Skip Navigation
Oklahoma State University

Human Subjects Research (IRB) - Applying to the IRB

IRB Steps

Applying to the IRB

The OSU Office of University Research Compliance coordinates the IRB application and review processes. The OSU IRB application form is available electronically and can be downloaded by visiting the Forms section of the website. The URC staff is available at any time to assist you with completion of the application form and to answer any questions about the required supporting documents.

  • Step 1:
    • When is an Application to the IRB Required?
    • Research as a Class Requirement
  • Step 2: Determining the Level of Review
  • Step 3: Training and Education
  • Step 4: Completing the Application
  • Step 5: Application Submission
  • Step 6: Application Review Process
  • Step 7: Protocol Modification
  • Step 8: Protocol Continuation

 

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.

Definitions

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.

Parts 2 and 3 of the Adobe application will help step you through the decision making process as to whether or not your study qualifies as research involving human subjects. Please print the determination for your records.

Research as a Class Requirement

Activities involving human subjects conducted for instructional purposes as a requirement for an OSU graduate or 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
    • Depression/suicide
  • 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 IRB Office at 405.744.5700.

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:

Applicants who are not sure of which category to select should contact the IRB chair or IRB Coordinator.

Definitions

Exempt Status

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 University Research Compliance 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.

Expedited

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.
    1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
    2. 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:
    1. 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
    2. 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:
    1. where
      1. the research is permanently closed to the enrollment of new subjects;
      2. all subjects have completed all research-related interventions; and
      3. the research remains active only for long-term follow-up of subjects; or
    2. where no subjects have been enrolled and no additional risks have been identified; or

    3. 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.

Full Board

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.

Training and Education

Human Subjects Training

All investigators who plan to conduct studies involving human subjects must complete the required human subjects training modules via the CITI website.

Required Training

Training in human research protection is provided through an on-line web-based course provided through the Collaborative Institutional Training Initiative (CITI) hosted by the University of Miami. Each OSU trainee will be required to complete the basic course in human research protection and a refresher course three years later. Training must be updated every three years. To access the CITI training program click on the link below.

Minors On-Campus Training

Individuals, whether affiliated with OSU or not, who will be working with minors on university property and in facilities or under the authority and direction of the university at other locations, including branch campuses, must complete the Minors on Campus training yearly per OSU policy 1-0135. Please click here to view this policy. Affiliated personnel should follow these directions in order to complete the training:

  1. Log in to http://talent.okstate.edu using your O-key account credentials (Firefox or Google Chrome are the best browsers to use with the site)
  2. Click on the Learning widget in the middle of the landing page
  3. Type “minors” into the search bar at the top of the page
  4. The active Minors On Campus-Online Course should populate
  5. “Request” the training
  6. The training will load to your Active transcript page with a “Launch” option
  7. Click the Launch option to start the training
  8. The training will remain “In Progress” until you watch the entire presentation and the confirmation page loads.

Graduate students and non OSU personnel should visit http://www.ostate.tv/?play=1BDBBFB4-E1D6-33A0-F052-BBC760F5F6E7 to complete the training.

 

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.

The Graduate College will not accept an IRB approval for research conducted for a thesis or dissertation if the student’s name is not on the approval page. If persons are added or removed as principal investigators for the protocol after its initial approval, a modification form, requesting approval to add personnel, must be submitted. (See Protocol Modification Form)

The applicant should carefully and thoroughly answer all questions on the application form. Most applications that are returned for revisions have incomplete responses. Please pay attention to the tool tips embedded in the application, which can be viewed by holding your cursor over the field. Note, in order to complete the IRB application, the application must be opened in Adobe Acrobat. Third party viewers such as Google Chrome and Apple Preview are not supported. 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;
  • One, single sided copy of a completed, signed (PIs & Advisor) application form;
  • 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 - (4 page maximum for each)

 

Application Submission

Submit applications to irb@okstate.edu.

The schedule for submission of your application is dependent on the level of review.

Type of Review Submission
Exempt Status Any time
Expedited Any time
Full Board COB 10-12 days prior to meeting date*

* Note: Meeting dates and application deadline dates for full board applications are posted on the IRB website.

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.

 

 

Application Review Process

The OSU IRB Office, located in the Office of University Research Compliance (URC) coordinates the receipt and review of all IRB applications. The URC staff will pre-review the application to ensure that all of the necessary materials are provided for IRB review. If additional information is needed before review can begin, you will be contacted by phone or email. Once complete, the application is entered in the IRB database and assigned a unique number that is used to track it through the review process and beyond.

Protocol Continuation

Ensuring responsible conduct of research must be an on-going process. DHHS regulations at [45 CFR 46.109(e)] require the continuing review of human subjects research by the IRB at intervals appropriate to the degree of risk, but not less than one year.

The goals of this process are to re-evaluate the acceptability of the risk/benefit ratio and subject safeguards, and to confirm that the approved protocol has been followed.

Any research activity initially reviewed and approved by the OSU IRB is subject to continuing review.

Continuation Process

A first notice for continuation is sent to the principal investigator 60 days prior to the first of the month of the protocol expiration date. This notice requests either written confirmation from the PI that the protocol has been completed, or directs the PI to the IRB website to access the required continuation/renewal form.

A second notice will be sent 30 days prior to the first of the month of the protocol expiration date. It is important that the continuation/renewal form be received at least two weeks before the expiration date to allow for review and processing.

If the PI does not request closure or submit a continuation/renewal form prior to the expiration date of the protocol, the PI will be notified that IRB approval of the protocol has expired and that the protocol has been closed. If the protocol is closed, no human subject data collection may continue without submission and approval of a new application form.

Continuation Application

The required Continuation/Renewal form is available for download under the Forms link on this page. The form requests information in the following areas:

  • Status of research activity;
  • Subject enrollment numbers for the approval period and total;
  • Research purpose and progress to date;
  • Past and/or proposed modifications to the protocol;
  • Adverse events;
  • Subject withdrawals;

The Continuation/Renewal form should be accompanied by the current informed consent document, recruitment script, and any new materials or instruments to be added to the protocol .

Forms are to be submitted to the IRB office, 223 Scott Hall a minimum of two weeks prior to the expiration date of the protocol.

Protocol Continuation Review

The IRB Manager makes the determination if a continuing protocol requires more extensive review than by the Manager at the exempt and expedited levels of review. Full board continuations will again be reviewed by the full board. For continuing protocols requiring full board review, the PI will need to be aware of the IRB meeting dates and deadlines to assure that review will occur before the expiration date.

The IRB reserves the right to change the review level of a continuing protocol based on changes to the protocol or in regulations governing human subject research. Review of full board continuations is conducted in a similar manner to the initial review. All members of the IRB receive the complete protocol file, including any modifications, consent documents and testing instruments, and the completed continuation/renewal form. One member of the IRB is designated to lead discussion of the continuation application. Any member also has access to any relevant minutes or communications regarding the protocol.

The IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less frequently than once per year . When determining the interval for continuing review, the IRB will consider, among other issues, the vulnerability of the subjects and the risks of the protocol procedures. The standard approval period for most protocols is one year. However, the risks associated with certain protocols may necessitate that reviews take place more frequently than annually. In these cases, the IRB may request that the PI report to the IRB on a shorter time interval, or after a specific number of subjects is enrolled. This information will be communicated to the PI in the official approval letter.

Post-Approval Monitoring

All protocols are subject to post-approval review by the IRB. The criteria for protocol selection include:

  • characteristics of the subject population;
  • level of board discussion during the protocol approval process;
  • level of risk to the subject population; and
  • occurrence of any official adverse events.

The review will consist of, at minimum, visible confirmation that the following items are consistent with those approved by the IRB:

  • Total subjects enrolled verses total approved;
  • Recruitment procedures/script;
  • Informed consent form;
  • Confidentiality/security procedures.

The exact documents or procedures to be reviewed will depend upon the protocol.

Investigator Closure

A study may also be closed by the investigator via email when ALL of the following criteria are met:

  • All subject recruitment and enrollment is complete;
  • All subject specimens, records or data have been obtained;
  • No further contact with subjects is necessary;
  • Analysis of subject identifiable data, records or specimens are complete, and;
  • identifiers and any code lists have been destroyed.

Administrative Closure

The IRB Office will administratively close a protocol if a continuation has not been received by the IRB staff prior to the end date.  The investigators may not continue to recruit new subjects, and activity with previously enrolled subjects must cease.  A new application must be submitted in order to continue the study once it has been administratively closed.  It is the investigator’s responsibility to keep track of the end dates of their protocols.

Protocol Modification

Your research activities must be carried out as described in your approved IRB protocol. Any change to protocols approved under expedited or full board guidelines requires an official modification request to and approval by the IRB.

For changes to protocols approved under exempt guidelines contact the IRB staff by email or phone.

A request for modification of an approved expedited or full board protocol must be made in writing by completing the Approved Protocol Modification Request form available in the Forms section of the IRB website. One signed copy of the form and any revised materials are to be submitted to the IRB office in the Office of University Research Compliance, 223 Scott Hall. Signed modification requests can be submitted electronically to irb@okstate.edu. Changes to any of the following must be submitted as modifications:

  • Project Title
  • Principal Investigators
  • Advisor
  • Sponsor (Funding source)
  • Subject population
  • Estimated # of Subjects
  • Subject recruitment
  • Inclusion/Exclusion Criteria
  • Research Site
  • Research Procedures
  • Consent Form
  • Assent Form

If you are unsure if the change you need to make requires an official modification request, please contact the IRB office at 405.744.3377 or irb@okstate.edu. Modification of a protocol does not change the original approval expiration date.

Unanticipated Problems & Adverse Event Reporting

Federal regulations at 45 CFR46.103 (b)(5) require written procedures for the prompt reporting of any unanticipated problems or adverse events involving risks to subjects, serious noncompliance, or suspension or termination of IRB approval to the appropriate institutional officials and the sponsoring agency, if there is one.

Adverse events are those which cause unanticipated harm to subjects or others. Unanticipated problems involve risks that are not explained in the consent process. To insure compliance with the federal regulations, the OSU IRB requires investigators to report any such occurrence to the IRB Chair within 24 hours of the event. A form for reporting these events and problems is available in the Forms section of this website.

Protocol Continuation

Ensuring responsible conduct of research must be an on-going process. DHHS regulations at [45 CFR 46.109(e)] require the continuing review of human subjects research by the IRB at intervals appropriate to the degree of risk, but not less than one year.

The goals of this process are to re-evaluate the acceptability of the risk/benefit ratio and subject safeguards, and to confirm that the approved protocol has been followed.

Any research activity initially reviewed and approved by the OSU IRB is subject to continuing review.

Continuation Process

A first notice for continuation is sent to the principal investigator 60 days prior to the first of the month of the protocol expiration date. This notice requests either written confirmation from the PI that the protocol has been completed, or directs the PI to the IRB website to access the required continuation/renewal form.

A second notice will be sent 30 days prior to the first of the month of the protocol expiration date. It is important that the continuation/renewal form be received at least two weeks before the expiration date to allow for review and processing.

If the PI does not request closure or submit a continuation/renewal form prior to the expiration date of the protocol, the PI will be notified that IRB approval of the protocol has expired and that the protocol has been closed. If the protocol is closed, no human subject data collection may continue without submission and approval of a new application form.

Continuation Application

The required Continuation/Renewal form is available for download under the Forms link on this page. The form requests information in the following areas:

  • Status of research activity;
  • Subject enrollment numbers for the approval period and total;
  • Research purpose and progress to date;
  • Past and/or proposed modifications to the protocol;
  • Adverse events;
  • Subject withdrawals;

The Continuation/Renewal form should be accompanied by the current informed consent document, recruitment script, and any new materials or instruments to be added to the protocol .

Forms are to be submitted to the IRB office, 223 Scott Hall a minimum of two weeks prior to the expiration date of the protocol.

Protocol Continuation Review

The IRB Manager makes the determination if a continuing protocol requires more extensive review than by the Manager at the exempt and expedited levels of review. Full board continuations will again be reviewed by the full board. For continuing protocols requiring full board review, the PI will need to be aware of the IRB meeting dates and deadlines to assure that review will occur before the expiration date.

The IRB reserves the right to change the review level of a continuing protocol based on changes to the protocol or in regulations governing human subject research. Review of full board continuations is conducted in a similar manner to the initial review. All members of the IRB receive the complete protocol file, including any modifications, consent documents and testing instruments, and the completed continuation/renewal form. One member of the IRB is designated to lead discussion of the continuation application. Any member also has access to any relevant minutes or communications regarding the protocol.

The IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less frequently than once per year . When determining the interval for continuing review, the IRB will consider, among other issues, the vulnerability of the subjects and the risks of the protocol procedures. The standard approval period for most protocols is one year. However, the risks associated with certain protocols may necessitate that reviews take place more frequently than annually. In these cases, the IRB may request that the PI report to the IRB on a shorter time interval, or after a specific number of subjects is enrolled. This information will be communicated to the PI in the official approval letter.

Post-Approval Monitoring

All protocols are subject to post-approval review by the IRB. The criteria for protocol selection include:

  • characteristics of the subject population;
  • level of board discussion during the protocol approval process;
  • level of risk to the subject population; and
  • occurrence of any official adverse events.

The review will consist of, at minimum, visible confirmation that the following items are consistent with those approved by the IRB:

  • Total subjects enrolled verses total approved;
  • Recruitment procedures/script;
  • Informed consent form;
  • Confidentiality/security procedures.

The exact documents or procedures to be reviewed will depend upon the protocol.

Investigator Closure

A study may also be closed by the investigator via email when ALL of the following criteria are met:

  • All subject recruitment and enrollment is complete;
  • All subject specimens, records or data have been obtained;
  • No further contact with subjects is necessary;
  • Analysis of subject identifiable data, records or specimens are complete, and;
  • identifiers and any code lists have been destroyed.

Administrative Closure

The IRB Office will administratively close a protocol if a continuation has not been received by the IRB staff prior to the end date.  The investigators may not continue to recruit new subjects, and activity with previously enrolled subjects must cease.  A new application must be submitted in order to continue the study once it has been administratively closed.  It is the investigator’s responsibility to keep track of the end dates of their protocols.