Is it Research? If yes, what then?
This slide presentation offers the researcher essential background information on federal definitions of research and the activities mandated by federal regulation regarding the protection of the human subjects of research.

Who is subject to the purview of the IRB Review Committee?
All research that is conducted by or under the direction of any employee or agent of Oakwood University (faculty, staff, or student) or in connection with his or her institutional responsibilities is under the purview of this committee. This includes all research, regardless of source of funding or the location of the participating human subjects.

1. Faculty, staff, and student initiated research is under the purview of this committee. This includes, but is not limited to, data gathering projects and class assignments involving human subjects. The IRB must review proposals if students are conducting research as part of a class assignment, or as part of the requirement for a degree, and the research involves human subjects, records gathered on human subjects, or human tissue
2. Sole exception: Research conducted in the classroom involving only students enrolled in that course and carried out only for instructional purposes in that course may be undertaken with the understanding that the instructor assumes responsibility for its ethical nature and for the protection of the rights and welfare of students involved.
3. Research initiated or sponsored by OU faculty/staff/students, that is neither funded by nor based at OU, should be submitted to the OU IRB for approval. This assurance is required even if the research has received approval from a human subjects committee at another institution (See Collaborative Agreements this website).

Applying for IRB Approval

1. What kind of research studies require IRB approval?
   Any research studies utilizing human subjects require IRB Approval. The definition of a human subject is a living individual about whom an investigator conducting research obtains data and/or identifiable private information through intervention or interaction with the individual.
2. How do I apply for IRB approval?
   See “Steps for Applying” under Institutional Review Board on this site.
3. When can I expect a decision about my IRB application?
   The length of IRB review depends on the nature of the study. The IRB will generally issue a decision about an application within 4 weeks of receiving the application and all required supporting documents. If an application qualifies for expedited review, this may be shortened to 7-14 days.
4. How will I be notified when my IRB application is approved?
   The IRB Office will issue an approval notification by email and/or mail when the decision is made.
5. How long is my approval good for?
   Most IRB approvals expire one year from the date of approval (exceptions may occur). However, some research may be considered EXEMPT from continuing IRB review and will not be required to submit a scheduled continuation review (renewal) application on an annual basis. See IRB policies for further information.

Consent Forms, Advertisements, Survey Instruments and Other Supporting Documents

1. I’ve heard there is a requirement for stamping consent forms and advertisements with approval dates and IRB Numbers. How do I do this?
   Submit separate clean copies of these documents for official IRB stamp, which will occur at the time of approval by the IRB.
2. Is it necessary to have a consent form for a survey?
   Yes. Full written informed consent is required unless the IRB approves a waiver of consent or a waiver of documentation. Please see the “Forms” section.
3. What if I only have a draft of my instrument (e.g., survey, questionnaire)?
   Indicate this when prompted in the application, and copy your instrument as a “DRAFT” document in order to provide the IRB with an idea of your intended methodology. After you have finalized the instrument, submit an amended application.

Amendments to IRB Approved Research Studies

1. What kinds of changes to my research study necessitate the submission of an amendment application?
   ANY change(s) to an approved research study require submission of an amended application.
   This includes:
   • Alteration of study design, methodology, or recruitment methods
   • Changes to any instruments, including surveys and questionnaires
   • Changes to consent documents
   • Addition/Deletion of principal investigators or key personnel
   • Alteration of Project Title
   • Addition/Deletion of research performance sites
2. How do I report a change to an IRB approved research study?
   Submit amended application. Remember you must modify the consent form if the proposed changes affect the informed consent process. The IRB will review the changes and you will be notified by email. IMPORTANT: You must wait to receive IRB approval before implementing any proposed amendments.

Scheduled Continuing Review/Renewal of IRB Approval

1. How often must I renew my IRB approval?
   Federal regulations require that the Institutional Review Board conduct a continuing review of human subject research at least once per year. The continuation of subject recruitment, data collection, or data analysis without IRB approval is prohibited after the expiration date assigned to the project by the IRB. You will be notified by the IRB when your approval is about to expire and it is time to complete your Scheduled Continuing Review.
2. How do I apply for a Scheduled Continuing Review of my approval?
   Submit a Scheduled Continuing Review (SCR) application. The IRB will review your application and you will be notified by email.
3. I received an expiration notice from the IRB Office, but I don’t intend to seek an extension of my approval (funding expired, data collection and analysis is complete, etc.). What should I do?
   Submit a Final Report form (see Forms).
4. Do I need to complete a Scheduled Continuing Review (SCR) of my IRB approval if my funding has ended?
   If you are still collecting and/or analyzing data, you must submit a Scheduled Continuing Review (SCR) form (see Forms). If the funding has ended, data analysis is complete, and the only activity is preparing submissions for publication, you do not need to complete an

Termination of IRB Approval

1. Can I continue to work on my research study if I have received a Final Termination Notice indicating that my approval has expired?
   No. After the approval period for your study has expired, you may no longer continue to work on the study, including collection and analysis of data. The IRB Office issues 3 expiration notices to the PI before automatically terminating the IRB approval of a research study. If you have received a final termination notice, and you plan to continue working on your study, contact the IRB Office to discuss your situation.
2. I want to terminate my IRB Approval (funding was lost, my study never received funding, data collection and analysis is complete, etc.)?
   Submit a Termination Application to IRB (See Forms).
3. I received an expiration notice from the IRB Office indicating my approval will soon expire. What should I do if I don’t intend to renew my approval?
   Submit a Termination Application to IRB (See Forms).

Adverse Events
How do I report an adverse event?
How to answer stipulations from the IRB.
Provide a written response to each of the committee’s stipulations along with the original signature of the PI on the cover letter.

If changes to the consent documents are required, include revised consent/assent forms with changes highlighted. Include a copy of any documents requested by the committee and highlight any changes made in response to stipulations.

STEPS FOR REQUESTING OAKWOOD UNIVERSITY INSTITUTIONAL REVIEW BOARD APPROVAL FOR DOING RESEARCH ON HUMAN SUBJECTS MUST BE COMPLETED FOR ALL RESEARCH INVOLVING HUMAN SUBJECTS, REGARDLESS OF THE MAGNITUDE OF INVOLVEMENT OR LEVEL OF RISK. IRB APPROVAL MUST BE OBTAINED PRIOR TO STARTING SUCH A PROJECT.

Step One:
The Principal Investigator of the proposed research project and other key investigators (determined by Principal Investigator) must complete an online training module.

Contact Research Office for this Training

Step Two:
Fill out the current appropriate application form posted under the IRB Forms Section of IRB website. An educational guide is also posted providing explanations for key items within the application.

Step Three:
Wait at least two weeks for the IRB Review Committee to notify the Principal Investigator if the submitted proposal (i) was approved, (ii) requires further explanation, or (iii) needs augments to the current protocol as per federal regulations and OU IRB policies.

 

Required Training
All IRB Committee Members, Investigators, and Key Research Personnel are required to complete the on-line course presented by the National Institute of Health (NIH) Office of Extramural Research “Protecting Human Research Participants” every five years.

Keep in mind, all investigators and key personnel submitting new research protocols (even if protocols are exempt from continuing review and only require approval of the chairperson of the appropriate department or an OU IRB member) are required to complete the course and submit a certificate of completion (dated no earlier than 5 years from the date the protocol was submitted).

Contact Office of Research for training information.

In addition, the OU IRB requires all IRB Committee Members, Investigators, and Key Research Personnel to review the “Belmont Report”, the Department of Health and Human Services Ethical Principles, Guidelines for the Protection of Human Subjects of Research, Revised Common Rule and Guidance

If the principal investigator has not completed the education requirement, research protocols will not be accepted and will be returned to the investigator.

If there are co-investigators or key research personnel who have not completed the education requirement, the new research protocol will be accepted; however, final approval of the protocol may be withheld until the requirements have been met.

Other Training
Understanding Privacy and Confidentiality

Informed consent is one of the primary ethical requirements underlying all research with human subjects; its purpose addresses the basic principle of respect for persons (Belmont Report). Informed consent ensures that subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. Informed consent must be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117 or 21 CFR 50.27.

The outline provided below incorporates those basic components in the referenced federal regulations

Informed Consent Outline
The proposed consent/assent/permission form or statement must include or address the following elements:

1. Title of study, identification of investigator(s), and (if applicable) sponsor(s) of the research.
2. a) A statement of research, b) purposes of the research, c) expected duration of the subject’s participation, d) procedures to be followed, e) identification of any experimental procedures
3. A description of any reasonably foreseeable risks or discomforts and benefits to the subjects or to others, which may reasonably be expected from the research
4. A description of the process for maintaining confidentiality of records identifying subjects
5. A statement that addresses that a) participation is voluntary, b) refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and c) that the subject may discontinue participation at any time, without penalty or loss of benefits to which the subject is otherwise entitled
6. Those procedures used for orderly termination of participation by the subject and explanation of any compensation for participation
7. Other areas as deemed appropriate

Student research or information gathering activities: It is understood that students may engage in research projects or information gathering activities as partial fulfillment for classroom requirements, therefore it is considered appropriate for instructors to submit one letter to the IRB chair that covers several exempt research projects that involve human subjects and are conducted by students in a course. Please note that this pertains only to student research projects that:

1. meet the criteria for exempt research,
2. do not involve sensitive topics such as drug habits or sexual behaviors, and
3. are conducted under the close supervision of the instructor, who will review the project descriptions and consent procedures and ensure that students complete the OU IRB-required training on the protection of human subjects in research (see OU IRB-Required Education for Principal Investigators and Key Research Personnel).

Student projects that do not meet all three criteria listed above will need to be submitted individually for review by the department chair or the OU IRB.

Protocol submission dates and meeting schedule for IRB are as follows:

FOR FULL BOARD REVIEWS:

Protocol Submission Date: Complete protocol must be submitted to the attention of the IRB Chair by 2^nd Tuesday of the month in Fall and Spring.

IRB Meeting Schedule: IRB meets 4^th Thursday of the month except during Holidays.

Meetings are In–person and via Zoom. (Times vary).

EXPEDITED AND EXEMPT REVIEWS:

Protocol Submission Date: Two weeks before desired response.

PLEASE NOTE:

The IRB will make every effort to inform when a response can be expected if submitted within two weeks of major holidays and near end of semester. Incomplete and /or missing information will delay approval.

 QUESTIONS: Contact Office of Research 256 726 8279.

The Education Guide is located under the corresponding IRB Application.  The IRB encourages the use of the guides as they provide a great deal of information related to specific questions in each application.

Other forms and addenda are also included here.

Click on the name of the document to download. Documents are in WORD or PDF format.

OU IRB APPLICATIONS AND GUIDES
Application. Behavioral & Social Science Research
Educational Guide. Behavioral & Social Science Research
Exempt from Review Form

ADDENDA
D – Children
I – Data Banking
M – Waiver of Signed Consent

FORMS (CONSENT AND REVIEW FORMS)
Faculty Sample Letter for Student Projects
Adult Consent Form Template
Parental Consent Form – Guidelines For Development
Handout. Rights Of Research Subjects
Adverse Events Form
Assent Form
Continuing Review and Termination Form
Final Report
Change of Protocol

University Documents
IRB Policies
Conducting IRB Review
Exempt Research Review
Expedient Review
Full Board Protocol Review
Vulnerable Populations
Privacy and Confidentiality
Collaborative Agreement
Web-based Surveys
References

Other Links
The Belmont Report
The Common Rule, Title 45 Code of Federal Regulations (CFR), Part 46