***Resources are Attached***
(1) Review the DHHS and FDA regulations in the attached material, and list the regulations you regard as material to determining whether an intervention is research or treatment.
(2) Review the definition of research in the revised Subpart A of 45 CFR Basic HHS Policy. Why are “scholarly and journalistic activities” deemed not to be research? Why are “public health surveillance activities” deemed not to be research?
(3) When clinicians or scholars decide that their activities are not research, and therefore do not consult with or submit anything to their IRB, it is difficult for an (Human Research Protection Program) HRPP's research oversight mechanisms to detect and correct potential errors. Are there ways for an HRPP to protect against this problem without being overly intrusive?
Subpart A of 45 CFR Part 46: Basic HHS Policy for Protection of Human Subjects Common Rule Departments and Agencies Facts about the Common Rule departments and agencies: 19 agencies (including HHS) followed the pre-2018 Requirements o Of these, 15 departments and agencies were official signatories with the rule codified in their own Code of Federal Regulations (CFR) sections o Four departments and agencies followed the pre-2018 Common Rule because of executive order or statutory mandate (Department of Homeland Security, Social Security Administration, Office of the Director of National Intelligence, and Central Intelligence Agency) 19 agencies (including HHS) follow the revised Common Rule. One department intends to follow the revised Common Rule o There is 1 new signatory to the revised Common Rule (Department of Labor) o Two agencies that followed the pre-2018 Common Rule because of executive order or statutory mandate have become official signatories to the revised Common Rule (Department of Homeland Security and Social Security Administration) o One original signatory (Department of Justice) intends to become an official signatory to the revised Common Rule The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA is not considered a Common Rule agency because its regulations differ from the Common Rule. List of Common Rule Departments and Agencies: DEPT. OR AGENCY CFR CITATION (2018 REQUIREMENTS) 1 Department of Homeland Security 6 CFR Part 46 2 Department of Agriculture 7 CFR Part 1c 3 Department of Energy 10 CFR Part 745 4 National Aeronautics and Space Administration 14 CFR Part 1230 5 Department of Commerce 15 CFR Part 27 6 Social Security Administration 20 CFR Part 431 7 Agency for International Development 22 CFR Part 225 8 Department of Housing and Urban Development 24 CFR Part 60 9 Department of Justice 28 CFR Part 46 10 Department of Labor 29 CFR Part 21 11 Department of Defense 32 CFR Part 219 12 Department of Education 34 CFR Part 97 13 Department of Veterans Affairs 38 CFR Part 16 14 Environmental Protection Agency 40 CFR Part 26 15 Department of Health and Human Services 45 CFR Part 46 16 National Science Foundation 45 CFR Part 690 17 Department of Transportation 49 CFR Part 11 18 Office of the Director of National Intelligence Follows CR because of EO 12333, as amended 19 Central Intelligence Agency Follows CR because of EO 12333, as amended 20 Consumer Product Safety Commission 16 CFR Part 1028 DISCLAIMER This booklet does not contain an official version of the United States Code (USC) or the revised Common Rule regulatory text. The statutory text included in this booklet shows sections of the United States Code (USC), current as of December 20, 2018, unless otherwise noted. For an official version of the statutory text and for information about the legislative history of theses statutory provisions, please visit the Office of the Law Revision Counsel’s United States Code website, available at: http://uscode.house.gov/browse.xhtml. *** The regulatory text included in this booklet shows the revised Common Rule, published in the Federal Register on January 19, 2017 (82 FR 7149), and further amended by an interim final rule published on January 22, 2018 (83 FR 2885) and a final rule published on June 19, 2018 (83 FR 28497). There may be slight discrepancies in the regulatory text below (e.g., spacing, capitalization) compared to the official version of the regulatory text. You can view an official version of the revised Common Rule regulatory text in the July 19, 2018 edition of the e-Code of Federal Regulations, available at: https://gov.ecfr.io/cgi-bin/ECFR. 1 https://gov.ecfr.io/cgi-bin/ECFR http://uscode.house.gov/browse.xhtml Statutory Authorities for Subpart A of 45 CFR Part 46 5 U.S.C. 301 §301. Departmental regulations The head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. This section does not authorize withholding information from the public or limiting the availability of records to the public. (Pub. L. 89–554, Sept. 6, 1966, 80 Stat. 379) 42 U.S.C. 289(a) §289. Institutional review boards; ethics guidance program (a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an "Institutional Review Board") to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research. (July 1, 1944, ch. 373, title IV, §491, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 873) 42 U.S.C. 300v-1(b) (omitted in the current version of the U.S.C.) §300v-1(b). Recommendations to agencies; subsequent administrative requirements (1) Within 60 days of the date a Federal agency receives a recommendation from the Commission that the agency take any action with respect to its rules, policies, guidelines, or regulations, the agency shall publish such recommendation in the Federal Register and shall provide opportunity for interested persons to submit written data, views, and arguments with respect to adoption of the recommendation. (2) Within the 180-day period beginning on the date of such publication, the agency shall determine whether the action proposed by such recommendation is appropriate, and, to the extent that it determines that— (A) such action is not appropriate, the agency shall, within such time period, provide the Commission with, and publish in the Federal Register, a notice of such determination (including an adequate statement of the reasons for the determination), or (B) such action is appropriate, the agency shall undertake such action as expeditiously as feasible and shall notify the