Human Subjects in Research
Using human subjects covers a wide range of projects –
from simple & informal opinion polls to highly controlled sleep studies.
Investigators should plan & train prior to using human subjects in research
Federal law requires ISU & Investigators to do two things to ensure the legitimate, ethical handling of the people who are our human subjects. Sponsors like NIH, DHHS and PHS also apply strict rules on both Investigators and ISU.
Two Aspects to Human Subjects Project Approval
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
This is true
- 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.
Human Subjects Manual & Guide - 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?
ISUPP 7050. General Policy for Use of Human Research Subjects
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 for your submission of 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 submission system, contact Tom Bailey, HSC Coordinator at 282-2179 or email@example.com .
Paper Protocol forms are not a valid option (since February 2015) – ISU website searches may still turn up old forms.
Related HSC Details
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.”
Are you a student investigator? You must ask to be added to Cayuse to be able to use Cayuse-IRB.
Access is not automatic. Email firstname.lastname@example.org with this info: your full name, an isu.edu email, your phone # (cell is ok) and academic major.
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
Federal Wide Assurance IRB Number
Expires December 18, 2017
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 Meeting Schedule
Due Date for Submissions (by 3pm)
In summer will
|meet as needed|
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, PWCC, 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
Michael Meyers, PhD, Education, Regular 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
Payments to Participants/Research with Human Subjects
per ISUPP 7080, policy of the same name.
This process covers only single payments of money, products, or services ($100 or more in value), that you provide to a participant as an incentive to participate.
HSC Payments Guide covers these processes from your protocol through how to access the funds through Financial Services.
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
Research Outreach & Compliance (ROC)
Contact Our Office:
Export Control Officer
1651 Alvin Ricken Drive, Room 107
Pocatello, ID 83201
921 S. 8th Ave., Stop 8046
Pocatello, ID 83209-8046