Frequently Asked Questions
Listed below are some of the questions that are frequently asked of our office. If you have a question that is not answered here, please feel free to use the electronic comment sheet, call or visit the HSPO.
- How do you define "Research" and "Human Participant"?
- Does the IRB need to look at this project?
- What type of Review is Required?
- What is the schedule for submissions to the IRB?
- Are there fees for regulatory compliance review?
- How do I close my study?
- Who is required to complete the human participants training?
How do you define "Research" and "Human Participant"?
Human research is defined under DHHS regulations as any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge; under FDA regulations as any experiment that involves a test article and one or more human subjects and is or is not subject to certain FDA requirements.
A human participant under DHHS regulations means an individual about whom an investigator who is conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information; under FDA regulations means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control and includes a human on whose specimen an investigational device is used.
Does the IRB need to look at this project?
The institution relies on the IRB to make this assessment due to the complexity of the rules, which necessitates that investigators at least communicate initially with the IRB. Call the Human Subjects Protection Office (HSPO) at 717-531-5687 to consult with an IRB Compliance Specialist. Several decision charts are available to help you prepare for the questions that will need to be addressed to make the determination.
- Human Subject Protections Decision Charts, OHRP
- When Should a QI/QA Project be presented to the IRB?
- Decision Tree for Review of Protected Health Information
What type of IRB review is required?
What is the schedule for submissions to the IRB?
Incoming submissions to the IRB are addressed in the order received. New research submissions undergo pre-review for completeness and, once ready for IRB review, are assigned to a reviewer or the next available meeting agenda, as applicable . Other submissions are reviewed in the order received, unless the submission involves an urgent issue that may affect participant safety. See the link above for the IRB schedule of meeting dates.
Are there fees for regulatory compliance review?
A regulatory compliance fee is accessed to support the activities of the Human Subjects Protection Office, the Office of Research Affairs, and the Clinical Trials Office. The fee is based on the type of IRB Review required (e.g. convened committee 'full board' review, expedited, exempt determination, continuing review, amendment, etc.). For more information contact Michele Stanton in the Clinical Trials Office at 717-531-3779.
How do I close my study?
For full board and expedited studies, complete a Progress Report Form at the time you wish to close your study.** For exempt studies, submit a letter explaining that study activities have been completed and a statement that the investigator has closed the protocol.
**Please note: You must continue providing progress reports for continuation review on your research until ALL data analysis is completed. A continuing review of a study in the data analysis phase will receive expedited review.
Who is required to complete the tutorial on human subjects protection?
In order to participate in the conduct of research, all investigators and key research personnel* involved with human participant research must complete the basic course and meet the continuing education requirements every 3 years. See Educational Resources for complete details.