Understanding Your Policy Requirements

Grants Welcome Packet

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CDC grants are subject to many public policy requirements to ensure that recipients are handling their funding responsibly and appropriately. These requirements have a broader national purpose. Your authorized organizational representatives’ signature on the grant application indicates the organizations intention to comply with all applicable public policy requirements.

Below we’ll cover a number of public policies for all awards, as well as public policies specific to Research awards. Use the drop-down menu to learn about each. A full listing of public policy requirements is in the HHS Grants Policy Statement, section I – 18, and section II-2. Always review the application and the Notice of Award for more details on public policy requirements specific to your award.

Public Policy for All Awards

Public policy requirements concerning civil rights, handicapped individuals, sex discrimination, and age discrimination require the submission of the Assurance of Compliance (hhs.gov). This is a one-time requirement for the award. Submission instructions are included on the form. To learn more, see the HHS Office for Civil Rights website.

Objectivity in Research and Financial Conflict of Interest (FCOI)

HHS promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. 1

Public Policy for Research Awards

Protection of Human Subjects in Research

If the proposed project involves research on human subjects, the applicant must comply with HHS Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects, unless that research is exempt as specified in the regulation.

This includes research conducted by CDC employees or supported by CDC through funding or provision of other tangible support, whether conducted inside or outside the United States. All recipients of CDC grants and cooperative agreements, and their performance sites engaged in research involving human subjects must obtain:

  1. An assurance of compliance with the regulations, and
  2. Initial and continuing approval of the research by an appropriately constituted and registered institutional review board.

In order to obtain a Federalwide Assurance (FWA) of Protection for Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website. Applicants may also write to the OHRP for an application.

Mailing address

Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

You can find additional CDC guidance regarding human subjects in research, including information about Institutional Review Boards (IRB), inclusion of women and racial and ethnic minorities in research, and inclusion of persons under 21 in research by visiting the Additional Requirements section of the CDC Grants website.

Animal Care and Use in CDC Laboratory Research

CDC has a legal, and moral responsibility to ensure that the animals entrusted to our care are treated in accordance with the highest standards of animal welfare and care. Research studies involving animals conducted at or supported by CDC must comply with the Animal Welfare Act (AWA) regulations implemented by the United States Department of Agriculture (USDA) under Title 9, Code of Federal Regulations, parts 1-3. Research studies must also comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) administered by the National Institutes of Health (NIH), Office of Laboratory Animal Welfare (OLAW).

Awards involving the use of animals will not be granted unless NIH OLAW has approved an Animal Welfare Assurance and the Institutional Animal Care and Use Committee (IACUC) has approved those components of the application related to the care and use of animals. For help with the application process, see a template of a domestic assurance form, and a foreign assurance form.

The OLAW website also provides additional resources, like the IACUC Guidebook, which is a great resource to the animal research community. The website also lists Frequently Asked Questions to help with common issues and concerns.

Please see CDC’s webpage for more information regarding Animal Care and Use in CDC Laboratory Research.

Recombinant DNA & Synthetic Nucleic Acid

Grant recipients that plan to conduct research involving recombinant DNA and/or synthetic nucleic acid are subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Office of Science Policy oversees the implementation of the NIH Guidelines.

Institutions subject to the NIH Guidelines must establish a standing Institutional Biosafety Committee. The requirements for the composition of this committee can be found in Section IV-B-2-a of the NIH Guidelines.

Research Integrity

Grant recipients conducting research must certify that their organization has established administrative policies as required by the HHS Office of Research Integrity (ORI). ORI is responsible for implementing the assurance system related to the procedures on scientific misconduct.

The responsible institutional official must assure on behalf of the institution that the institution:

  1. Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and
  2. Complies with its own policies and procedures and the requirements of this part.

The signature of the institution official on the face page of the application submitted under this Notice of Funding Opportunity (NOFO) certifies compliance with the HHS regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

ORI also requires an annual report (PHS Form 6349), that details overall information on allegations, inquiries, and investigations that the recipient organization handled. The annual report confirms that the organization has established internal policies and procedures that comply with PHS regulations for reviewing, investigating, and reporting allegations of misconduct in science conducted at, or sponsored by, the organization. In order to access the annual report, you must have an active account, and be logged onto ORI’s Annual Report System.

Select Agents and Toxins

Grant recipients that plan to use select agents and toxins while conducting research are subject to additional policies and regulations outlined by the Federal Select Agents Program (FSAP). The FSAP is made up of the Centers for Disease Control and Prevention/Division of Select Agents and Toxins, and the Animal and Plant Health Inspection Services/ Agriculture Select Agent Services. The FSAP oversees the possession, use, and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. The FSAP regulates 65 select agents and toxins. The select agent list is reviewed at least every two years for accuracy.

As part of the federal government’s decision to implement robust oversight of select agents and toxins, the FSAP issued the Select Agent Regulations. One of the fundamental elements of the Select Agent Regulations is to keep select agents and toxins out of the possession of individuals who might intend to misuse them, such as a bioterrorist. FSAP works closely with the Department of Justice’s Criminal Justice Information Services Division (CJIS) to identify those individuals who are prohibited from access to the select agents and toxins regulated by the FSAP based on the restrictions identified in the USA PATRIOT Act 2

1 Reference 42 CFR Part 50, subpart F , and the HHS GPS under section II-14 for additional information. In addition, a revised Final Rule amending this PHS regulation was published on August 25, 2011 in the Federal Register. The revised Final Rule also applies to the companion regulation at 45 CFR Part 94, “Responsible Prospective Contractors,” imposing similar requirements for research contracts. The 2011 revised FCOI regulation is applicable to an institution applying for or receiving PHS funding from a grant or cooperative agreement.

2 (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001; Public Law 107-56): Possession by Restricted Persons.

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