Any Principal Investigator related to Ursinus College (as defined below) who engages in scholarly research involving human subjects, either on- or off-campus, must apply to the Internal Review Board for approval of the research. 

• Ursinus College faculty and staff
• Ursinus College faculty who are on leave, and who are conducting research involving human subjects either at Ursinus College, with grant funds administered by Ursinus College, or with Ursinus College students 
• Researchers not affiliated with Ursinus College who are conducting primary research with human subjects on campus. These unaffiliated researchers include visitors to the campus and off-campus scholars engaged in human subject research on campus. While at Ursinus, these individuals may, through the courtesy of an on-campus liaison, conduct Board-approved research on human subjects. The liaison should provide the visitor with appropriate institutional forms including this Policy, and assure that the forms are sent to the Board before the research is undertaken.

All researchers including faculty and students collecting data or those who have access to the resulting data, must complete training in human subjects protection prior to submission of a proposal to the Board. Click on the Training Tab for more information. 

Researchers must obtain approval before undertaking the research. Individuals who meet the definition of a “principal investigator/faculty member” must apply for approval from Ursinus’ Board even if another institution’s or organization’s Institutional Review Board has approved their research.

How do I know if I am doing human subjects research?
Research projects involving human subjects require either review and approval by an IRB, or a determination that the research is exempt. The first question a researcher should consider with respect to IRB review is whether the research project fits the federal regulatory definition of research, and if so, whether it also involves human subjects. In light of the responsibility to protect human subjects and the potential regulatory consequences of not obtaining IRB review and approval, the investigator should err on the side of caution and consult with the IRB when uncertain whether a study constitutes human subjects research.  Certain categories of human subject research (for instance:non-sensitive and anonymous survey and some pedagogical research) are exempt from federal human subject research regulations.  Those wishing to undertake such exempt research should still obtain confirmation of the exempt status by submitting the Exemption Request Form

  Student Projects:
There is often confusion as to what student projects the Institutional Review Board must consider. Generally, student research involving human subjects falls into one of two categories:

• Research Practica - the goal of which is to provide research training 
• Research Projects, either directed or independent, which employ systematic data collection with the intent to contribute to generalizable knowledge

A “Research Practicum” is a course of study that involves the supervised practical application of previously studied theories of research method. A number of departments offer courses that require students to interview or observe other people. The purpose of these courses is to train students and give them an opportunity to practice various research methods. Such projects do not require review by the Board.

A “Research Project” is any student-initiated and/or student-conducted research that does not fall under the definition of a research practicum, which uses human subjects, and intends to contribute to generalizable knowledge. Dissemination of findings to a scientific audience is a sufficient, but not a necessary, criterion for defining research. Dissemination includes, but is not limited to, honor’s theses; presentation at a scientific meeting or conference; submission to or publication, paper or electronic, in a scientific journal; and Internet postings. If the project falls under this definition of research, review and approval of a human participant’s research protocol by the Institutional Review Board (IRB) is required.

Please Note

• Instructors are advised to discuss these guidelines with students before the instructional assignment/project begins so informed decisions can be made about whether IRB review is needed.
• If even the slimmest likelihood exists that an instructional assignment/project may fall under the definition of research outlined in this document, instructors are advised to submit the appropriate human participants research protocol to the IRB for review and approval.
• Please remember that IRB approval of a research protocol cannot be granted retroactively under any circumstances.
• When overseeing instructional assignments/projects that do not fall under the definition of research outlined in this document, instructors are asked to advise students to identify the project as a class assignment. Labeling such projects as research is inaccurate and misleading for the students, as well as for others with whom the students may interact as a necessary component of completing the assignment. When overseeing instructional assignments/projects, instructors are asked to advise students that any data from human participants that are collected or analyzed should not contain personal identifying information when such information is not required for completion of the assignment/project.
• Instructors continue to be responsible for the ethical behavior of their students in conducting instructional assignments/projects.

Guidelines for Oral History/Ethnography

This guidance is for research using oral history and ethnographic methods for data collection to help determine if Institutional Review Board (IRB) review is required. It is based on Title 45 Code of Federal Regulations (CFR) Part 46 and communications between other universities’ IRBs and Dr. Michael Carrome, Associate Director for Regulatory Affairs at the Office for Human Research Protections (OHRP). These communications were designed to clarify statements that OHRP made to the Oral History Association and the American Historical Association in 2003.

Oral history is a method for data collection, and, analogous to the method of sampling blood, the intended purpose (i.e., goal) for using this method dictates whether its use falls under the federal regulations that cover protections of human research subjects and operations of IRBs (i.e., Department of Health and Human Services regulations at 45 CFR 46). Blood samples taken solely for medical reasons do not fall under 45 CFR 46. However, just as when blood sampling methods are used to collect information that will be analyzed to contribute to generalized knowledge, when oral history procedures are used to that end, that research does meet the definition of research under 45 CFR 46.102(d) and must be reviewed by the IRB. The information and examples below further illustrate this point.

Oral History Goals Requiring IRB Review

• Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) would constitute “research” as defined by 45 CFR part 46.
                                                                                                                                                                Example:  An open ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.
• Creation of archives by oral historians and qualitative investigators to provide a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR part 46, the creation of such an archive WOULD constitute “research” under 45 CFR part 46.                                                                                                        
   Example:  Open ended interviews conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future research. 

Oral History Goals Excluded from IRB Review

• Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals with no intent to draw conclusions or generalize findings WOULD NOT constitute research” as defined by 45 CFR part 46.
                                   
  Example:  An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories. However, if a researcher wanted to use Holocaust Museum data which identified individuals, he or she would have to apply to the IRB.

Please Note
Projects that do not fit the above criteria for “research” as defined by 45 CFR part 46 do not need to be submitted to the IRB for human participants protection review.  If either generalizable knowledge or archives for others to do research is a possibility, IRB review and approval must be obtained prior to the involvement of human participants. IRB approval of a research protocol cannot be granted retroactively under any circumstances.

Advisory

• If even the slimmest likelihood exists that a project may fall under the definition of research outlined in this document, investigators are advised to submit the appropriate human participants research protocol to the IRB for review and approval. 
• Please remember that IRB approval of a research protocol cannot be granted retroactively under any circumstances.