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
Note on Adding or Removing Personnel in an Amendment: When adding or removing personnel with an Amendment, you will need to either add or delete their name under question 4 in the Investigator Project and Information Section of the study. If the person being added is intended to be a Co-Investigator this will grant them access to submit future Amendments to the study.
How To: Cayuse IRB Quick Start tip sheets; The Cayuse help center is also useful:
To access the info in the links below you will need to Sign up for Cayuse Support; Sign up is FREE and can be done when clicking any of the links below.
- Creating a New Study
- Creating an Initial Submission
- Completing a Submission
- Viewing and Downloading Letters
- Addressing Comments
- Viewing Submission Details and History
- Linking a Study to Cayuse SP
- Understanding Submission Types
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 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
Are you a student investigator or new faculty?
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 firstname.lastname@example.org with this info:
FULL NAME, an isu.edu email, your BENGALWEB username, your phone # (cell is ok), ACADEMIC MAJOR and Campus Location (i.e. Pocatello, Merdian, etc.)
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., Suite 107 STOP 8286
Dr. Ralph Baergen, Committee Chair
Liberal Arts Room 247, STOP 8056
Federal Wide Assurance IRB Number
Expires July, 17, 2024
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 2022 Meeting and
Protocol Submission Schedule
|August 12th||August 19th|
|August 26th||September 2nd|
|September 9th||September 16th|
|September 23rd||September 30th|
|October 7th||October 14th|
|October 21st||October 28th|
|November 4th||November 11th|
|December 2nd||December 9th|
Protocols are due via Cayuse IRB by close of business day of each submission deadline to be considered during the next meeting.
Committee Members List
Ralph Baergen, PhD, Philosophy, Chair
Cathy Arvidson, PhD, ISU School of Nursing/HCE, Regular member
Cynthia Blanton, PhD, Health & Nutrition Sciences, Regular member
Sue Pearson, PWCC, Corrections Representative
Jeff Doerr, Community Member
Fred Hyde, MD, Alternate Community Member
Steve Lawyer, PhD, Psychology, Regular member
Cara Liday, PhD, Pharmacy, Regular member
Janette Olsen, PhD, Health Education, Alternate member
Kate Reedy, PhD, Anthropology, Regular member
Robert Rieske, PhD, Psychology, Alternate member
Cindy Seiger, PhD, Physical & Occupational Therapy, Regular member
Bill Woodhouse, MD, Family Medicine, Regular member
Chad Yates, PhD, Counseling, Regular member
Samantha Blatt, PhD, Anthropology, Alternate member
Chris Owens, PhD, Pharmacy, Alternate 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.
- Sample Parental Consent
- Sample Youth Assent
- Sample Child Assent
- Consent Form Checklist
- Sample Key Information Cover Sheet
HSC - Adverse Event Reporting Form (can also be done in Cayuse under amendments)
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: $1500 for initial review; $500 for renewal
Updated June 26, 2018