What do PRIM&R members think about payment, coercion, and undue influence?

by Emily A. Largent and Alan Wertheimer, PhD

How do institutional review board (IRB) members and human research protections professionals think about the relationship between payment, coercion, and undue influence? 

This is a topic of obvious interest to the research community: Researchers routinely offer payment to prospective research participants as an incentive to enroll or as compensation for their participation in research. IRBs are, in turn, asked to review these payments for their ethical implications.  Yet, there is little systematic data about attitudes toward payment in general, and specifically, when IRB members consider payment coercion or undue influence.

To address these questions, in 2010, we surveyed randomly selected PRIM&R members who had previously self-identified as interested in IRBs and human subjects research. Our complete results have recently been published in IRB: Ethics and Human Research.

Here, we’ll highlight three of our findings:

1. We found persistent ethical concern about the effect of offering payment to research subjects.  Sixty-one percent of respondents reported feeling somewhat, moderately, or very concerned that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. 


2. Virtually all respondents agreed that an offer of payment constitutes undue influence if it “distorts a subject’s ability to perceive accurately the risks and benefits of research.” However, a surprising 80% also judged that the offer of payment constitutes undue influence simply because it motivates someone to do something they otherwise would not.
   
   Although more than 90% of respondents agreed with a definition of coercion tied to threat of harm, a substantial majority also agreed that research participants are coerced when an offer of payment—not a threat of harm—gets them to participate when they otherwise would not or when they feel they have no alternative but to participate.
   
   There was, however, notable divergence between how individuals viewed the meaning of coercion and undue influence in the abstract and how they applied these concepts to the concrete scenarios included in the survey.


3. The majority of respondents expressed acceptance of payment as reimbursement for expenses or as compensation for time, effort, and incon¬venience—regardless of the study population.  By contrast, fewer respondents accepted payment as an incentive to participate (about half) or as compensation for risk (about one-third). 

Although survey respondents endorsed limiting the amount of payment offered to research participants, the connection between attitudes toward payment and actual IRB practices is unclear.  Not only is further research needed, but we also believe that policy guidance and educational efforts should clarify the concepts of coercion and undue inducement.  We would love to see PRIM&R’s leadership and members continue engaging in these important conversations. 

Stay tuned for a forthcoming blog post in which we will argue that some of our findings reflect misconceptions about coercion and undue inducement!

Eleven from ’11: The posts that continue to affect our daily work

by Avery Avrakotos, Education and Policy Coordinator

Professionals engaged in the protection of human and animal subjects felt the tides of change in 2011: The Department of Health and Human Services  proposed an overhaul to the regulations governing human subjects protections. Across the country, people provided feedback and comments on the proposed change; the animal care and use community reacted when the National Institutes of Health suspended all new grants for research involving chimpanzees. These are just two of the stories that characterized the landscape of research protections in 2011.

Below, we have selected a roundup of 11 Ampersand posts that we hope grabbed your attention, incited conversation, and prompted reflection:

1. Research in the midst of tragedy by Wendy Tate, PSM, CIP – This guest blogger reflected on the challenges of research in emergency situations in the wake of the attempted assassination of Congresswomen Gabrielle Giffords.
   


2. They entered my home without my consent by Andy Burman – A home invasion brought the importance of consent into perspective for a member of the PRIM&R Blog Squad at the 2010 AER Conference.
   


3. Preparing the next generation of professionals in human subjects research by Nick Slack, MBE – This guest blogger shared his vision for the future professionalization of the field of human subjects protections.
   


4. Tracing the roots of research ethics by Sylvia Baedorf Kassis, MPH – With history as her backdrop, this Blog Squad member urged readers to take a look back and remember the role of ethics professionals in past atrocities.
   


5. Human embryonic stem cell research: Court victory, but challenges remain by Melinda Abelman, MSc, CIP – In May, a US Court of Appeals overruled the ban on government funding for embryonic stem cell research. The embryonic stem cell research oversight manager at Partners Healthcare System shared her view on the ruling.
   


6. That’s why they call them trials by Barbara Brenner – Diagnosed with amyotrophic lateral sclerosis (ALS), this post’s author offered a unique view on clinical trials from the perspective of a potential participant.
   


7. Thirty years of trials, failures, leadership, and inspiration – 2011 marked 30 years since the emergence of HIV. This piece excerpts speeches given by two early leaders in the fight against HIV, Jonathan Mann, MD, MPH, and C. Everett Koop, MD, ScD.
   


8. Featured member profile: Julie Washington – After witnessing her mother’s plight as a research subject, this PRIM&R member devoted her career to human subjects protections.


9. PRIM&R’s comments on the ANPRM by Elisa Hurley, PhD – PRIM&R responded to the DHHS advance notice of proposed rulemaking (ANPRM) with a set of comments addressing many of the document’s proposals and questions . 
   


10. ‘Science Times’ synthesis – With two important reports released within a single week, the December 23 edition of Ampersand’s ‘Science Times’ synthesis was brimming with news for both the animal and human subjects communities.
    


11. Could the Bioethics Commission’s criteria for ethical study design become central to an IRB’s deliberation? by Elisa Hurley, PhD – The Presidential Commission for the Study of Bioethical Issues released a report containing 14 recommendations for increasing human subjects protections. PRIM&R’s education director explored the ethical questions that the report raised regarding study design.

With 2012 well underway, there are a host of new pieces around the corner, and we urge you to stay tuned to the discussion in this forum. If you have a topic or a piece you’re interested in sharing, please contact us. In the meantime, we encourage you to share your favorites from 2011. What pieces left you thinking long after the reading was done?

Embracing ethics: My experience at the 2009 AER Conference

Oluyemisi Akinwande, a 2009 Advancing Ethical Research Conference scholar, remarks on what she learned at the conference, and shares updates on how her experiences have influenced her work at home in Nigeria.

I became familiar with PRIM&R’s AER Conference in an interesting way; in the midst of clearing away some old papers, I stumbled on one that had information on a research ethics meeting being held in Nashville, TN. I found the prospect exciting; I had never heard of, or attended, a conference on ethics before!

In light of research ethics being a key component of my work at the Institute of Human Virology Nigeria (IHVN), I investigated, applied for, and received the scholarship.

The IHVN, where I worked at the time as the head of research operations, had recently created a department to ensure proper coordination of all aspects of research amongst the faculty at the Institute of Human Virology Baltimore, the University of Maryland School of Medicine, and the various collaborating universities and teaching hospitals in Nigeria. This involved obtaining ethical approvals, training members of the ethics committees, training investigators and other members of the research team, assuring compliance, and so on. Thus, the opportunity to attend the 2009 AER Conference seemed a fitting place for me to increase my education, widen my scope, and build my network.

When I arrived in Nashville, the organization of logistics by PRIM&R was excellent. Every aspect was handled promptly and professionally. Travel and settling in at the hotel went well, and a tour of the Vanderbilt University Clinical Research Center was arranged for scholars on the day prior to the conference. The tour provided me an opportunity to learn about the structure and coordination of research. While at the university, we had a lunch meeting with some of the institutional review board (IRB) members who gave talks about IRB structure, composition, and research protocols. This day provided an excellent opportunity for me to get to know the scholars from other countries.

The conference was full of very educational sessions.  All the sessions I attended provided a wealth of information on research ethics and good clinical practice, at different levels, and for different roles. As part of the conference, there was also an exhibition hall that showcased several organizations and a poster session.

As a scholar, I was assigned a conference buddy: Nancy Erdey of Case Western University School of Medicine. I communicated with Nancy via email prior to the conference, and we arranged a place to meet. She was a very good companion at the conference. While we didn’t attend the same sessions all the time, we always arranged to meet for breakfast, lunch, and in between the sessions. During those meetings, she explained the history of PRIM&R, the significance of some of the displays, and helped me navigate the hotel. Nancy was an asset to making me feel at ease at the conference; it was as though I came with a friend or ran into a friend I had always known.

My attendance at the conference broadened my understanding of research ethics and showed me the importance of each member of the research team, including the community members. The conference also helped shed light on events happening in other parts of the world.

On my return to Nigeria, I continued to provide oversight for research operations at IHVN and shared my experiences from the conference with my colleagues at every opportunity. Outside IHVN, I gave talks on research ethics to doctors in training programs, including the residency program in community and preventive medicine at the Obafemi Awolowo University Teaching Hospital, Ile Ife, Nigeria. I also shared my experiences from the conference and scholarship program during these sessions.

My current position is at the International Center for AIDS Care and Treatment Programs of the Mailman School of Public Health, an international non-governmental organization for the prevention, treatment, and care of HIV/AIDS and related diseases, and for operational research through public health evaluations. In this new position, I am in charge of research and public health evaluation. I have organized and co-facilitated training workshops in the fundamentals of clinical research using the opportunity to increase awareness on ethical issues and the need for compliance to local and international regulations. In this current training program, I’ve shared and discussed ethical case studies, one of which is the Jesse Gelsinger case study, which I learned about from my PRIM&R conference materials.

Overall, my affiliation with PRIM&R has been short, but very rewarding. It has infused me with confidence and broadened my horizons in research ethics. I intend to nurture this professional association and spread the news to others.

Gratitude and growth: As the IRB evolves, PRIM&R’s there to help educate our members

PRIM&R is pleased to bring you a post from Mindy Reeter, a member of the PRIM&R Blog Squad at the 2011 Advancing Ethical Research Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

It's hard to believe it's been one month since PRIM&R's 2011 Advancing Ethical Research Conference! I feel so fortunate to have attended the conference as a Blog Squad member. I hail from the University of Illinois College of Medicine at Peoria's (UICOMP) IRB, which serves a whole community, including three hospitals in Peoria.

Seventeen years ago, each of the three hospitals had their own IRBs and submission to each IRB was required if the research was to take place at all three sites. The first IRB director secured a multiple project assurance under which all the hospitals fell as a community. Under this "community" model, the UICOMP IRB became a one-stop-shop for IRB review.

The individual IRBs at the three hospitals collapsed into one university/community IRB with multiple members from each originating hospital. As other research sites began to designate the UICOMP IRB as their IRB of record, individuals from these institutions were invited to serve as IRB members and as members of an advisory board called the Liaison Committee. This model made for a large IRB committee, but one that was truly representative of the community it served.

The majority of the current members of the UICOMP IRB are the original members of the community IRB. We are very lucky to have maintained such a stable membership over time. Nine years ago, we began to ask members to serve as secondary reviewers of new studies. Our members are volunteers and we were very nervous to ask them to take time outside of the meeting to do IRB work. Our members took on the challenge as the current IRB chair stepped down and two members stepped up. Our new chairs attended the PRIM&R conference that first year and have attended every year since.

Our IRB has grown along with our membership: We continue to serve as the IRB of record for the three Peoria hospitals and for multiple Peoria medical offices, a cancer center and their 17 regional sites, a Midwest affiliate of St. Jude, and two hospitals in Galesburg, IL. We also have Authorization Agreements with the University of Illinois at Chicago, the University of Illinois at Urbana-Champaign, and Bradley University.

Our IRB members have gone through the transition to a primary/secondary review system with required documentation, implementation of the HIPAA Privacy Rule, required CITI training, adoption of the UPIRSO policy, new conflict of interest reporting requirements, transition to an electronic submission system, and an FDA audit... all as volunteers!

Hopefully, the economy will soon find itself in an "upturn," and the university will be able to fund attendance to future PRIM&R conferences for our prized IRB members!

I want to thank PRIM&R again for selecting me as a member of the Blog Squad for the 2011 AER Conference.

New year, new beginnings: PRIM&R and the IRB Forum

By Kimberly Hensle Lowrance, Managing Director

The New Year is a time for new beginnings, and at PRIM&R, that idea is especially true. We marked the start of 2012 by moving across town and are now busy unpacking and settling into new office space. But we’re not the only ones with a new place to hang our proverbial hats (and mittens, scarves, and coats—the first snow of 2012 arrived today in Boston)! Effective immediately, the IRB Forum, a resource-rich online community for research protections professionals, now has a new home at PRIM&R.

We look forward to adding the IRB Forum to PRIM&R’s network of rich educational resources. Jon Merz, a professor at the Center for Bioethics at the University of Pennsylvania, is the IRB Forum's current independent moderator and will continue in that role. We are very grateful for Jon’s dedication to the community, as his balanced approach to the site’s information-sharing has been key to its success. Retaining Jon as the site’s moderator is important to encourage the free flow of ideas and dialogue, as well as to foster the very helpful answering of everyday IRB-related questions.

Our appreciation also goes to Robert “Skip” Nelson, the IRB Forum founder, for his ongoing support and counsel, and to the leadership of the Center for Bioethics at the University of Pennsylvania for their commitment to the Forum and for working closely with PRIM&R to make this move possible.

PRIM&R’s immediate plans are to update the technical operations of the site and to increase its visibility. Membership in the site will remain free.

Though you can still find the IRB Forum at www.irbforum.org, PRIM&R’s new office address is 20 Park Plaza, Suite 720, Boston, MA 02116. Our phone number, 617.423.4112, remains the same, but all extensions are now three digits. Please see our staff listing for updated contact information.

If you have questions, please do not hesitate to be in touch. Thank you, and Happy New Year to you and yours!

My take-home message

PRIM&R is pleased to bring you a post from Dawnett Watkins, a member of the PRIM&R Blog Squad at the 2011 Advancing Ethical Research Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

During the 2011 Advancing Ethical Research (AER) Conference, I attended a session in the Federal Regulations track in which a representative of the Office of Human Research Protections (OHRP) spoke. This speaker revealed that protocols approved under CFR 46.101(b)(5) are often approved under this exempt category in error. The speaker explained the OHRP realizes that there is some misunderstanding with this designation and that they are working on fixing this. Based on her comments, I deduced that OHRP is not coming down hard on folks who make this error, but needless to say, this was still an “ah-ha” moment for me.

So, what exactly should be approved in this category? It seems as though the only protocols that should be approved are those that are approved by a federal department agency head, such as studies on federal public benefit or service programs.

I went home and reviewed chart six of the OHRP’s decision tree and was able to connect what the speaker had said with the content of the regulations. The first sentence of the regulations reads, “Is the research or demonstration project conducted or approved by the Department or Agency Head?” Take note of the capitalization in this sentence—I, mistakenly, did not do so. Department and Agency Head being capitalized here refers to the Feds. Who knew? Definitely not me!

Our institutional review board (IRB) met a couple weeks after I returned from the conference, so I decided to use this as a training item during our meeting. My board’s reaction was that the capitalization makes sense now, but that the Feds could do a better job of making this very clear on the decision charts. After reviewing the website, I found the OHRP’s guidance on 45 CFR 46.101(b)(5).

There it was in black and white; we should be consulting with the Department of Health and Human Services funding agency before approving protocols under exemption five. Furthermore, the examples provided are ones of federal programs. To me, this means that we cannot, and should not, be approving local or state programs in which the head or director of the program has asked one of our investigators to study the effectiveness of said program.  Our IRB minds may tell us that if a director of a state or local agency, which provides a benefit or service to the community, requests an evaluation on his or her program by one of our investigators, it is a slam dunk decision and exempt category five is where approval lies. Our IRB minds would be incorrect. It seems to me that, for the most part, we need to forget that exemption five is available, because my guess is that for most of us, our investigators will not be asked by a federal agency to evaluate a public benefit or service agency.

Our IRB will re-evaluate the handful of protocols that have been granted approval under this exemption as soon as possible (and hope that nice lady from OHRP either doesn’t read this blog or that she really is nice!).

'Science Times' synthesis

What will 2012 bring us in research news? Only time will tell! For now, we’ve provided a glimpse of New Year headlines. As always, don’t forget to leave your comments. We are eager to hear your thoughts on researchers’ responsibilities with regard to the altered flu virus.

Week of January 3, 2012

Animal studies cross campus to lecture hall: Once, the study of animals occurred only in the sciences, while liberal arts and social sciences fixed on the study of humans. Now, the field of animal studies includes art, literature, anthropology, film, theater, philosophy, religion, and more.

Genome study points to adaptation in early African Americans: Researchers scanning the genomes of African Americans say they see evidence of natural selection as their ancestors adapted to the harsh conditions of their new environment in America.

Week of December 27, 2011

Debate persists on deadly flu made airborne: While investigating a deadly virus, researchers inadvertently made the virus more contagious. The question now is what to do with this information.

The hormone surge of middle childhood: Research of middle childhood, which is said to begin around five or six, has historically been limited. New forays into this area provide interesting insight.

A glimpse into the Presidential Commission for the Study of Bioethical Issues

PRIM&R is pleased to bring you a post from Mindy Reeter, a member of the PRIM&R Blog Squad at the 2011 Advancing Ethical Research Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

Wow! I am still in awe of three presenters at the 2011 Advancing Ethical Research Conference session titled, Staff Report from the Presidential Commission for the Study of Bioethical Issues (PCSBI). It was led by Valerie Bonham, Kayte Spector-Bagdady and Michelle Groman, three smart, passionate women who are a part of the PCSBI.

Michelle presented information on the PCSBI’s December 2011 review of contemporary issues and concerns in human subjects protections.

The PCSBI sought to conduct an inventory of all ongoing, federally-funded research. In doing so, however, they discovered that this information is not easily accessible. The PCSBI had to reach out to all 18 agencies that adhere to the “Common Rule” and ask them individually to report any ongoing research within their agency.

Since some agencies had no requirements to track this information, hours of preparation were required for this project. The PCSBI subsequently uncovered tens of thousands of active, federally-funded research studies. The inventory of these research projects does not indicate how ethically these studies are being conducted, but is a good first step toward transparency.

I usually leave PRIM&R with some ideas of how to improve my office, but this year I went home with a broader understanding of the research enterprise, rather than just the institutional review board portion of the field. Instead of feeling like I had been told what changes may occur with the regulations, I felt as though I actually understood how and why those changes were being considered.