Respond to the following discussion posts. Each question needs to be at least 2 paragraphs with a 7 sentence minimum per paragraph.
Original Question:
What is “IRB shopping”?
Discuss the possible influences of the four paradigms of clinical research in modern day IRB shopping.
Assuming that an investigator “shopped” an IRB to approve a risky protocol – what possible implications might this have to the:
- Subject
Sponsor
- Research site
- Marwa
IRB Shopping is defined as selecting an IRB that will make the review process easier and possibly result in a favorable decision for the investigator and the sponsor. It is an under-researched yet highly-relevant ethical issue. This happens when the research trial gets a conditional or negative IRB review, so the investigator drops the IRB concerns and comments and selects another IRB forum that will give a favorable review and better decision (Board, 2016). In other situations, few researchers seek out IRBs that are more kind, easy, lenient, and can approve the study with less scrutiny. This occurs in some organizations which lower their IRB ethical standards to gain more research projects. Investigators and sponsors were found to have IRB shopped, that is, to have taken a protocol in one version or another to more than one IRB to get a favorable ruling.
- Paradigm 1: Researcher Paternalism: this paradigm addressed mainly the social value of the research added to the society in terms of Utilitarianism. It articulates the philosophical justification for research, specifying the benefits of biomedical research for society and the need for individual sacrifice to achieve those benefits. In this paradigm period, the main protection for research participants was the integrity of the researcher and the researchers judgment, thus the research judgment was the key protection for the subjects. Also, there was a sharp distinction between care and research that the principal investigator or the physician should differentiate as the subject trusts them to cure (Emanuel & Grady, 2007). In the case of the IRB shopping status, this paradigm should urge the investigators integrity while choosing an easy IRB to approve a risky or unethical clinical trial and endanger the health and well-being of the participants.
- Paradigm 2: Regulatory Protectionism: After the scandals of Tuskegee syphilis and the Jewish Chronic Disease Hospital case, the result was a regulatory system, codified in 1981 as Title 45 Code of Federal Regulations, Part 46, entitled Protection of Human Subjects. The goal of the oversight system was protectionism through the regulatory process to protect participants from researchers and the inherent risks that they and their research posed. Both Institutional review board (IRB) review and informed consent were thought to be the best mechanisms to protect research participants from the risks and burdens of research. In addition, there were special protections built into the regulations for prisoners, pregnant women, and children deemed especially vulnerable to harm posed by research (Emanuel & Grady, 2007). This paradigm addresses organizations and IRBs that fraud the regulatory system and make the review process unethical and harmful to the participant by applying less proper scrutiny. Investigators and Sponsors should respect their participants and apply all the necessary precautions taken to protect the subjects enrolled. They should follow the regulatory system and stop favoring their interests over the patients well-being.
- Paradigm 3: Participant Access: The underlying ethical principle emphasized in this period was the right to autonomy. Individuals did not need to be protected by regulation; rather they should be entrusted to know their good and interests and be free to pursue them. Autonomy was invoked as overriding many protections provided by federal regulations (Emanuel & Grady, 2007). The participants access must prevent the investigators and sponsors from IRB shopping, as they should inform the subjects of all the risks and benefits associated with the study protocol, and thus they should be honest with the IRB review process and stop circumventing.
Paradigm 4: Collaborative Partnership: This paradigm is based on the recognition that clinical research does not occur in isolation; clinical research is a collaborative, social enterprise. It involves a community of scientists, a community of participants, and medical practitioners, as well as the larger society required to fund the research and also assimilate the results into the health delivery system. The community is a necessary partner for successful research (Emanuel & Grady, 2007). The community partnership paradigm recognizes that risks and benefits both during and after research are best evaluated by involved communities. Community partnership must be a motive to prevent IRB shopping action, the collaboration of different community categories can influence the strict review process, preventing the organizations and IRB members waive their review process.
The possible consequences that an investigator might face if shopping an IRB to approve a risky protocol, endanger the subjects and put them in danger and harm, and introduce them to some unnecessary risks that might be avoided by a normal IRB review process. This action is prejudicial to the rights and well-being of their research participants. Additionally, the integrity of the research as a whole would be harmed and questioned by the regulatory authorities. OHRP would audit IRBs for indications of a lack of critical review and should take remedial action as appropriate. IRB operations and enforcement records are opened to the public view, also liability insurance carriers will be interested in pressuring their clients into operating their research protection programs properly. Regarding the sponsor and the research site, they might face regulatory actions from FDA and OHRP, during the inspections and face some legal actions and penalties. IRB shopping can be deterred by some enforcement techniques, including registration of submitted protocols and modifications, audits, opening IRB decision records to public view except for redaction of trade secrets, opening enforcement records to public access, and opening assurances to public access (circare_anprm_response_201109, Citizens for Responsible Care and Research, Inc. (CIRCARE)).
References:
Board, T. V. I. I. E. (2016, May 17). Am I IRB Forum Shopping? Introduction. Research Ethics SimplifiedTM. https://researchethicssimplified.com/am-i-irb-foru…
circare_anprm_response_201109, Citizens for Responsible Care and Research, Inc. (CIRCARE)).
Emanuel, E. J., & Grady, C. (2007). Four paradigms of clinical research and research oversight. Cambridge Quarterly of Healthcare Ethics: CQ: The International Journal of Healthcare Ethics Committees, 16(1), 8296. https://doi.org/10.1017/s0963180107070090
Tyler
IRB shopping is when a research sponsor will choose the IRB that they work with, usually based on the leniency of the IRB towards the research being done by the sponsor (Department of Health and Human Services, 1998). Oftentimes it may occur if a sponsor receives an unfavorable review from a particular IRB and switches their application to a new IRB without notifying the new IRB of the previous ruling (FDA, 2002). On March 6th 2002, the FDA proposed a rule to help combat IRB shopping but it was ultimately not approved (Lederman, 2006). The rule would have required sponsors to disclose to subsequent new IRBs of any decisions made by a previous IRB. The FDA mentioned that requiring this disclosure would be the best way to combat the practice of IRB shopping. However, in an investigation, the FDA found that IRB shopping was not common enough to warrant passing the ruling. They also mentioned that a new IRB reporting system under the rule change would substantially increase the workload of IRBs and that it would not provide any more protections to human research subjects (Lederman, 2006).
Mazur (p. 72) describes how risk involved in research is based on human estimation and can vary from one location to another. One institution or person may believe there is more risk in a study and another may believe that there is significantly less risk involved. This difference in estimation of risk is one reason why IRB shopping is able to occur. Different IRBs are going to have different opinions on risk in a study and how to combat the presence of the risks. Some sponsors may shop around with IRBs and choose the IRB which deems the study to have the least amount of risk and requires less testing and safety measures which would ultimately save the sponsor money.
The four paradigms of Clinical Research, research paternalism, regulatory protectionism, participant access and collaborative partnership, may have all had influences on modern day IRB shopping. During research paternalism, social value was often put above the value of the research participants themselves (Emanuel & Grady, 2007). It was thought that the researcher knew what was best for the patient and the researcher was often concerned about their own image. Regulatory protectionism saw the removal of some decision-making from researchers and gave it to IRBs and research participants themselves. Participant access saw the autonomy of the research participant grow through informed consent and the right to choose for themselves. This was due to events such as the AIDs pandemic when participants were denied access to research treatment even though they were suffering from a fatal disease. Collaborative partnership saw decision-making transformed into the hands of the community, with the FDA implementing regulations such as community consultation for emergency research (Emanuel & Grady, 2007). I believe that through the four paradigms, research organizations saw their freedom to do as they pleased slowly being taken away and given to others. My opinion is that they wanted a way to be perceived as if they were following regulations but still acting in their own interests. IRB shopping is a great way to circumvent the advancements in research protection that occurred during the four paradigms of Clinical Research.
I was unable to find documentation of IRB shopping occurring in the United States, but I did find an example that occurred in Canada. In 2005 SFBC Anapharm submitted an IRB application for a trial involving an immunosuppressive drug (Letendre, 2016). The original IRB that reviewed and approved the study stipulated that all research participants must be screened for Tuberculosis (TB) and shown to have a negative test before beginning the trial. Initial testing of the drug was successfully completed with every patient being tested for TB. However, in later testing stages for the drug, SFBC Anapharm elected to submit their study protocol to a new IRB. The new IRB removed the TB testing stipulation from the study altogether. One research participant unknowingly had latent TB which transformed into active TB when taking the immunosuppressive drug. 20 individuals with the study ultimately ended up testing positive for TB after this. It is estimated that the research organization saved around 40 dollars per patient by not administering TB costs (Letendre, 2016).
I think this is a wonderful demonstration of the dangers which could be posed to research subjects, sponsors and research sites. First and foremost, research subjects are put in the most danger from IRB shopping. If a more lenient IRB is found, it might mean that fewer protections will be approved for research subjects as was the case with those enrolled in the trial run by SFBC Anapharm. The sponsor’s image may be tarnished if they engage in IRB shopping. If a sponsor was caught engaging in IRB shopping, many IRBs in the future may be hesitant to work with them or review their studies. It may also stain the image of the sponsor in the public eye. The research site may also have their image tarnished and be putting themselves in harm’s way at the same time. Overall, IRB shopping should never be done to avoid regulations or procedures that were put in place to ensure the safety of test subjects. I believe that research subject safety should always come first and foremost and a dollar sign should not be put ahead of the health and safety of any human being.
References:
Department of Health and Human Services . (1998, June). Institutional Review Boards: a Time for Reform . Retrieved August 31, 2022, from https://oig.hhs.gov/oei/reports/oei-01-97-00193.pd…
Emanuel, E. J., & Grady, C. (2007). Four paradigms of clinical research and research oversight. Cambridge quarterly of healthcare ethics : CQ : the international journal of
FDA. (2002, March 6). Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews. Federal Register . Retrieved August 31, 2022, from https://www.federalregister.gov/documents/2002/03/…
Lederman, D. (2006, January 18). IRB ‘shopping’ not a problem, FDA concludes. Inside Higher Ed. Retrieved August 31, 2022, from https://www.insidehighered.com/news/2006/01/18/irb…
Letendre, M. (2016, April 11). The Montreal Tuberculosis Outbreak Revisited. Research ethics simplified. Retrieved August 31, 2022, from https://researchethicssimplified.com/the-montreal-…
Mazur, D. J. (2007). Evaluating the science and ethics of research on humans: A guide for Irb members. Johns Hopkins University Press.
Saritha
IRB shopping is the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol. The sponsor is choosing IRBs that they believe will approve the protocol. This practice has raised concerns about the moral issues and integrity of the IRB approval process. This also points to the chances of deception, cheating and loopholes within the IRB approval process. (Spellecy, R., & May, T. 2012). In 2016 FDA announced that it would not regulate or ban IRB shopping because such choosiness either does not occur or is not a significant problem. But activists criticized it as the IRB shopping practice is problematic because it could allow ethically suspect studies to avoid adequate oversight. (Brainard J, 2006).
The four paradigms- Researcher Paternalism, Regulatory Protectionism, Participant Access and Collaborative Partnership- incorporate different values and provide approaches to research oversight and protecting research participants. During World War II, researcher paternalism was the only protection offered to a research participant. Regulatory protectionism introduced the Institutional Review Board and individual informed consent to protect vulnerable participants. From this, the ethical principles of respect, justice and beneficence emerged, which underpin the ethical requirements of informed consent, participant selection and risk analysis. The participant access paradigm emerged in the mid-1980s, focusing on individual autonomy and allowing participants to assess the risk and benefits of a study for themselves. The community partnership paradigm of research oversight attends to how researchers collaborate with active participants to ” protect” the host community. To an extent, IRB system is causing unreasonable burdens on researchers for approval, but non-compliances should not happen in the IRB system. The research participation should occur most efficiently and effectively, promoting societal good through valuable research while respecting and attending to the rights and well-being of individuals and communities. (Emanuel E & Grady C, 2006).
If the Investigator shopped an IRB for approval for a risky protocol, it is unethical and dangerous for subjects safety. This usually happens when a protocol obtains an unfavourable review from IRB; the Investigator abandon that IRB and chooses a different one that will provide a more favorable review. (Letendre M, Parente J, 2016) This can seriously impact the rights and well-being of the research participant. This practice is risky for the sponsor as this can adversely impact the integrity of the research study, which may lead to failure to get approval from the FDA. The Investigator is risking the site for chances of black-listing if subjects safety is affected. This practice questions the research sites trust and ethical standards in the public and research community.
Reference:
1. Emanuel E & Grady C, 2006, Paradigms of Clinical Research and Research Oversight, https://collab.its.virginia.edu/access/content/attachment/6c8b7f20-0de5-43a8-9d6e-7812621c0002/Syllabus/db1e5d48-2f23-4279-ad97-72c7246865a5/EmanuelGrady-FourParadigmsofClinicalResearch.pdfLinks to an external site.
2. Brainard J, 2006, FDA Wont Regulate IRB Shopping, https://www.chronicle.com/article/fda-wont-regulate-irb-shopping/Links to an external site.
3. Spellecy, R., & May, T. (2012). More than cheating: deception, IRB shopping, and the normative legitimacy of IRBs. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 40(4), 990996. https://doi.org/10.1111/j.1748-720X.2012.00726.xLinks to an external site.
4. Letendre M, Parente J, 2016, Am I IRB forum shopping?-Introduction, The Veritas IRB editorial board, https://researchethicssimplified.com/am-i-irb-forum-shopping-introduction/Links to an external site.
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