What is an Institutional Review Board (IRB)?
The IRB is Swarthmore College’s committee that reviews and approves protocols for the use of human subjects in research. The IRB reviews research conducted by Swarthmore College faculty, staff, and students. Federal regulations require that the IRB membership represent a variety of backgrounds, training, and experience and is comprised of faculty, staff, and community representatives.
What is human subject research?
The Department of Health and Human Services (DHHS) regulations [45 CFR Part 46] defines “research” as a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge,” while a “human subject” is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
What types of activities qualify for IRB review?
The criteria to determine whether a project requires IRB review is based on it being:
- "Research" defined as:
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" AND
- The project involves "human subjects" defined as:
a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.
Therefore, to qualify as needing IRB review, a project must meet the following 3 criteria:
- A systematic investigation involving a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. Some common methodologies include:
- surveys and questionnaires
- interviews and focus groups
- analyses of existing data
- evaluations and assessments of social or educational programs, unless generalizability (see below) is not intended
- cognitive and perceptual experiments
- collaborative projects intended to contribute to generalizable knowledge
- Activities that are intended to develop or contribute to generalizable knowledge by drawing general conclusions, informing policy, or generalizing findings beyond a single individual or an internal program. It is important to note that academic publication or presentation of results does not solely define an activity as research. Activities that are typically NOT generalizable include:
- Classroom exercises (e.g., research in a methodology course) designed to fulfill course requirements or to train students in the use of particular methods or devices and which will not be generalized or made publicly available outside of the course.
- Quality assessment and quality improvement activities intended only to provide information for assessing or improving the program, department, consortium, or course without sharing findings beyond such as:
- Internal projects (e.g., some institutional research)
- Internal evaluations (e.g., course evaluations)
- Internal standard practice assessments
- Collaborative projects (e.g., pooling data among various colleges, universities, or consortiums without sharing beyond such)
- Oral histories projects that are designed solely to document a specific historical event, unless conclusions will be drawn, findings will be generalized to another population or event, or archives will be made for the purpose of providing a resource to others for research.
- An interaction or intervention with or collection of identifiable private information from a living human subject.
While some activities may not constitute as human subject research and do not qualify for IRB review, standards of ethical conduct still apply (e.g., class exercises should be monitored by the instructor to ensure that they provide adequate protection to any human subjects involved). Each investigator is responsible for NOT conducting human subject research without prior IRB review and approval. If you have questions about whether a project meets the definition of human subjects research, contact the IRB office for a determination. If you wish to have a written determination, provide a written request via email to firstname.lastname@example.org.
Who needs to obtain IRB review and approval?
Regardless of the funding source or where the research will be carried out, any faculty, staff, or student research that involves human subjects must receive IRB approval before it begins.
What if my research is co-sponsored by another institution?
Swarthmore’s IRB may decide to accept that institution’s IRB approval as adequate, but investigators should not assume that simply because a project has IRB approval from somewhere else, it does not need review by our IRB.
What if all or part of my research will be conducted internationally?
An investigator is still required to comply with applicable local rules, including local laws and regulations and the requirements of a hosting institution such as a local university.
What if I am not affiliated with Swarthmore College, but would like to conduct research with Swarthmore College community members?
Researchers outside of Swarthmore College who propose to conduct research on members of the Swarthmore community must request permission from either the Dean of Student’s Office for student members and/ or the Provost’s Office for faculty and staff members. If the Dean and/ or Provost authorizes permission, the outside researcher should then contact the IRB office to determine if IRB approval is necessary. The IRB will require the researcher provide written notification of approval from the relevant departments before any IRB determination may be made.