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.

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.

He was supposed to use an unproven medical device when trying to resuscitate my husband David after he had a heart attack in October.  

The paramedic was so busy trying to save Dave’s life, though, that he forgot to make Dave a guineau pig for the medical profession and a medical device manufacturer. It is difficult to describe how immensely relieved I am.

Dave, despite my continuing objection, is part of a nationwide study is underway to determine whether the manufacturer’s device improves resuscitation outcomes in cardiac arrest cases. Some study subjects get the device, which may or may not help them; others get a sham device — a placebo, in essence — that researchers know won’t help. The study also is trying to determine whether doing CPR longer before administering shocks to cardiac patients improves resusciation rates.

As soon as the paramedics walked into our house the day Dave was stricken, he became part of the study without our knowledge or consent.  He got the longer CPR and was supposed to get the device but did not, according to Medical College of Wisconsin records. MCW is running the Milwaukee branch of the study.

The device could not have saved Dave. His brain had gone too long without oxygen and the damage already was done. He died six days later without regaining consciousness.

I have been trying to get all of Dave’s data removed from the study ever since learning, more than a month after he died, that he was shanghaied into it. So far I’ve been unsuccessful. The Medical College, which has acknowledged errors in the way Dave’s case was handled, has declined to remove all of the data, citing federal guidelines. College reps say they will expunge the data if I can get specific federal waivers. So now I’m working on that, but am not optimistic – the guidelines are written for researchers by researchers to enable research. Once you are in a study, even if you weren’t asked, you can’t get out.  (The guidelines are non-binding, but the Medical College adheres to them.)

Here are some key parts of the Food and Drug Administration guidelines…

FDA recognizes that a subject may withdraw from a study; however, the withdrawal does not extend to the data already obtained during the time the subject was enrolled. FDA’s longstanding policy has been that all data collected up to the point of withdrawaI must be maintained in the database and included in subsequent analyses, as appropriate…

There is particular concern with a study’s reliability when subjects withdraw their data in a non-random way because they are unhappy with their experience, either because they failed to obtain a desired effect or suffered an adverse event. Loss of these subjects’ data could greatly distort effectiveness results and could hide important safety information (for example, toxicity) of a poorly tolerated treatment. 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…

And, in a footnote, the FDA says:

It should be appreciated that FDA’s response applies to the most potentially difficult situation, that is, studies involving an exception from the informed consent requirements in which subjects, due to a life threatening medical condition, are unable to provide informed consent to participate in the study. Subjects may subsequently withdraw from such studies, but the data collected up to withdrawal may not be removed….

Yeah, but what if you wind up in a study through unscrupulous conduct, or mere incompetence or negligence? What if a researcher did not seek permission from a patient or the patient’s family simply because said researcher needed more subjects?

Tough luck. The only consequences are those borne by the patient and family.

Consider the ethical and practical ramifications of no-consent studies.  If that resuscitation device was used on David, I would always wonder if that is what kept him alive, in a coma, for six agonizing days while we — his family members — struggled with tremendously, tremendously difficult decisions. The paramedic’s devotion to duty over research means that we don’t have to live with that uncertainty, and I am so very grateful for that.

What if the device was used and Dave was revived just enough to remain in a vegetative state for years and years and years? The Medical College folks tell me that researchers are aware of that possibility and will shut down the study if it looks like the device is making that happen. Still, by the time it’s detected, it has already occurred, and then what?

Does the Medical College pay the bills? And how does it compensate for the continuing pain endured by the family? In the meantime, how does it reassure families that the device is not responsible for those kinds of outcomes?

Or do the researchers just go on to the next study, ignoring the wreckage they’ve left behind?

The construct of the study also, of course, means that patients who could potentially benefit from the device will get the placebo instead. That’s the flip side of the same ethical issue.

Whatever happened to “First, do no harm”?

That is the very short version of why the Medical College of Wisconsin did not inform me for more than a month that David was enrolled without his or my consent in a medical study when he had a heart attack. His chart was misfiled in a non-urgent category and staff did not get back to it for about three weeks. College officials could not explain, though, why it took 11 days to mail the notification letter to me after it was written.

Far more importantly, that heart attack not only took Dave’s life — it also apparently took away our rights to decline to participate in a medical study. The Medical College folks are still looking into it, but believe that federal rules will not allow them to disenroll Dave entirely from the study he was dragged into when paramedics started working to revive him.

I want to thank Tom P. Aufderheide, who is heading up the study at the college, and David Clark, assistant dean of clinical research there, for meeting with me yesterday. They explained what happened in Dave’s case, apologized for the notification screw-up and said the matter was being referred to their own Institutional Review Board. They asked for my suggestions to improve the notification process, and said they would remove David from the study from the point they should have contacted me — 12 to 24 hours after he was stricken. They said they did not think the feds would allow them to erase him entirely from the study.

Now that is totally unsatisfactory. While federal regulations allow family members an opportunity to decline to have their loved one enrolled in a study, Dave may be trapped in a bureaucratic twilight zone simply because he had a heart attack.

The regulations say this:

 If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject’s family member who is not a legally authorized representative, and asking whether he or she objects to the subject’s participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review. (Emphasis added)

Except, said Aufderheide, there is no therapeutic window with heart attacks. Immediate intervention is needed; no one can wait 20 minutes for the family and emergency responders to wrap up their discussions about participating in study. (The college’s protocol for the study, though, does have one reference to a therapeutic window. A section discussing resuscitation techniques says that ”Several investigators have utilized this period of chest compressions as a therapeutic window…”)

I understand the need for immediate action. I can also understand the reasoning that went into the research team’s decision to wait 12 to 24 hours after someone suffers a heart attack to try to contact the family. When the college tried to contact families at the hospital right away, family members were concerned about whether their loved ones would live or die and not about some damned study.

That college’s decision to delay contact, though, seems to directly contradict the intent of the regulation, which is to allow patients the opportunity, either through their own wishes or through direction from the family, not to be enrolled in the study.

It may well be very impractical for the Medical College to seek immediate permission to enroll a heart attack patient in the study, but at some point patients and families have to have the right to remove their information entirely from the study.  The feds have to recognize that.

In America, we don’t conduct medical experiments on people without their consent. Do we?

The purpose of the letter, it said, ”is to inform you that Mr. Doege participated in an out-of-hospital study with the Milwaukee County paramedics.”

This was the first I’d heard about any study. David never regained consciousness after his Oct. 19 heart attack and could not have volunteered.

“In emergent situation, it is not possible for us to obtain informed consent from the participant in this research,” the letter said. “Therefore, prior to the start of this study, the Milwaukee community was notified of the specifics of the research through the local media such as the Milwaukee Journal Sentinel.”

It turns out that if David did not want to participate in this study he should have notified the Medical College as far back as November 2007, more than a year before he had his heart attack, when the Medical College published a notice in the newspaper.

Doesn’t make much sense, does it? Any process that is so offensive to common sense is probably a bad process. And the idea that a medical institution can enroll you in a study just because you cannot say ‘no’ is a very scary concept.

I am trying to say ‘no,’ but the Medical College of Wisconsin may not allow me to do so. I have requested that David be removed from the study, but it is not clear at all that MCW will respect my request. 

There are a couple of reasons I’m trying to say no. Dave and I agreed that the involuntary enrollment process was problematic, at the very least. We actually discussed it one day after something about it was in the newspaper.

The Medical College also simply did not give me a reason to support the study or David’s inclusion in it. Its letter essentially said “Yeah, we did some stuff with your husband and we’re finally getting around to telling you.”

The letter itself did not give the first clue as to what the study was about (I assume that is because the lack of detail makes the mail merge so much easier). It instead said I should check out a web site, or call or write. I opened the letter on Wednesday evening, the start of the Thanksgiving weekend. I obviously have Internet access, so at least could immediately get an idea what the study involved and did not have to spend four days wondering what the hell they had done to my husband and whether he suffered because of it.

I read about the study on the web site and I read the federal regulations, to which the letter also referred me, that control what must be done if researchers want to do a study without the informed consent of its subjects.

And yesterday I called the Medical College to request that it remove David completely from its study.

I may be too late. The MCW representative I talked to said David was already IN the study and the only thing left to object to was his continuing involvment, which won’t happen anyway since he died.

That’s not how it is supposed to work, though. The regulations cited in the MCW’s own letter, as I pointed out to the Medical College guy, include this requirement:

The conditions imposed by the federal regulations are, on a practical level, impossible to meet. Is it believable that Medical College personnel did not know this from the beginning of the study or do we simply have here a little wink and a nod at the regs so the researchers get to do what they want to do anyway?

Here is what the college’s own protocol for the study says:

When a subject has been enrolled, paramedics will call the research personnel via cell phone. Paramedic base operations will also call research personnel to alert them to subject enrollment. Research personnel will go to the receiving hospital to attempt contact with the subject’s LAR (legally authorized representative) or family as appropriate to inform them of subject’s enrollment into the study.

Whoopsie. Didn’t happen, at least that last part.

Another section says:

The Research Team will provide information about the emergency research study to the patient or their representative at the earliest feasible opportunity after administration of the intervention. (emphasis added)

And here, just for laughs, is one more:

In the event the subject is not competent to participate in the process, written informed consent will be acquired by the research team from a family member or the individual with durable power of attorney, (LAR), for healthcare decision-making. The informed consent process will be conducted by trained members of the research team and will begin during the first three days of the patient’s hospital stay. (emphasis added)

David was in the hospital for six days. Members of his family were there for hours and hours each day. I know of no effort by the Medical College to contact any of us.

When I told Mr. Medical College during our phone conversation that I did not want David in the study, he  asked me if I had power of attorney to make that decision for David. When I referred again to the family consent portion of the regulations, he snapped, ”I was just asking!”

The college learned that David died Oct. 25 when it contacted the hospital on Nov. 10, according to Mr. Medical College. The college, he said, sent its letter to me that day.

But, but, but … the letter was dated the 10th, but it was postmarked the 21st, meaning that it sat around for 11 days before someone got off his or her lazy ass and put it in the mail.

Our conversation did not end well. Mr. MCW’s voice, while not rising to the shout level, got a lot louder than an everyday conversation level as he insisted David was already in the study and SO THERE!  When I said I wanted David’s privacy respected, he demanded to know what definition of privacy I was using. 

 I told him again that I did not want David’s data included in the study. I told him I wanted the college to remove it. I told him I wanted the Medical College’s confirmation that it had done so in writing.

He took my contact number and said someone would be in touch to let me know if my request would be granted. The notification might be in writing or it might not be, he said.

So far, I haven’t heard anything. Maybe our fine medical researchers will wait another month or so to let me know what is going on.

And I’m left here wondering why we’ve given so much power to medical reasearchers. They are involuntarily enrolling people who are at their most vulnerable into medical studies on the absurd premise that it is a reasonable to require people to opt out a year or more in advance, even though they have no idea they will become eligible to participate.

The information needed to opt out is in an ad in a newspaper that most people do not get. And what if someone is visiting from out of town and weren’t around when the ads ran? Too bad for them, I guess.

Those who do opt out of the study can wear wristbands telling medical personnel that very thing. How many wristbands might one end up wearing if one opts out of all such non-consent studies?  

I understand the need for medical research. I also understand the abuses that have occurred disguised as medical research. The power to conduct studies on people incapable of either objecting or agreeing to participate invites abuse. 

The disregard of protocols in conducting the research is abuse. There have been larger abuses, surely, but the failure to inform and involve families in the manner promised is an abuse.

And as for the Medical College of Wisconsin, the answer is still “no.”

That is, if I have anything to say about it.