- Adult Medication Protocol (v1.7, 09/17)
- Pediatric Medication Protocol (v1.3, 05/16)
- Adult Surgical Protocol (BetaFat) (v1.6, 06/16)
RISE Ancillary Studies can be proposed by either RISE investigators or investigators from outside of RISE. The RISE Steering committee will evaluate ancillary study proposals that are not a part of the RISE protocol but involve RISE participants, data or biological samples. These studies may involve only a subset of participants or may include all participants; however, the data collection, analyses, or, rarely, interventions that are proposed will be extracurricular to the Protocol. They must be submitted for review and approval by the RISE Steering Committee. Ancillary studies will have to obtain funding from outside RISE, including funding to cover any necessary effort by the Clinical Centers, Coordinating Center and Central Laboratory. Before initiation, all ancillary studies also need to be approved by the RISE DSMB.
Major factors in approval of ancillary studies will include:
- compatibility of goals with those of RISE
- scientific-clinical import
- burden on RISE subjects and staff
Ancillary studies will receive a primary, secondary and statistical review. An outside reviewer may be used if there is insufficient expertise within RISE in a specific area. Reviews will be returned to the applicant and appeals of decisions may be made to the RISE Steering Committee. Please contact the RISE Coordinating Center for more information on collaborating on a RISE ancillary study.