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Human Subjects Committee (HSC)

The Human Subjects Committee (HSC), also designated as the Institutional Review Board (IRB), is the body responsible for reviewing and monitoring studies involving Human participants.

What is Required for Humans Subjects Project Approval?

 

 

Sponsors like NIH, DHHS and PHS apply strict rules on both Investigators and ISU.  Federal law requires ISU and Investigators to do two things to ensure the legitimate, ethical handling of the people who are our human subjects -

  1. Have Protocols reviewed and approved by the HSC
  2. Complete Training specific to Human Subjects

Not every project that collects information from or about people is Human Subjects Research. Under federal regulations, research is a systematic investigation designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)), meaning knowledge intended to apply beyond the people and setting studied. Quality improvement (QI), program evaluation, and evidence-based practice projects use existing evidence to improve a specific program, clinic, course, or service, for local use.

Presenting or publishing a project, calling it QI, or using surveys, data, and statistics does not decide the question. Purpose and design do.

How to request a determination:

  1. Watch the short video "Research or Quality Improvement" (less than 15 minutes) Recommended for first-time requesters.
  2. Complete the HSC Project Determination Request. Download it and fill it out in Adobe Acrobat Reader or Preview. Student projects need the faculty advisor's signature. (To see what a completed request looks like, view this example of a completed form for a quality improvement project.)
  3. Email the complete form to humsubj@isu.edu. Tom Bailey, HSC Coordinator, reviews each request and will follow up if anything needs clarification.
  4. Receive your determination via email:
  • Not human subjects research: you will receive a Not Human Subjects Research (NHSR) determination letter. Keep it for your records; sites, conferences, and journals often ask for it.
  • Human subjects research: complete CITI training and submit a protocol in Cayuse (see below).
  • Consultation needed : the HSC Coordinator or Chair will contact you to talk through your project.

Already know your project is research?

Skip the form. Complete CITI training and submit your protocol directly through Cayuse.

Before you begin

Do not start your project until you have an NHSR determination letter or HSC approval. An NHSR determination is no IRB approval; it confirms that HSC review is not required.

Presenting or publishing a QI project?

Suggested wording: "This project was received by the Idaho State University Human Subjects Committee (IRB) and determined not to be human subjects research."

Questions?

Contact Tom Bailey, HSC Coordinator, at 208-282-2179 or humsubj@isu.edu

Learn more

OHRP Human Subject Regulations Decision Charts (2018 Requirements)

OHRP Quality Improvement Activities FAQs

 

 

  • Complete Human Subjects CITI Training
  • Who? Each Investigator, all co-investigators & students on their research team
  • When? Prior to submitting a protocol for HSC review

One or more of these CITI Training modules for HSC protocols based on the research being proposed:

(Note: A proposal cannot be fully approved until all personnel on it have completed the necessary CITI modules)

  • Social & Behavioral Research - 17 modules @ approx. 8 - 16 hrs. to complete
    • For most investigators in Social and Behavioral or Humanities disciplines (note: the RCR training does not satisfy HSC requirements)
  • Minimal Risk Research, a.k.a. Class Projects - 3 modules @ approx. 1.5 - 3 hrs. to complete
    • Investigators conducting no more than minimal risk research
  • Biomedical - 17 modules @ approx. 8-16 hrs. to complete
    • For most investigators in biomedical/health or other non-Social and Behavioral disciplines
  • Data & Lab Specimens - 10 modules @ approx. 4 - 6 hrs. to complete
    • Investigators conducting research with pre-existing data and/or lab specimens 

Cayuse IRB is the online system used for submitting Human Subjects studies.

    • Access to Cayuse is NOT AUTOMATIC. Send the following information to humsubj@isu.edu with the Subject Line "Cayuse IRB Access Request"
      • Full Name
      • MyISU Username (Please DO NOT send your User ID #)
      • Phone # (Cell # is ok)
      • Academic Major/Department
      • Campus Location (i.e. Pocatello, Meridian, etc.)

You will receive a reply on your email once the account request is submitted - Allow 24 hours for the Cayuse system to update before trying to log in.

The IRB offers these consent templates:

If you have any trouble accessing these links, please contact Tom Bailey (humsubj@isu.edu; 208-282-2179).

FWA 00014037 

Expires August 25, 2029

Assigned to ISU by the Division of Policy and Assurances/Office for Human Research Protections/ U.S. Dept. of Health and Human Services

Note: Protocols are due by the close of the business day of the deadline to be considered for the next meeting.

Submission Deadline Meeting Date
Aug. 21 Aug. 28
Sept. 4 Sept. 11
Sept. 18 Sept. 25
Oct. 2 Oct. 9
Oct. 16 Oct. 23
Oct. 30 Nov. 6
Nov. 13 Nov. 20
Nov. 27 Dec. 4
Dec. 11 Dec. 18

Member Department Committee Position
Chris Owens, PharmD, MPH Pharmacy Chair
Melody Weaver, PhD Nursing Regular Member
Cynthia Blanton, PhD Nutrition & Dietetics Regular Member
Kristen Hulet PWCC Corrections Rep.
Jeff Doerr Non-Affiliated Community Rep.
Janette Olsen, PhD Health Education Regular Member
Kate Reedy, PhD Anthropology Regular Member
Bill Woodhouse, MD Family Medicine Regular Member
Chad Yates, PhD Counseling Regular Member
John Holmes, PharmD Pharmacy Regular Member
Shawn Edrington Art Regular Member
Andy Silva, PhD Psychology Regular Member
Hana Meshesha, PhD Counseling Alternate Member

Proposals being sponsored by outside industry can be reviewed by the ISU HSC with the following fees:

  • $1500 for initial review
  • $500 for renewal.

HSC - IRB Fees for private industry-funded projects

HSC Contacts

Tom Bailey, Committee Coordinator
V: 208-282-2179; Email: humsubj@isu.edu

Chris Owens PharmD, MPH, Committee Chair
V: 208-282-2762; Email: owenchri@isu.edu

Concerns?

Report anonymously through Maxient (formerly Convercent)