The Catholic University of America

Summary of Federal Laws

Research

Title II of The Comprehensive Drug Abuse Prevention and The Public Health Service Act

42 U.S.C. § 289b, 42 U.S.C. § 299c-3 

The Office of Research Integrity (ORI) oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration. 

NIH Genomic Data Sharing Policy

The GDS Policy applies to all NIH-funded research (e.g., grants, contracts, intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Supplemental Information to the GDS Policy provides examples of genomic research projects that are subject to the Policy.

It describes the responsibilities of investigators and institutions for the submission of human and non-human genomic data to data repositories and the secondary research use of such data as well as expectations regarding intellectual property. The GDS Policy also reflects NIH’s commitment to responsible data stewardship and includes a number of provisions to assure the protection of human data.  

Conflict of Interest Policy

Institutions receiving research money from the Public Health Service (PHS) must maintain and enforce a written conflict of interest policy and take steps to prevent scientific misconduct. An awardee institution must have a policy for investigating and acting on suspected or alleged misconduct. In certain situations the PHS must be immediately notified of the apparent misconduct. The conflict of interest policy must identify, evaluate and resolve conflicts of interest, and if they cannot be resolved, report them to the PHS.

Recordkeeping
Financial disclosures must be updated annually. Records of financial disclosures must be kept for three years after the expiration of an award or grant (42 C.F.R. §§ 6.04 and 6.05). The regulations on conflict of interest define and set standards for the management of financial interest that will, or may reasonably be expected to, bias a clinical research project, the evaluation of the safety or effectiveness of a drug, or a medical treatment or device. The PHS rule in this area applies to subgrants, the National Science Foundation (NSF) policy does not.

Institutional Review Board

All research involving human subjects requires the establishment of an Institutional Review Board (IRB).

Assurances
An institution is eligible for PHS funding when it has an assurance on file with ORI stating that is has developed and will comply with an administrative process for responding to allegations of research misconduct in PHS-supported research that complies with the PHS regulation cited above. An institution establishes an assurance when an official signs the face-page (SF 424 (R&R) or PHS 398) of the grant application form or when the institution files a separate assurance form. Once established, institutions maintain their assurance by filing the Annual Report on Possible Research Misconduct (between January 1 and March 1 each year), submitting their policy for responding to allegations of research misconduct for review when requested by ORI, revising their policy when requested by ORI to bring the policy into compliance with the PHS regulation, and complying with the PHS regulation. See http://ori.hhs.gov/assurance/ for more.

Resources

Guidance Memorandum on Compliance with Public Access Rules (8-19-15)  Prepared by AAU, APLU, and ARL. This letter was sent to campus senior research officers specifying how to comply with agency grant rules on public access to the results of federally funded research. There are a number of resources and links w/in the letter.

 Higher Education Compliance Alliance Resource Page

NACUA Sponsored Research page (password protected)

NACUANOTES Vol. 11, No. 7 - Who Can Obtain Access to Research Data? Protecting Research Data against Compelled Disclosure--February 27, 2013

Responsible Conduct of Research (Northern Illinois University)

 

Guide to Research Compliance (University of Minnesota)


University of Minnesota: Office of the Vice President for Research

 

 

 

updated 7-27-18 mlo