3 Comments
HHS announced that the comment period for the Common Rule Notice of Proposed Rulemaking (NPRN) has been extended to January 6, 2016 in response to a community request for more time to review the proposed rule.
The NPRN seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The proposed rule is intended to modernize, strengthen, and make more effective the federal policy for the protection of human subjects.
Learn more about the proposed rule from the HHS Office for Human Research Protections (OHRP).
I read the comment raised by ethicists publicly against some of the changes.
The problem is that we need response from subjects, not from lawyers who may protect the unlikely rare event but not the majority of subjects.
1) My subjects 25 years ago were consented with a 2 page form they actually read before signing. I now have a 12 page form, most dictated by my IRB, and not understandable by me let alone a 6th grader (not the part I write, the part the IRB template is). I completely agree with the suggestion to simplify the consent. Studies have shown that most subjects don’t read the consent. Ann Intern Med. 2011 Sep 6;155(5):316-22.
2) In a minimal risk study (noninvasive) of a colleague, in anticipation of the common rule, the study sites were doubled in a few months, while until then, it was a painstaking process to work with every IRB on the exact verbiage they wanted at each site for the same protocol. I don’t see the argument of “local conditions” – the law is the same all over the US, if we are talking noninvasive low risk studies, or clinical studies using routine procedure, the common rule should apply. We are not, and should not, talk about other countries – using a US consent in China or Africa is culturally impossible, and vice versa.
3) Subjects don’t like re-consenting. Until recently, our (and most US) IRBs explicitly wanted us to say what we wanted to do and not leave it open to new research directions. We weren’t allowed to use cell lines from one set of subjects as controls for the other set. Please allow consenting for unspecified research on blood samples or saliva. If subjects have a concern later, they can change their mind, and it happens, but with protections such as GINA in place that will not make it easy to discriminate if the unheard of accident happens and a subject is found out somehow. Studies show that the anxieties raised by consents and lawyers are largely unfounded, at least in genetics.
4) Be realistic, where was harm done? Gelsinger, on many accounts, for sure. Treat truly risky trials different that no or minimal risk research, don’t use the same consents for both
I had a brain tumor removed at a large teaching/research hospital and signed a consent form donating the tissue for the hospitals tissue bank. I was asked if I wanted the sample back after it was no longer needed, I declined. I must admit my hoped was that my consent would help future research into tumors similar to mine. From my perspective, once I gave my consent it was no longer mine. But I can see how many people would not feel this way and it is incredible important to make sure that the donors have a broad variety of consent forms, not just one. The forms must be clear, short, and state the intent/research completely.
I was, and am, happy to donate all material from my lumpectomy for triple-negative breast cancer, in the hope that this would help find ways of treating this aggressive cancer. I can’t imagine not wanting to help research aimed at treating illnesses. I do wish, though, that there were a way to insure that profits from the use of such donated tissues are required to be put back into research. Patients like me donate such tissues for free in order to help others who are ill, not to generate handsome profits for individual researchers, institutions, or businesses.