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Office for Human Research Protections (OHRP)NewsRecent Announcements (October 26, 2004) - You are invited to the Belmont Commemoration On behalf of Tommy G. Thompson, Secretary, Department of Health and Human Services (HHS), I invite you to join OHRP on November 16, 2004, as HHS honors the members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-79) and commemorates the 25th anniversary of the publication of the Belmont Report, produced by that Commission. The event will take place on November 16 in the Great Hall of the Humphrey Building, 200 Independence Avenue S.W., Washington D.C. 20201, 2:30 p.m. - 3:30 p.m. We hope that you will be able to join us. Please R.S.V.P. no later than Monday, November 1st at (703) 741-7051. And plan to arrive between 2:00 p.m. and 2:15 p.m. on November 16th, to allow time to go through security. I look forward to seeing you then. Bernard A. Schwetz, D.V.M., Ph.D. (September 9, 2004) - Belmont Commemorative Event, November 16, 2004 Dear Colleagues: On behalf of Tommy G. Thompson, Secretary, Department of Health and Human Services, I would like to invite you to share in a commemorative event celebrating the 25th anniversary of the Belmont Report, a milestone in Federal responsibility, leadership and commitment to protecting the rights and welfare of those who participate in research. The Report was produced as part of the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-79). Members of the original Commission will be honored guests at the event, along with the Commission's staff and special consultants. The event will take place on November 16th, 2004, at 2:30 p.m. in the Great Hall of the Hubert H. Humphrey Building, 200 Independence Avenue, S.W., Washington, D.C. 20201. The Belmont ceremony will include a ten-minute video highlighting those who took part in the creation of the Belmont Report, their work at that time and the importance of that work in today's research environment. I hope you will be able to join us in November for this special commemoration. Bernard A. Schwetz, D.V.M., Ph.D. (August 17, 2004) - Guidance on Research Involving Coded Private Information or Biological Specimens The Office for Human Research Protections (OHRP) has issued guidance on research involving coded private information or human biological specimens. The document also references pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens. You can find the guidance document, Guidance on Research Involving Coded Private Information or Biological Specimens at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf. OHRP welcomes comments on this document: please go to the OHRP website at http://www.hhs.gov/ohrp and click on "Public Comments" in the left menu. (August 9, 2004) - As part of their regulatory requirements, the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) are requesting public comments on a proposed research protocol entitled "Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder (ADHD): A Functional Magnetic Resonance Study. This proposed research would be conducted at the HHS National Institutes of Health (NIH) and supported by NIH's National Institute of Mental Health (NIMH). Documents related to the proposed research are available at OHRP's website, at http://www.hhs.gov/ohrp/children/adhd.html. The documents are also available via the FDA website: go to http:/www.fda.gov/ohrms/dockets/ac/acmenu.htm then select the year 2004, then scroll to Pediatric Advisory Committee (PAC) meeting at the bottom of the list. To submit electronic comments, go to http://www.fda.gov/dockets/ecomments then click on Docket Search, then at Docket ID type in "2004N-0337" Send written comments to the Division of Dockets Management (HFA-305), Docket No. 2004N-0337, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The Pediatric Ethics Subcommittee of FDA's Pediatric Advisory Committee (PAC) will meet on September 10, 2004, to discuss this protocol and develop a recommendation as to whether this research should proceed. On September 15, 2004, the PAC will meet to review the recommendation of the subcommittee. http://www.hhs.gov/ohrp/children/adhd.html To access the Federal Register notices, please see http://www.hhs.gov/ohrp/children/nimh_subcomm.pdf for the PAC subcommittee meeting, and http://www.hhs.gov/ohrp/children/nimh_pac.pdf for the PAC meeting. (July 13, 2004) - All Federalwide Assurances (FWAs) expire 3 years after their approval date. Of course, updates to FWAs should be submitted throughout the 3 years whenever there are changes in the information provided on the approved FWA. To check your institution's FWA expiration date, go to the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp#ASUR. If your institution needs to renew its FWA, follow the instructions at http://www.hhs.gov/ohrp/humansubjects/assurance/renwfwa.htm, and fax the completed form to OHRP at (301) 402-0438. If you have any questions, please see the staff assignments on our website at http://www.hhs.gov/ohrp/daqi-staff.html#DC (bottom of page). You may call the staff person using our toll-free number, 866-447-4777. (July 7, 2004) - The Office for Human Research Protections (OHRP) is proposing to require registration of institutional review boards (IRBs) that review human subjects research conducted or supported by the Department of Health and Human Services (HHS) and that are designated under an assurance of compliance approved for federalwide use by OHRP. The proposed registration requirements will make it easier for OHRP to convey information to IRBs and will support the current IRB registration system operated by OHRP. Under the current OHRP IRB registration system, the submission of certain information is required by the existing HHS human subjects protection regulations, and certain other information may be submitted voluntarily. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with the proposed IRB registration requirements of the Food and Drug Administration (FDA), and creating a single HHS IRB registration system. FDA simultaneously is publishing a proposed rule regarding FDA IRB registration requirements. Comments on the OHRP notice must be received on or before October 4, 2004. That notice can be accessed as a pdf document at: http://www.hhs.gov/ohrp/news/irbnotice.pdf The FDA notice can be accessed at: http://www.accessdata.fda.gov/scripts/oc/ohrms/dailylist.cfm?yr=2004&mn=7&dy=6. Please note that the correct URL for viewing the current IRB registration form is http://www.hhs.gov/ohrp/humansubjects/assurance/regirb.htm. (June 29, 2004) - Advisory Committee Meeting July 26-27, 2004 The Department of Health and Human Services' (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP) will meet on Monday, July 26, 2004, from 8:30 a.m. to 5:00 p.m. EST, and on Tuesday, July 27, 2004, from 8:30 a.m. to 4:00 p.m. EST, at the Sheraton Four Points Hotel, 1201 K Street, N.W., Washington, D.C. For further information, please see the Federal Register announcement: http://www.gpoaccess.gov/fr/retrieve.html and type in page 35348, then click SUBMIT. The SACHRP July meeting agenda is posted at: http://www.hhs.gov/ohrp/sachrp/mtgings/mtg07-04/agenda0704.pdf (June 17, 2004) - Registration for the OHRP National Conference in Chicago, IL Don't miss the unique opportunity to register for the upcoming OHRP National Human Subjects Protections Conference focusing on gene transfer research. Speakers from the U.S. Food and Drug Administration and the NIH's Office of Biotechnology Activities will provide updates on federal oversight activities related to the use of gene transfer products in humans. The conference entitled "Human Subjects Protections in Gene Transfer Research" is sponsored by Rush University Medical Center and the University of Chicago in Chicago, Illinois, on July 9 and 10, 2004. A Pre-Conference Workshop entitled PRIM&R "IRB 101sm On the Road" will be held on July 8, 2004. For registration and program see brochure at: http://www.rush.edu/research/updates.html (June 16, 2004) - Registration for the OHRP National Conference in Chapel Hill, NC Don't miss the unique opportunity to register for the upcoming OHRP National Human Subject Protections Conference focusing on Human Subject Research in the international arena. The faculty for this event will include highly respected national and international speakers. The conference entitled "Roadmap for Success in International Research: Strategies for Protecting Human Research Subjects Globally," is sponsored by RTI International, Family Health International, and North Carolina State University in Chapel Hill, NC, on August 2-3, 2004. Deadline for the reduced registration rate is June 30. For program information, see the brochure at: https://register.rti.org/internationalirb/ |
Last revised: October 26, 2004
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