Research Practitioner articles from September 2004

Research Practitioner archives from September 2004

Research Practitioner CME program/CE program.
September 1, 2004... General Education Objectives CME and CE Programs 1. Discuss current thinking regarding specific methodologies in the design and execution of clinical research. 2. Incorporate emerging ethical and legal principles in the practice...

From the editors.
September 1, 2004... To date, 21 U.S.-based organizations have been accredited by either the Association for the Accreditation of Human Research Protection Programs (AAHRPP) or the Partnership for Human Research Protection (PHRP). These organizations should be...

National Institutes of Health "open access" discussions.(In the News)
September 1, 2004... On July 28, National Institutes of Health (NIH) director Elias Zerhouni told a gathering of 43 scientific journal publishers and editors that eventually all NIH-financed research will be available freely to the public. The announcement came...

More debate about children, antidepressants, and suicide.(In the News)
September 1, 2004... One of the leading medical science news stories this past summer was a report on suicide risk in children taking antidepressant medications. On August 20, the U.S. Food and Drug Administration (FDA) proposed to update labels on antidepressant...

Accreditation 1 year later--a status report from AAHRPP.(Association for the Accreditation of Human Research Protection Programs)
September 1, 2004... In 2001, a group of organizations committed to the ethical conduct of human research created the Association for the Accreditation of Human Research Protection Programs (AAHRPP) to provide accreditation to organizations engaged in research...

The partnership for human research protection: setting the standard for safety.
September 1, 2004... Research involving human subjects has evolved to a degree not thought possible 30 years ago, when the current oversight system was put into place. Several years ago, the National Committee for Quality Research end the Joint Commission on...

Continuing education.
September 1, 2004... Instructions Continuing Nursing Education 1. Read the articles: Accreditation 1 year later--A status report from AAHRPP and The Partnership for Human Research Protection: Setting the standard for safety. 2. Using the enclosed...

AAHRPP tools: instructions to apply as a preliminary applicant.(Issues In Human Subject Protection)(Association for the Accreditation of Human Research Protection Programs, Inc.)
September 1, 2004... Note: The tools and resources printed on pages 165-173 were provided by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) for Research Practitioner subscribers. Additional resources can be found on the...

Tip sheet: evaluating protections of privacy interests of research participants and confidentiality of data in proposed research.
September 1, 2004... Tip Sheets are designed to help organizational staff write policies, procedures, and other supporting documents for their Human Research Protection Program that help meet the AAHRPP Accreditation Standards end Elements. The Tip Sheets are...

Tip sheet: evaluating provisions for monitoring data and safety in proposed research.(AAHRPP tip sheets)
September 1, 2004... Related accreditation elements: II.4.B and III.2.D A regulatory criterion for IRB approval is that, when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants. IRBs...

Tip sheet: financial conflicts of interest of investigators.(AAHRPP tip sheets)
September 1, 2004... Related accreditation elements: I.3.G and III.1.A Funding and regulatory agencies have various criteria for reporting, evaluating, and managing conflicting interests of investigators. Organizations should have policies and procedures...

Tip sheet: unanticipated problems involving risks to participants or others.(AAHRPP tip sheets)
September 1, 2004... Related accreditation elements: I.3.J and III.2.B The regulations require that organizations have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and appropriate federal officials of...

Partnership for human research protection Interactive Survey System (ISS).(Issues In Human Subject Protection)
September 1, 2004... Pages 174 and 175 include screen shots of one of the PHRP standards and show how the interactive survey tool looks. The interactive tool prompts users for responses. ELEMENT C--Operational Responsibilities View Points The...

Considerations in regulatory compliance.(Current Considerations)
September 1, 2004... In the July 6, 2004, Federal Register, the Food and Drug Administration (FDA) issued the proposed rule titled: Institutional Review Boards; Registration Requirements. FDA is proposing to require Institutional Review Boards (IRBs) to register...

NIH OBA announces Q&A document on IBC meetings update.(Regulatory Update)(National Institutes of Health's Office of Biotechnology Activities )(Institutional Biosafety Committees)
September 1, 2004... The National Institutes of Health's Office of Biotechnology Activities (OBA) has a set of questions and answers (Q&A) about convening meetings of Institutional Biosafety Committees (IBCs), including 2 new questions that were added on August...

Clinical trial design conference announced.(Regulatory Update)(Brief Article)
September 1, 2004... FDA and the Harvard-Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology are co-sponsoring a 1-day workshop on October 19, 2004 titled "Adaptive Clinical Trial Designs: Ready for Prime Time?" Speakers and...

FDA final biotechnology consultant guidance released.(Regulatory Update)(Brief Article)
September 1, 2004... FDA has released the final version of a draft guidance it released in May 2003. The document is titled "Guidance for Industry: Independent Consultant for Biotechnology Clinical Trial Protocols." On June 12, 2002, President Bush signed the...

FDA announces standard format that drug sponsors can use to submit human drug clinical trial data.(Regulatory Update)
September 1, 2004... On July 21, 2004, FDA announced a standard format, called the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium (CDISC), which sponsors of human drug clinical trials can use to submit data to...

OHRP releases guidance on research involving coded private information or biological specimens.(Regulatory Update)(Office for Human Research Protections (subsidiary of HHS; monitors safeguards of test subjects) )
September 1, 2004... On August 10, 2004, OHRP released this guidance, which applies to research involving coded private information or human biological specimens ("specimens") that is conducted or supported by HHS. This guidance document: * provides guidance...

FDA annual guidance agenda provides clues to agency priorities.(Regulatory Update)
September 1, 2004... On an annual basis, FDA publishes a comprehensive list of topics for future guidance document development or revision. The current list was published in the July 9, 2004, Federal Register, and FDA seeks any additional ideas from the public....