraw from research and that they include a discussion of what withdrawal will mean and how it will be handled in their research protocols and informed consent documents. Furthermore, the final guidance addresses the question of what investigators, when seeking the informed consent of subjects, should tell the subjects about data retention in the event the subjects withdraw.

For HHS-conducted or supported research that is regulated by FDA, FDA's guidance on this issue also should be consulted. FDA's guidance entitled, “Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials” can be found at http://www.fda.gov/​OHRMS/​DOCKETS/​98fr/​FDA-2008-D-0576-gdl.pdf.

II. Electronic Access

Persons with access to the Internet may obtain the guidance document on OHRP's Web site at http://www.hhs.gov/​ohrp/​policy/​subjectwithdrawal.html or http://www.hhs.gov/​ohrp/​policy/​subjectwithdrawal.pdf.

III. Comments

Interested persons may submit comments regarding this guidance document to OHRP at any time. Please see the ADDRESSES section for information on where to submit written comments.

Dated: September 15, 2010.

Jerry Menikoff,

Director, Office for Human Research Protections.