The Catholic University of America

Summary of Federal Laws

Research

Compliance Partners

Associate Provost for Research

Related Policies

Conflicts of Interest

Research Misconduct

Protection of Human Subjects in 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, and 42 U.S.C. § 300v;

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. Extensive resources are available on the ORI web page.

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.

The GDS Policy takes effect for competing grant applications submitted for the January 25, 2015, receipt date; contract proposals submitted to NIH on or after January 25, 2015; and for intramural projects generating genomic data on or after January 25, 2015. 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.

Dec. 2013 letter to HRSA Grantees on Pilot Program for Enhancement of Employee Whistleblower Protection
The latest whistleblower statutes went into effect July 1, 2013 per the National Defense Authorization Act for FY 2013. The statute at 41 USC 4712 applies to all employees working for contractors, grantees, sucontractors and subgrantees of federal grants and contracts.The requirement to comply with and inform all employees of the Pilot Program is in effect for all grants, contracts, subgrants and subcontracts issued beginning July 1, 2013 through Jan. 1, 2017.

 

Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors, Final Rule; 76 Fed. Reg 53256, August 25, 2011.
This final rule is effective as of September 26, 2011. Compliance Date: Aug. 24, 2012.

An Institution applying for or receiving PHS funding from a grant, cooperative agreement, or contract that is covered by this rule must be in full compliance no later than August 24, 2012; and immediately upon making its institutional Financial Conflict of Interest (FCOI) policy publicly accessible. The new regulations lower the disclosure threshold of FCOI from $10,000 to $5,000, require training on the new policy, require disclosure of all signficant COIs related to institutional responsibilities, require compliance with the rule by subcontractors and require public disclosure (generally on a university web site ) of certain conflicts of interest of senior key personnel. The web site shall note that info provided is current as of the date listed and is subject to updates annually and within 60 days of the identification of a new COI.  See the UC Berkeley Research Advocate for more on this new rule. Policies on COI will need to be reviewed in light of the new rule. See also NIH news dated 8/23/11 as well as the Hogan Lovells advisory dated 8-29-11 titled US Department of Health and Human Services Issues Final Rule on Investigator Financial Conflict of Interest. Suggested language for the subcontractor to be in compliance  with their own COI policy is as follows. Note the other option is language stating subcontractor will comply with awardee's policy on COI. 

Collaborator represents that it maintains an appropriate written, enforced policy on conflict of interest pursuant to 42 C.F.R. §50.604(a). Further, Collaborator shall report to University any identified and active financial conflicts of interest (“FCOI”) and shall provide assurance that Collaborator has managed, reduced, or eliminated said FCOI. If an FCOI arises during the course of the Project, Collaborator shall manage, reduce, or eliminate it and report to University within 60 days subsequent to the disclosure. Collaborator shall make no obligations against the funds to be awarded under this Agreement until any FCOI is managed, reduced, or eliminated in accordance with this paragraph.

 

NIH has created an excellent resource web page on the 2011 Revised Regulations, including an FAQ and a summary of major changes. The site also includes a checklist for policy development.

See the October 18, 2012 Policy Clarification regarding Disclosure Requirements for Reimbursed and Sponsored Travel.

See also the AAMC March 2012 report on implementing this  rule.Note the new COI provisions are codied at 45 CFR Part 94.1 et seq.


Institutional Conflicts of Interest at NIH Grantees

Officer of Inpsector General (US Dept.of Health and Human Services) Report issued 1-10-2011. This report found that only half of NIH grantee institutions had policies in place relating to institutional (as opposed to researcher) conflicts of interest. OIG renewed its recommendation that NIH require grantees to id, report and address such conflicts.

 

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.

NACUANOTE Oct. 30, 2009 on Human Stem Cell Research: 2009 NIH Guidelines
By Alexander Dreier and Robert Kenney, Hogan and Hartson

Final NIH Guidelines on Stem Cell Research: 74 Fed. Reg. 32170 (July 7, 2009)

Effective July 7, 2009. These guidelines apply to NIH funded stem cell research.

 August 13, 2010 Final Rule promulgated by the Department of Agriculture on Research Misconduct, at 75 Fed. Reg. 49357. These rules relate solely to USDA funded extramural research.

Complying with the NIH Public Access Policy-Copyright Considerations and Options: SPARC/Science Commons/ARL white Paper by Michael W. Carroll; Feb. 2008: The paper notes as follows on two new mandates effective April 7, 2008 for schools:

First, the grantee must ensure proper manuscript submission. ***Second, the grantee also has a distinct obligation to grant NIH copyright permission to make the manuscript publicly accessible through PMC not later than 12 months after the date of publication. This obligation is connected to manuscript submission because the author, or the person submitting the manuscript on the author's behalf, must have the necessary rights under copyright at the time of submission to give NIH the copyright permission it requires.

The white paper analyzes the second requirement and suggests options for compliance.

Revised Policy On Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research:Released Jan. 11, 2008, effective April 7, 2008 Now mandatory:

The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

 

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

November 2009 OIG Report: How Grantees Manage Financial Conflicts of Interest in Research Funded By the NIH

 

 

updated 10-19-15 to add Compliance with Public Access Policies

CCR updated CFR links 6/30/15