Institutional Review Board

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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.

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.
SEE BELOW IN IRB Resources

Institutional Review Board Resources

Institutional Review Board Materials

APA Ethics Guidelines

Please note: These guidelines do not discuss the additional safeguards for special populations such as minors and people who are institutionalized. If you intend to work with these types of individuals, please check the NIH regulations for those populations.

8.01 Institutional Approval
When institutional approval is required, psychologists provide accurate information about their research proposals and obtain approval prior to conducting the research. They conduct the research in accordance with the approved research protocol.

8.02 Informed Consent to Research
(a) When obtaining informed consent as required in Standard 3.10, Informed Consent, psychologists inform participants about (1) the purpose of the research, expected duration and procedures; (2) their right to decline to participate and to withdraw from the research once participation has begun; (3) the foreseeable consequences of declining or withdrawing; (4) reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort or adverse effects; (5) any prospective research benefits; (6) limits of confidentiality; (7) incentives for participation; and (8) whom to contact for questions about the research and research participants’ rights. They provide opportunity for the prospective participants to ask questions and receive answers (see also Standards 8.03, Informed Consent for Recording Voices and Images in Research; 8.05, Dispensing with Informed Consent for Research; and 8.07, Deception in Research).

(b) Psychologists conducting intervention research involving the use of experimental treatments clarify to participants at the outset of the research (1) the experimental nature of the treatment; (2) the services that will or will not be available to the control group(s) if appropriate; (3) the means by which assignment to treatment and control groups will be made; (4) available treatment alternatives if an individual does not wish to participate in the research or wishes to withdraw once a study has begun; and (5) compensation for or monetary costs of participating including, if appropriate, whether reimbursement from the participant or a third-party payor will be sought (see also Standard 8.02a, Informed Consent to Research).

8.03 Informed Consent for Recording Voices and Images in Research
Psychologists obtain informed consent from research participants prior to recording their voices or images for data collection unless (1) the research consists solely of naturalistic observations in public places, and it is not anticipated that the recording will be used in a manner that could cause personal identification or harm, or (2) the research design includes deception, and consent for the use of the recording is obtained during debriefing (see also Standard 8.07, Deception in Research).

8.04 Client/Patient, Student, and Subordinate Research Participants
(a) When psychologists conduct research with clients/patients, students or subordinates as participants, psychologists take steps to protect the prospective participants from adverse consequences of declining or withdrawing from participation.

(b) When research participation is a course requirement or an opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.

8.05 Dispensing with Informed Consent for Research
Psychologists may dispense with informed consent only (1) where research would not reasonably be assumed to create distress or harm and involves (a) the study of normal educational practices, curricula, or classroom management methods conducted in educational settings; (b) only anonymous questionnaires, naturalistic observations or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability or reputation, and confidentiality is protected; or (c) the study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants’ employability, and confidentiality is protected or (2) where otherwise permitted by law or federal or institutional regulations.

8.06 Offering Inducements for Research Participation
(a) Psychologists make reasonable efforts to avoid offering excessive or inappropriate financial or other inducements for research participation when such inducements are likely to coerce participation.

(b) When offering professional services as an inducement for research participation, psychologists clarify the nature of the services, as well as the risks, obligations and limitations (see also Standard 6.05, Barter with Clients/Patients).

8.07 Deception in Research
(a) Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study’s significant prospective scientific, educational or applied value and that effective nondeceptive alternative procedures are not feasible.

(b) Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress.

(c) Psychologists explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data (see also Standard 8.08, Debriefing).

8.08 Debriefing
(a) Psychologists provide a prompt opportunity for participants to obtain appropriate information about the nature, results, and conclusions of the research, and they take reasonable steps to correct any misconceptions that participants may have of which the psychologists are aware.

(b) If scientific or humane values justify delaying or withholding this information, psychologists take reasonable measures to reduce the risk of harm.

(c) When psychologists become aware that research procedures have harmed a participant, they take reasonable steps to minimize the harm.

8.09 Humane Care and Use of Animals in Research
(a) Psychologists acquire, care for, use, and dispose of animals in compliance with current federal, state and local laws and regulations, and with professional standards.

(b) Psychologists trained in research methods and experienced in the care of laboratory animals supervise all procedures involving animals and are responsible for ensuring appropriate consideration of their comfort, health and humane treatment.

(c) Psychologists ensure that all individuals under their supervision who are using animals have received instruction in research methods and in the care, maintenance and handling of the species being used, to the extent appropriate to their role (see also Standard 2.05, Delegation of Work to Others).

(d) Psychologists make reasonable efforts to minimize the discomfort, infection, illness and pain of animal subjects.

(e) Psychologists use a procedure subjecting animals to pain, stress or privation only when an alternative procedure is unavailable and the goal is justified by its prospective scientific, educational or applied value.

(f) Psychologists perform surgical procedures under appropriate anesthesia and follow techniques to avoid infection and minimize pain during and after surgery.

(g) When it is appropriate that an animal’s life be terminated, psychologists proceed rapidly, with an effort to minimize pain and in accordance with accepted procedures.

8.10 Reporting Research Results
(a) Psychologists do not fabricate data (see also Standard 5.01a, Avoidance of False or Deceptive Statements).

(b) If psychologists discover significant errors in their published data, they take reasonable steps to correct such errors in a correction, retraction, erratum or other appropriate publication means.

8.11 Plagiarism
Psychologists do not present portions of another’s work or data as their own, even if the other work or data source is cited occasionally.

8.12 Publication Credit
(a) Psychologists take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have substantially contributed (see also Standard 8.12b, Publication Credit).

(b) Principal authorship and other publication credits accurately reflect the relative scientific or professional contributions of the individuals involved, regardless of their relative status. Mere possession of an institutional position, such as department chair, does not justify authorship credit. Minor contributions to the research or to the writing for publications are acknowledged appropriately, such as in footnotes or in an introductory statement.

(c) Except under exceptional circumstances, a student is listed as principal author on any multiple-authored article that is substantially based on the student’s doctoral dissertation. Faculty advisors discuss publication credit with students as early as feasible and throughout the research and publication process as appropriate (see also Standard 8.12b, Publication Credit).

8.13 Duplicate Publication of Data
Psychologists do not publish, as original data, data that have been previously published. This does not preclude republishing data when they are accompanied by proper acknowledgment.

8.14 Sharing Research Data for Verification
(a) After research results are published, psychologists do not withhold the data on which their conclusions are based from other competent professionals who seek to verify the substantive claims through reanalysis and who intend to use such data only for that purpose, provided that the confidentiality of the participants can be protected and unless legal rights concerning proprietary data preclude their release. This does not preclude psychologists from requiring that such individuals or groups be responsible for costs associated with the provision of such information.

(b) Psychologists who request data from other psychologists to verify the substantive claims through reanalysis may use shared data only for the declared purpose. Requesting psychologists obtain prior written agreement for all other uses of the data.

8.15 Reviewers
Psychologists who review material submitted for presentation, publication, grant or research proposal review respect the confidentiality of and the proprietary rights in such information of those who submitted it.

Reference: Ethical Principles of Psychologists and Code of Conduct

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
- How to merge multiple PDF’s
- How to merge multiple word documents

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:

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)