Human Subjects Research

At Goshen College all research involving human subjects should be approved by the Institutional Review Board or “IRB.”  At the links below, you will find relevant documents for proposals to the IRB.

Institutional Review Board (IRB) Schedule 2013-2014

IRB will meet on the following Wednesdays.  Please have all materials submitted for review by close of business (5:00pm Eastern Time) the Friday before.
Wednesday, Sept. 18th, 2013
Wednesday, Nov. 20th, 2013
Wednesday, Jan. 29th, 2014
Wednesday, Mar. 12th, 2014
We will review all the pending submissions in our files each time we meet and will contact you with our decision by the Friday following our meeting.

IRB Procedures

Faculty, staff and student researchers at Goshen College should use the steps below to determine what kinds of procedures they will need to follow if they plan to do any research involving human subjects.

The Basics

In order to determine whether your work is “research” that involves “human subjects” according to Federal policies and the “Common Rule” (Federal policies of the Dept. of Health and Human Services), use the questions below…

a)  Is it “research”?

For your project to be classified as research, you must be able to answer “yes” to BOTH of these questions:

– Is it a systematic investigation using pre-determined methods, testing and evaluation?

– Is it designed and intended to develop or contribute to generalizable knowledge?

b) Does it involve “human subjects”?

Your project DOES involve research on human subjects and requires approval if ANY of the following specifications are true:

– your project involves a living individual from whom you acquire information (data) through interaction or by intervention in normal daily activities (including gathering specimens from an individual).

– your project involves a living individual about whom you acquire identifiable private information.

– your project involves an individual who is either healthy or is a medical patient participating in research through receiving an investigational drug, participating in a control group, or on whom (or on whose specimen) an investigational device is used.

If your project involves research (as defined in “A” above) and human subjects (as defined in “B” above), then your activities ARE subject to the Common Rule and the IRB must approve the project.

If you are a student in a class that has a research assignment, first review this pdf to see if you need to do anything further:

GC Student Research Checklist

If you are not a student or if after you review the checklist above you determine you need to apply for approval, please follow the process below.

Steps for applying for approval to do research:

Step 1)

Complete the online training modules, scoring 80% or better on ALL modules, at the Cooperative Institutional Training Initiative (CITI) web site at: https://www.citiprogram.org

Step 2)

Review the “Checklist” documents below to determine how to classify your research (“exempt” or “non-exempt”):

Exempt Research Checklist (complete this form entirely if you determine your project is “exempt”)

Non-Exempt Research Checklist (“Expedited” and “Full Board Review”) (complete this form and then use the proposal guidelines in the “GC Application for Research Approval” if you determine your project is “non-exempt”)

Step 3)

Both Exempt and Non-Exempt applications should fill out and sign the form below:

GC Application for Research Approval

Templates for Forms Participants need to fill out.

Informed Consent Form Template

Assent Form Template – necessary for work with minor children

Study Information Sheet Template – this sheet is intended to ensure participants in a research project have all the relevant information before they participate in research activities.  Use this with a paper and pencil survey, as the “first page” of an online survey, or as a sheet you hand to possible recruits who are “signing up” to participate.

Step 4)

Deliver the following documents to Ross Peterson-Veatch, Associate Vice President for Academic Affairs in Administration Building, Suite 13 either through campus mail or in person.

  • proof of completion of the CITI Modules
  • the signature pages of all your application materials

All other materials send via email to Ross Peterson-Veatch, at rosspv@goshen.edu, including:

  • exempt or non-exempt research checklist (whichever applies to your project)
  • study descriptions
  • proposed survey instruments or interview questions
  • proposed recruiting materials
  • proposed consent forms

Step 5)

Wait for approval before recruiting any subjects or gathering any data.

If you have any questions about this process or about approvals at Goshen College, please contact:

Ross Peterson-Veatch,
Associate Vice President for Academic Affairs
1700 S. Main St.
Goshen, IN 46526
ph. (574) 535-7504
fax (574) 535-7660
email: rosspv@goshen.edu