Holly Fernandez Lynch, "Patients in non-traditional Research Roles: Implications for Oversight"
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Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted. Such efforts hold great promise, but also raise potential challenges for ethical oversight. How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups? This symposium brought together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.
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Holly Fernandez Lynch, "Patients in non-traditional Research Roles: Implications for Oversight"
- 1. CENTER FOR SURGERY AND PUBLIC HEALTH Patients in Nontraditional Research Roles: Implications for Oversight June 29, 2018 Funded by Patient Centered Outcomes Research Institute (PCORI)- Sep 2015 to Aug 2018 Holly Fernandez Lynch, J.D., M.Be. John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics @HollyLynchez
- 2. CENTER FOR SURGERY AND PUBLIC HEALTH Overview What did we hear? What do we recommend? What do others think?
- 3. CENTER FOR SURGERY AND PUBLIC HEALTH PCOR “helps people and their caregivers communicate and make informed healthcare decisions” by generating the sort of rigorous data that can help answer questions about: – What a patient should expect to happen – The potential benefits and harms of various options in comparison to one another – How to maximize the outcomes that people “notice and care about” Defining PCOR
- 4. CENTER FOR SURGERY AND PUBLIC HEALTH PCOR involves “the evaluation of questions and outcomes that are meaningful and important to patients and caregivers, and that engages patients beyond their traditional role as research subjects” Defining PCOR
- 5. CENTER FOR SURGERY AND PUBLIC HEALTH Respondents frequently identified involvement of patients in nontraditional roles as a novel issue for ethical/regulatory oversight of PCOR 1. Engaged as advisors/consultants – providing insight based on their experience, reviewing study instruments and recruitment materials, etc. 2. Engaged on recruitment, community engagement, dissemination of results 3. Collaborating as co-investigators on data collection/analysis (rare) What did we hear? Qualitative Research Refresher
- 6. CENTER FOR SURGERY AND PUBLIC HEALTH • Disagreement re: how IRB should “handle” patients in nontraditional roles • Patients with a view “behind the curtain” perceived IRBs as a barrier to conducting research important to them (contentious relationship) • Int’l protection: different approaches to training, testing, “onboarding” • True engagement of patients in nontrad roles is a challenge – but not IRB’s • Compensation of patients in nontraditional roles important but unresolved What did we hear? Qualitative Research Refresher
- 7. CENTER FOR SURGERY AND PUBLIC HEALTH • Asked about patients in nontraditional roles as “personnel in research projects as advisors, consultants, or investigators where they are involved in any aspect of research from topic development through study design, implementation, interpretation, and dissemination” – How challenging is it to have pts serve in nontrad roles? – How much responsibility does IRB have to protect pts in nontrad roles / protect their institutions from related problems? – Does IRB consider pts in nontrad roles to be subjects? – Does IRB require pts in nontrad roles to provide consent, get training, disclose COIs? – Who should ensure pts in nontrad roles are adequately trained in research ethics? What did we hear? Survey Research Refresher
- 8. CENTER FOR SURGERY AND PUBLIC HEALTH • 84% of respondents felt very or somewhat challenged by reviewing PCOR in which pts in nontrad roles had access to identifiable data • Compared to only 24% feeling challenged by pts serving on advisory boards What did we hear? Survey Research Refresher
- 9. CENTER FOR SURGERY AND PUBLIC HEALTH • 27% of respondents considered pts in nontrad roles to be research subjects even if they are not enrolled in research • 37% always/often required pts in nontrad roles to provide informed consent • 60% felt IRB had high responsibility to protect pts in nontrad roles • 55% felt IRB had high responsibility to protect institution from problems that may arise from pts in nontrad roles What did we hear? Survey Research Refresher
- 10. CENTER FOR SURGERY AND PUBLIC HEALTH • Variation in training required for patient partners –~Half said their IRBs always/often required pts to undergo CITI (59%) or HIPAA training (50%) or make COI disclosures (53%) –97% view training patients in research ethics as the PI’s responsibility • 60% put some responsibility for training on IRB • 27% on funder • About ½ on pts and institutions What did we hear? Survey Research Refresher
- 11. CENTER FOR SURGERY AND PUBLIC HEALTH Goals: 1. Avoid overprotection • Acknowledge that consent conflates their role as a patient partner with a research subject and prevents true engagement on the same terms as others 2. Avoid inappropriate exceptionalization • Don’t require more or less of patient partners than of others in similar positions 3. Facilitate the meaningful inclusion of patients essential to PCOR • Reduce barriers related to knowledge, compensation, etc. Recommendations re: Including Patients in Nontrad Roles
- 12. CENTER FOR SURGERY AND PUBLIC HEALTH RECOMMENDATION 1 • PCORI (or another funding or regulatory body) should endorse a formal taxonomy for differentiating research-related roles patients and other stakeholders might assume, in order to systematize decision-making and policy. Recommendations re: Including Patients in Nontrad Roles
- 13. CENTER FOR SURGERY AND PUBLIC HEALTH RECOMMENDATION 2 • Study Personnel: Patients and other stakeholders should be considered ‘study personnel’ when they interact with research subjects in a study-related capacity and/or have access to identifiable data. This category would include patient co-investigators as well as patients in other roles, such as patients who collect data via surveys, obtain consent from research subjects, and recruit research subjects. • Advisor: Patients and other stakeholders should be considered ‘advisors’ when they do not have access to research subjects and/or identifiable data but do formally advise on protocol development, study endpoints, or recruitment strategies, or participate in activities that may inform study design or conduct. • Research subject: Patients and other stakeholders should be considered ‘research subjects’ whenever they satisfy the definition provided in the federal regulations. Recommendations re: Including Patients in Nontrad Roles
- 14. CENTER FOR SURGERY AND PUBLIC HEALTH RECOMMENDATION 3 • Principal investigators should classify patients and other stakeholders participating in their research in accordance with the above taxonomy and follow standard procedures for reporting study personnel to the IRB in accordance with IRB policies. Recommendations re: Including Patients in Nontrad Roles
- 15. CENTER FOR SURGERY AND PUBLIC HEALTH RECOMMENDATION 4 • Patients and other stakeholders who are study personnel should receive required standard ethics training (CITI, GCP, etc.) as a baseline. Recommendations re: Including Patients in Nontrad Roles
- 16. CENTER FOR SURGERY AND PUBLIC HEALTH RECOMMENDATION 5 • PCORI (or another funding or regulatory body) should endorse and make available educational modules aimed at facilitating and improving the ability of patients and other stakeholders to serve effectively in study personnel roles, providing guidance on ethical, scientific/methodological, and logistical challenges that they may encounter. Recommendations re: Including Patients in Nontrad Roles
- 17. CENTER FOR SURGERY AND PUBLIC HEALTH RECOMMENDATION 9 • IRBs should not require informed consent or the application of other relevant human subjects protections for patients and other stakeholders in research roles who do not satisfy the regulatory definition of ‘research subject.’ Recommendations re: Including Patients in Nontrad Roles
- 18. CENTER FOR SURGERY AND PUBLIC HEALTH RECOMMENDATION 10 • Principal investigators should establish clear expectations with patients and other stakeholders who are study personnel and advisors concerning remuneration and other potential benefits of involvement (e.g., authorship) and compensate them in ways that fairly acknowledge their time and contribution to the project, in accordance with PCORI’s Compensation Framework Recommendations re: Including Patients in Nontrad Roles
- 19. CENTER FOR SURGERY AND PUBLIC HEALTH • Our study showed that engaging patients in nontraditional roles can raise confusion and inconsistency for IRBs and that such patients may need more support to maximize their contributions, rather than protection • Our recommendations focus on not exceptionalizing patient partners in nontraditional roles – Give them training – to protect participants and institutions – Give them resources for meaningful engagement – Acknowledge that patients can be more than subjects Summing Up
- 20. CENTER FOR SURGERY AND PUBLIC HEALTH • Jane Perlmutter, PhD – Cancer Survivor and Patient Advocate • Megan Morash, RN – IRB Chair, Partners Human Research Committee • Jeremy Sugarman, MD, MPH, MA – Professor of Bioethics and Medicine, Berman Institute of Bioethics, Johns Hopkins University Response Panel
Editor's Notes
- Case studies at 3 institutions Interviews of 13 experts in PCOR/IRBs Focus groups of IRB types at PRIM&R, PCORI investigators, and PFACs Identified as novel issue – and possibly the only one But actually maybe not even so novel with CBPR
- Differing IRB opinions about pts in nontrad roles: Don’t need protection Need protection Unsure Ethics and privacy training, TB testing, what does the institution require for onboarding staff? Barriers to true patient engagement including “cultural” barriers and lack of familiarity with research culture, too much training turns patients into insiders, not representative of broader patient community, “capture” by industry interests, compensating patients for their contributions Viewed as an issue for investigators and funders, not IRBs
- National survey of IRB chairs at research intensive universities in the US
- Signs of overprotection if a quarter of IRB still require non-subjects to be treated as subject Could stifle patient engagement in research in nontraditional roles if IRBs are ambivalent
- Should improve consistency
- Consent or other special requirements will continue to make patient partners “other” when the goal is to integrate But then again, there may be a need to level the playing field in terms of training in order to maximize the value of patient contributions and to protect other patients/institution Try to get patients up to the level of other research stakeholders and then treat them the same
- This recommendation is intended to improve consistency across research institutions and IRBs – so if a patient partner is treated as a member of study personnel at one site, they won’t be treated as a participant at another site, for example. This can also help make it more routine and have a simpler way of thinking through the issues that might arise with different types of engagement, rather than reinventing the wheel each time. Could be PCORI, but not all PCOR is funded by PCORI – so could also have other funders develop the taxonomy, but then it won’t be binding on others. So it may be best to develop this through regulatory guidance, although PCORI has the biggest dog in the fight.
- Adopt the following taxonomy of the types of roles patients can play The idea is to separately identify patients who look like research staff because they are engaging with subjects or their data v. patients who are really serving exclusively as advisors – and noting that both of those can be different than participating as a research subject These roles might be played simultaneously, which will be discussed in the next session Categorizing patients in this way can help identify areas of oversight they need, similar to other study personnel, and areas where certain requirements might be overkill. We thought about separating study personnel into two categories for co-investigators v. other research staff, but really the operational feature is access to subjects and their data, which can overlap in both cases.
- The idea behind this recommendation is to avoid exceptionalism – classify every stakeholder according to this taxonomy, whether or not they are a patient Then, since advisors don’t typically get reported to the IRB, no need for the IRB to oversee patient advisors. And since the IRB may get a list of study personnel, include patients when they play that role. If we can normalize patients in their various roles, it becomes clearer what kind of oversight is required. No reason to think that patients need to be specially protected in any of the non-subject roles. We don’t typically think advisors and study staffs are the ones in need of protection.
- This is another recommendation aimed at avoiding exceptionalism: if others who have access to subjects and their data need training, so do patients when playing those roles. This doesn’t seem necessary for advisors though, as they will not have the same sort of capacity to influence participant experience and protections.
- Beyond the sort of training required for study personnel, we determined that it may be important for patient partners in all roles to have additional training directed specifically to their needs to help level the field, so that they can fully understand research and how it is carried out, in order to offer helpful and relevant guidance, rather than be excluded by the cultural differences between career researchers and patients. This was a recommendation rooted in advancing meaningful inclusion. We recommend that PCORI or another national body provide this sort of educational module, as it is unlikely that investigators will have the resources to provide this sort of training on their own, and there is no reason for each institution to reinvent the wheel. But if we want patients to be able to meaningfully engage, they may need support to do so. Of course, we also want to avoid them becoming too “insider” to really offer the patient perspective any more. Jane will discuss some of the educational approaches already offered by PCORI.
- Skipping over recommendations about patients in multiple simultaneous roles, as that is the focus of the next session. Two more recommendations relevant to patients in nontraditional roles. This one seeks to address overprotection evidenced in many of the survey respondents – and we recommend that consent should only be required from subjects. Requiring consent from other types of study partners is an unnecessary bureaucratic hurdle and suggests that they are not truly partners, but rather different in type.
- Finally, this recommendation seeks to emphasize that it is inappropriate to expect patient partners to contribute solely on a volunteer basis when other personnel and advisors are all compensated financially and in kind with recognition in publications and speaking engagements. To fully include the patient’s perspective, these things also need to be addressed. Importantly, adequate compensation will help improve the diversity of patient partners who are available to provide their perspective and shouldn’t raise any of the ethical issues that are sometimes associated with payment of research participants, as study partners aren’t exposed to risk. PCORI encourages fair financial compensation for all patient partners, acknowledging their value as contributors PCORI research proposals are expected to include a plan and budget for compensating patient partners Compensation should reflect expertise, responsibility, type of work, and degree of participation contemplated – and should be consistent with other members of the research team