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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 -

  1. Have Protocols reviewed and approved
  2. 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

Resources

The Human Subjects Committee (HSC) – a mix of ISU faculty & private citizens with relevant expertise working under a designated chair.   

HSC reviews

  • 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
  • Definitions
  • 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.

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 humsubj@isu.edu .

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 humsubj@isu.edu 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
V: 208-282-2179
Email: humsubj@isu.edu

Dr. Ralph Baergen, Committee Chair
Liberal Arts Room 247, STOP 8056
V: 208-282-3371
Email: baerralp@isu.edu

 

Federal Wide Assurance IRB Number

FWA 00014037 

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
Submission
Deadline
Meeting
Date
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.

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