Compliance Updates 

Compliance Updates will help foster a culture of awareness and knowledge for the continually changing regulations and polices related to research activities.

You should routinely visit this site for updates!

May 2010

New Financial Conflict of Interest (FCOI) Rules Proposed

The rule proposes a general revision to the existing regulations on the responsibility of applicants for promoting objectivity in research (42 CFR Part 50 Subpart F and 45 CFR Part 94).

In particular, the proposed regulations would:

Require PHS-funded investigators to disclose to their institutions all Significant Financial Interests (SFIs) related to their institutional responsibilities. This would move the responsibility for determining if an investigator's SFI are related to his/her PHS-supported research from the investigator to the institution.
Lower the monetary threshold at which interests require disclosure, generally from $10,000 to $5,000.
Require institutions to provide the PHS Awarding component (e.g. NIH) significant additional information on identified FCOI and how they are being managed.
Require every PHS-funded institution to post, on a publicly accessible website, information on certain SFIs that the institution has determined are related to PHS-funded research and constitute FCOI.

June 2010

FDA Issues Final Guidance on Statement of Investigator (Form FDA 1572)

Information Sheet Guidance for Form FDA 1572

June 28, 2010

BIS Publishes Rule Based Upon a Systematic Review of the CCL.

Federal Register: RIN 0694-AE56

July 19, 2010

The Centers for Disease Control and Prevention (CDC) is pleased to announce that the final version of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th ed. is now available on CDC's biosafety website:http://www.cdc.gov/biosafety/publications/

September 21, 2010

OHRP has posted on its website a finalized guidance document entitled, “Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues.” The guidance document provides OHRP’s first formal guidance on this topic and finalizes the draft guidance entitled, “Guidance on Important Consideration for When Participation of Human Subjects in Research is Discontinued”.

October 4, 2010

OHRP has posted a new item of correspondence on its view about the meaning of "noninvasive" as the term is used in expedited review category 3, which is the expedited review category that applies to the prospective collection of biological specimens for research purposes by noninvasive means. OHRP's statement can be viewed at http://www.hhs.gov/ohrp/policy/correspond/. Specifically, that statement clarifies that OHRP agrees with the Food and Drug Administration's position that for purposes of expedited review category 3, the following procedures are considered noninvasive:

Vaginal swabs that do not go beyond the cervical os; Rectal swabs that do not go beyond the rectum; and Nasal swabs that do not go beyond the nares.

December 2, 2010

OHRP has posted on its website a finalized guidance document entitled, "Guidance on IRB Continuing Review of Research." The guidance document supersedes OHRP’s January 15, 2007 guidance entitled “Guidance on Continuing Review.”

December 2, 2010

OHRP has posted on its website a finalized guidance document entitled, "Guidance on IRB Approval of Research with Conditions." The guidance document provides OHRP’s first formal guidance on this topic.

January 2011

The Food and Drug Administration has issued a final rule, effective March 7, requiring consent forms signed by participants in certain clinical trials to contain "a specific statement that clinical trial information will be entered into a databank." The databank is clinicaltrials.gov, maintained by the National Institutes of Health and the National Library of Medicine.

Data submissions to clinicaltrials.gov were mandated under 2007 legislation modernizing the FDA, which also required the agency to revise its regulations for informed consent documents and procedures.
Link: http://edocket.access.gpo.gov/2011/pdf/2010-33193.pdf
 

March 2011

Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates has been published. This http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-053.html

provides guidance to PHS awardee institutions and IACUCs on the use of alternate IACUC members and date of IACUC approval.

March 2011

USDA policy changes / Updated Animal Care Resources Guide Effective March 25, 2011

 July 2011

OHRP has updated its Guidance on Written IRB procedures:

 August 2011

HHS -  Tightens Financial Conflict of Interest Rules for Researchers

http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf

Summary of Major Changes to the 1995 Regulations

December 2011

NIH announced its adoption of the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide) effective January 1, 2012.

OLAW has developed a webpage that provided teh Position Statements, resources for implementing the Guide, and listing of public comments on adoption of the Guide.