The US Department of Health and Human Services is seeking public comment on proposed new guidelines that would deny patients and their families the right to entirely withdraw from medical studies even when patients were enrolled improperly or without the knowledge or consent of the patients or families.

Federal “guidance,” as this proposal would be, often is seen by those it guides as coming down from the heavens. The guidance offered, in short, is perceived as mandatory, not optional.

I have been trying to get the records of my husband, David, expunged from a medical study since I learned Nov. 26 he was enrolled essentially from the moment the paramedics walked in our front door on Oct. 19 after he had a heart attack. David died Oct. 25 without regaining consciousness. Although I was standing a few feet away, nobody thought to mention to me that David was officially a guinea pig. (More on this here and here and here.) My latest effort involves writing to the US Food and Drug Administration and asking that David’s records be expunged from the study. I don’t really expect to be successful, but feel the need to try.

There are two parts to proposed guidance that pretty much say that once researchers get you in one of these studies, you will remain there no matter what egregious behavior got you enrolled in the first place.

First, there is a note attached to the guidance:

OHRP believes the interpretations provided in the proposed draft guidance below are harmonious with those provided in FDA’s final guidance document. In particular, FDA’s guidance document explains that under applicable FDA law and regulations, data collected on study subjects enrolled in an FDA-regulated clinical trial up to the time of subject withdrawal must remain in the trial database in order for the study to be scientifically valid. Likewise, OHRP’s proposed draft guidance clarifies that when a subject informs an investigator of his/her decision to discontinue participation in research, or an investigator decides to terminate a subject’s participation regardless of the subject’s consent, the investigator may continue to analyze already collected individually identifiable private information about that subject.

Then the guidance makes clear that once researchers have information, they can keep using it.

When a subject chooses to completely discontinue participation in a research study, or an investigator decides to completely terminate a subject’s participation in a research study without regard to the subject’s consent, the investigator may continue to analyze individually identifiable private information about that subject or data that was derived by the investigator through a previous use or test of that subject’s individually identifiable biological specimens prior to the subject’s decision to discontinue participation in a study or prior to an investigator’s decision to terminate a subject’s participation without regard to the subject’s consent,, provided the analysis of such private information or data was described in the IRB-approved protocol.

It still strikes me as just flat wrong to allow medical researchers to enroll patients in studies without their consent just because they are not able to respond. If enrollment is the first step, then somewhere along the way, patients or their families should have the right to say “no.” Completely. From the beginning. Retroactively. If criminal records can be expunged, then surely medical records can be expunged as well.

The deadline for comments is Jan. 30. They can be emailed to discontinueparticipation@hhs.gov (include “Guidance on Discontinuation of Subject Participation” in the subject line); faxed to 301-402-2071; or mailed to Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.