Institutional Review Board

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The methods and procedures that will be used for all projects involving human subjects must be reviewed by the IRB prior to any data being collected. After approval of the project, data may be collected for one year. Procedures should not be modified after a project has been approved. If changes are necessary, an amendment must be filed with the IRB.


DOES MY PROJECT REQUIRE IRB REVIEW?

1. Are you collecting information from living people?
       Yes = continue to question 2
       No = IRB review not required

2. Is your project a systematic investigation designed to develop or contribute to generalizable knowledge?
       Yes = See flow chart and contact IRB for guidance
       No = IRB review not required

Exemptions will be determined by the IRB chairperson and one IRB member. Researchers may not determine whether or not their own research is exempt. Decisions will be made based on the exemption categories described by The Office for Human Research Protections (45 CFR 46).
Expedited review will be conducted by the IRB chairperson and one IRB member. Categories of research that meet the following criteria are eligible for expedited review:
  • Research appearing on the OHRP Expedited Review List and found by the reviewer(s) to involve no more than minimal risk (as defined in 45 CFR 46),
  • Minor changes in previously approved research during the authorized approval period,
  • Requests for extensions of previously approved research during the authorized approval period.
Full reviews will be conducted by all members of the IRB. Research that the IRB believes meets one or more of the following criteria will require full review:
  • Research that poses more than minimal risk
  • Research that involves protected populations
  • Research that involves deception, such as providing misleading or untruthful information to participants
  • Projects that involve procedures that are intrusive or potentially traumatic
  • Projects that include collection of sensitive information

DEADLINES FOR SUBMITTING APPLICATIONS

Exempt and expedited applications will be accepted on a rolling deadline.

Applicants should allow a minimum of 1 week for review. Exceptions: applications received in May, June, July, and August may take a minimum of 3 weeks to review.

Full-review applications will be accepted on a rolling deadline.

Applicants should allow a minimum of 3 weeks for review. Please contact the IRB chair at irb@defiance.edu for information on full reviews in May, June, July, and August.

INSTRUCTIONS FOR SUBMISSION

  1. Complete required training on research ethics (certificates will be accepted for 5 years)
  2. Complete the proposal for research involving human subjects (see preview)
  3. Submit all materials (see checklist) with your application to the IRB. Any materials that cannot be uploaded with your proposal should be emailed to irb@defiance.edu.
CHECKLIST
  • Proposal for research with human subjects
  • All measures/surveys
  • Consent documents
  • Recruitment documents (if applicable)
  • Assent documents (if applicable)
  • Current training certificates for ALL investigators

LETTER OF SUPPORT FOR CONDUCTING RESEARCH OFF-SITE

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.


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:

  • Name of the Defiance College liaison who will be responsible for monitoring compliance with Defiance College IRB procedures.
  • A copy of their IRB proposal and approval letter from their IRB.

CONSENT FORMS

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.

  • 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
  • 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.

ASSENT

When a legally-authorized representative gives consent (e.g., the guardian of a child), the researcher should also seek assent from the subject.

  • 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.


CONTACT

If you have any questions, please email irb@defiance.edu.

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 CRF 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.