Responsibilities

The Institution is responsible for:

protecting the rights and welfare of human participants of research;
ensuring that affiliates cooperating in the conduct of federally sponsored research do so with an appropriate assurance of compliance and satisfaction of the Institutional Review Board (IRB) certification requirements;
establishing and maintaining the IRBs;
acquiring appropriate Assurances or Amendments;
requiring additional safeguards in research that involves: (1) fetuses, pregnant women, or human ova in vitro fertilization, (2) prisoners, (3) children, (4) the cognitively impaired, or (5) other potentially vulnerable groups;
overseeing the performance of all research involving human participants, including complying with Federal, state, or local laws as they may relate to such research.

The Institutional Review Board (IRB) is responsible for:

ensuring that risks to participants are reasonable in relationship to the potential benefits, if any, to participants and the importance of the knowledge that may reasonably be expected to result;
reviewing, and having the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human participant research;
reporting decisions and requirements for modifications to the investigators promptly;
observing the quorum requirements;
ensuring that legally effective informed consent will be obtained and documented in a manner that meets federal requirements;
preparing and maintaining adequate documentation of its activities;
suspending or terminating previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants;
ensuring effective input for all initial and continuing reviews conducted on behalf of performance sites where there will be human research participants;
providing continuing review of each research activity at least every 12 months and may be more frequent on the basis of the degree of risk to participants.

The Investigator is responsible for:

protecting the rights and welfare of the human research participants;
complying with all federal, state, or local regulations established to protect human research participants;
providing a copy of the IRB-approved and signed informed consent form to each participant at the time of consent;
promptly reporting proposed changes in previously approved research activities to the IRB prior to their implementation;
promptly reporting any injuries or other unanticipated problems involving risks to participants and others to the IRB;
reporting progress of approved research at least every 12 months;
complying with all IRB decisions, conditions, and requirements that are established within the guidelines of the 45CFR46 and 21CFR50 if applicable;
ensuring that legally effective informed consent will be obtained from each participant;
ensuring that informed consent is documented;
reporting all suspected non-compliance according to the IRB policy on non-compliance;
notifying the Food and Drug Administration whenever it is anticipated that an experimental new drug or device exemption will be required.