Purpose

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. All proposed research that involves (1) intervention or interaction with human subjects, (2) the collection of identifiable private data on living individuals and/or (3) data analysis of identifiable private information on living individuals requires review and approval by the IRB prior to the initiation of the research.

Research that is limited to the collection of private information on individuals requires prior approval. If the research is exempt, the application must be approved by the IRB Manager or the IRB Co-Chair before data collection begins. If the research is non-exempt, the application must be approved by the IRB before data collection for exempt research begins.

The IRB will review the proposed research project as to:

  • the risks to human research subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose the research participants to risk, and whenever appropriate, by using procedures already being performed on subjects for diagnosis or treatment purposes.

  • the risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result.

    • For the purpose of IRB consideration, “benefit” is defined as a valued or desired outcome; an advantage.

    • For the purpose of IRB consideration, “risk” is defined as the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. In evaluating risk, the IRB is to consider the conditions that make the situation dangerous, per se (i.e., as opposed to those chances that specific individuals are willing to undertake for some desired goals).

    • In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (i.e., as distinguished from risks and benefits of treatments or procedures that the patient would undergo if not participating in the research).

    • In evaluating risks and benefits, the IRB does not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of research on public policy).

  • the selection of human subjects for research participation is equitable.

  • human research subjects are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent is obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required by federal regulations and IRB policies.

  • informed consent of human research subjects is obtained in advance of research participation and appropriately documented in accordance with, and to the extent required by federal regulations and IRB policies.

  • the research plan, when appropriate, makes adequate provisions for monitoring the data collected to ensure the safety of human research subjects.

  • there are adequate provisions to protect the privacy of human research subjects and to maintain the confidentiality of research data.

  • appropriate additional safeguards have been included in the study to protect the rights andwelfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, decisionally impaired persons, or economically or educationally disadvantaged persons).

As a secondary purpose, the IRB must seek to ensure that the University, affiliate institutions, and the investigators that it serves are compliant with the ethical standards and regulations governing human subject research.