Here are my comments on proposed US Department of Health and Human Services’ “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.”

The proposed guidelines include inadequate protections for the patient and his or her family. While both these guidelines and FDA guidance protect the research and the researchers, they do not fully protect the patient and family.

The FDA’s guidelines (Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials) cite concerns that allowing data to be deleted from studies will make them scientifically invalid. The guidelines state that “allowing subjects to withdraw data could even provide an opportunity for unscrupulous parties to ‘improve’ study results by selectively encouraging certain subjects to withdraw from a study.”

While that is a valid concern, the guidelines are silent on data that is collected through improper or unethical means. The  stringent prohibition on expunging data could even provide an opportunity for unscrupulous or indifferent parties to deliberately violate notification procedures or be negligent in applying them.

In these instances, patients or families ought to be able to expunge data entirely from the study. There must be consequences for researchers and protections for patients and families when subjects are improperly enrolled in no-consent studies. While it is true that participation in a study cannot be undone, it is also true that a society that can expunge criminal records can expunge improperly obtained medical records as well when circumstances indicate its appropriateness.

HHS guidance should make provision for patients or families to opt out of no-consent studies entirely when enrolling the patient involved negligence or misconduct on the part of the researchers.

This issue has been near and dear since I learned Nov. 26 that my husband was enrolled, without his consent or my consent,  in a medical study after he had a heart attack at home Oct. 19. David died Oct. 25 without regaining consciousness. When I requested that his medical records be expunged, the Medical College of Wisconsin turned me down, citing guidance from the Food and Drug Administration and the the proposed guidance from the Department of Health and Human Services. I’ve written to the FDA to appeal the ruling to seek a waiver from the guidance.

You, too, can comment on the pending HHS guidelines if you wish. The deadline is Jan. 30.

Comments, according to HHS,  may be submitted by any of the following methods: (1) E-mail to discontinueparticipation@hhs.gov and include “Guidance on Discontinuation of Subject Participation” in the subject line; (2) Fax: 301-402-2071; (3) Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

More information is available here.