Source: http://counsel.cua.edu/fedlaw/Phs.cfm
Timestamp: 2017-11-23 01:50:40
Document Index: 477247022

Matched Legal Cases: ['§ 289', '§ 299', '§ 300', 'art 94', '§50', 'art 94']

42 U.S.C. § 289b, 42 U.S.C. § 299c-3, and 42 U.S.C. § 300v;
Promoting Objectivity in Research, 45 CFR Part 94
NIH Genomic Data Sharing 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.
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.
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.
Revised Policy On Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research:Released Jan. 11, 2008, effective April 7, 2008 Now mandatory:
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)
November 2009 OIG Report: How Grantees Manage Financial Conflicts of Interest in Research Funded By the NIH
Responsible Conduct of Research (Northern Illinois University)
Columbia University Research Administration Home
Guide to Research Compliance (University of Minnesota)
ORI Page on Responsible Conduct of Research
University of Minnesota: Office of the Vice President for Research
updated 10-19-15 to add Compliance with Public Access Policies