Key Issues to Address When Terminating Human Subject Studies at a VA Facility with a Human Research Protection Program VHA Office of Research and Development, March 25, 2016 Category Issue Comment 1. Timeline Define the date for the Intervals vary anywhere between 60 days to 1 projected closure of the year, with the usual range being between 3 to 9 Human Research months. Protection Program (HRPP) 2. Notification of any Any HRPP relying upon relying HRPPs the VA Facility’s IRB of Record and/or Research and Development Committee must be informed immediately as this directly impacts the relying VA Facility’s HRPP. 3. Categorization of Different studies will If there are any studies with CRADAs, the studies: have different issues termination clauses of those CRADAs need to be (a) which studies are involving termination reviewed. non-human subjects, and/or transition. exempt, or For data and biorepositories, effort should human be made to transfer those studies as permitted subjects within the approved protocol and the applicable (b) funded (ORD, informed consent and HIPAA authorization. other federal funding, industry) (c) collaborative (d) Repositories data – or biospecimen 4. Subject status: Subject safety is the Determinations must be made for any Determine which priority for terminating notifications that must be made for subjects in studies have subjects and/or transitioning any any currently active human subjects studies. which are currently subjects study. receiving any interactions, interventions, and/or follow-up monitoring. 5. Transfer of studies: It is unknown whether Determine if any of any of the studies will or the studies will or can can be transferred to be transferred to other VA facilities. another institution Category Issue Comment
Key Issues to Address When Terminating Human Subject Studies at a VA Facility with a Human Research Protection Program VHA Office of Research and Development, March 25, 2016 Category Issue Comment 1. Timeline Define the date for the projected closure of the Human Research Protection Program (HRPP) Intervals vary anywhere between 60 days to 1 year, with the usual range being between 3 to 9 months. 2. Notification of any relying HRPPs Any HRPP relying upon the VA Facility’s IRB of Record and/or Research and Development Committee must be informed immediately as this directly impacts the relying VA Facility’s HRPP. 3. Categorization of studies: (a) which studies are non-human subjects, exempt, or human subjects (b) funded (ORD, other federal funding, industry) (c) collaborative (d) Repositories – data or biospecimen Different studies will have different issues involving termination and/or transition. If there are any studies with CRADAs, the termination clauses of those CRADAs need to be reviewed. For data and biorepositories, effort should be made to transfer those studies as permitted within the approved protocol and the applicable informed consent and HIPAA authorization. 4. Subject status: Determine which studies have subjects which are currently receiving any interactions, interventions, and/or follow-up monitoring. Subject safety is the priority for terminating and/or transitioning any subjects study. Determinations must be made for any notifications that must be made for subjects in any currently active human subjects studies. 5. Transfer of studies: Determine if any of the studies will or can be transferred to another institution It is unknown whether any of the studies will or can be transferred to other VA facilities. Category Issue Comment
AO_ACOS_Manual.docx