IRBs can resolve most research-related complaints, but a policy implemented last year by the National Institutes of Health’s (NIH) Office of Human Subjects Research Protections (OHSRP) offers assistance when the conflict reaches a stalemate.

Policy 104, Managing Research-Related Complaints from Subjects, applies to NIH investigators, non-NIH investigators when the NIH IRB is the reviewing IRB, the NIH IRB, the OHSRP, and Institute/Center (IC) leadership. The policy was implemented on Sept. 21, 2020.1

The policy advises the principal investigator (PI) to notify the OHSRP Office of Compliance and Training in the case of unresolved complaints, regardless of whether the NIH IRB is the reviewing IRB. OHSRP will work with the appropriate parties and offices to assist with the complaint. Matters outside the scope of the Human Research Protection Program (HRPP) will be referred to the appropriate NIH office or IC. Matters within the scope of the HRPP also could be handled by NIH offices other than OHSRP.

The IRB may take any or all of the follow actions, according to the policy. It can modify the research protocol and/or consent(s), suspend or terminate IRB approval for some or all of the PI’s studies, require additional education for the investigator(s), and inform other IC or NIH officials to consider additional actions.

Looking to the Future

Could federal regulations, state statutes, or professional accreditation standards require the use of a neutral third-party mediator or arbitrator in the future? Relocating the dispute resolution system outside the IRB could have more cost than benefit, said Kristen Underhill, JD, DPhil, MSc.2 The non-neutrality of IRBs can be problematic, but this is offset by the structural advantages of IRBs involved in dispute resolution for research-related injuries and by the IRB mandate to protect subjects.

“Imposing the requirement of a third-party neutral from outside the institution would also scale up the costs of disputes and could impose inefficient levels of process for minor complaints. Requiring subjects to bear these costs would impair access to the forum, as most subjects would be unable or unwilling to pay,” Underhill wrote. “Institutions could bear the costs, but this may impair neutrality of the forum for third-party decision-makers that were repeatedly retained. Requiring research sponsors to bear the costs would increase the expense of research more generally, posing tradeoffs between paying for more research or more administrative costs.”

Nor does Underhill believe changes to the Common Rule should be made to address the resolution systems. This could increase inefficiencies in the current system and discourage innovation. “Mandating and monitoring IRB compliance with new regulatory requirements for complaint resolution, especially when the frequency of complaints may be low, is likely to increase inefficiencies in the current system,” she noted. “It may also discourage innovation, such as institutions that began using local trusted authorities in culturally or linguistically distinct participant populations to assist in handling disputes.”

Underhill spoke to personnel from 30 hospitals and universities to see how they resolve grievances from research studies. The respondents indicated an openness to guidance about the issue. This, along with the informal nature of many of the respondents’ processes, could facilitate the incorporation of new ideas without a regulatory requirement, she wrote.

REFERENCES

  1. Office of Human Subjects Research Protections. Policy 104: Managing Research-Related Complaints from Subjects. Sept. 21, 2020.
  2. Underhill K. Righting research wrongs: An empirical study of how U.S. institutions resolve grievances involving human subjects. Yale J Health Policy Law Ethics 2019;18:2.