Applying to the IRB
The OSU CHS Office of Research coordinates the IRB application and review processes.
If you have questions about the application process please contact the IRB office at email@example.com for assistance.
- Step 1: When is an application to the IRB required?/ Research as a class requirement
When is an Application to the IRB Required?
It is the policy of Oklahoma State University that all research involving human subjects conducted by faculty, students or staff of OSU, shall be submitted to the OSU Institutional Review Board for review before it is initiated. This is true regardless of the location where the research is conducted.
To determine if your project requires IRB review you will need to assess first if it meets the definition of research, and then if human subjects are truly involved.
For some categories of research it is difficult to determine whether or not they qualify as human subject research. A flow chart to assist with this decision is available at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1
Research as a Class Requirement
Activities involving human subjects conducted for instructional purposes as a requirement for an OSU undergraduate class usually do not fall with in the definition of research and would not require IRB review.
However, exceptions do occur and if any of the following criteria are met, the project must be reviewed by the IRB:
- The results will be generalizable
- The project will be conducted with a special population (children, prisoners, decisionally impaired)
- The project will be conducted in a prison, nursing home, hospital or school
- The project includes collection of sensitive information such as:
- Sexual attitudes, preferences or practices
- Alcohol or drug use or other illegal conduct
- The project includes audio or videotaping
- Participants will be directly identifiable
The IRB encourages all faculty who plan to include research with human subjects in their curriculum to contact the IRB office in order to verify review guidelines and ensure efficient review, if necessary. Any questions regarding the need for review can be directed to the Research Office at 918-561-1400.
- Step 2: Determining the Level of Review
Determining the Level of Review
Research involving human subjects will be reviewed at one of three levels depending upon the IRB's evaluation of the potential risk and benefits to the human subjects and the federal guidelines that define the review process. These are:
- Full Board
Applicants who are not sure of which category to select should contact the Office of Research.
Federal regulations allow some human subject research to be exempted from review by the full IRB (45 CFR 46.101 (b)). However, OSU does not authorize investigators to make this determination. Researchers must submit an IRB application for review to the Office of Research to determine exempt status.
Approval of research as exempt does not absolve the investigator(s) from ensuring that the welfare of the subjects is protected and that methods used to gain subjects' informed and voluntary consent are appropriate.
To be considered for approval for exempt status, the research must meet the requirements of one or more of six categories listed in the federal regulations (45 CFR 46.101 (b)). A flow chart to assist with determining if a research project qualifies for exempt review is available at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c2.
An expedited review process is available for research activities that present no more than minimal risk to human subjects, or that request a minor change in previously approved research that involves no additional risk and that involve only procedures listed below in one or more of the following categories.
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Furthermore, the expedited review procedure may not be used for classified research involving human subjects.
Note: These activities should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review process when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis ).
Note: Some research in this category may qualify for exempt status. This category refers only to research that does not qualify.
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Note: Some research in this category may qualify for exempt status. This listing refers only to research that does not qualify.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
- Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Prospective collection of biological specimens for research purposes by noninvasive means .
Collection of data through noninvasive procedures.
Continuing review of research previously approved by the convened IRB as follows:
- the research is permanently closed to the enrollment of new subjects;
- all subjects have completed all research-related interventions; and
- the research remains active only for long-term follow-up of subjects; or
where no subjects have been enrolled and no additional risks have been identified; or
where the remaining research activities are limited to data analysis
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption, where categories 1-3 and 5-8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no more than minimal risk and not additional risks have been identified.
Any protocol which uses a methodology which is sensitive and of higher probability for causing harm or distress to subjects is subject to full board review.
Additionally, any protocol using prisoners as subjects or involving pregnant women, fetuses and human in vitro fertilization will be reviewed by the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be reviewed by the full board.
- Step 3: Training and Education
Human Subjects In Research Training
This is an online course for all university personnel involved in human subject research research. All personnel must complete prescribed mandatory training prior to protocol approval and prior to working with humans.
Who is required to take this training?
Key Study Personnel (KSP) include the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants' identifiable private information during the course of the research.
All KSP associated with your project must complete the prescribed CHS Collaborative Institutional Training Initiative (CITI) education on the protection of human subject research before the IRB can grant final approval for submissions. Training requirements may vary, based on the specific study activities. Approved training expires every 3 years.
Training is available online through CITI Program.
Prior CITI Training
If you have completed the CHS CITI training modules within the last 3 years, this information will be verified by our office upon each IRB submissions.
If you or your KSP completed the CITI certification with another institution and/or organization within the last 3 years, you can affiliate your certification with CHS by following the online instructions on the CITI website. Coursework completion certificate and course modules will be reviewed for reciprocity. If the coursework is comparable, CHS will accept their training.
Name Title Contact Amber Hood, MS, CPIA, CIP Director, Regulatory Compliance and Research Facilities firstname.lastname@example.org
Elisa Jolls, EdD Assistant Director, Human Research Protection Program email@example.com
- Step 4: Completing the Application
Completing the Application
Applications submitted to the IRB require an OSU faculty or staff member as Principal Investigator (PI). Students may also act as principal investigators, but must have a faculty or staff advisor.
Applications are to be submitted via the online system, IRBManager. The applicant should carefully and thoroughly answer all questions on the application form. Most applications that are returned for revisions have incomplete responses. If the research is externally funded, materials submitted must include the funding proposal. The OSU IRB requires documentation of approval from appropriate authorities for research conducted at any location outside of OSU. This should be submitted with the application, prior to approval, and any time a location is added as a modification.
A complete application to the IRB includes the following:
- Completion of required IRB training;
- Documentation of approval from authorities if research is conducted outside OSU;
- Informed consent/assent forms;
- Recruitment materials, script, flyers, letters;
- All instruments (questionnaires, surveys, tests);
- Grant proposal (if for funded research);
- Bio, resume or vitae for all PI (student or faculty) and advisor
IRB Manager Tools
- Step 5: IRB Application Review Deadlines
The schedule for submission of your application is dependent on the level of review.
Level of Review Deadline for Submission Exempt/ Expedited No Deadline Full Board COB 12-14 days prior to meeting date*
Please be sure that you have allowed ample time for review, keeping in mind that the IRB committee members all have other full-time positions.
Most exempt status and expedited reviews can be accomplished in 7 to 10 days. Special population and full board reviews will take longer.