lar investigator

Transcript

1 When the LAR Is Also the Investigator I once worked in a lab that conducted anti - aging research. The lab was operated by Dr. Smith, who also owned and operated an assisted living facility nearby. Dr. Smith was intrigued by homeopathic remedies that he t hought might slow the aging . His research centered on vitamin and nutritional and improve quality of life process supplements, topical creams and salves, exercise programs and so on. Laboratory personnel were constantly going to the assisted living facil ity and drawing blood, taking skin samples, measuring bone density and respiratory capacity and the like. some research participants, I began feeling uncomfortable when I noticed that of our ad early senility or dementia and had little idea of what was going on, had their consent who h to research participation signed by Dr. Smith. When I asked him about this, he looked a bit told me that these individuals had signed over their power anxious but of - attorney to him upon - entering the facility and that he was therefore allowed to make decisions for them , including , research participation. When we were informed that we were going to be visited by some representatives of a grant foundation that might fund our work, Dr. Smith explicitly told us to say that we knew nothing about how our various biological specimens were procured. He also told us to say that ed our current research was on the cusp of success even though none of our assays had indicat anything unique or exciting. He also made a point to remind a ll of us of the confidentiality and stipulations in our employment nondisclosure , which sounded like a veiled threat contracts should any of us discuss some of Smith’s problematic practices with the funding team or any other outsiders. We did not get th e grant, and a fter a few months, I simply couldn’t tolerate th e situation any longer , and I left. Please comment. Expert Opinion: When the LAR Is Also the PI we might first is in, me Before examining the stark conflict of interest that Dr. Smith discuss so issues bearing on Dr. Smith’s (erroneous) understanding of his authority. Although unusual, it is not unheard of for some individuals entering an assisted living for making ce facility to have the facility’s administrator appointed as their surrogate rtain s. Such persons would likely be without family or friends willing to assume a proxy or decision 1 surrogacy role. Of course, if they have judgmental capacity, they would have the right to make their own decisions; nevertheless, they could still appoi nt the facility administrator to make whatever decisions they would prefer not to (e.g., medical, financial, property, etc.). But i f they are without such capacity, a court or some legally authorized entity would have to appoint the facility administrator as their proxy or durable power of attorney (DPA) in order for that 2 ,3 appointment to have legal force . Now, assuming that Dr. Smith has been legally authorized as these persons ’ DPA, the above scenario tells us that he believes his DPA also entitles him to act as their “legally authorized representative” or LAR. The LAR is defined in the Code of Federal Regulations as:

2 “An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subje ct’s participation in the procedure(s) involved in the (c) research.” (45 CFR 46.102 ) The LAR’s primary responsibility, much like the surrogate’s or proxy’s in instances of clinical decision making, is to protect the rights and welfare of the search subject, especially by honestly representing the latter’s preferences or potential re 2 ,3 presumed values about research participation. automatically qualifies him as a LAR is, at Dr. Smith’s belief that his authority as DPA w states that have explicitly addressed this issue have, in best, extremely questionable. The fe fact, required court - appointed guardians to also obtain specific court authorization to make 2 decisions on a ward’s participation in a research project. But very few, if any, states specifically llow what Dr. Smith is blithely assuming : namely, that a DPA automatically confers authority a on that person to also serve as a LAR. The decision about the candidacy of surrogates, proxies or DPAs to serve as LARs is commonly left to the discretion of an i nstitutional review board 3 (IRB). And with that, we come to the heart of this scenario: It beggars belief that Dr. Smith has secured a responsible IRB to review his research and participant recruitment methods. k sufficient judgmental capacity, no IRB would Obviously, among those residents who lac ppoint Dr. Smith as a LAR until he could a recognized as such. make a case to the IRB that he be But resident had judgmental capacity or not, an IRB, court, or other judicial authority whether a likely i nsist that the PI of a project cannot serve as a LAR, just as a surgeon c annot do would nonemergent surgeries without his patients’ or their legally authorized representatives’ consent. The United Kingdom’s Medicines and Human Use (Clinical Trials) Regulation 20 04 4 To explicitly disallows anyone serving as an LAR who is involved in the conduct of the trial. allow such would recall the embarrassing memories of research exploitation of vulnerable persons such as occurred in the United States at Willowbrook, the Je wish Chronic Disease Henry Beecher in his famous 1966 Hospital in the Bronx, and the ones that were chronicled by 5 . article “ Ethics and Clinical Research ” Dr. Smith cannot possibly do justice to both roles of LAR and PI. As a LAR, Very simply, sked with protecting his charges from coercion, exploitation and manipulation. His job is he is ta to assess what his charges would voluntarily desire or what is in their best interests. He is obligated to question whether research participation might benefit his charges or whether the burdens or discomforts of participation outweigh any benefits his charges might experience. His primary role is very similar to the surrogate’s in a clinical setting: to reflect, as much as possible, what the participant would wan t by way of participation or not, according to the 2,3 participant’s known or presumed preferences and beliefs. As the project’s PI, however, Dr. Smith is ultimately “using” his research subjects just as any investigator does. Research participants ar e traditionally thought to serve as a means to an end — that end being the confirmation of a research hypothesis or securing generalizable 6 knowledge. Precisely because research participants are being used as instrumentalities in a project that might not be — indeed, their participation might eventuate in nefit them in any way nothing but unpleasantness — their authentic, voluntary consent is crucial. But Dr. Smith is in no position to make that judgment for them in an honest and objective way , given his keen in terest in enrolling as many participants as he can and generating data . That is why an IRB would surely disqualify him as a LAR.

3 Dr. Smith’s role as the administrator of the facility only heightens worries about exploitation and coercion for any of the residents, whether they are judgmentally able or not . s their Just as prisoner might feel compelled to consent to research participation for fear that for refusing, it is easy to imagine that Smith’s assisted living them warden might penalize — like dismissal from the living center or subsequently ht fear some kind of reprisal residents mig taking — if they would balk at participating in his research projects. Such a situation poor care - 7 would qualify as coercion rather than manipulation or exploitation: T he r do not wish esidents to participate because of their associated discomforts ; but they also fear that anticipation of . Thus, their refusal will result in even more discomforts per their living conditions at the facility are worse off however they cho ose. Not only do they perceive no net benefit from they participating, but their baseline welfare has been reduced: They can either suffer unpleasantries from participating in the research or suffer unpleasantries from refusing. Some readers might obje ct that, after all, the research interventions that Dr. Smith employs are only minimally risky, e.g., drawing blood, taking skin samples, measuring bone density, etc. But that objection misses the very keen, protective sensibility that IRBs and the Office for Human Research Protections impose on investigators. A familiar rule, for example, is that an investigator should only enroll participants without judgmental capacity in an 3 If the same or s imilar research could investigation that is directly related to their incapacity. be done on persons who have capacity, then it should be. As the 2009 OHRP Recommendations on Individuals with Impaired Decision Making in Research asserted: “Ease of of individuals who lack recruitment or study cost should never alone justify the inclusion 3,p.7 consent capacity.” Also, the Common Rule requires that “additional safeguards have been included in the study to protect the rights and welfare” of all subjects who are “likely to be vulnerable to coercion or undue influence. ” (45 CFR 46.111(b)). Thus, an IRB might appoint an additional party to perform oversight of the LAR him or herself. Indeed, one must always bear in mind that in many cases, even the best qualified persons to serve as a LAR will only have a dim idea of 3 w hether or not his or her charge would want to participate in . scientific research Does Dr. Smith even have a way of assessing his participants’ capacity to make decisions? Could he show, for example, that he adjusts the degree of risk or discomfort of the research intervention in which residents are specifically participating (like weighing a resident versus drawing blood) to the resident’s level of decision making? Would he be able to show that he honors anyone’s dissent or refusal to participate in his study, regardless of their judgmental status? Or would he be hard pressed to point to anyone who has refused to participate? Presumably, Dr. Smith was aware of all these eye - popping moral lapses in his censoring and threatening his staff per the upc oming site visit of a potential grantor. It is hard to imag in e what kind of documentation Dr. Smith would his compliance with ethical and have to show legal guidelines for conducting research. Did he have an ethics advisory group available? Who were its members? How were they appointed? What entity served as his IRB? What quality measures could he point to that demonstrated his compliance with research protection guidelines, especially given his trio of staggeringly conflicted roles as facility admini strator, PI, and LAR?

4 One hopes that the contributor of this dilemma didn’t depart from her employment with Dr. Smith without also contacting legal authorities in the Department of Health and (ies) h’s facility, so as to alert them to Human Services as well as the licensing entit of Dr. Smit the charade posing as research that Dr. Smith was perpetrating. References: Servis KW. Letter to Administrators; Subject: Medicare Part D Authorized. Available at 1. www.health.state.ny.us/professionals/nursing_home_administrator/docs/dal_06 - 01_medicare_part_d_authorized_representatives.pdf National Bioethics Advisory 2. Research Involving Persons with Mental Commission. Disorders that May Affect Decisionmaking Capacity . December 1998, Volume 1, Chapter Three: Advance Planning, Surrogate Decision Making, and Assent or Objections. http://bioethics.georgetown.edu/nbac/capacity/Advance.htm 3. Office for Human Research Protections (OHRP), Secretary’s Advisory Committee on Human Research Protections (SACHRP). Recommendations from the Subcomittee for nclusion of Individuals with Impaired Decision Making in Research (SIIIDR). the I http://www.hhs.gov/ohrp/sachrp/20090715LetterAttach.html . Available at 4. Statutory Instrument 2004 No. 1031 . The Medicines and Human use (Clinical Trials) Regulation 2004 . Available at http://www.opsi.gov.uk/si/si2004/20041031.htm#28 . 5. al of M edicine , 1966;274: New England Journ Beecher HK. Ethics and clinical research. 60. Also see the collection of articles in Emanuel EJ, et al (eds). Ethical and - 1354 , Baltimore, MD: The Johns Hopkins University Regulatory Aspects of Clinical Research - 28, and pages 2 25 - 283. Press, 2003, pages 1 nd Levine RJ. Ethics and R egulation of Clinical Research, 2 6. edition . Baltimore, MD: Urban and Schwartzenberg, 1986, pages 3 10. - 7. Emanuel EJ, Currie XE, Allen Herman. Undue inducement in clinical research in eveloping countries: is it a worry? Lancet , 2005;366:336 - 4 0. d

5 © 2009 Emory University

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