In order to fulfill the requirements of this subpart each IRB shall:
(a) Follow written procedures:
(1) For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
(2) For determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review;
(3) For ensuring prompt reporting to the IRB of proposed changes in research activity; and
(4) For ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.
(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Environmental Protection Agency of:
(1) Any unanticipated problems involving risks to human subjects or others;
(2) Any instance of serious or continuing noncompliance with this subpart of the requirements or determinations of the IRB; or
(3) Any suspension or termination of IRB approval.
(c) Except when an expedited review procedure is used (see Sec. 26.1110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.