IRB FAQs – Responsibilities

What are the responsibilities of the IRB?

The IRB protects the rights, safety and welfare of human research participants by:

  • Reviewing the full protocols for planned research studies to ensure that, in its judgment, the research meets the criteria found at 45 CFR 46.111;
  • Confirming that the research plans do not expose participants to unreasonable risks;
  • Conducting continuing review of approved research at intervals defined by the degree of risk of the research, but not less than once a year, to ensure that human participant protection remain in force;
  • Considering unanticipated problems, interim findings, and any recent literature that may be relevant to the research; and
  • Assessing suspected or alleged noncompliance with approved procedures, complaints expressed by research participants, or violations of institutional policies.

What authority does the IRB have?

The IRB has the authority to:

  • Approve, disapprove or terminate all research activities that fall within its local jurisdiction according to relevant federal regulations and institutional policy;
  • Require modifications in submissions, including previously approved research;
  • Require that information, in addition to that specifically mentioned in 45 CFR 46.116, be given to participants when the IRB determines that this information would add to the protection of their rights and welfare;
  • Require documentation of informed consent or allow waiver of documentation, in accordance with 45 CFR 46.117; and
  • Observe or have a third party observe the consent process and the research.

For more information on the roles and responsibilities of the IRB, see 45 CFR 46.109.

Is IRB review required for quality improvement (QI) projects?

No. Quality improvement activities do not need to be submitted to the UMCIRB. The federal regulations governing human research do not require review by the IRB of QI activities. The UMCIRB does not have jurisdiction over QI activities and there are no standard operating practices, formal or informal, that require review of QI activities by the UMCIRB or its staff. It is our assumption that department administrators, faculty and staff at an academic institution understand the difference between QI activities and human research. If they do not, there are tools on our website, as well as on the Office of Human Research Protections website, to help decipher the difference between the two. The manager or director of the clinical areas in which a quality improvement project is being carried out should be consulted for verification and/or documentation that the project is supported.

Consultation with a UMCIRB staff member for assistance making the determination of whether a project is human research versus quality improvement may be sought when an individual is unable to make the determination on their own because the line between the two is so uncertain.

The following tools are available for use in making the distinction between QI and human research: