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Oklahoma State University

Human Subjects Research (IRB) - Application Process

Application Process

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.