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IRB Advisor – February 1, 2004

February 1, 2004

View Issues

  • Compassionate use of investigational drugs requires IRB approval, regs say

    The question remains: Is full-panel review necessary?
  • Socio-behavioral studies sometimes offer fewer risks

    IRBs need to be aware that the tools and data collection techniques used in socio-behavioral research may appear riskier than they actually are, and the public benefits may be greater; therefore, its a good idea to refrain from categorically rejecting research that involves unknown factors, suggests John Laub, PhD, a professor of criminology and criminal justice at the University of Maryland in College Park.
  • Protocols involving oral history still need review

    IRB members who are confused about whether research containing an oral history is subject to IRB review are not alone. The Office for Human Research Protections (OHRP) has written two letters on the matter, leaving some room for contradictory interpretation until guidelines are issued, possibly this year.
  • IRB role at small colleges sometimes a little murky

    Small colleges and undergraduate departments at universities are finding it increasingly important to formalize their human subject protection programs while making certain IRBs are reviewing what they should and not filling agendas with a lot of unnecessary reviews, several experts say.
  • Sharing data requires policies and procedures

    The longtime research tradition of sharing data has been challenged in recent years with the implementation of the Health Insurance Portability and Accountability Act (HIPAA) and its privacy requirements. However, the National Institutes of Health (NIH) has confirmed its commitment to the tradition with its mandate requiring certain grant proposals to describe how data will be prepared for public use.
  • How Adults Learn

    According to Minneapolis training experts Ron and Susan Zemke, adults learn for a purpose. They wrote, Adults tend to have a problem-centered orientation to learning. So when designing an education program they suggest you keep in mind the following.
  • ORI seeking educational program proposals

  • Training needs can be met with a variety of tools

    Human subjects training is typically a part of human subjects protections programs. Such training has taken the form of in-house seminars given at regular intervals and web-based activities. Regardless of the form, the objectives are simple: Give those involved in human subject research ethics and regulatory information that will promote beneficence and compliance with regulations.