Society of Research Subject Advocates

Question:

At our GCRC we require that upon annual study renewal the PI submit a safety report that is commensurate with the level of risk assigned to the study at initial review and in accordance with the DSMP. I would like to know if this is standard at other sites and how you handle a renewal application that doesn't have a safety report.

Question:

At your respective institutions, which protocols are reviewed or audited by the RSAs? Do you perform regulatory reviews on all protocols? on only high risk protocols? Something in between? What is the selection process?

Question:

Question:

How long should research data and documents be stored? It seems unanimous that all IRB committee records are retained for three years. However, do you also apply this statement to the data the researchers collect? How long should research data and documents be stored?

Question:

I would be interested to know if you all require (medical) orders to be written for the protocols or if you handle it another way. For instance, I understand from some PIs not at UVM that they sign a delegation of responsibility for the nursing care and the nurses then follow the protocol guideline/guide sheet agreed upon during protocol meetings. Any input would be helpful, thanks. (By Pete Chertouny)

Question:

Please comment on whether it is (in)appropriate to require a potential subject to come to clinic fasting prior to signing consent, in anticipation that he/she will agree to sign consent and then be able to participate immediately in fasting screening studies or procedures. We believe that requiring fasting that is not otherwise indicated other than for research participation, represents engaging in a study procedure prior to IC; others disagree. Please send me references, regs, policies, guidance or warning letters on this. Thanks much.