- What is FERPA and does it apply to research?
- The Federal Educational Rights and Privacy Act (FERPA) is a Federal Law that protects the privacy of student records, both financial and academic. FERPA laws apply to research projects. For more information and to learn if FERPA rules apply to your research
- Should I submit an amendment or a new application?
- The general rule of thumb is that if you change any two of the three Ps (purpose, population, procedure) with one amendment request you need to submit a new application. If you change any two of the three over multiple amendment requests or if you are unsure if you need to submit a new application or an amendment, please contact the Office of Research Compliance.
- What requires IRB approval?
- Any systematic investigation that is designed to develop or contribute to generalizable knowledge via interaction (or obtaining identifiable data about) with living individuals.
- Determinations can be obtained by completing online determination form that is available on our forms page or by contacting our office.
- See OHRP decision charts here
- Does Title IX apply to research?
- Yes. All KSU employees and students are Title IX reporters and must follow KSU Policy
- Who do I contact with questions?
- The Office of Research Compliance is here to help and we can be contacted at email@example.com. You can also contact any IRB member.
- Is my study regulated by the FDA and does it invoke 21CFR 50?
- The FDA defines a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
- A test article is defined as any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354- 360F of the Public Health Services Act.
- To know more about 21CFR50
- A comparison of the HHS and FDA regulations is available here
- KSU IRBs will not review FDA regulated studies at this time.
- Practicum and Internship Guidance
Practicums and internships are required by many academic programs and offer students an excellent opportunity to gain firsthand experience in their field of study.
The majority of practicums and internships do not involve human subjects research. However, practicums and internships that include systematic investigations that are designed to develop or contribute to generalizable knowledge may require IRB review.
Common internship and practicum activities and scenarios are listed below along with guidelines for IRB review. In all circumstances, students are to adhere to the principles of the Belmont report and abide by relevant professional ethics.
The faculty person overseeing the practicum or internship is responsible for obtaining an IRB determination/review from the host site or KSU as necessary.
If a student is to obtain or access medical or educational records for projects that are not under the oversight of the KSU IRB, the faculty person overseeing the project is responsible for ensuring the proper approvals are in place
An experience that falls within the business activities of the hosting agency and data is collected, but research (as defined in the federal regulations) is not the intent.
Student conducts a unique project that involves data collection in order to inform business processes, measures quality initiatives, or similar and the results will not develop or contribute to generalizable knowledge.
An experience where no data of any kind is collected.
Serving as an engaged* investigator on a KSU IRB approved project.
Yes – appendix A must be filed.
Serving as a research associate on a human subjects research project approved by a non-KSU IRB.
An IRB reliance agreement if required by the external institute.
No- if not required by the external institute.**
Independent research project that meets the federal definition of human subjects research regardless of performance site.
Yes – if reviewed by a non-KSU IRB please contact the Office of Research Compliance.
*engaged means interacting with human subjects and/or obtaining or viewing identifiable data
**a written determination from the external PI/IRB should be maintained in the faculty files
- Retroactive IRB approval
There are no provisions in the federal regulations that allow the IRB to approve research that has already been conducted.
- Does the IRB have a stance on scholarly and journalistic activities?
Generally, scholarly and journalistic activities do not fall within the scope of the IRB.
For more details on guidance from OHRP