Attachment A - Response Off. Inspector Gen. Report, July 7, 2017
2. OHRP’s position in the HHS hierarchy and HHS’s control over its resources may limit its ability to operate independently;
3. OHRP’s practice of not reporting publicly on all of its compliance activities may give the appearance of limited oversight and independence; and made the following recommendations:
Issuing guidance that clarifies (for stakeholders and the public) OHRP’s role
As described above, the OIG report notes that OHRP’s role lies on a spectrum between enforcing compliance and developing policy. While both policy and compliance are within the mission of OHRP, the authority of its policy recommendations and findings depends on the possibility of non-compliance findings and consequent actions. No policy will be fully implemented in an environment where its enforcement is unlikely or impossible.
SACHRP recommends that OHRP make its dual responsibilities of policy development and compliance enforcement explicit, and that the explicit description reassert its authority to act against entities found out of compliance with 45 CFR 46 regulations for the protection of human research subjects in HHS funded research.
Evaluating OHRP’s position within HHS, including (1) whether to place OHRP at the same hierarchical level within HHS as the research agencies it oversees and (2) the potential advantages and disadvantages of such a change
The OIG report makes the observation that:
OHRP is under the Assistant Secretary for Health, whereas the agencies that fund research—such as NIH—are directly under the Secretary of Health and Human Services. This means that OHRP is at a lower level in the HHS organizational hierarchy than the research-funding agencies and may face greater pressure in arguing its decisions because it does not have an equal voice with those agencies
The practical consequences of elevating OHRP’s hierarchical level within HHS to the level of the Secretary are unclear, but the symbolic importance of positioning the office responsible for compliance at the same level as the entities it oversees would be significant, as suggested by the OIG report. It is worth remembering that OHRP’s functions have already been elevated once, when it was moved from within the NIH, where it reported to the Director, to the Office of the Assistant Secretary for Health, to avoid the appearance of a conflict of interest. As the debate around the SUPPORT trial shows, that appearance of conflict remains.
SACHRP recommends elevating OHRP’s position within HHS to be commensurate with that of the entities it regulates.
Evaluating the sufficiency of OHRP’s resources to carry out its mission and exploring with the Office of Management and Budget and congressional appropriators ways to elevate the prominence of OHRP’s budget—for example, by including it as a line item in the President’s budget.
The OIG notes that the Office can independently decide how to best fulfill its mission through a balance between its compliance and policy development activities. The description of such decision-making as independent may be disingenuous in the face of shrinking budget and resources, particularly when compared to the growth of regulated entities.
The OIG report notes that OHRP’s budget “has generally been flat, averaging about $6.9 million annually since 2000.” Since that report was published, OHRP’s budget has been less than $6.5 million annually, and with adjustment for inflation, it is only about 63% of what it was at its peak in 2003. For comparison, the NIH budget has risen from $27 billion to $37 billion annually over the same period, although it has remained essentially flat when adjusted for inflation. While the NIH budget does not translate directly into the volume of NIH-funded research studies with human participants, these trends raise the possibility that OHRP’s resources and capabilities are shrinking while the major source of Federally-funded research funds expands.
In addition to possible changes in the volume of regulated research, the past several years have brought major changes in research regulations and in the research enterprise, significantly increasing the policy and advisory obligations of OHRP. These changes include:
It is beyond the expertise of SACHRP to evaluate whether OHRP’s existing resources are sufficient to address its ongoing policy and compliance obligations, while also addressing these additional needs, but the complexity of the current environment suggests the need for a formal planning and budgeting exercise for the Office.
As implied by the OIG report, the most definitive way that regulated entities can affect OHRP’s compliance function is by arguing for a decrease in its budget. Once an appropriate budget is established, ensuring independence requires that this budget be protected from inappropriate reactive pressures or from real or apparent conflicts of interest.
SACHRP recommends that OHRP’s budget should be shielded from inappropriate changes unrelated to changes in mission, scope or responsibilities. One way to achieve such independence would be to index the budget to Federal research expenses, perhaps as indicated by a surrogate like the NIH budget.
Finally, HHS should consider seeking statutory authority for OHRP’s independence
In both the current report and a previous report from 2014 (Report of OIG Review of Allegations of Interference in OHRP Compliance Determination for SUPPORT), the OIG concluded that OHRP had been able to act independently, but also noted that “no law establishes OHRP's organizational independence.” While offering the model of the Inspector General (IG) Act as a way to create such statutory independence, the OIG observed that “Federal OIGs routinely consult with experts in the programs they review,” implying that statutory independence would not preclude the kind of debate that developed around SUPPORT.
The IG Act creates offices that have oversight of Federal program. The oversight function of OHRP, in contrast, is focused on regulatory compliance of entities receiving Federal funds for research. As illustrated by SUPPORT, the concern for OHRP is not necessarily direct influence or interference by research entities in its compliance activities, but rather the influence or interference by other Federal entities that disagree with its findings and feel they have an equivalent expertise or authority.
Despite this difference in scope, there are several aspects of the IG Act that could serve as useful models:
§5(21) a detailed description of any attempt by the establishment to interfere with the independence of the Office, including (A) with budget constraints designed to limit the capabilities of the Office; and (B) incidents where the establishment has resisted or objected to oversight activities of the Office or restricted or significantly delayed access to information, including the justification of the establishment for such action;
Documenting and disclosing improper interference might be more difficult for OHRP, given the complexity of its relationship to Federal funding entities and institutions or other entities receiving such funds. Identifying such interference would be more likely if OHRP was at the same hierarchical level as the research agencies it oversees (see preceding recommendation).
The OIG report concluded that some of the problems around SUPPORT that led to concerns about OHRP’s independence arose because OHRP’s role and authority to interpret regulations was not clear to Federal research agencies. This role and authority are currently not defined by statute, but are reflected in the Office’s mission.
SACHRP recommends that HHS consider seeking statutory authority for OHRP to directly collect, on its own authority, all documents related to its investigations.
SACHRP recommends that HHS consider seeking statutory clarification of the role and authority of OHRP as the primary interpreter of the regulations in 45 CFR 46 for the protection of human participants in HHS funded research,
Content last reviewed on November 19, 2018