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  • Regulatory NewsRegulatory News

    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
  • Regulatory NewsRegulatory News

    FDA Unveils Draft Guidance on How to Document IRB Activities

    The US Food and Drug Administration (FDA) has joined forces with the Office for Human Research Protections (OHRP) to prepare draft guidance on how to record the activities of institutional review boards (IRBs). The guidance offers advice for institutions, or in some cases the IRBs themselves, that have to prepare and document IRB activities via minutes, which should include summaries of what occurred during a convened meeting and the IRB’s findings and determinations.  ...
  • FDA Draft Guidance Seeks Clarity on IRBs' Clinical Research Oversight Responsibilities

    A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors. The draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed , aims to clarify the roles of IRBs, which are charged ...
  • DHHS Plans to Assess Need for Revisions to Human Research Protections at Upcoming Meeting

    • 21 September 2012
    The US Department of Health and Human Services (DHHS) is planning to meet in October to discuss whether current protections afforded to human research subjects are adequate, or whether new regulations and guidelines are needed. The meeting, announced in the Federal Register on 20 September , will involve DHHS' Secretary's Advisory Committee on Human Research Protections ( SACHRP ). The group, which acts as an advisory committee, is charged with providing recommendatio...
  • Human Protections Oversight Body Seeks New Members

    • 06 September 2012
    Officials at the US Department of Health and Human Services (DHHS) are looking for two new members to serve on the Secretary's Advisory Committee on Human Research Protections (SACHRP), the agency announced in a Federal Register posting . SACHRP is a part of DHHS's Office of Human Research Protections, which, along with the US Food and Drug Administration (FDA), is responsible for overseeing the rights and welfare of participants enrolled in clinical trials conducte...
  • Federal Agencies Team Up to Issue Draft Guidance on IRB Transfers

    The US Food and Drug Administration (FDA) has released a draft guidance intending to instruct sponsors, clinical investigators (CIs) and Institutional Review Boards (IRBs) on best practices for transferring clinical trial oversight to a new IRB. The proposed guidance harmonizes regulatory interpretations between FDA and the US Department of Health and Human Services' Office for Human Research Protections (OHRP). The agencies said in a Federal Register statement they pl...