91Pron¹ú²ú

IRB approval is required for human subject research performed by all faculty, students, and staff. Not disclosing your research and failure to receive IRB approval will result in the suspension of your research privileges.

If you are unsure whether your project qualifies for IRB approval, use this decision tree from 91Pron¹ú²ú or this decision tree from the Office for Human Research Protections.

If your project involves existing data, secondary use of information, or biospecimens, use this decision tree.

IRB approval is not required for routine assessment activities used for internal purposes only.
For cases in which academic assessment data (e.g. grades, course work, rubrics, surveys, focus groups, senior projects, etc.) are only used to provide student feedback, improve a course or academic program, or report findings to the Office of Assessment for University-wide academic program improvement, 91Pron¹ú²ú IRB approval is not required. In addition, the release of assessment data to present evidence of improvement in student learning outcomes/academic programs to accrediting agencies does not constitute distribution of research results outside the University, and therefore does not require IRB approval.

IRB approval is required if assessment results/findings are to be used in research/scholarly activities.

If there are plans to publish/distribute assessment results outside of 91Pron¹ú²ú (e.g. publish results in hardcopy or online formats, present findings at a conference, etc.), IRB approval is required. If you have any intention to distribute assessment results/findings or would distribute the findings if they are interesting/valuable you should obtain IRB approval prior to the collection of assessment data from students/classroom activities. Students should be provided advanced notice of the classroom-related assessment research activity within the course syllabus.

In the event that interest for distributing assessment results/findings or analyzing assessment data for research purposes develops at a later date, IRB approval for the analysis/use of existing data is required as soon as there is intent to analyze the existing data for research/distribution purposes. In addition, IRB approval is required prior to the analysis of previously collected (past semesters) assessment data for research distribution purposes.

In the context of an Institutional Review Board (IRB), research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. This can include activities such as experiments, surveys, interviews, observational studies, or any other methodical collection and analysis of data.

Key elements of this definition:

• Systematic investigation: Research follows a structured plan or method.
• Generalizable knowledge: The findings are intended to be applicable beyond the specific group or setting studied, contributing to a broader understanding or theory.

If a study aims to produce findings that will be shared through publications, presentations, or applied more broadly, it is typically considered research and requires IRB review if it involves human subjects. If a study is primarily focused on assessment of a program, pedagogy, practice, etc. and is not meant to be generalizable or shared outside the institution, it is not classified as research and is not subject to IRB review.

All researchers on a proposal at 91Pron¹ú²ú should submit CITI training certificates with their submission. All researchers are required to complete at least two training modules:

1. Responsible Conduct of Research (RCR) module
   
   - AND -
2. Discipline-specific training module:
• Social & Behavioral Research (this applies to the vast majority of proposals)
• Biomedical Research
• Good Clinical Practice
• Research with Data or Laboratory Specimens Only
• Students Conducting No More Than Minimal Risk
• Students – Class Projects

In addition, researchers may opt to complete other modules such as Conflicts of Interest or Information Privacy & Security.

The three levels of IRB review—Exempt, Expedited, and Full Review—differ based on the level of risk to participants and the type of research being conducted:

1. Exempt Review:
• Minimal risk or less: The research involves very low or no risk to participants.
• Eligibility: Common for studies involving anonymous surveys, educational tests, public behavior observations, or analysis of existing de-identified data.
• Review process: Reviewed by the IRB staff or a single IRB member. Does not require ongoing review after approval unless changes are made.
• Examples: Anonymous surveys, educational research, or use of public records.
2. Expedited Review:
• Minimal risk: Involves some risk, but it is still low.
• Eligibility: Applies to specific types of research, such as studies involving non-invasive data collection (e.g., blood samples, surveys, focus groups) or research on existing data where subjects can be identified.
• Review process: Reviewed by the IRB chair or a designated IRB member, rather than the full board, but requires ongoing review for any changes.
• Examples: Collection of small blood samples, non-invasive physical measurements, or behavioral research with minimal risk.
3. Full Review:
• Greater than minimal risk: The research involves higher potential risks to participants (physical, psychological, legal, or social).
• Eligibility: Required for studies that involve vulnerable populations (children, prisoners, pregnant women) or more invasive procedures.
• Review process: Must be reviewed and approved by the full IRB at a convened meeting, with ongoing review and monitoring.
• Examples: Clinical trials, research involving sensitive topics or vulnerable populations, or studies with potential for significant harm.

In summary, Exempt reviews are for very low-risk research, Expedited reviews are for low-risk studies, and Full Reviews are for higher-risk or more complex research.

Complete proposals will include the following documents.

• Form A (Request for Review – Initial and Continuing)
• Form B (for Exempt studies) -OR- Form C (for Expedited and Full review)
• Form D (only if the study involves deception)
• Research Protocol (see guidelines)
• Data collection instruments (copyrighted instruments also require a letter giving written approval for use)
• Informed Consent documents (see guidelines)
• CITI training certificates for all researchers
• Responsible Conduct of Research
  AND
• Discipline-specific training module

Submitting an incomplete application will result in delayed approval.

Send all your materials attached in an email to irb@lewisu.edu. This email inbox does not have a dedicated administrator (though it is checked frequently) and so you will receive an autoreply message to confirm that your proposal has been reviewed. If you don’t receive an automatic reply, or if you haven’t heard about the status of your proposal within the appropriate timeframe, please contact the IRB Chair directly.

Approval time is dependent on the level of review. If all materials are included in the original submission and there are no requested revisions -

• EXEMPT proposals are reviewed by the IRB Chair and can typically be approved within 1 week.
• EXPEDITED proposals require only a single IRB member to approve. The IRB Chair can approve, but most often these proposals are sent to an IRB member with more similar disciplinary knowledge to the proposal. Given the back and forth and that most IRB members are faculty volunteers, these proposals are typically approved in 1-2 weeks.
• FULL proposals require the approval of the full board at a convened meeting. IRB members are typically provided 2 weeks to review all materials before meeting. Given the requirement to convene the board and the challenges of finding a time when all can meet, proposals under full review are typically approved in 3-4 weeks.

We strive to respond to submissions as quickly as possible, but when there is a high volume (multiple proposals for course projects), when studies require more than the Chair to review, or when proposals are incomplete or require revision, the process is delayed. We thank you for your attention to preparing complete proposals, following the guidance, and for your patience.

The is the most comprehensive source for regulatory information.

An Institutional Review Board (IRB) must be composed of members with diverse backgrounds to ensure thorough and balanced review of research involving human subjects. According to U.S. regulations (), the IRB must include:

1. At least five members with varying expertise and perspectives.
2. One member with scientific expertise: A person with knowledge in areas such as biology, medicine, psychology, or other sciences.
3. One member with non-scientific expertise: Someone whose primary concerns are in non-scientific areas, such as law, ethics, or community advocacy.
4. One member not affiliated with the institution: This person should have no ties to the institution (e.g., no employment, family relations), providing an independent viewpoint to avoid potential bias.
5. Diverse representation: The IRB should include members of different genders, ethnicities, and cultural backgrounds, to ensure that the review process reflects broad perspectives and avoids discrimination.

In addition, experts may be consulted for specialized knowledge as needed, but they do not vote unless they are official IRB members. This composition ensures ethical and comprehensive review of human subjects research.