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National Institutes of Health (NIH)

Alphabet Soup (US Federal Agencies): CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of DHHS); DHHS: Deparment of Health and Human Services; OHRP: Office For Human Research Protections (part of DHHS); ORI: Office of Research Integrity (part of DHHS); OIG: Office of the Inspector General

New and Noteworthy

Monday April 20, 2009: Public Meeting on U.S. Public Law 110-85. The National Institutes of Health will a public meeting and requesting input from interested parties on issues that the agency will consider as it develops regulations to expand the clinical trial registry and results data bank commonly known as ClinicalTrials.gov in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [Public Law 110-85]. Comments on these issues from all interested parties will inform the development of draft regulations, which will be made available for public comment via a Notice of Proposed Rulemaking (NPRM) that will be issued in the Federal Register at a later date. Accessed on 2009-04-02 at: http://prsinfo.clinicaltrials.gov/public-meeting-april09.html See the March 23, 2009 Federal Register Notice for full details: http://edocket.access.gpo.gov/2009/E9-6198.htm

General Information Resources

Reports and Meetings Relevant to the Protection of Human Subjects

A Staff Report for the Use of the Subcommittee on Oversight and Investigations in Preparation for Its Hearing Human Tissue Samples: NIH Research Policies and Practices. 2006-06-13 and 14. Majority and Minority Committee Staff, House Committee on Energy and Commerce. Available from http://energycommerce.house.gov/108/home/staff%20report.pdf

Statement Sullivan Working Group Report on Regulatory Activities Within the NIAID Division of AIDS. 2006-05-26. Available from http://www3.niaid.nih.gov/about/overview/councilcommittees/sullivanstatement.htm

Questions and Answers Sullivan Working Group Report on Regulatory Activities Within the NIAID Division of AIDS. 2006-05-26. Available from http://www3.niaid.nih.gov/about/overview/councilcommittees/sullivanqa.htm

Findings and Recommendations Sullivan Working Group on DAIDS Regulatory Activities. Available from http://www3.niaid.nih.gov/about/overview/councilcommittees/PDF/SullivanReport.pdf

Moving From Observational Studies to Clinical Trials: Why Do We Sometimes Get it Wrong? National Institutes of Health. 2005-01-11 and 12. Available from http://www.meetinglink.org/omar/ct/index.htm

Human Research Protections in Clinical Trials: A Public Perspective. Report to the Director. NIH Council of Public Representatives. October, 2001. Available from http://copr.nih.gov/reports/hrpct.asp

Full Meeting of the Director's Council of Public Representatives to Discuss Draft Human Research Protections Report. Meeting Minutes NIH Council of Public Representatives. 2001-10-01. Available from http://copr.nih.gov/minutes/fall2001_report_meeting.asp

Report and Recommendations on Public Trust in Clinical Research. Report to the Director. NIH Council of Public Representatives. 2005-01-14. Available from http://copr.nih.gov/reports/public_trust.asp

Inviting Public Participation in Clinical Research: Building Trust through Partnerships. NIH Council of Public Representatives Workshop Proceedings. 2004-10-24 and 26. Available from http://copr.nih.gov/reports/October_2004_COPR_WORKSHOP_Proceedings.asp

Report to the Advisory Committee to the Director of NIH from the Office for Protection from Research Risks Review Panel. 1999-06-03. Available from http://www.nih.gov/about/director/060399b.htm

Human Subject Protection Advisory Committee to the Director of NIH. 2001-06-01. Available from http://www.nih.gov/about/director/060701acd.htm

NIH Council of Public Representatives Meeting Minutes Index. Available from http://copr.nih.gov/meetings.asp. (Many meetings focus on human research protections.)

NIH Initiative to Reduce Regulatory Burden Identification of Issues and Potential Solutions. 1999-03-10. Available from http://grants2.nih.gov/grants/policy/regulatoryburden/index.htm

Protecting Human Subjects: Status of Recommendations. Statement of George Grob. Deputy Inspector General for Evaluation and Inspections. Testimony Before the House Committee on Government Reform, Subcommittee on Criminal Justice, Drug Policy and Human Resources. 2000-05-03. Available from http://oig.hhs.gov/reading/testimony/2000/00503fin.htm

National Institutes of Health Videocasts Bioethics. Available from http://videocast.nih.gov/PastEvents.asp?c=22


NIH Grant Information

For information on making requests under of the Freedom of Information Act related to research conducted or funded by NIH, try CIRCARE's Tips For Making Requests Under the Freedom of Information Act and Agency Addresses

Recently of Interest at NIH

NIH Seeks Input on Proposed Repository for Genetic Information. National Institutes of Health Press Release. 2006-08-30. Available from http://www.nih.gov/news/pr/aug2006/od-30.htm

Department of Health and Human Services, Office of Inspector General. Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards. Available from: http://oig.hhs.gov/fraud/docs/complianceguidance/PHS%20Research%20Awards%20Draft%20CPG.pdf (Comments must be received by 2005-12-28)

OEI-01-04-00150: Outside Activities of Senior-Level NIH Employees. Department of Health and Human Services / Office of Inspector General. 2005-08-05. Available from http://oig.hhs.gov/oei/reports/oei-01-04-00150.pdf

Report of the National Institutes of Health Blue Ribbon Panel on Conflict of Interest Policies (Draft of 2004-05-06). Available from http://www.nih.gov/about/ethics_COI_panelreport.pdf

Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services. 70 FR 22, February 3, 2005, Pages 5543-5565. 5 CFR Parts 5501 and 5502 [RIN 3209-AA15]. Available from http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/05-2029.htm. (Interim final rule with request for comments.)

National Institutes of Health Ethics Program

Minutes of Previous Meetings of the IC DECs and Ethics Coordinators




Last Updated: 2009-04-02

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