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Transcript for audio podcast:
Independence of the Office for Human Research Protections

From the Office of Inspector General of Department of Health and Human Services

https://oig.hhs.gov

[Katherine Harris] The HHS Office of Inspector General released a report on the independence of the Office of Human Research Protections. I'm here with team leader Kimberly Ruppert, from the Office of Evaluation and Inspections, who will discuss this report. Kimberly, could you start off by explaining what the OHRP is and what it does in the Department?

[Kimberly Ruppert] Of course. As you might be aware, the Department of Health and Human Services supports a lot of research-somewhere around $20 billion across thousands of research institutions like universities and hospitals. Much of this research, such as clinical trials, can only be conducted when individuals volunteer to be part of that research as human subjects. These human subjects could be exposed to different risks depending on the research, and it's the job of the Office of Human Research Protections, or OHRP, to make sure that they are protected. One of the main ways that the Office does this is check that research institutions are following the federal rules that are in place to protect human subjects. And to do this, OHRP conducts what it calls compliance evaluations, which are often in response to complaints it received, but they can also be completely random.

[Katherine Harris] What was the purpose of this report?

[Kimberly Ruppert] We looked at whether OHRP, was able to independently conduct the compliance evaluations that I just mentioned. We did this review because of the importance of OHRP's independent oversight. The primary responsibility to protect human subjects really falls on those research institutions as well as the funders of research, and there needs to be strong oversight, given the potential risk these volunteers can face.

[Katherine Harris] What did you find?

[Kimberly Ruppert] We found that OHRP largely conducted its compliance evaluations independently from both the agencies that fund the research as well as the institutions that are conducting the research. First, we found that OHRP had the final say as to whether and how to initiate its compliance evaluations. Second, we found that it was able to obtain the information it needed to conduct its evaluations. This would be information that OHRP requested from the research institutions and the funding agencies. And then lastly, the office maintained its findings in its evaluations. Since 2000 OHRP has conducted 492 evaluations, and only changed one finding in this time.

[Katherine Harris] What else did you learn about OHRP's independence?

[Kimberly Ruppert] We also found some things that may limit that independence.

First, we found Stakeholders have different opinions as to what OHRP's role and actions should be, in terms of enforcing protections for human subjects. These opinions were presented publically over the last few years in response to OHRP's actions in one particular evaluation that they conducted, and we think that this public debate and pushback to the office's actions could limit its independence in the sense that the office may be a little more hesitant to take on potentially controversial evaluations and even could be more guarded in its compliance actions, because it may anticipate a negative reaction.

Second, within the department organizational structure, OHRP is in the Office of the Assistant Secretary for Health, while the research funding agencies that it oversees are higher up in the Department hierarchy, directly under the Secretary. This may mean that OHRP faces greater pressure in arguing its decisions because it doesn't quite have an equal voice with those agencies.

Third, OHRP's resources are determined by the department rather than by Congress or the Office of Management and Budget, and we think this may limit its independence. Some stakeholders we spoke with thought that the office was under-resourced. OHRP does have four staff conducting compliance evaluations overseeing all department research.

[Katherine Harris] Does your report include any recommendations to address possible threats to independence?

[Kimberly Ruppert] Yes, it does. Interestingly, there's no law that makes OHRP independent. So one thing we point out in our report is that it's really on the department to encourage a shared understanding that the office's independence is in fact important. So we recommend that HHS address the factors that may limit OHRP's independence. We left it up to the department as to the best way to do this, but we made some suggestions like posting guidance to clarify OHRP's roles, and evaluating its position within the department organizational structure.

[Katherine Harris] Is there anything else you would like to mention about this report?

[Kimberly Ruppert] Sure. We'd like OHRP's activities to be more transparent to the public, so that everybody knows what they're doing. One way to do this would be for the office to post more information on its website, like data on its compliance activities. And we did include this as a recommendation in our report.

[Katherine Harris] Well, I want to thank team leader Kimberly Ruppert for taking the time to explain this work.

[Kimberly Ruppert] You're welcome.

[Katherine Harris] You can learn more about the OIG's work on our website oig.hhs.gov. I'm Katherine Harris and thanks for listening.

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