Turn and face the strange
Dr. Jerry Menikoff, M.D., J.D.
Office for Human Research Protections
Department of Health and Human Services
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Re: Comments on Docket No. HHS-OPHS-2011-0005
Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
76 Federal Register 44512 (proposed July 26, 2011) (to be codified in Title 45 CFR parts 46, 160, and 164).
Dear Dr. Menikoff:
Thank you for undertaking the long-overdue task of reforming the way in which research involving human participants is governed in this country. You and your colleagues are to be commended for your efforts. Your critiques of the current system, made manifest by the Common Rule over the last 20 years, are right on the money:
Minimal-risk research is over-regulated at the expense of genuinely risky research
Multi-site studies suffer from redundant review by multiple IRBs
The informed consent process has gone haywire: forms are long, complicated, opaque and focus on protecting institutions rather than individual research participants
Privacy rules are inadequate for a postgenomic world
The current system does not allow for efficient data collection so that existing regulations can be monitored and adjusted on an iterative basis
Under the current system some high-risk studies, such as those that are not federally funded, escape oversight altogether
There is disharmony: Researchers often find it impossible to honor the letter and/or the spirit of different and sometimes-conflicting regulatory regimes (e.g., the Common Rule and HIPAA)
Anyone involved in research on human beings in any capacity would be hard-pressed to dispute the truth of these seven criticisms.
That said, based on the analysis and proposed remedies set forth in the Advanced Notice of Proposed Rulemaking, I am deeply concerned that HHS is in the process of missing a major opportunity to reimagine and improve the entire human participant research enterprise. Instead I fear that the Department has succumbed to an ad hoc approach that will, sooner or later, be exposed: it will come to be seen as a failure to address the deep-seated systemic flaw that has led to frustration and dissatisfaction on the part of both investigators and participants.
The ANPRM's self-described mission is to find ways "to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay and ambiguity for investigators." While noble on its surface and perhaps salutary in the short term, this goal offers little long-term hope of unburdening investigators or keeping the taxpaying public financially and emotionally invested in research. Why not? What is missing is the rhetoric of collaboration. Of partnership.
If, as research participants, we are worthy only of "protection" and not engagement or education, then we will remain, in the words of Kohane et al (Science. 2007 May 11;316(5826):836-7), "passive, disenfranchised purveyors of biomaterials and data." The disenfranchised, it seems to me, are unlikely to blossom into loyal constituents.
Similarly, if researchers are not encouraged—or obliged—to transcend their treatment of participants* as repositories of data to be mined or worse, bureaucratic hurdles to be overcome, then those researchers are destined to be disappointed. Participants who give of their time and biological materials—to say nothing of their tax dollars—without any eventual promise that they or their descendants will benefit, cannot be expected to roll up their sleeves forever, can they?
In his 2010 Presidential Address to the American Society of Human Genetics (Am J Hum Genet. 2011 Mar 11;88(3):254-61), Roderick McInnes observed:
In our model, the subjects have little voice in the research process, they waive rights of benefit sharing in general, the data and samples are ''owned'' by the researcher, and the results go to journals and are not specifically ever directed back to or shared with the research subjects.
Dr. McInnes was speaking about genetic research performed on indigenous peoples, but I ask you: Is what he describes not the norm for research involving human research participants from all cultural groups and economic strata in the United States?
The consequences of this "let them eat cake" attitude have already become apparent. People who are curious about science but weary and wary of the status quo found in academic studies, have begun to organize and do research themselves: in their garages, in their kitchens, in silico, and in community labs. DIYbio, BioCurious, GenSpace, DIYgenomics and Genomera are just a few of these grassroots organizations.
Chronically ill people, for whom research is neither a hobby nor an abstraction, have grown impatient as well. PatientsLikeMe, the online health platform predicated on openness, information sharing and patient ownership and control of data, had less than 5000 users in 2007. Today it has over 117,000. It is difficult to see this sort of exponential growth as anything less than an indictment of the way conventional biomedical research on human beings is governed. And it is difficult to imagine that anything less than wholesale change will sustain such federally funded and federally governed research over the long haul.
I understand, Dr. Menikoff, that you have taken on a thankless and quixotic task. But I would argue that that's all the more reason to take this opportunity to swing for the fences. Don't settle for tweaking the Common Rule or harmonizing it with HIPAA. Don't settle for "protecting" and "facilitating." Aim higher.
Change the game. Change the culture.
Sincerely,
Misha Angrist, PhD, MFA
*the obsequious connotations of the word "subjects" in this context is noteworthy and makes this an opportune time to eschew its usage altogether
