Human Subjects in Research
Notes: With concerns of the spread of COVID -19, the IRB has mandated that researchers proposing new research projects must do the following before approval will be granted:
- Revise the study to eliminate face-to-face contact, or
- Wait until the epidemic recedes to the point that face-to-face parts of the study can be conducted without violating the social distancing and other recommendations presented by the CDC.
"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; 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 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 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 2020 Meeting and
Protocol Submission Schedule
|August 14th||August 21st|
|August 28th||September 4th|
|September 11th||September 18th|
|September 25th||October 2nd|
|October 9th||October 16th|
|October 23rd||October 30th|
|November 6th||November 13th|
|December 4th||December 11th|
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
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
Robert Rieske, PhD, Psychology, Alternate member
Cindy Sieger, PhD, Physical & Occupational Therapy, Regular member
Bill Woodhouse, MD, Family Medicine, Regular member
Chad Yates, PhD, Counseling, 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 (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
Updated June 26, 2018