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Parallel Processes at the NIH By Sally J. Rock ey an d Amy P. Patterson

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his report highlights the complexities experienced by institutions that conduct Public Health Service-funded research involving human subjects and that need to negotiate the requirements of two sets of federal regulations: 45 C.F.R. 46, covering protections for human research subjects, and 42 C.F.R. 93, the PHS policies on research misconduct. As the nation’s single largest sponsor of biomedical and behavioral research, the National Institutes of Health seeks to exemplify and promote human research protections and the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. The NIH is committed to protecting the rights and welfare of research participants and to upholding integrity standards for research supported with public funds. However, human subjects protections must always take priority. When confronted with situations that involve the two sets of federal regulations, the NIH faces issues similar to those faced by the institutions that must investigate these matters. It works closely with federal partners and with institutions to achieve a satisfactory outcome. As Bierer and Barnes point out, anticipation of problems; communications with appropriate federal agencies and offices, NIH staff, and institution officials; and considerations of requirements for confidentiality Sally J. Rockey and Amy P. Patterson, “Parallel Processes at the NIH,” The Intersection of Research Fraud and Human Subjects Research: A Regulatory Review, special report, Hastings Center Report 45, no. 4 (2014): S33-S34. DOI: 10.1002/hast.340

are all vital for the proper management of these delicate and complex situations. When an allegation of noncompliance with human subjects regulations (45 C.F.R 46) involves an NIH-funded study, the Office for Human Research Protections (OHRP), which is in the Department of Health and Human Services, contacts the NIH Office of Science Policy (OSP) for information about the study. OSP, in turn, consults with the NIH Office of Extramural Research and the funding institute or center (IC) to gather facts and perspectives. OSP shares the information with OHRP and may arrange followup meetings to address remaining questions and issues

The safety of participants is always a priority when allegations involve research with human subjects. related to human subjects protections. As part of its science policy development function, OSP also analyzes the “lessons learned” from compliance cases to see whether they point to a more general issue that can be addressed through additional guidance or new policy. The Office of Extramural Research-Research Integrity (OER-RI) serves as the entry point at NIH for allegations of research misconduct and is responsible for preliminary assessments of allegations of research misconduct. Allegations that are likely to fall under the research misconduct regulations (42 C.F.R. 93) are forwarded to DHHS’s Office of Research Integrity (ORI) for its oversight. OER-RI is sensitive that certain research activities that may be identified as violating human subjects protections regulations may also fall within the realm of research misconduct and may or may not be recognized as such by institutions. To prevent inadvertent errors, OER-RI makes an effort to inform NIH extramural staff about those clinical situations that may also involve a violation of research misconduct standards. It also reminds staff that findings of research misconduct

SPECIAL REP ORT: T h e I nt er sec t io n o f Resea r ch Fra u d a n d H u ma n S u bj e c ts Re s e a rc h : A Re g u l a tory Re v i e w

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are made against members of the research team, so the focus is not on the research protocol itself. The list of research actions involving human subject research that may violate both federal regulations 45 C.F.R. 46 and 42 C.F.R. 93 that Bierer and Barnes have provided will be a very useful reference for NIH staff and for NIH-funded institutions. OER-RI works with NIH IC research integrity officers (RIOs) to ensure that allegations are appropriately brought to the attention of ORI and, if necessary, the RIO at the research institution. As previously stated, the safety of human research participants is always a priority whenever allegations involve research with human subjects. This is especially a concern when the allegations originate from individuals or groups other than the IRBs. OER-RI will inform OHRP of those research misconduct allegations that also involve human subject research. Moreover, NIH IC RIOs and other senior IC staff members will work with research institutions to ensure that risks to research participants are minimized. Frequently, ORI is the initial recipient of allegations. ORI will share these with OHRP and OER-RI as appropriate. Communications among OER-RI, NIH IC RIOs, ORI, and OHRP on such allegations are conducted through an established, secure electronic platform. Compliance oversight is a shared responsibility, although ORI has authority to oversee research misconduct investigations and actions, and OHRP is responsible for implementing the regulatory requirements for protecting human subjects in research. While working with both offices, OER-RI

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observes the requirements for confidentiality related to research misconduct allegations. Institutional processes with respect to human subjects violations or research misconduct may occur simultaneously but need not conclude at the same time. As Bierer and Barnes note, investigations into alleged research misconduct are often lengthy. Findings of research misconduct may not be made for some time after the IRB or OHRP has made a determination of noncompliance. It is important to note that investigations into harms to human subjects and noncompliance with the human subjects protections regulations should be on a separate timeline from activities related to potential research misconduct so that risks to human subjects can be addressed as quickly as possible. During these situations, it is vital that involved institutions or federal agencies with oversight authorities, such as OHRP and ORI, and those with funding and stewardship responsibilities, such as the NIH, work together to determine what and when information can be disclosed. A balance must be achieved to uphold ethical responsibilities to research participants while protecting the investigation procedures for research misconduct and the reputation of the respondents. At the NIH, OSP and OER-RI will consult and work with relevant staff from funding ICs to achieve that balance. Bierer and Barnes recommend that IRBs and RIOs work together to manage allegations of research misconduct in human subjects research protocols. Using an analogous process, OSP and OER work together to handle these types of issues for NIH.

July-August 2014/ H AS TI N GS CE NTE R RE P O RT

Parallel processes at the NIH. Commentary.

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