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I frequently find notices in my local newspaper from researchers who are in the process of doing follow-up research on some study that they conducted a few years back. There, they provide an overview on the research topic at hand and give the participants a chance to opt-out of the follow-up piece. Otherwise, they are included by fetching data from their medical records.

To me, this practise seems questionable. If I were to guess, only a minority of the people involved in the previous study are likely to come across the notice.

Is this ethically sound? If not; what are the alternatives?

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    I would hope that all other avenues of attempted contact have been attempted before this is, i.e. they made their best effort and this is their last attempt. – Compass Jul 14 '15 at 18:30
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    Of course, this may have been covered in the consent to the original study. Some level of 'public notice' may be required, and you would not be party to any private communications. – Jon Custer Jul 14 '15 at 19:53
  • It seems to violate informed consent – aussetg Jul 15 '15 at 8:09
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    I strongly suspect that this is the situation @Compass mentions. Making a newspaper announcement after previous attempts at communication have failed a) means that you've made a good-faith attempt to notify the relevant people, even if it's unlikely to succeed, and (just as importantly) b) provides a public demonstration that you've done so in case of future objections. If you can reasonably assume they would have consented had you been able to reach them, you can now say "we've done all we possibly can" and go ahead. – Andrew Jul 15 '15 at 13:34
  • In California, if you want to make a certain class of corporation, you are legally required to take out a newspaper ad for a certain period of time (on the order of weeks). I wouldn't be surprised if somewhere, someone has a guideline that says that you need to do the same for certain studies. – chipbuster Jul 16 '15 at 2:35
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You'd need to obtain the first informed consent and examine the wording. If the informed consent does state that the collected samples or information may be used for other research-related purposes and the new projects will be announced on some specified channels, then the researchers have fulfilled their due diligence.

The problem being the general participants are really not very well-informed when it comes to providing biological specimen or medical records. For example, most of them may not realize that their samples can reveal a lot more as technology evolves. Unlike a questionnaire or an interview, the respondents know clearly what's written and said, but they may not realize what their blood or DNA can reveal, or what they can reveal a few more years down the road when molecular technology further develops, and the researchers want a re-analysis.

The researchers are usually not to blame, however, as they are probably equally clouded by the ever-changing hot topics. There are many occasions that a study was set up to test compound A, but fearing that compounds B, C, D... etc. may be the next scientific focal points, the researchers may opt for writing in the "opt out from reanalysis" statement into the consent form even they are not entirely sure what are to be reanalyzed and even if that analysis will ever happen. As for why opt out but not opt in, part of the reason is cost control: It's extremely difficult to track people down and collect a consent form again. For that, I can empathize.

If you will potentially be one of these studies' participants and are worried about this opt out mechanism, do realize that you don't owe them anything and you are completely free to walk away or require an amendment to limit the use of your samples, or request your sample or copies of record be destroyed after the study. The worst is that they will say no and you'll walk away without a chance to participate or receive the stipend. However, you'll have your peace of mind.

So to answer your question, this practice is defensible as other mechanisms can be cost-prohibitive. However, I personally do not feel it is entirely fair as I am doubtful that the participants fully know the consequences and their rights when it comes to giving biological samples or related medical records. Guidelines are being developed, and hopefully more education on how to be an informed participant will happen.

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