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

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?
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 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

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 humsub@isu.edu 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
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 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)

Meeting Date

Jan 6th

Jan 13th

Jan 20th

Jan 27th

Feb 3rd

Feb 10th

Feb 17th

Feb 24th

Mar 3rd

Mar 10th

Mar 17th

Mar 24th

Mar 31st

Apr 7th

Apr 14th

Apr 21st

Apr 28th

May 5th

May 12th

May 19th

 

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:

Deb Easterly
Assistant Vice President for Research Outreach & Compliance
Phone: (208) 282-2618
Email: eastdebb@isu.edu
 
Serving as ISU's
Research Integrity Officer
Export Control Officer   
Email: orexpctr@isu.edu
 
Physical Address:
Business and Technology Center
1651 Alvin Ricken Drive, Room 107
Pocatello, ID 83201
Directions

Mailing Address:
921 S. 8th Ave., Stop 8046
Pocatello, ID 83209-8046

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