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• IC Deputy Ethics Counselor (DEC) clearance for "covered research protocols", as applicable.
  • "Covered research protocols" include the following and need clearance by the IC Ethics Office (also referred to as "DEC Clearance"):
    • studies of investigational drugs and devices
    • studies with a research question about a commercially available drug or device
    • studies involving collaborations with a substantially affected organization (SAO) or another for-profit entity when the entity is receiving specimens and/or data from the NIH for the purpose of developing a product
  • Most interventional protocols will be covered research protocols unless the intervention does not involve the criteria listed above (e.g., a behavioral intervention might not meet the criteria for a covered research protocol or use of a device for physiological exploration where there is no intent to develop a commercial application).
  • Non-covered research protocols include NIH research protocols that are categorized as Natural History studies, unless these studies meet the criteria for covered research protocols listed above.
  • When the PI determines that the protocol meets the definition of a covered research protocol, the following steps occur. (See Policy 102, Investigator Conflict of Interest and Government Royalties for more detailed information on this process.)
    1. NIH investigators and statisticians on covered research protocols must review the Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in Clinical Research at the NIH found in the Reference section at the end of Policy 102, Investigator Conflict of Interest and Government Royalties.
    2. Relevant NIH federal employees must complete any public, confidential, or supplemental financial disclosure reports required by NIH Ethics requirements.
    3. NIH employees who do not file financial disclosure reports must sign a Conflict of Interest (COI) Certification for Federal Employees (Non-NIH and NIH) Who Do Not File a Financial Disclosure Report. Most commonly, in the context of a NIH study team, it is the study statistician who is a federal employee and who is not otherwise required to file a financial disclosure report who needs to complete the COI Certification. In addition, non-NIH federal employees who are working on an NIH study team are not financial disclosure filers at the NIH, so they must also complete this COI Certification.
    4. NIH investigators or statisticians who are not federal employees, must also sign the Conflict of Interest (COI) Certification for Non-Federal Employees.
    5. The PI initiates DEC review in the eIRB system by going to the tab labeled Manage Ancillary Reviews.  Additional information can be found in the NIH DEC Researcher's Guide.  https://irbo.nih.gov/confluence/download/attachments/106791208/NIH_DEC_Researchers_Guide_FINAL.pdf?version=1&modificationDate=1673285699042&api=v2.   
    6. The PI's Ethics Office conducts an assessment of actual and apparent conflicts of interest for all investigators listed on the protocol and, if any federal employees have actual or apparent conflict of interest, the Ethics Office works with the employee, the NIH PI, NIH Ethics Official(s) and, as needed or appropriate, the NEO Director and/or the Office of the General Counsel, Ethics Division, to identify an appropriate remedy under applicable law.
    7. Upon completion of the COI review, approval of the IC DEC is noted in the eIRB system (also known as the DEC Clearance).

• Radiation Safety Committee (RSC):
  • Scans, tests and procedures that involve radiation that are specified in the protocol are considered by the IRB to be research procedures. If the scan, test or procedure is dictated solely by the clinical needs of the individual participant (and therefore vary for each participant), then this is considered a clinical procedure, and should not be included in the protocol or the consent documents. Dosimetry must be calculated for all radiation described in the protocol and the appropriate required radiation language from the Consent Library (under section of the library labeled "Radiation") must be included in the consent. See the link to the Consent Library on the Consent Templates and Guidance page of the OHSRP website.
  • Information about submission of RSC reviews in the eIRB system can be found here. (https://irbo.nih.gov/confluence/download/attachments/106791208/NIH_RSC_Reviewers_Guide_FINAL.pdf?version=1&modificationDate=1673285694054&api=v2)in the RSC Researcher's Guide.
  • Protocols will only require review by the RSC if they meet the following criteria in which case the forms required by the RSC should be submitted in electronic IRB system. This review must be completed prior to review by the IRB.
    • Uses a radioactive research drug(s) regulated under the FDA requirements for review by the Radioactive Drug Research Committee (RDRC)
    • Involves use of any radiation in pediatric participants (<18 years old) with an annual effective dose > 0.5 rem or healthy pediatric volunteers (any dose level)
    • Uses any radiation in healthy adult volunteers, excluding DEXA and chest X-Ray
    • Uses therapeutic administration of radioactive materials (Examples include therapeutic use of I-131, Lu-177, Y-90, Th-227, Ra-223, or Ir-192 permanent seed implants. The following would be excluded from required RSC review: Use of linear accelerator such as total body irradiation or high dose-rate afterloader such as brachytherapy for breast or prostate cancer.)
    • Involves novel uses of radiation, including any radioactive Investigational New Drugs (IND) and radiation-producing investigational devices
    • The radiation itself is the research agent being studied in the protocol (For example: The protocol compares the effectiveness of 2 different doses of radiation therapy; comparison of the effectiveness of drug X vs drug X + radiation therapy; study of the uptake and biodistribution of a novel radioactive tracer.)
• Other reviews: As determined by the protocol, additional ancillary reviews may also be required prior to initial review of the protocol by the IRB (e.g., Institutional Biosafety Committee, NIH Office of Technology Transfer, Cooperative Research and Development Agreements (CRADAs) and/or review by the NIH Select Agent Program). Investigators should refer to NIH Policy 106, Ancillary Reviews for information about reviews by these specific entities.

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