Who at NIH will assess the consent forms for the demonstration projects?
Consent forms will be evaluated by Dr. Jean McEwen (mcewenj@mail.nih.gov), an ELSI expert on the NHGRI staff, in consultation with an HMP consent working group and by other NIH staff who are familiar with research and clinical trials that study the relevant body sites. The purpose of the assessment is to determine whether the discussion of data release in the consent form is adequate for the investigators to comply with the data release standards that will be applied to these awards and to make sure that any other unique ELSI issues raised by the design of the particular project are adequately addressed in the consent form. This NIH assessment does not take the place of appropriate IRB review, which will continue to be required for all proposals involving human subjects.
