Dr. Stephen Rosenfeld is an experienced researcher and IRB executive, having served in leadership positions at Western IRB and Quorum Review. Together with colleagues, he recently founded the non-profit North Star Review Board. We recently had the opportunity to talk to Stephen about the role of IRBs, including independent IRBs, and the recent GAO report on IRB oversight and effectiveness. We hope you find this as thought-provoking as we did!
Stephen, tell us about yourself, including your background, the kinds of research you have conducted, and how you got involved in IRB review:
I am a hematologist by training and spent 19 years at the National Institutes of Health (NIH) conducting both basic and clinical research, particularly on aplastic anemia and bone marrow failure. I also earned a master’s in business administration from the Georgetown McDonough School of Business. I was always interested in computers and information technology and ended my time at the NIH as the Chief Information Officer (CIO) at the NIH Clinical Center. I then became the CIO at MaineHealth, a large independent healthcare organization. My longstanding interest in research ethics led me to take the position of CEO of Western IRB (WIRB), where I served for several years before becoming the Executive Board Chair of Quorum Review. At Quorum, I began to solidify my ideas about the IRB as a collaborative endeavor with investigators. I am currently back in Maine where I serve as the President of Freeport Research Systems, LLC and the Executive Director and Review Board Chair of the North Star Review Board. I have served as the chair of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and currently serve on the Boards of Public Responsibility in Medicine and Research (PRIM&R) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
What do you see as the main purpose of the IRB?
While many view the IRB’s main role as ensuring regulatory compliance, I believe it goes beyond that. The regulations set minimum expectations but often are not specific about implementation. For example, the regulations require that an IRB determine if there are adequate provisions to protect the privacy of research participants and to maintain the confidentiality of research data, but it is up to each IRB to determine what the adequate measures are for a particular research study.
While most would agree that the main goal of the IRB is to ensure adequate protections of participants, to me, this sounds paternalistic. Instead, I believe that the IRB should ensure that the risks we are asking potential participants to assume for a given study are scientifically necessary and justified by potential benefits of doing the research. Information should be presented to participants in an open and honest manner so that their choices about participation are clear, fair and reasonable.
Tell us about North Star Review Board and how it is different from other IRB’s?
North Star Review Board was founded in 2021 by me and other experienced IRB professionals to provide a different model for IRB review. North Star is an independent review board, that is, we are not affiliated with an entity that also conducts human subjects research. In addition, we are also nonprofit which eliminates the potential conflict between profit and function and the perception that we place the interests of investors over the interests of research participants. This, in turn, helps build trust in science and the research enterprise. As a not-for-profit organization, as our fees reflect our costs to provide services and we can maintain lower fees and costs than many for-profit IRBs.
In what other ways is North Star unique?
We are a “learning IRB” which means we are committed to using tools and the philosophy of continuous learning to help us be consistent, reasoned, and justified in our operations and review decisions. We use the data about our review processes and decisions to promote consistency and to factor into our administrative system. We also strive to be transparent to clients and stakeholders about the outcome of our deliberations. While we must focus on ensuring compliance with the regulations, we also are aware that the regulations do not specifically address many current topics in research ethics. Having a highly experienced staff and board members allows North Star to acknowledge these unanswered questions and promote open discussion that includes the perspective of research participants.
How have independent IRBs evolved over time?
The biggest change has been consolidation and acquisition of the smaller independent IRBs so that in the United States currently, there are 2 very large organizations offering IRB services and only about a dozen smaller independent IRBs.
What do you see as the main difference between the smaller and very large independent IRBs? Is there still a role for small independent IRBs?
Generally speaking, competition and choice in any marketplace are desirable and this includes the independent IRB market. So, I hope that there will continue to be a variety of IRBs to meet the varied needs of research entities which can range from large pharmaceutical companies that do multi-site clinical trials, to small, specialized companies that conduct research on very specific topics like rare diseases.
The larger IRBs may be better suited to meet the needs of organizations with less budgetary constraints, that need less personalized attention because they are well-experienced in clinical research but need lots of administrative and other support for multi-site and/or complex studies. Smaller research organizations, especially those with less experience, who need more individualized attention from the IRB and are also doing smaller, generally single site studies and are price-sensitive, are likely better served by the smaller IRBs whose costs are generally more flexible and who can provide more individualized help to investigators.
I know from experience that the consolidation of IRBs has left many researcher entities with fewer realistic choices for IRB review because of cost and need for more assistance. We started North Star in part, to fill this void and to demonstrate that high quality IRB review was possible using a non-profit model. we are filling a need for realistic IRB choices for clients who simply cannot afford the larger IRB’s.
We can certainly relate to your last comment as Learn eCORE sees a void in the availability of high quality but affordable research ethics training for smaller research entities.
Another issue is the concern, real or perceived, about independent IRBs that are investor-owned, is that there is a primary focus on return on investment that outweighs an IRB’s primary duty to ethics and protecting participants. Even the perception of financial priorities can decrease trust in research.
How can this potential for conflict of interest in for-profit IRBs be addressed?
IRBs that are for-profit, and especially investor owned, can avoid the appearance of conflict through clear management policies that ensure that the IRB’s ability to fulfill their mission is not impacted by the profit margin.
What is the role for independent IRBs in research oversight; how do they fit in with the other types of IRBs (organizational, private, government)?
For larger research entities, especially, academic institutions, it makes sense for them to have their own IRBs. Their challenge can be to ensure the IRB is independent of other institutional interests.
How do you think the revised Common Rule requirement for single IRB review of cooperative research is working? How is this requirement impacting IRB’s?
I was a proponent of the single IRB review concept because the delays and cost of multiple reviews rarely if ever translate into better participant protections, and create significant burden on researchers. But single IRB review is resource intensive and requires lots of coordination that can be difficult to manage by a PI at an academic site. This, I believe, has resulting in shifting many large, multi-site clinical studies to independent IRB. Single IRB review was felt to be in line with the main purpose of the revised Common Rule, to decrease administrative burden while improving, or at least not reducing, human subjects protections. I would love to see an in-depth evaluation of whether single IRB review has achieved these twin goals.
In early 2023, the General Accounting Office (GAO) issued a report “IRBs: Actions needed to improve federal oversight and examine effectiveness”. GAO was asked to examine independent IRBs, processes used to protect human subjects, and standards of IRB quality. This report describes their findings related to the IRB market and OHRP and FDA oversight of IRBs. The report lists 4 major recommendations: to improve data accuracy in OHRP’s IRB registry, that OHRP and the FDA conduct annual risk assessments of their IRB oversight activities and to work with stakeholders to study and implement approaches for measuring IRB effectiveness.
What are your thoughts about this report and its recommendations?
The issues addressed by this report are important. IRB effectiveness is of great interest. So, the idea of getting stakeholders together to discuss this has merit.
However, I think that the GAO missed an opportunity with their investigation because they did not address the potential for structural conflicts of interest in different independent IRB models and made no recommendations to explore this issue.
As far as IRB oversight, the report basically foisted responsibility back on OHRP and the FDA. OHRP is a small agency that has very limited funding to conduct much IRB oversight unless an allegation of non-compliance has been made. Unless HHS finds a way to increase funds and staffing for this, I don’t see this changing much.
Their report’s focus on IRB effectiveness is one that continues to be a hot topic within the research ethics community.
IRB effectiveness is very difficult to measure, in part because it is not possible to have a true control group of studies that do not undergo IRB review. I think generally, most would accept that the IRB model has met its main goal of eliminating extremely unethical studies like Tuskegee, and that overall changes to the research environment to promote ethical design have resulted since IRB review has been in place.
Given that we cannot do a controlled study on IRB effectiveness, most studies on this topic have been process-oriented, like looking at time to approval or administrative burden. I think the more appropriate focus should be on IRB quality measures of such as whether relevant ethical issues are appropriately and consistently recognized and discussed by an IRB, or IRB member expertise. However, these types of quality measures are difficult to study but I absolutely believe we need to shift the focus to ways to measure IRB quality.
I would have liked to have seen the GAO report push for IRB quality measures.
A statistic that stood out to us in the GAO report, was that while independent IRBS are the minority of IRBs in the US, (about 2% of active IRBs registered with OHRP as of April 2021 which the report pointed out is likely even smaller given the continuing IRB consolidation trend), the proportion of research studies using independent IRBs has increased. In 2021, independent IRBs reviewed the largest share of FDA-regulated studies (48%). Why do you think this is?
First, let me state that I am a proponent of using a single IRB for multi-site studies. I know about the delays and difficulties in managing issues raised when every site does their own IRB review. However, single IRB review is administratively resource intensive and can require much coordination on the part of the lead IRB. For very large clinical trials conducted by academic institutions, this coordination can be difficult for their IRB’s or their lead PIs to manage. For pharma-sponsored trials, most pharmaceutical companies do not have their own IRBs. This has led to the use of larger independent IRBs who can perform these administrative tasks in addition to serving as the IRB of record.
I would like to see robust evaluation of the single IRB requirement to see if it is truly helping to meet one of the main stated goals of the revised Common Rule, to decrease administrative burden while maintaining appropriate protections of research participants.
Let’s switch gears a bit and talk more about IRB operations.
Should IRB members be compensated for their work?
IRBs vary in whether they compensate IRB members and this is also a topic upon which stakeholders do not agree. I personally think IRB members should be compensated. In fact, I cannot think of a compelling argument for NOT compensating IRB members! Lack of compensation leads to turnover and the perception that service on the IRB is a necessary evil. In my experience, service on an IRB is a rewarding intellectual activity; an opportunity to discuss difficult issues with peers; and an opportunity to learn. There is no reason it should come at the price of uncompensated time.
Is accreditation, such as that offered by the Association for the Accreditation of Human Research Protections Programs (AAHRPP) important for IRBs?
AAHRPP is the main organization in the United States that accredits IRBs. They basically raise the compliance bar and required accredited IRBs to go beyond basic compliance. It takes an institutional commitment to obtain and maintain accreditation, especially in terms of staffing, which I think is good. Also, AAHRPP provides for networking through their Collaborative AAHRPP Network (CAN). This enables members to share experiences and practices from a broad range of study types and disciplines which I have personally found to be quite valuable. In full disclosure, as the chair of AAHRPP’s board of directors, I’m not quite neutral about this! On the other hand, North Star Review Board, my own independent IRB, doesn’t yet have the resources to seek accreditation. So I can see both sides.
Finally, what do you see as some of the more pressing challenges currently facing IRBs in general?
The issue of consistency in review, not only across similar studies, but even within the same study that comes back to the IRB multiple times over its course, for review of modifications and annual re-certification, is one that I think most IRBs struggle with. The minutes generally do not have detail on discussion points or how the IRB arrived at a decision. Collecting this information and organizing it so it can be readily used is something I have been working on for many years.
While I also think that accreditation is important, I worry that the entities that seek IRB accreditation through AAHRPP, are less in need of it because they have already made a commitment to staffing and resources for the IRB. Many IRBs in smaller entities don’t get the institutional support or budget to seek IRB accreditation and I believe it is important for the IRB and Bioethics communities to determine how to help these IRBs.
