Human Subjects in Research
"Using human subjects" covers a wide range of project types –- from gathering simple and informal opinion polls to performing highly controlled sleep studies -- Investigators should plan & train prior to using human subjects in research.
Complete Two Steps for Human 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 -
- Have Protocols reviewed and approved
- Complete Training specific to Human Subjects
One - Prior Planning & Human Subjects Committee Approval Required
- Complete protocols detailing your project plan
- Submit your protocol for review to the Human Subjects Committee (HSC)
- Wait to start until HSC approves your protocol
These steps apply
- whether you intend to publish results,
- regardless of your funding,
- whether the research is part of a course or degree requirement,
- regardless of project location.
Two - Training specific to Human Subjects Required
- 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
The Human Subjects Committee (HSC) – a mix of ISU faculty & private citizens with relevant expertise working under a designated chair.
- protocols 8 times each year between the end of August and mid-December.
- only those protocols submitted by the deadline - 5 business days prior to meeting dates.
HSC Role - Responsible for the oversight of all projects involving the use of people as research subjects. At ISU, the “Institutional Review Board” (IRB) is the Human Subjects Committee.
explains everything you need to know about working with Human Subjects at ISU, in detail.
- Protocol preparation
- Exempt Research
Effective February 1, 2017 - the Human Subjects Manual & Guide is no longer a source for forms. Use Cayuse IRB to prepare protocols, and for sample consent forms.
Which Policy Applies?
General Policy for Use of Human Research Subjects ISUPP 7050
The Online Human Subjects Protocol Tool
In Cayuse - The online system used for grant proposals has a module called:
Cayuse – IRB (Human Studies Compliance) is Human Subjects-specific
Cayuse – IRB is the tool
- Required to submit a protocol
- Where you assemble/enter your protocol information
How To: Cayuse IRB Quick Start tip sheets
After trying Cayuse IRB, if you have questions about protocol information requirements or the online system, contact Tom Bailey, HSC Coordinator at 282-2179 or firstname.lastname@example.org .
Paper Protocol forms are not a valid option (since February 2015) – ISU website searches may still turn up old forms.
Related HSC Details
Are you a student investigator?
You must ask to be added to Cayuse to be able to use Cayuse-IRB.
Access is not automatic.
The ONLY way to request access is to SEND AN EMAIL TO email@example.com with this info:
FULL NAME, an isu.edu email, your phone # (cell is ok) and ACADEMIC MAJOR.
Use the subject line "Cayuse IRB Access Request".
You 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.
Do Not Send BENGAL ID #s.
Human Subjects Committee/IRB Contacts:
Tom Bailey, Committee Coordinator
Business and Technology Center, Bldg 86
Off campus at 1651 Alvin Ricken Dr., Rm 107 STOP 8046
Dr. Ralph Baergen, Committee Chair
Liberal Arts Room 247, STOP 8056
Human Subject means
“a living individual about whom an investigator (whether professional or student) conducting research obtains either
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.”
Federal Wide Assurance IRB Number
Expires October 5, 2020
Assigned to ISU by
the Division of Policy and Assurances/Office for Human Research Protections/ U.S. Dept of Health and Human Services]
Human Subjects Committee
Fall 2018 Meeting and
Protocol Submission Schedule
|August 17th||August 24th|
|August 31st||September 7th|
|September 14th||September 21st|
|September 28th||October 5th|
|October 12th||October 19th|
|October 26th||November 2nd|
|November 9th||November 16th|
|November 23rd||November 30th|
|December 7th||December 14th|
Protocols are due to firstname.lastname@example.org by
close of business day of each deadline.
Committee Members List
Cathy Arvidson, PhD, ISU School of Nursing/HCE, Regular member
Ralph Baergen, PhD, Philosophy, Chair
Cynthia Blanton, PhD, Health & Nutrition Sciences, Regular member
Ross Castleton, St. Anthony Corrections, Alternate member
Jeff Doerr, Community Member
Fred Hyde, MD, Alternate Community Member
Tara Johnson, PhD, Dental Hygiene, Regular member
Steve Lawyer, PhD, Psychology, Regular member
Cara Liday, PhD, Pharmacy, Regular member
Julie McLaughlin, Prison Contact, Other Alternate member
Janette Olsen, PhD, Health Education, Alternate member
Kate Reedy, PhD, Anthropology, Regular member
Cindy Sieger, PhD, Physical & Occupational Therapy, Regular member
Bill Woodhouse, MD, Family Medicine, Regular member
Consent Forms for Human Subjects
The actual forms are part of the Cayuse-IRB tool.
These are templates for your reference. See the Human Subjects Manual & Guide for instructions.
HSC - Adverse Event Reporting Form (still only on paper)
Use this form to report to HSC in the event of incidents of injury or other adverse effects by human subjects
HSC - IRB Fees for private industry-funded projects proposals review
updated June 26, 2018
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Research Outreach & Compliance (ROC)
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1651 Alvin Ricken Drive, Room 107
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