DCO Activity Data

Definitions:

Incident Reports ("IRPTs") – Incident reports are notifications that OHRP receives from institutions to meet their regulatory obligation to report incidents of unanticipated problems involving risks to subjects or others; serious or continuing noncompliance with these regulations the requirements or determinations of the IRB; and suspensions or terminations of IRB approval. All incident reports are reviewed by DCO within 2 business days to identify incidents that may place research subjects at an increased risk and require immediate action from OHRP.

Full reports are complete initial reports that will not require a follow-up report.

Initial reports will require a follow-up report to be completed. This may be required for instances where the institution has not implemented a corrective action plan or has not completed gathering all information but is required to report incidents as required by the pre-2018 Requirements at 45 CFR 46.103(b)(5), and the 2018 Requirements at 45 CFR 46.108(a)(4).

Follow-up reports provide additional information to a previously submitted initial report.

Complaints – While the data prior to 2022 includes all complaints received by OHRP, data beginning in 2022 represents the total number of complaints OHRP receives that meet the regulatory definition of human subjects research (HSR) as defined by the Common Rule (45 CFR 46). Most of the complaints received by OHRP pertain to issues that do not involve HSR. Often these complaints are about research that is not covered by the Common Rule or pertain to issues that are not related to research at all. Generally, the source of complaints sent to OHRP include, but are not limited to, research subjects and their family members, individuals involved in the conduct of research such as investigators and study coordinators, institutional officials, journalists, or media. OHRP takes all complaints seriously.

Active Cases – This data represents the number of OHRP cases that are ongoing and includes both for-cause and not-for-cause cases.

For-cause evaluations occur at OHRP's discretion, in response to OHRP's receipt of substantive written allegations or indications of noncompliance with the HHS regulations. Sources of such allegations or indications of noncompliance include, but are not limited to, research subjects and their family members, individuals involved in the conduct of research such as investigators and study coordinators, institutional officials, and research publications.

For-cause cases are those that are generally initiated as a result of allegations of non-compliance. Sources of such allegations or indications of noncompliance include, but are not limited to, research subjects and their family members, individuals involved in the conduct of research such as investigators and study coordinators, institutional officials, and research publications. OHRP may choose to use other mechanisms to address allegations or indications of noncompliance rather than conducting a for-cause evaluation. In general, information about these compliance activities are not provided to the public. For further details see OHRP’s guidance, "Compliance Oversight Procedures for Evaluating Institutions".

Not-for-cause compliance oversight evaluations are conducted in the absence of substantive allegations or indications of noncompliance. Institutions are selected for not-for-cause evaluation based on a range of considerations, including: (a) the volume of HHS-conducted or -supported research in which they are engaged; (b) whether they have a history of a relatively low level of reporting to OHRP under the requirements of HHS regulations at 45 CFR 46.103(b)(5); (c) the need to evaluate implementation of corrective actions following a previous for-cause compliance oversight evaluation; (d) geographic location; (e) status of accreditation by professionally recognized human subject protection program accreditation groups; and (f) status of recent human subject protection evaluations or audits by other regulatory agencies (such as the Food and Drug Administration).

For more information about compliances cases and how they are conducted, please visit OHRP’s website at: https://www.hhs.gov/ohrp/compliance-and-reporting/evaluating-institutions/index.html