Institutional Review Board
IRB Quick Links
Defiance College's Institutional Review Board (IRB) is charged with upholding research ethics according to federal guidelines, state and local guidelines, and university policies. It does so through the management of research conducted by campus personnel that involve human subjects, including applications and protocol updates.
Researchers, including faculty and students, will find the following information on this page:
- Does my work need IRB oversight?
- Review types (Exempt, Expedited, or Full Reviews)
- DC IRB review process
- Guidance on consent/assent forms
- Guidance for external researchers
- DC IRB contact information
- Additional information and links
Does my work need IRB oversight?
Any activity that meets the definition of research that involves human subjects. This includes direct contact with human subjects, obtaining medical material from human subjects, accessing private or identifiable information about humans. If you are not sure if your research meets these definitions, please visit the Department of Health and Human Services.
Review Types
EXEMPT REVIEW
"Exempt" review may be granted to research that fits one of the approved categories
as defined by federal regulation 45 CFR 46.
EXPEDITED REVIEW
"Expedited" review may be granted to research that poses "minimal risk" and fits one
of the federally designated expedited review categories (OHRP Expedited Review List).
The DC IRB also considers Expedited review when researchers make minor changes in
previously approved research during the authorized approval period.
FULL REVIEW
"Full" review applies to any research that:
- poses more than minimal risk
- involves protected populations
- involves deception, such as providing misleading or untruthful information to participants
- involves procedures that are intrusive or potentially traumatic
- included collection of sensitive information
DC IRB Review Process
Before submitting a research application, all members of the research team (including the Principal Researcher and any student researchers) must complete research ethics training and complete Lesson 1 (When HHS regulations apply) and Lesson 2 (What is Human Subjects Research). Additionally, all researchers should review the Research Ethics Guidelines (PDF). Psychology researchers should review the American Psychological Association Ethics Guidelines.
As of Summer 2023, the IRB submission process has changed. All IRB proposals must be submitted by the principal investigator on Moodle under the IRB Proposal Defiance College IRB Proposal Submission Page.
- Examine the types of reviews (exempt, expedited, or full) and select and download the document that is most appropriate for your research
- Complete the appropriate IRB research form and submit under the appropriate term (i.e., Spring 2024)
- If you have more than one submission per semester, use the successive submission files (i.e., first proposal is submitted to “research proposal submission” and your second proposal is submitted to “research proposal submission 2”)
- You should merge all documents, including training certificates for all investigators (including the principal investigator), into one PDF file
The IRB committee will review the application and offer updates and suggestions if needed. If the application reaches the standard of human subjects research and follows ethical research guidelines according to Exempt, Expedited, or Full review, the IRB committee will then approve the application. Exempt, Expedited, and Full review applications are accepted on a rolling basis.
How to Apply
- Complete required training on research ethics (Lessons 1 & 2 Only)
- Complete application for humans subject research (Exempt review, Expedited review, Full review)
- Submit all necessary materials (listed below) with your application to the IRB Moodle page in one PDF file. Any materials that cannot be uploaded with your proposal should
be emailed to irb@defiance.edu.
Materials checklist:
- Application for research with human subjects (Expedited, Exempt, or Full review)
- Current research ethics training certificates for ALL investigators
- Consent documents
- Assent documents (if applicable)
- Recruitment documents (if applicable)
- All measures/surveys (if applicable)
- Letter of support for conducting research offsite (only if research will take place
off of DC campus)
REVIEW SCHEDULE
Exempt and Expedited Review Schedule
Expect approximately four weeks for review during the academic year. Expect applications
to take approximately three weeks to review if received during summer months: May,
June, July, and August.
Full Review Schedule
Expect approximately six weeks for review during the academic year. Please contact
the IRB chair at irb@defiance.edu for information on full reviews in May, June, July, and August.
Guidance on Consent/Assent Forms
CONSENT
Informed consent must be obtained for all human subjects involved in research. Consent
should be obtained from the participant or a legally authorized representative under
circumstances that minimize the possibility of coercion. All information provided
to the subjects must be in language that is understandable to the participant or legally
authorized representative. Under no circumstances should the consent include language
that the subject representative is waiving his or her legal rights or releases the
investigator, institution, or agents from liability for negligence.
Per 45 CFR 46.116, the following information must be given to the subject when seeking informed consent:
- An explanation of the purposes of the research and the expected duration of the subject's participation
- A description of the procedures to be followed including identification of any procedures which are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
- For research involving more than minimal risk, an explanation as to whether any compensation
and an explanation as to whether any medical treatments are available if injury occurs
and, if so, what they consist of, or where further information may be obtained
When appropriate, one or more of the following should also be provided to the subject when seeking consent:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
- Any additional costs to the subject that may result from participation in the research;
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
- The approximate number of subjects involved in the study.
Sample Consent Forms:
- Subject Consent Style 1 (DOCX)
- Subject Consent Style 2 (DOC)
- Minor-Parental Consent (DOCX)
ASSENT
When a legally-authorized representative gives consent (e.g., the guardian of a child),
the researcher should also seek assent from the subject.
Assent should include:
- Any information that can affect an individual's decision to participate
- An explanation of the proposed research procedures (procedures that are not part of the individual's care should be described as optional)
- The research purpose
- Any discomforts or risks
- A statement indicating that participation is voluntary, refusal to participate at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled
- The language for the assent form should be appropriate for the level of participant.
Sample documents for assent:
- Minor Assent (DOCX)
Guidance for External Researchers
External researchers who wish to conduct research with Defiance College students as participants must be granted approval from the Defiance College IRB.
In order to consider the request, the IRB requires external researchers to submit the following a copy of their IRB proposal and approval letter from their IRB to irb@defiance.edu.
Contact DC IRB
If you have any questions, please email irb@defiance.edu.
Additional Information & Links
- SUSPENSION OR TERMINATION OF IRB APPROVAL OF RESEARCH: The Defiance College IRB reserves the right to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that is associated with unexpected serious harm to subjects (45 CFR 46.113). If approval is suspended or terminated, the researcher will receive written notice of the suspension or termination, reasons for the IRB's actions, and will be reported to the relevant institutional officials.
- OFF-SITE RESEARCH: If the research will be conducted at a site other than Defiance College, and the site is not involved in conducting the research, a letter of support is needed. The letter of support should state that Defiance College researchers have been given access to the site and must be signed by an official from the site. The letter must be submitted to the IRB with the researcher's proposal for research with human subjects and is required to be on file before work can begin at that site.
- Review Process Flow Chart (PDF)
