OHRP occasionally posts correspondence with institutional review boards, investigators, research institutions, or federal agencies when we believe that others may find our discussion of issues referenced in the correspondence useful for understanding the applicability and interpretation of the Department of Health and Human Services (HHS) regulations for the protection of human subjects in research (45 CFR part 46).
OHRP will notify the other correspondent(s) involved before posting such correspondence.
OHRP welcomes comments on the viewpoints expressed in the correspondence. Comments may be submitted to OHRP by email at firstname.lastname@example.org. Please include the date and subject matter of the correspondence, given below, in the email subject field. Alternatively, comments may be submitted by mail to:
Office for Human Research Protections
1101 Wootton Parkway
The Tower Building, Suite 200
Rockville MD 20852
Comments received, including any personal information provided, will be made available to the public upon request.
Correspondence Regarding the Application of 45 CFR part 46 to the Activities of a Clinical Data Registry
This correspondence responds to several questions about the application of 45 CFR Part 46 to activities of a clinical data registry.
Correspondence Regarding the Application of 45 CFR part 46 to the Activities Related to a National Health Registry
These OHRP correspondences respond to questions about the application of 45 CFR Part 46 to activities related to a national health registry.
Correspondence on “Non-engaged” Scenarios (September 22, 2011)
As noted in OHRP’s October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research, the scenarios of when an institution is not engaged in human subjects research are not all-inclusive (see http://www.hhs.gov/ohrp/policy/engage08.pdf). Since the guidance document was issued, on a case-by-case basis in response to specific requests from institutions, OHRP has found some institutions in certain circumstances to be not engaged, even though the exact non-engaged scenario is not included in OHRP’s October 16, 2008 guidance document.
Since these exceptions have been granted on a case-by-case basis in certain circumstances, institutions should not extrapolate from these descriptions and determine they are not engaged. If investigators or institutions have questions about whether their involvement in a non-exempt human subjects research study would make them engaged in the research, contact OHRP by phone at (866)447-4777 (toll-free within the U.S.) or (240)453-6900, or by e-mail at email@example.com. When OHRP receives requests that institutions be considered "not engaged", the analysis will be guided by consideration of whether the institution's participation is so limited or marginal that considering them to be "engaged" would not meaningfully add to protection of the human subjects in research. The following are descriptions of the activities that OHRP determined did not make the institution engaged in the specific non-exempt human subjects research projects that were in question:
The institution received a grant award from the National Institutes of Health (NIH) for the conduct of non-exempt human subjects research (i.e. was an awardee institution), but no specific human subjects research studies were described in the grant application. In this case, the awardee institution planned to solicit research proposals that would be funded under the awardee institution’s NIH grant. Institutions other than the awardee institution could receive these sub-awards from the awardee institution. The institution receiving the NIH award would have no involvement in the conduct of the research conducted at the other institutions.
Note that in this case, OHRP determined that the awardee institution of the NIH award was not engaged in the non-exempt human subjects research studies that were to be carried out by other institutions under the award. This was an exception to the “engaged” scenario described in section III.A.(1) of OHRP’s October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research.
The institution’s employees helped to maintain and operate a data center that had been approved by an institutional review board (IRB), and these employees also obtained individually identifiable private information from the data center to assist investigators from engaged institutions with any of the following activities, provided the activities had been described in the IRB-approved data center protocol:
1. Consulting with an investigator from an engaged institution on elements within the dataset that would meet the investigator’s needs;
2. Consulting with an investigator from an engaged institution on analytic strategy;
3. Designing the analysis for an investigator from an engaged institution;
4. Developing analytic code for an investigator from an engaged institution; and
5. Interpreting the results of analyses run in the data center for an investigator from an engaged institution.
Note that OHRP determined that the institution operating the data center was not engaged in the human subject research being carried out by other institutions, even though the services provided by the institution operating the data center were not typically performed by the institution for non-research purposes. This is in contrast to the “non-engaged” scenario described in section III.B.(1) of OHRP’s October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research. The “non-engaged” scenario described in section III.B.(1) of OHRP’s guidance document is limited to commercial or other services that are typically performed by an institution for non-research purposes, and identifies other conditions that need to be satisfied.
Magnetic Resonance Imaging (MRI) Research Facility
The MRI research facility’s involvement in human subjects research was limited to the following:
1. Permitted use of their MRI research facility for intervention or interaction with subjects by investigators from another institution that was engaged in the research; and
2. Involved their employees or agents interacting or intervening with human subjects in the research by providing investigators from the engaged institution with only technical assistance in operating the MRI equipment.
Note that OHRP determined that the MRI research facility was not engaged in the human subjects research being carried out by other institutions even though the MRI services being provided were not typically performed by the MRI research facility for non-research purposes. This is in contrast to the “non-engaged” scenario described in section III.B.(1) of OHRP’s October 16, 2008 Guidance on Engagement of Institutions in Human Subjects Research. The “non-engaged” scenario described in section III.B.(1) of OHRP’s guidance document is limited to commercial or other services that are typically performed by an institution for non-research purposes, and identifies other conditions that need to be satisfied.
(This correspondence is available in PDF format at (PDF 28 KB).)
Expedited Review Category 3 applies to the prospective collection of biological specimens for research purposes by noninvasive means ( see Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review). In response to a recent question, OHRP has clarified its view about the meaning of "noninvasive." Under Expedited Review Category 3, the following procedures are considered noninvasive:
- Vaginal swabs that do not go beyond the cervical os;
- Rectal swabs that do not go beyond the rectum; and
- Nasal swabs that do not go beyond the nares.
This clarification is consistent with the Food and Drug Administration's position on these procedures.
This OHRP letter clarifies that OHRP fully agrees with the Food and Drug Administration’s position on the benefits of relying on a single central IRB for multicenter research.
This letter to a commercial company, which offers a web-based system for managing student subject pools, clarifies that imposing penalty credits on students who fail to show up for scheduled appointments with investigators without cancelling by a specified deadline violates the requirements of Department of Health and Human Services (HHS) regulations at 45 CFR part 46.116(a)(8). Such penalties may not be implemented for non-exempt human subjects research conducted or supported by HHS or for non-federally supported research to which an FWA applies.
OHRP would like to clarify some of our views about when institutions are engaged in research, in response to a recent query about when survey firms that are involved in the conduct of non-exempt human subjects research would be considered engaged in a research study under the HHS human subject protection regulations (45 CFR part 46). Specifically, two related issues were raised, so we have addressed each in turn: (1) clarifying when a survey firm may be engaged in human subjects research; and (2) clarifying the relationship between engagement and the Federalwide Assurance (FWA). This clarification was originally posted on an online discussion site, the IRB Forum, on January 13, 2009.
This memorandum to the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI), provides clarification regarding several issues related to the implementation of changes to protocols and informed consent documents for NCI/CTEP-sponsored clinical trials in a manner that satisfies the requirements of the Department of Health and Human Services regulations for the protection of human subjects (45 CFR part 46).
This letter culminates exchanges between OHRP and Dr. Peter Pronovost at Johns Hopkins University School of Medicine regarding whether the HHS regulations would apply to certain planned activities implementing a program designed to reduce catheter-related infections at a number of locations across the country, and certain supplementary activities. Dr. Pronovost has agreed to the posting of this letter.
During 2005, OHRP engaged in an in-depth discussion with NCI staff, PedCIRB members and staff, FDA staff, and Children’s Oncology Group (COG) investigators, among others, regarding circumstances under which a PedCIRB member who is also a COG investigator would have a conflicting interest for a particular protocol undergoing review by the PedCIRB. The OHRP letter to NCI describes the evolution of OHRP’s viewpoint on this issue.
Last Updated: September 7, 2011