Human Subjects Research

Goshen College’s IRB has been approved by the Office for Human Research Protections (OHRP). Federal Wide Assurance: FWA00030542

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) Timeline

Depending on the level of risk to participants, the IRB chair may determine that a proposal requires full or expedited approval. Expedited proposals will receive approval on a rolling basis, with an initial response within two weeks. Revision time may vary depending on the proposal. If the IRB has received proposals that require full approval, we will meet within one month to consider the proposal.

IRB Procedures

The Goshen College IRB operates according to the following 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 five online training lessons provided by the Office of Human Research Protection (OHRP). After completing each lesson, save a copy of the completion certificate for submission in Step 3 below. You should end up with a total of five certificates to submit.

Step 2)

Review the proposal template document below to determine how to classify your research (“exempt” or “non-exempt”), and to create your proposal. Fill out all sections of the document.

IRB Application Template

Step 3)

Send all materials via email to Justin Heinzekehr at justinbh@goshen.edu, including:

your certificates of completion from the four OHRP lessons
your completed proposal – making sure to include:
- signed cover page (can scan or use electronic signature)
- proposed survey instruments or interview questions
- proposed recruiting materials
- proposed consent forms
any other necessary documents for your proposal such as:
- research site approval for off-campus projects
- other permissions from organizations you are working with
- permissions from other IRBs if you are doing work at another institution with an IRB

Step 4)

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:

IRB members are:

Justin Heinzekehr, Director of Institutional Research and Assessment (chair)
Ann Vendrely, Vice President of Academic Affairs and Academic Dean
Jeanette Harder, Professor of Social Work
Doug Schirch, Professor of Chemistry
Rebecca Hernandez, U.S. Organizational Development and Racial Equity Director, Mennonite Central Committee