IRB question?

The only dumb question is the one you do not ask.

IRB Frequently asked questions (FAQ)

Where do I submit my completed IRB forms?

What is the Saint Martin’s University policy for the use of human subjects in research?

Who is subject to the University’s policy and standards for protection of human subjects in research and investigational activities?

Who may conduct research involving human subjects?

To what activities do Saint Martin's University policy and standards for protection of human subjects in research and investigational activities apply?

What kinds of research must be reviewed by the Institutional Review Board (IRB)?

Who is responsible for applying the policy and standards?

How do I determine if my study requires full board, expedited, or exempt review?


Q: Where do I submit my completed IRB forms?

Completed IRB forms should be submitted to the IRB chair. A signed paper copy and an electronic pdf should be supplied. The current IRB chair is listed on the Board Members page.

Q: What is the Saint Martin’s University policy for the use of human subjects in research?

The complete policy and standards for the use of human subjects in research are presented in the Saint Martin’s University policies and standards for protection of human subjects in research and investigational activities document. In summary, investigations conducted at or sponsored by Saint Martin's University that involve the use of human subjects must adhere to the codes of ethics, policies, and procedures set forth in this document. Some of the key requirements are the following:

  • Projects should be carefully designed to minimize risk to the subjects and to anticipate risk.
  • Participation of human beings as subjects in research must be voluntary.
  • Consent processes and documentation must conform to the IRB requirements and comply with applicable law and sponsor guidelines.
  • Confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains express permission of the subject to do otherwise.
  • All research projects involving human subjects must be submitted for prior review unless certain specified instructional exemption criteria are fully met. (The checklist may be used to assist in determining whether a project must be reviewed by the IRB).

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Q: Who is subject to the University’s policy and standards for protection of human subjects in research and investigational activities?

Any individual who is responsible for a research activity involving human subjects conducted at, sponsored by, or utilizing facilities, students, or personnel of, Saint Martin's University.

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Q: Who may conduct research involving human subjects?

Any person may conduct appropriately approved research. However, a qualified faculty or staff member must supervise any research project involving human subjects and is responsible for monitoring the conduct of the research. A qualified faculty member must hold the rank of instructor or above. A qualified staff member is one who holds an equivalent rank.

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Q: To what activities do Saint Martin's University policy and standards for protection of human subjects in research and investigational activities apply?

The Saint Martin's University policy and standards for the protection of human subjects in research and investigational activities apply to any research activity which involves human subjects, independent of whether or not the research is undertaken on a large or small scale; the project is preliminary or fully designed; the project is externally or internally funded; the research is conducted by faculty, students, or staff members; or involves minimal or more than minimal risk to the subjects.

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Q: What kinds of research must be reviewed by the Institutional Review Board (IRB)?

In order to determine whether or not the research proposed meets the criteria for approval set by Saint Martin's University and certain sponsoring agencies, all research involving human subjects must be submitted for prior review, unless the only involvement of human subjects is in an instructional project which fits within one or more of the exemption categories set forth in the policy and standards. To assist investigators in determining whether their project is exempt from review, the checklist should prove helpful.

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Q: Who is responsible for applying the policy and standards?

Compliance with ethical and professional standards governing the use of human subjects at Saint Martin's University is an important shared responsibility. The primary responsibility for the subjects in research necessarily lies with the investigator(s) and project supervisor(s). The responsibility for review of human subjects research is the province of the University’s Institutional Review Board.

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Q: How do I determine if my study requires full board, expedited, or exempt review?

The following checklist is designed to help qualified faculty and staff members determine whether a project involving human subjects must be reviewed by the IRB. Note: Students may not make this determination. To determine whether a project utilizes human subjects and may require review by the IRB the following questions should be answered:

A1. Does this project involve working directly with people, i.e. collecting information through intervention such as interviews, procedures, or questionnaires?

A2. Does this project collect data indirectly through the review of records or non-detected observation e.g., through a one-way glass?

A3. Can the data or information as collected be linked with an individual through a name, ID number, etc.?

If the answer to any of the questions posed above is 'yes', then the project may be subject to review by the IRB, assuming it qualifies as a bona fide research project. In order to determine whether the project represents "research" the following questions should be answered:

B1. Is the purpose of the project to carry out a systematic investigation that is designed to develop or contribute to generalizable knowledge?

B2. Is the project part of an internship, research practicum, independent study, independent research, honors project, thesis, dissertation, capstone course, or other formal research activity?

B3. Is the purpose of the project strictly instructional in nature and does it have as its aim the development of student knowledge and skills independent of the data collected?

If the answer to either B1 or B2 is ‘yes', or B3 is 'no', the project must be reviewed. If the answers to B1 and B2 are 'no' and to B3 is 'yes', a project is instructional and may be exempt from review, if it satisfies certain criteria. By answering questions C1 – C4 below, it is possible to determine whether an instructional project requires review by the IRB.

C1. Will the data collected in this instructional project be used at a later time as part of a research project?

C2. Will this instructional project place the persons participating at risk, as risk is defined in the policy and standards?

C3. Will this instructional project involve children, prisoners, incompetent persons, or pregnant women as subjects in the study?

C4. Does this instructional project fit one or more of the exemption categories listed in appendix A of the policy and standards?

If the answer to C1, C2, or C3 is 'yes', or C4 is 'no', the project must be reviewed. If the answers to C1, C2 and C3 are each 'no', and the answer to C4 is 'yes', then it is not necessary to submit the project for review by the IRB. Instead the qualified faculty or staff member in charge will assume responsibility for assuring that the project is carried out according to the principles detailed in Saint Martin's University policy and standards for protection of human subjects in research and investigational activities.

All projects not explicitly exempted by a qualified faculty or staff member, as determined by the above checklist are required to be reviewed by the IRB in order to comply with federal and University regulations concerning the use of human subjects in research. An investigator should allow at least one month for review of any project submitted to the IRB unless the project qualifies for an expedited review. Following submission, projects placed in the expedited category will not require the review of the entire committee but will be reviewed by a committee selected referee to determine compliance with human subject research guidelines. An investigator may determine whether a given project is eligible for expedited review by consulting the list of research projects which qualify for expedited review given in appendix B of Saint Martin's University policy and standards for protection of human subjects in research and investigational activities.

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