Institutional Review Board (IRB)

Application

This policy applies to research in which information on individual human subjects is collected under the auspices or WU, whether by faculty members or students.

Purpose

The purpose of the IRB is to ensure that research complies with ethical and legal guidelines when:
• researchers, whether faculty members or students, act under the auspices of WU and
• collect information on individual human subjects.

Appointment

  1. When WU has research students, the Board shall appoint appropriately qualified persons to form an IRB.
  2. The IRB shall decide how many times it should meet formally each year.
  3. The IRB may appoint such sub-committees as it deems necessary to further its objectives.
  4. IRB members must have appropriate training in ethical research of human subjects.

Duties

  1. Maintain legislative compliance regarding research involving human subjects.
  2. Minimize risk of litigation regarding research involving human subjects.
  3. Oversee policy development for research involving human subjects
    1. Liaise with the Research Committee.
    2. Collaborate with faculty to formulate policies for specific subject areas.
    3. Propose policy to the Board regarding research involving human subjects.
    4. Propose practices and procedures to the Academic Council regarding research involving human subjects.
    5. Evaluate the effectiveness of research policy and practices involving human subjects, and report to the meeting of Academic Council and to the Board.
  4. Appoint a sub-committee of IRB members to evaluate all proposals of staff and students for research involving human subjects.
  5. Maintain standards of training regarding research involving human subjects.

Implementation

  1. Researchers must propose ethical compliance systems in writing before commencing research, and may not commence research until the IRB has approved the proposal.
  2. Proposals must include as a minimum:
    1. An interpretation of the research against the requirements of Code of Federal Regulations, Title 45 Part 46, Protection of human subjects.
    2. The disclosure of information to research subjects.
    3. The means for obtaining written permission from research subjects and for storing those documents.
    4. The methods of data collection.
    5. The security of data against leak or theft, and the methods of archiving, destroying, or deleting it.
    6. The method of de-identifying data on individuals, if applicable.
    7. An assessment of the risk that de-identified data could be re-identified, if applicable.
    8. The risk of any foreseeable harm to research subjects.
  3. Proposals to the IRB may be either a separate document or included in the research proposal.
  4. The IRB retains the right to audit researchers’ compliance with ethical standards at any time during research, require corrections, and to withdraw approvals if necessary.
  5. Researchers may apply for variations in their proposal during research if the original proposal is at risk of failing to ensure compliance with ethical standards.

IRB approval procedure

  1. When a research supervisory committee has given preliminary approval to a research proposal, its chairperson shall send the proposal to the IRB members.
  2. Within seven days, each IRB member shall recommend a decision to other IRB members with their reasons for their recommendation. They may include advice on improvements to be made.
  3. As a minimum, they must consider each of the following:
    1. Subjects are not placed at undue risk.
    2. Subjects will receive appropriate information before being asked to give consent.
    3. Subjects will voluntarily agree to participate.
    4. Whether subjects will be de-identified and any related procedures.
  4. Their recommendations shall be one of the following:
    1. Expedited and approved: The proposed research does not involve individuals. (For example, it involves only institutions, or comprises only documentary studies or analysis of existing data sets.)
    2. Approved: The proposed research clearly complies with ethical standards and has no issues of concern and no unacceptable risks.
    3. Approved: The proposed research is approved subject to specific conditions.
    4. Rejected: The proposed research clearly does not comply with ethical standards.
    5. Rejected: The proposed research might comply with prescriptive ethical standards but has issues of concern and/or unacceptable risks.
  5. If any IRB committee member recommends a rejection for any reason, other IRB committee member shall respond in order to achieve a consensus decision.
  6. The IRB chairperson shall determine when a consensus decision has been attained.
  7. The IRB chairperson shall inform the researcher and the chairperson of the research supervisory committee of the IRB’s decision in writing and the reasons for the decision.
  8. IRB shall add any new lessons learned to a document of satisfactory and unsatisfactory practices in research ethics.
The IRB is a committee appointed to approve, monitor, and review all research involving human subjects. The IRB should ensure that the subjects are not placed at undue risk, that they have voluntarily agreed to participate and that they have received appropriate informed consent. The IRB must meet all federal regulations and the institution must be able to demonstrate that it is in compliance, including providing evidence that all IRB members have had appropriate training. (Title 45 Code of Federal Regulations Part 46.)
(DEAC handbook, 2017 ed. p. 75.)