OHRP strongly recommends that the Authorized Institutional Official,
the IRB Chair, and the IRB Research Administrator to complete the
relevant OHRP Assurance Training Modules or comparable
training that includes the content of the OHRP modules. These modules
describe the major responsibilities that must be fulfilled under
the Assurance by these IRB officials.
OHRP recommends that the institution and the IRB develop educational training materials
and establish training requirements for IRB members, research investigators,
and other institutional personnel who have access to human subjects
or to identifying confidential information. Training materials should
encompass relevant ethical principles and Federal regulations, state
and local laws, OHRP and other applicable training assistance, and
institutional policies that protect human research subjects. OHRB
further recommends that IRB members should fulfill human subjects
protection training requirements before reviewing human subjects
research. Likewise, investigators and other relevant personnel should
complete this training before conducting human subjects research.
Federal
Assurance requires the institution to prepare written procedures
and guidelines to be followed by the IRB for initial and continuing
review, for reporting its findings and actions to the investigator
and to the institution, and for suspending or terminating IRB approval.
Procedures must also define investigator reporting processes for
research protocol submission, proposed protocol changes, unanticipated
risks, and noncompliance with Federal policy or IRB determinations.
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