2.8 Assurance of Compliance (Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination)
Before a grant award can be made, a domestic applicant organization must certify that it has filed with the DHHS Office for Civil Rights: an Assurance of Compliance (Form DHHS 690) with Title VI of the Civil Rights Act of 1964 (P.L. 88352, as amended), which prohibits discrimination on the basis of race, color, or national origin; Section 504 of the Rehabilitation Act of 1973 (P.L. 93-112, as amended), which prohibits discrimination on the basis of handicaps; Title IX of the Education Amendments of 1972 (P.L. 92-318, as amended), which prohibits discrimination on the basis of sex; and the Age Discrimination Act of 1975 (P.L. 94-135), which prohibits discrimination on the basis of age.
The Assurance of Compliance Form DHHS 690 is available from http://www.hhs.gov/forms/HHS690.pdf.
Assurance of Compliance Form DHHS 690 is now used in lieu of individual assurances: Form DHHS 441, Civil Rights; Form DHHS 641, Handicapped Individuals; Form DHHS 639-A, Sex Discrimination; and Form DHHS 680, Age Discrimination.
2.9 Research Involving Recombinant DNA, including Human Gene Transfer Research
The National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) apply to all projects (NIH-funded and non-NIH-funded) involving recombinant DNA molecules that are conducted at or sponsored by an institution that receives NIH support for recombinant DNA research. As defined by the NIH Guidelines, recombinant DNA molecules are either: (1) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (2) DNA molecules that result from the replication of those described in (1).
The NIH Guidelines set forth principles and standards for safe and ethical conduct of recombinant DNA research and apply to both basic and clinical research studies. The NIH Guidelines should be carefully reviewed and implemented to ensure that proper biosafety and containment practices are employed for all projects involving recombinant DNA research, including review by an Institutional Biosafety Committee that meets the requirements of the NIH Guidelines. More information about the NIH Guidelines and IBCs can be found at: http://oba.od.nih.gov/rdna_ibc/ibc.html. Further, the NIH Guidelines, in Appendix M, include special review and reporting requirements for the conduct of human gene transfer studies. Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of NIH funds for recombinant DNA research at the organization or a requirement for NIH prior approval of any or all recombinant DNA projects at the organization. A copy of the NIH Guidelines is posted at the following URL: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html and may be obtained from the NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9838. Additional information on the special requirements that pertain to human gene transfer can be found in a series of Frequently Asked Questions at: http://oba.od.nih.gov/rdna/rdna_faq_list.html.
NIH requires grantees and investigators (except Phase I SBIR/STTR applicants and grantees) to comply with the requirements of 42 CFR part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.” A Final Rule amending this PHS regulation (and the companion regulation at 45 CFR part 94, “Responsible Prospective Contractors,” imposing similar requirements for research contracts) was published on August 25, 2011 in the Federal Register (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf) and incorporated in the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards - Subpart A (Section 4.1.10). An Institution applying for or receiving PHS funding from a grant or cooperative agreement that is covered by the rule must be in full compliance with all of the revised regulatory requirements no later than August 24, 2012, and immediately upon making its institutional Financial Conflict of Interest (FCOI) policy publicly accessible as described in the regulation. In the interim, Institutions should continue to comply with the prior version of the regulation published in 1995 and report Investigator FCOIs to NIH as required by that framework.
By signature of the Authorized Organization Representative on the Face Page of the application (for paper PHS398 applications), or in checking the “I agree” box on line 17 of the SF424 (R&R) Cover Component (for electronic SF424 (R&R) applications), the Authorized Organization Representative of the applicant organization certifies compliance with the requirements of 42 CFR part 50, Subpart F, including that:
1. There is in effect at the Institution an up-to-date, written and enforced administrative process to identify and manage Financial Conflicts of Interest (FCOI) with respect to all research projects for which NIH funding is sought or received;
2. The Institution shall promote and enforce Investigator compliance with the regulation’s requirements including those pertaining to disclosure of Significant Financial Interests;
3. The Institution shall identify and manage Financial Conflicts of Interest and provide initial and ongoing FCOI reports to the NIH consistent with this subpart;
4. When requested, the Institution will promptly make information available to the NIH/HHS relating to any Investigator disclosure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of a Financial Conflict of Interest;
5. The Institution shall fully comply with the requirements of the regulation.
When the Institution determines that a Financial Conflict of Interest exists (see #3 above), the Institution must report the FCOI to the NIH awarding IC through the submission of an initial and annual FCOI report using the eRA Commons FCOI Module. An initial or first annual FCOI report submitted after the Institution implements the requirements under the 2011 revised regulation will include the information provided in 42 CFR part 50.605(b)(3).
For any FCOI previously reported, the Institution shall provide an annual FCOI report that addresses the status of the financial interest and any changes to the management plan. Annual FCOI reports must be submitted for the duration of the project period, including extensions with or without funds. The annual FCOI report must be submitted to NIH when annual progress reports are due. Please note that annual FCOI reports are not part of the annual progress report. The annual FCOI report will include the following information:
Status of the Financial Conflict of Interest
Changes to the management plan
The information above is only a sample of the regulatory requirements found in 42 CFR part 50, Subpart F. Applicants must read the regulation in its entirety to ensure compliance with all of the requirements.