University Committee on Human Subjects (UCHS)

1. University Committee on Human Subjects (UCHS) • Our contract with the Federal government is our “Federalwide Assurance” (FWA), and our FWA number is FWA00004513. • ORIA is proposing the renaming of UCHS to the “Institutional Review Board for Human Participants,” or IRB for short.

2. Researcher Education/Training • Human participant research training is required of ALL investigators (faculty, students, staff) AND their research staff, as well as instructors assigning human participant research projects to students in their classes. • Our current online training program will be changing in the not-too-distant future. Matthew Aldridge, our new Education Coordinator, will be developing this new training, which will consist of various modules. (Not all investigators will need to complete all modules.)

3. Applying to UCHS • Because we are off-campus and campus mail to and from 35 Thornwood Drive is sometimes slow, deadlines for the receipt of protocols are important to note • Expedited protocols must arrive at least TWO weeks before research can begin (including recruitment of subjects) – and it could be longer if there are problems with the protocol • Expedited renewals are also due TWO weeks before the termination date (reminders are sent to investigators 4-6 weeks in advance of termination) • Full review protocols are due THREE weeks before our monthly meeting to allow time for exchange between reviewers and investigators BEFORE the meeting

4. Student researchers Undergraduate and graduate students are supposed to have a faculty supervisor read through and approve their protocols before submitting to UCHS. Unfortunately, we are receiving poorly written materials that have not been reviewed by a faculty member—just signed on the last page. This can result in unnecessary delays for student researchers, and headaches for our reviewers. Please urge your faculty to take a more active role in the supervision of their students’ human subjects research protocols. This will cut down considerably on delays to the start of their research projects!

5. What does UCHS review? • All “research involving human participants” conducted by faculty, students, and staff (whether sponsored research or not) • Along with the obvious types of research, this includes simple surveys and the use of secondary data containing personal information. • Classes in which research involving human participants is an assignment

6. Human subject means 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. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge—i.e., is meant to end up in a publication (journal, brochure, thesis) or presentation.

7. Which review for a protocol? Use the decision charts* from the Office for Human Research Protections (OHRP) as a reference to determine if the project: • Involves “human subjects” • Is considered “research” • Is exempt** from all but initial review by UCHS, or • Will require a full or expedited review *http://www.hhs.gov/ohrp/humansubjects/guidance/ decisioncharts.htm **Investigators may not self-exempt on human subjects research—they must file an application with UCHS.

8. Questions? • If you have questions on specific procedures we follow at Cornell, please contact Sarah Demo at UCHS@cornell.edu or at 5-5138. • If you have general questions about research guidelines, please contact Matthew Adlridge, Education Coordinator, at ma354@cornell.edu or 5-6182. • Our web site is being updated and we will have more information and links to help you, your faculty, and your students.