Working together is a challenge no matter what industry one finds themselves. This theme could not have been more at the forefront than at Day 2 at the PRIM&R Conference in Boston. Veritas IRB attended a series of fascinating presentations which ranged from genome editing, to communication of risks and benefits to participants, identifying major challenges in therapeutic misconception, IRB collaborative reviews and ethical issues when conducting international genetic research. Then, as if these topics weren’t heated enough, day 2 of the conference capped off with a Town Hall meeting that roused many debates on the future of the NPRM. To say this series of discussions was exciting would be an understatement. Certainly an excellent takeaway message from Day 2 would be the following: Let’s focus on developing a better synergy across our industry.

IRB Collaborative Partnerships: “Trust but verify”

Two presentations were dedicated on the IRB cooperative review and oversight: “Operationalizing Collaborative IRB Review” and “Institutional Considerations When Accepting IRB Review from an Independent IRB or Academic Partner”. Both presentations focused on identifying key factors to successfully establish collaborative partnerships between the relying IRB and the external IRB, which may either be commercial/independent, academic-based or a body created by a regulatory agency.

Reliance Agreements: A roadmap to successful partnerships

Reliance agreements are contracts whereby the relying IRB outlines the conditions and processes under which they will delegate the reviews and oversights of studies to the external IRB. These agreements may be one-way and study-specific or may also be reciprocal and cover a multitude of future studies.

When an IRB or institution is considering contracting a reliance agreement with an external IRB, it is usually due to the fact that it has identified a duplication of efforts or resource constraints that are causing prejudice to the efficiencies of its human research protection program (HRPP). It is important to get institutional officials’ buy-in early on the opportunities of developing reliance agreements, as they have authority over the institution’s HRPP. It was identified that some institutions’ legal counsels are initially reluctant to recommend reliance agreements due to the potential liability implications associated with the delegation of some institutional responsibilities to an external body.

This is exactly why speakers recommended that reliance agreements establish mechanisms to develop trust, identify duties that will remain under local control, outline state/provincial legal obligations and provide clear communication channels.

Operational considerations also can’t be fully covered in reliance agreements. Therefore, Standard Operating Procedures are required to ensure effective collaboration.

Key factors to successful collaborations

The key factors to successful collaborations between institutions and IRBs involve the necessity for the relying IRB to clearly identify what are the objectives of the collaborative partnership. For instance, an institution may decide to focus its resources to certain types of research by outsourcing its oversight to an external body. It may also decide to impose limitations on researchers who may or may not be eligible to use the services of an external IRB.

3 elements have been identified to ensure successful IRB collaborative partnerships:

1. Confirm the external IRB’s qualifications
2. Maintain some local oversight duties
3. Develop clear and comprehensive communication processes

NPRM Town Hall Meeting: Can’t we all work together?

The U.S. Department of Health and Human Services (HHS), along with 15 other federal departments and agencies, issued a Notice of Proposed Rulemaking (NPRM) in order to significantly amend the “Common Rule”. Drafters of the NPRM are actively seeking public input on its proposed changes and PRIM&R’s Town Hall session was an excellent opportunity for stakeholders to share their views. The Town Hall panel, masterfully moderated by David Strauss, was comprised of representatives of PRIM&R’s Public Policy Committee and other stakeholders.

Various elements of the NPRM were covered during the meeting, which included the utility of publicly posting informed consent forms on the Web, single IRB review requirement and the adequacy of broad consent for the use of biospecimens in research.

A delicate balancing act

Without going into too much detail involving each debated topic, we noticed that the challenge of the NPRM is to strike a balance between developing efficiencies to meet research targets and having research protection mechanisms that the public can trust.

There appeared to be fear among some of the panelists towards centralizing ethics review without fully exploring what will be the role of local institutions in the protection of research participants. In the same fashion, there appears to be reluctance among the experts towards developing a research protection mechanism that gives a greater role to research participant autonomy. Several experts in research ethics have qualified the current research protection system as being paternalistic.1

This balancing act could not have been better illustrated than during the debate on whether efficiency in enrollment and approval is an ethical value.

Working towards a common goal

Interestingly, in the opinion of patient advocate, Diana Chingos: “efficiency is a really important value to patients who want access.” However, improving efficiency must be achieved transparently. For example, research has shown in newborn screening programs that parents want to be informed so that they have freedom of choice over their child’s wellbeing. The same would go for decision-making about the use of biospecimens.

It was mentioned during the Town Hall meeting that it has been challenging to empower research participants to comment on the NPRM. If participant views on the NPRM are missing, is it because of a communication issue? This may support the need for more time in allowing for the public to comment on the NPRM.

At the end of the day, we all want research to be conducted in accordance to the highest ethical standards to ensure public trust in the successful enterprise of science.

1 See for example A. Wertheimer, Rethinking the Ethics of Clinical Research: Widening the Lens, 2010, Oxford University Press

 F.G. Miller and A. Wertheimer, “Facing up to Paternalism in Research Ethics”, The Hastings Center Report Vol. 37, No. 3 (May – Jun., 2007), pp. 24-34

The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.