How does the NHLBI policy differ from the NIH policy?
A. The NHLBI policy is aligned with the NIH policy and extends the requirement of DSM plans to include clinical research with greater than minimal risk in addition to clinical trials. The NHLBI policy explicitly requires IRB approval of the DSM plan. 2) Q. Who determines whether my research protocol has greater than minimal risk? A. Your IRB has primary responsibility for determination of the level of risk to study participants. When a decision is made to fund your grant or contract, the PO will issue instructions to release funds for your research protocol if the study is clearly minimal risk, as defined in 45 CFR 46.102 (i). ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102 .) If the PO considers your protocol to be of greater than minimal risk, an IRB-approved DSM plan will be requested. If you disagree with the PO ‘s assessment, you may be asked for clarification or certification of your IRB’s determination of risk. 3) Q. Does this policy apply to all award mechan
