 |
|
|
|
|
 |
|
| Home | About NHGRI | Newsroom | Staff |
|
|
|
|
 |
IRB News and Updates
June 12, 2008The Genetic Information Nondiscrimination Act (GINA) was signed into law on May 21, 2008. This federal legislation prohibits health insurers and employers from discriminating based on genetic information, including participation in research that involves genetic testing, counseling, or education. The provisions of GINA will take effect in May 2009 (health insurance) and November 2009 (employers). Please see the GINA Quick Guide for more information. The NHGRI Institutional Review Board is currently evaluating the impact of GINA on our forms and templates; updates will be posted here over the next year. No changes are currently being requested since the legislation is not yet "in effect."
May 28, 2008Implementation of the new policy regarding "Reimbursement of Travel and Subsistence Expenses for NIH Clinical Research Protocol Participants" is being delayed per Dr. John Gallin, Director of the Clinical Center. The Clinical Center will follow the current process for patient travel until a number of issues are resolved. No actions pertaining to this new policy need to be taken by investigators until further notice.
April 15, 2008New Travel Reimbursement Policy for Research Subjects effective May 1, 2008NIH has implemented a new policy on reimbursement for travel and subsistence Please note: the effective date for this policy is May 1, 2008, for all new and continuing reviews applications. Updated Conflict-of-Interest Guide, Ethics Clearance, and Consent StatementsThe NIH Guide to Preventing Financial and Non-Financial Conflicts of Interest in Human Subjects Research at NIH The updated Guide requires investigators to include a statement about conflicts-of-interest review in all informed consent documents. Investigators may select appropriate language from a document of suggested statements. Transition to electronic web-based Protocol Tracking and Management SystemThe NHGRI IRB has begun to implement a new protocol tracking and management system (PTMS), which will allow investigators to submit protocols, amendments, and other associated IRB actions via a secure website. Originally developed by NINDS and currently in use by several other NIH IRBs, PTMS will streamline the IRB review process and significantly reduce the amount of paper used in that process. Please Note: It is important to submit the "Protocol Conflict of Interest Statement" to the NHGRI Deputy Ethics Counselor (DEC) for clearance well in advance of your new and continuing protocol submissions to the IRB. A two-month lead time is suggested in order to ensure that clearance is granted by the time of the IRB meeting at which your protocol will be reviewed. The IRB will not be able to review or approve your protocol until DEC has granted clearance. ***Last minute submissions to the DEC may lead to the suspension of continuing protocols and significant delays in approving new ones. Investigators will be contacted about the timing and training regarding this new application, which will be phased in over Summer and Fall 2008. Protocol TemplatePlease note that the NHGRI IRB Protocol Template All IRB documentation should be submitted to Victoria Willits, the NHGRI IRB Coordinator, in 10 CRC 6-3340. Place documents in one of the plastic bins just inside the entrance to this office.
August 15, 2007 UpdateNew IRB coordinator, Updated IRB Protocol Template and ChecklistsPlease note that the NHGRI IRB Protocol Template Victoria Willits is our new IRB Coordinator. All IRB documentation should be submitted to her in 10 CRC 6-3340. Please place documents in one of the plastic bins just inside the entrance to this office.
March 6, 2007 UpdateRevised Conflict-of-Interest Review by the National Human Genome Research Institute (NHGRI) Deputy Ethics Counselor (DEC)An updated version of the Guide to Preventing Financial and Non-Financial Conflicts of Research in Human Subjects Research at NIH Effective immediately, all new and continuing IRB protocols (as well as amendments that involve adding new investigators) will be subject to conflict-of-interest review by the NHGRI Deputy Ethics Counselor (DEC). To obtain review and clearance, PIs should complete and send the Protocol Conflict of Interest Statement Send the Protocol Conflict of Interest Statement to: Please contact Barbara Fuller or Sara Hull with any questions about this new policy.
November 1, 2006 UpdateNew 1195 and 1195-1 FormsThe NIH Medical Executive Committee and HSRAC have approved updated 1195 Please note some of the key changes to the forms:
Please contact Sara Hull with any questions about these forms.
June 26, 2006Use of Short Written Consent Forms with Oral ConsentIn certain circumstances (e.g., low literacy or illiterate subjects, blind research subjects, unexpected enrollment of non-English speaking subjects), the NHGRI IRB may approve an oral consent process in conjunction with a short written consent form. (See 45 CFR 46.117(b)(2).) In such cases, the IRB will review and approve:
The Short Written Consent Form for Non-English Speaking Research Subjects has already been translated into a number of languages. These translated forms are available by contacting IRB Administrator Sara Hull.
June 21, 2006Important Information About IRP Research Involving Stored Human Samples, Specimens or DataThe following letter and related documents clarify that all research involving identified or coded tissues and data must be conducted under an IRB-approved protocol. If an investigator wishes to use samples that were collected under a now-terminated protocol, s/he must either initiate a new protocol or request an exemption from IRB review for this new research activity. From Dr. GottesmanIf you are conducting research that involves stored human specimens, samples or data, please carefully read the attached two documents. The first specifies a DHHS requirement for continued IRB oversight of all human subjects research, and the second provides details as to how NIH will accomplish this. Research involving stored identified or coded specimens or data, when IRP investigators can identify the sources, must receive prospective and continuing NIH IRB approval. Any activities that are not consistent with this requirement must stop until NIH IRB approval is granted.
Please note that human subjects research at the NIH must be in compliance with the requirements set forth in the attached documents. Michael M. Gottesman, M.D. To view the To view the
Last Updated: June 16, 2008 |
|
|
Privacy CopyrightContactAccessibilitySite MapStaff DirectoryFOIAHome |
   |
|
Print Version
for participants in clinical research trials in the intramural clinical research program. The new policy requires the PI to establish a protocol-specific rate for travel (i.e., local and long-distance transportation) and subsistence (i.e., meals and lodging) ranging from zero up to the full government rate. 