Research Involving Human Subjects

Shortcuts Human Subject Research Requiring IRB Review CIRB Jurisdiction FDA Regulated Research VA Regulated Research CIRB Reviewer Checklists   Campus Institutional Review Board 483 McReynolds University of Missouri Columbia, MO 65211 573 882-9585 phone 573 884-0663 fax umcresearchcirb@missouri.edu

All activities meeting the federal definition of "human subject research" require IRB review. If an investigator has a question about whether an activity is research involving human participants subject to IRB review, they should contact the Campus IRB for a determination. The Campus IRB will take the following approach to make the determination:

Activities Requiring IRB Review (PDF, 96K)

The MU Office of Research governs the Human Research Protection Program ("HRPP") and authorizes the Campus IRB to prospectively review and make the determination of whether an activity is exempt or subject to IRB Review. Federal regulations and accrediting organizations do not permit the investigator to make this determination. Please contact the Campus IRB if you have questions as to whether proposed activities are subject to IRB review.

• A Message from MU Chancellor Brady Deaton on the Importance of Protection of Human and Animal Subjects in Research (Word, 112K)

Human Subject Research Requiring IRB Review

The Campus IRB must prospectively review and approve any activity that either (1) meets the definition of "research" and involves "human subjects" as defined by DHHS, OR (2) meets the FDA definition of "research" and involves "human subjects."

• Campus IRB Authority 2876.3 (PDF, 80K)

The investigator should contact the Campus IRB to make the determination of whether the proposed activity is "Research" involving "human subjects" as defined by DHHS or the FDA and requires IRB review. CIRB Contact Information

DHHS Definitions: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102

1. "Research" as defined by DHHS regulations means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]
2. "Human Subject" as defined by DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]
3. "Intervention" as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. [45 CFR 46.102(f)]
4. "Interaction" as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
5. "Private information" as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
   
   NOTE: Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to be considered information to constitute research involving human subjects. This may include identifiable private information obtained from a primary subject about a third party.
6. "Identifiable information" as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

FDA Definitions: 21 CFR §50

1. "Research" as defined by FDA regulations means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
2. "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act" means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
3. "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act" means any activity that evaluates the safety or effectiveness of a medical device. [21 CFR 812.2(a)]
4. "Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3(c), 21 CFR 56.102(c)]"
5. "Human Subject" as defined by FDA regulations means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]

CIRB Jurisdiction

Proper Forum

The Campus IRB has the authority to monitor compliance of all human subject research on the MU campus in the areas of Behavioral & Social Sciences, exclusive of activities involving animals, biomedical, FDA or VA conducted research. All investigators proposing to conduct research involving humans must submit an application to the appropriate IRB that governs the proposed activities. If the research team has questions about where to submit the proposal, they should contact the Campus IRB (573-882-9585) for further directives.

• Campus IRB Authority Policy (PDF, 80K)

The Campus IRB is the proper forum to review ALL human subject research conducted under the jurisdiction of the University of Missouri-Columbia campus EXCEPT for those studies involving participants under the jurisdiction of the Health Sciences IRB (Item #1 below) or the use of Animals (Item #2 below).

Choosing the Right IRB

• Choosing the Right IRB

1. Applications requiring submission to the Health Sciences Institutional Review Board:
   1. The Principal Investigator is employed at any of the following:
      • Children's Hospital
      • Ellis Fischel Cancer Center
      • Howard A. Rusk Rehabilitation Center
      • Missouri Rehabilitation Center
      • University Hospital and Clinics
      • Columbia Regional Hospital
      • School of Medicine
      • School of Health Professions
      • Charles and Josie Smith Sinclair School of Nursing
      • School of Veterinary Medicine
      • Harry S. Truman Memorial Veterans Hospital
      • Missouri Institute of Mental Health
   2. The subject population includes patients (either inpatients or outpatients) in any of the institutions listed above;
   3. The research involves physical stress to the subjects (e.g., exercise physiology projects);
   4. The research involves any collection of human blood, tissue, or bodily fluids;
   5. The research falls under the regulation of a Veteran's Administration entity
   6. The research falls under the regulation of the Food and Drug Administration (FDA).
   7. The research involves a delivered fetus, the delivery process, placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, or hospitalized neonates.
      
      NOTE: Other areas that may be under the jurisdiction of the Health Sciences IRB includes, but is not limited to, The University Physicians, Green Meadows Clinic, Public Health Clinics, any clinic or healthcare organization with the primary focus of medical treatment. Please contact the Campus IRB if you have questions. Contact Information
2. Applications requiring submission to The Office of Animal Care Quality Assurance:
   1. Any research activities involving the use of animals.

All other human subject research applications must be submitted to the Campus IRB.

The Campus and Health Sciences IRBs use different forms and have different procedures. Investigators need to use the forms and follow the procedures of the IRB to which they are applying for approval. Any exception to the above rules concerning which IRB to use must be approved by both the Campus and Health Sciences IRB Compliance Officers.

No exceptions will be made to the appropriate forums listed above without prior consent from both IRB Compliance Officers. The primary objective of both IRBs is to expedite the review process and avoid delays based on inappropriate forums. As needed, the Compliance Officers of the HSIRB and Campus IRB will consult on a case-by-case basis on the appropriate forum for those research protocols that might be better reviewed in a different venue. The Compliance Officers will dispose of any questions regarding forums before an Investigator has committed time and resources to the IRB application and supporting review documentation.

FDA Regulated Research

Research falling under the following categories meets the FDA definition of human subject research, and will be transferred to the Health Sciences IRB:

1. The activity involves the use of a drug other than the use of a marketed drug in the course of medical practice.
2. The activity involves the use of a medical device other than the use of a marketed device in the course of medical practice.
3. The results of the activity are submitted to the FDA or held for inspection by the FDA.
4. The tissue specimens are being used to test the effectiveness of a medical device and the information is submitted to the FDA for approval of the device.
5. The activity involves one or more of the following: FDA regulated articles: food or drug dietary supplement that bears a nutrient content or a health claim, a food or color additive for human consumption, infant formula, biological or electronic product for human use, or other article subject to the FD&C Act.
6. Individuals are directed by a research protocol rather than by medical practice, when they are or become participants in research (either as recipients of an FDA regulated product (approved or experimental) or as controls).
   OR
7. Individuals participate in an investigation either as subjects or as controls where an investigational device is used on them or on their specimens.

VA Regulated Research

Research falling under the following categories may be subject to VA regulations and will be transferred to the Health Sciences IRB:

1. The researcher or key personnel are employed or associated with the VAMC or VA entity.
2. The research will be conducted at the VAMC or VA entity.
3. The researcher's or key personnel's responsibilities in the proposed activities involve collaboration with the VAMC or VA entity.  (i.e. Business Associate's Agreement; Data Use Agreement; etc.)
4. The researcher intends to recruit human subjects or access data under the jurisdiction or auspices of the VAMC or VA entity.
5. The researcher intends to recruit human subjects or access data from the VAMC or VA entity.
6. The research activities fall under the jurisdiction of any Veteran's Administration regulated entity, organization or agency.

CIRB Reviewer Checklists

Determining Proper Forum

The Campus IRB will review the proposal in accordance with the reviewer's checklists to make the determination of whether the proposed activities are subject to IRB review, and in the proper forum:

1. Determining When an Activity is Human Subject Research (PDF, 48K)
2. Determining When Human Subject Research Activities are FDA Regulated (PDF, 48K)
3. Determining When Human Subject Research Activities are VA Regulated (PDF, 32K)

Campus IRB application forms are tailored to its research population

The Campus IRB uses forms tailored to the Behavioral and Social Sciences research community. Each IRB forum has different procedures unique to its research community. Investigators must submit an application to the proper forum governing the proposed research activities and comply with the submission requirements and procedures from which they are seeking approval. If research activities will involve collaboration between the Campus and Health Sciences research communities, the Campus IRB and Health Sciences Compliance Officers will make a determination as to the proper forum that will review the proposal.

The Campus IRB Compliance Officer shall direct the coordination of the IRB review process. Any transfer of a campus based Behavioral and Social Science research proposal must be approved by the Campus IRB Compliance Officer prior to being transferred to the Health Sciences IRB. A campus based Behavioral and Social Science research proposal may not be transferred to the Health Sciences IRB for convenience. The proposal must meet the minimum criteria for transfer to the Health Sciences IRB and coordinated through the Campus and Health Sciences Compliance Officers.

• Campus IRB Authority Policy (PDF, 80K)