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handling conflicts in the review of clinical research at nimh

Current NIMH Review Structure. Interventions Research Review Committee (ITV)development, evaluation, and improvement of mental health treatment interventionsefficacy to effectiveness trialsServices Research Review Committee (SRV)assessment, evaluation, and improvement of mental health services and service systemseffectiveness trialsSpecial Emphasis Panels (SEPs)including Conflict of Interest panels for ITV and SRV membersRFA's, centers, some training grants.

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handling conflicts in the review of clinical research at nimh

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    1. Handling Conflicts in the Review of Clinical Research at NIMH Peer Review Advisory Committee January 23, 2006

    3. ITV and SRV approximately 25 members each, including 2-3 public reviewers and numbers referred to ITV have been approximately 130 -145 to ITV and 90 -110 to SRV increasing number and diversity/breadth of applications over the last three years – use of many ad-hoc reviewers to keep workload manageable each round, many applications diverted to SEP’s – this included member conflicts actual workload kept to approximately 65-75 applications per round

    4. Restructuring Plan – effective July 1, 2006 Interventions Committee for Adult Mood and Anxiety Disorders (ITMA) Interventions Committee for Schizophrenia Spectrum Disorders, Personality Disorders, and Dementia (ITSP) Interventions Committee for Disorders involving Children and their Families (ITVC) The resultant proposal involves 5 committees. We propose to divide ITV into three committees: Interventions Committee for Adult Mood and Anxiety Disorders (ITMA): Reviews applications concerned with mental health interventions for mood and anxiety disorders and related mental health problems. Study populations will include adults ages 18 years and older. Interventions Committee for Schizophrenia Spectrum Disorders, Personality Disorders, and Dementia (ITSP): Reviews applications concerned with mental health interventions for schizophrenia spectrum disorders, personality disorders, dementia, and related disorders. Study populations will include adults ages 18 and older.   Interventions Committee for Disorders involving Children and their Families (ITVC): Reviews applications concerned with mental health interventions for the range of disorders occurring in children. Study populations will include children ages 0 to 21 years and their families, where children’s outcomes are a primary measure.   The resultant proposal involves 5 committees. We propose to divide ITV into three committees: Interventions Committee for Adult Mood and Anxiety Disorders (ITMA): Reviews applications concerned with mental health interventions for mood and anxiety disorders and related mental health problems. Study populations will include adults ages 18 years and older. Interventions Committee for Schizophrenia Spectrum Disorders, Personality Disorders, and Dementia (ITSP): Reviews applications concerned with mental health interventions for schizophrenia spectrum disorders, personality disorders, dementia, and related disorders. Study populations will include adults ages 18 and older.   Interventions Committee for Disorders involving Children and their Families (ITVC): Reviews applications concerned with mental health interventions for the range of disorders occurring in children. Study populations will include children ages 0 to 21 years and their families, where children’s outcomes are a primary measure.  

    5. Conflicts of Interest generally not a big a problem as trials tend to be small N=500–600 is a large trial - typically a multisite R01 R34’S – treatment development applications typically have 30-50 subjects projects involving multi-site trials/multiple PI’s create greatest conflict situations do screen for drug company conflicts if a definitive test of a particular agent is proposed – or a head to head comparison, i.e. one agent better than another – these are rare new committee structure will often provide a home of member conflicts have not had to request waivers

    6. Conflicts of Interest (cont) Permanent member participant in an application – assigned to another standing study section or SEP. Temporary reviewer identified as having a significant role with an application – not invited to participate. Temporary reviewer – minor role (i.e., consultant) with an application likely out-of-the-room conflict.

    7. COI SEPS do not necessarily aim for parent committee representation – past or present best practice is to not have committee SRA do the meeting percentiled against the NIMH base (ITV+SRV) anecdotally - no advantage or disadvantage to PI’s re. funding – lower rate of unscoring

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