Institutional Review Board

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a group of people formally designated to review and monitor research involving human subjects. The purpose of the IRB is to protect the rights and welfare of individuals who are participating as subjects in the research. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. Once approved, the IRB must monitor the progress of the ongoing research, prospectively approve modifications, and, if necessary to protect subjects, suspend a research project.

Why IRB?

The Andrews University Institutional Review Board (IRB) is endorsed with the responsibility of overseeing that all research involving the use of human subjects are conducted under ethical and scientific sound principles that ensure the rights and welfare of human subjects recruited to participate in such studies are safeguarded, and that the study will yield outcomes that are to the good of society, in compliance with federal regulations and its operating policy. For more information about the origins of IRB please visit The Belmont Report and the OHRP Guidelines

Membership

The board comprises individuals of varying disciplines from within the university and community, who are experienced and knowledgeable of the kinds of research done at the university. Such diversity ensures a comprehensive approach to protecting the rights and welfare of human participants and a complete and adequate review of research proposals is achieved. Proposals may be reviewed under one of the three categories: Exempt, Expedited and Full.

IRB Categories

Exempt: Studies are exempt from full review if they have the following characteristics as described under the Protection of Human Subjects Title 45 Code of Regulation part 46 (45 CFR 46.101).

1.     Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of, or the comparison among instructional techniques, curricula, or class management methods.

2.     Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), Survey procedures, interview procedures or observation of public behavior if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to subjects.

3.     Research involving the use of education tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures or observation of public behavior (including observation by an investigator who is also a participant in such behavior). All research involving survey or interview procedures is exempt without exception, when all the respondents are elected or appointed public officials or candidates for public office).

4.     Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or indirectly or through identifiers linked to the subjects.

5.     Research and demonstration on projects which are conducted by or subjects to the approval of department or agency heads and which are designated to study, evaluate, or otherwise examine: (i) Public benefit or service programs (ii) procedures for obtaining benefits or services under those programs (iii) possible changes in or alternatives to those programs or procedures or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

6.     Taste and food quality evaluation and consumer acceptance studies (i) if wholesome foods without additives are consumed (ii) if a food is consumed that contains a food ingredient at or below the level the and for a use found to be safe or agricultural chemical or environmental contaminant at or below the level found to be safe by the FDA or EPA.

 

Expedited: Studies will be categorized Expedited if all of the following characteristics as described in the Protection of Human Subjects Title 45 Code of Regulation part 46 (45 CFR 46.111) are satisfied.

 

1.     Risks to subjects are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

2.     Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.

3.     Selection of subjects is equitable.

4.     Informed consent will be sought from each prospective subject or subject's legally authorized representative in accordance with and to the extent required by 46.117.

5.     Informed consent will appropriately be documented, in accordance with and to the extent required by 46.117.

6.     When appropriate the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.

7.     When appropriate the research plan makes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

 

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons additional safeguards have been included in the study to protect the rights and welfare of these subjects.

 

Full: Studies that have risk to human subjects. All studies that do not meet the Exempt and Expedited reviews will be considered under Full category.

IRB Review process

Full reviews are usually discussed at the full board sessions, while expedited and exempt reviews are evaluated by the chair, research compliance administrator or/and another designee(s) from among members of the IRB.

 

The board meets once monthly; usually the second Monday of every month. For more details about the meeting schedules please visit IRB Meetings Schedule site.

Links

IRB Resources

IRB Application Guidelines

IRB Meetings Schedule


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Andrews University is a Seventh-day Adventist institution of higher education
Phone: 1-800-253-2874   E-mail: enroll@andrews.edu
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Berrien Springs, Michigan 49104