VI. Procedures for submitting a project for review
- Criteria for Full Review
- Criteria for Expedited Review
- Criteria for Exemption
- Criteria for Projects that are Beyond the Scope of IRB and Excluded from IRB Review
- Criteria for Projects Already Approved by another Institution’s IRB
Review for faculty and student research projects involving human subjects is initiated by the researcher(s) by submitting a research proposal to the IRB or the appropriate Departmental Coordinator. Before submission, it is important for the researcher(s) to review the material below to understand the categories of review. Full review must always be conducted by the IRB. Expedited and Exempt review may be reviewed by Departmental Coordinators. If the researchers are in a department with a Coordinator, they should inquire about Expedited or Exempt forms which may be particular for their department. If the researchers are in a department that does not have a Coordinator they should use the forms accompanying this policy. If the researcher(s) have any questions they can contact the IRB Chairperson or, if available, their Departmental Coordinator. The researcher(s) should complete the questions below for each category of review and follow the procedures listed for their project’s appropriate category.
Categories of Review
Research projects involving human subjects are subject to full review of the IRB if the following criteria are met. Projects are deemed eligible for full review, if the researcher(s) respond YES to any of the following questions:
- Does this project involve participants from a vulnerable population, including individuals under 18, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons?
- Does this project involve the collection of information that could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation?
- Does this project involve the collection of information regarding sensitive aspects of the subject's behavior, such as drug or alcohol use, illegal conduct, or sexual behavior?
- Is the project sponsored or funded by an agency or organization outside of Muhlenberg College?
If the researcher(s) answers YES to question 1or 4 above, they should fill out Appendix A and submit to the IRB Chairperson. If the researcher answers YES to question 2 or 3 the project may qualify for expedited review only if the following three criteria are met:
- anonymity of the participant is guaranteed;
- when possible, potential participants are informed of the sensitive nature of the topics prior to their participation;
- the study does not exceed minimal risk.
Research projects involving human subjects may be eligible for an expedited review if the following criteria are met. In order for the project to be deemed appropriate for an expedited review, the researcher(s) must have answered NO to all of the questions above for full review and be able to respond YES to any of the following questions:
- Is this project presenting minor changes to a project previously approved by the IRB? (within one year or less of initial IRB approval)
- If the researcher(s) answers YES to question 1, they should consult with the Departmental Coordinator for appropriate forms. If there is no Departmental Coordinator, proceed to Appendix B and submit as instructed.
- Does this project involve only minimal risk to the participants?
- Minimal risk, as defined by federal guidelines (46.102i.), means that the probability or magnitude of harm or discomfort anticipated are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.
- Note: If the researcher(s) answers YES to question 2, they should review Section C and D below. If the project does not qualify for exemption, or is not beyond the scope of the IRB, the next appropriate step is to consult with the Departmental Coordinator for appropriate forms. If there is no Departmental Coordinator, proceed to Appendix B and submit as instructed.
Research projects involving human subjects may be exempt from IRB full and expedited review if the following criteria are met. The researcher(s) must answer NO to all of the questions for full review and be able to respond YES to at least one of the following questions:
- Does this project involve the use of diagnostic educational tests, survey procedures, interview procedures, or observations of public behavior in which individual demographic information obtained from participants is not recorded and therefore is not directly or indirectly identifiable or damaging to the subject?
- Does this project involve the use of existing data that is publicly available or in which the subjects cannot be identified?
- Is this project designed to evaluate a public benefit or service program?
- Does this project involve a taste or food quality evaluation using wholesome foods, or those deemed safe by the FDA?
Note: If the researcher(s) answers YES to at least one of the above questions, they should consult with their Departmental Coordinator about appropriate forms. If there is not a Departmental Coordinator they complete Appendix C and submit as instructed.
If reviewing the above checklists has not led to an Appendix for guidelines on preparing a submission to IRB, it may be that the research does not fall under the purview of this policy and does not require IRB review. A project does not require submission to the IRB if the researcher(s) can answer YES to any of the following questions:
- Does this project involve faculty members’ assessment of the effectiveness of their pedagogical strategies that is solely for their individual use?
- Does this project involve student research that is not reported beyond the classroom?
- Does this project involve the informal collection of information by students from respondents -- for example, informally interviewing friends or relatives for purposes of class discussion or assignments – rather than a systematic investigation?
- Does this project constitute institutional research or internal research, including the gathering of data from or about Muhlenberg students, faculty, or staff members by college offices or organizations, with the intent of using the data solely for internal informational purposes or for required data-collectionpurposes?
- Is this project being conducted as an oral history, a journalistic investigation, or a documentary film?
Note: Answering YES to at least one of the above questions indicates that the proposed research does not fall under the purview of the IRB and does not require review. If the researcher(s) answera NO to all of the above questions, they should review all of the above categories again and complete the appropriate Appendix. The researcher(s) should contact the IRB Chairperson or their Departmental Coordinator with any questions regarding Categories of Review.
If the researcher(s) is conducting research that has been previously approved, within a one-year time limit, by another Institution’s IRB they should provide the IRB Chairperson with signed documentation of the approval. Review of research funded by or conducted at Muhlenberg, or for which a member of the Muhlenberg academic community has primary responsibility, must follow the procedures outlined for other Categories of Review listed above.