Procedure

Procedures For The Review of Research Involving Human Subjects

  1. Getting Answers to Questions about Projects Involving Human Subjects
    • For assistance in submitting projects for review contact the Office of Grants and Sponsored Programs or any IRB member.
  2. Determining Human Subject Involvement
    • The initial determination as to whether a project should be considered human subject research should be made by the investigator. He/she should consult the Grants Office and or an IRB member for advice on this question. Final authority for making this determination rests with the IRB.
    • In general, research which involves data gathered solely for internal, on-campus use would not need to be reviewed (i.e., course evaluation or institutional research). If, however, the results of this research will be disseminated in any way, then the research must receive prior approval. If no dissemination is planned at the time the data are gathered, but the possibility of future dissemination exists, the project director would be advised to submit the project for approval prior to initiating the research.
  3. The Application
    • The project director is responsible for preparation of the “Application for Approval of Investigations Involving the Use of Human Subjects.” The IRB has developed an application that will provide information required for review by either the IRB or an IRB-approved Peer Review Committee. Copies of informed consent documents, surveys/questionnaires, and other pertinent documents should be submitted with the Application. Each section of the Application should be completed thoroughly, and the signature of the project director/investigator, and the faculty sponsor if student research is involved, is required. The application should be submitted to the Grants Office, in McClain Hall 203, if the project will be reviewed by the IRB, or to the appropriate approved Peer Review Committee if the project meets the criteria for peer review. Incomplete applications will be returned to the principal investigator with a memo stating deficiencies. Once corrected, the application may be resubmitted for review. IRB-approved Peer Review Committees are responsible for ensuring that all applications submitted for peer review are complete.
  4. Types of Review
    • There are two types of review at Truman State University. These are: (1) IRB review, and (2) review by an IRB-approved Peer Review Committee. Only certain types of projects may be reviewed by a Peer Review Committee, which functions under the authority of the IRB. IRB-approved Peer Review Committees are responsible for ensuring that only projects that meet the peer review criteria are reviewed and an investigator always has the right to request a higher level of review than that required.
    • The investigator, project director, or faculty sponsor is responsible for ensuring the appropriate review of any project which involves human subjects, any student project which involves human subjects, or any classroom project which involves a sensitive subject or issue. Review must be completed before the project is undertaken.
  5. The Review Process
    • The review of human subjects research is designed to meet the investigator’s objectives while protecting the rights and welfare of the subjects. One of the most important roles of the IRB is educational. Consultation with IRB members during all stages of the research process is encouraged.
    • The review process is confined to procedures affecting the rights and welfare of human subjects. No evaluation of the content or merit of the project is made, unless subjects are found to be “at risk”. The review focuses on such issues as risk to subjects, voluntary participation, informed consent, and confidentiality.
    • NOTE: Approval of a project by the IRB only signifies that the procedures adequately protect the rights and welfare of the subjects and does not indicate University approval to conduct the research.
  6. Review by the IRB
    • The IRB meets twice each month during the academic year. Applications must be received in the Grants Office the Friday prior to a meeting in order to be presented at the next meeting.
    • The IRB is available to review any project involving human subjects, although certain types of minimal risk projects may be reviewed by an IRB-approved Peer Review Committee. The investigator may choose to submit a project that qualifies for peer review to the IRB at his/her discretion.
    • Any project which falls within one of the following categories must be reviewed by the IRB:
      1. It is externally funded.
      2. It places subjects at more than minimal risk (physical, emotional, psychological or social risk)
      3. It involves minors or other vulnerable populations (prisoners, pregnant
        women and fetuses, mentally disabled individuals).
      4. It investigates behaviors and/or experiences related to sensitive topics.
      5. It is carried out to partially fulfill a Master’s Degree requirement.
    • Examples of projects which must be reviewed by the IRB include:
      1. Research which might place subjects at greater risk than that experienced in everyday life (physical, psychological, emotional or social).
      2. Research involving psychological or physiological intervention.
      3. Non-curricular, interactive research in schools.
      4. Research involving deception.
      5. Interviews or surveys about sensitive topics.
      6. Research about special populations; e.g. minors, prisoners, mentally ill.
      7. Research conducted outside the United States, regardless of the procedures involved.
  7. IRB Review Results
    • The IRB will take one of the following actions in regard to applications reviewed:
      * Approve: The IRB will approve the project as submitted.
      * Defer for Revisions: The IRB will defer a project contingent upon modification. The project may not proceed until final approval from the IRB is received.
      * Disapprove: When the IRB disapproves a project, considerable revision is usually needed. The investigator may revise and resubmit the proposal. The project may not proceed until final approval from the IRB is received.
    • Disposition of the IRB application is forwarded to the applicant by the IRB Administrator within one week following the review of the application. The “Application for Review of Investigations Involving Human Subjects” and the IRB Review Form will be kept on file by the Office of Grants and Sponsored Programs.
  8. Review By an IRB-approved Peer Review CommitteeThe categories of projects which may be reviewed by an IRB-approved Peer Review Committee include:
    1. Research conducted in established educational settings that involves normal educational practices.
      • Examples include: research involving educational strategies; comparisons of the effectiveness of instructional techniques, curricula, or classroom management methods.
    2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), IF information taken from sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
    3. Research involving survey or interview procedures, EXCEPT when responses are recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subject; or the subject’s responses could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation if they became known; or the research deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
    4. Research involving the observation (including observation by participants) of public behavior EXCEPT when observations are recorded in such a manner that the human subject can be identified, directly or through identifiers linked to the subject; or the subject’s responses could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation if they became known; or the research deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
    5. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, IF these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
    6. Taste and food quality evaluation and consumer acceptance studies, IF (1) wholesome foods without additives are consumed, or (2) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or (3) a food contains an agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration, or (4) the food is approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.Examples of projects which can be reviewed by an IRB-approved Peer Review Committee include:
      1. Anonymous, mail or telephone surveys concerning innocuous topics.
      2. Anonymous, non-interactive, non-participating observation of public behavior.
      3. Secondary analysis of existing data.
      4. Educational research involving no interaction with students; e.g., regular classroom activity.
      5. Research involving the use of educational records if the information taken from these sources in provided to the researcher is such a manner that subjects cannot be identified.
      6. Interviews and interactive surveys on non-sensitive topics. (minors or special populations may not be subjects)

      Examples of projects which cannot be reviewed by an IRB-approved Peer Review Committee include:
      1. Survey or interview techniques which involve minors as subjects.
      2. Research involving the observation of the public behavior of minors.
      3. Projects which deceive or mislead the subjects about the purpose or nature or the research.
      4. Techniques which expose the subject to discomfort or harassment beyond levels encountered in everyday life.
      5. Research involving prisoners, fetuses, pregnant women or human in-vitro fertilization.
      6. The review of medical records if the information is recorded in such a way that subjects can be identified, directly or through identifiers linked to the subjects.

  9. Peer Committee Review Results
    • Peer review committees may take one of three actions in regard to applications reviewed. A Peer review committee cannot “Disapprove” research involving human subjects. A project which cannot be “Approved” or “Deferred for Revision” by a peer review committee must be referred to the IRB for review.
      IRB-approved Peer Review Committees may take one of three actions:
      * Approve: The peer review committee may approve the project as submitted.
      * Defer for Revision: The peer review committee may defer a project contingent upon minor modifications. The project may not proceed until final approval from the committee is received.
      * Refer to the IRB: The peer review committee may refer a project to the IRB for review when:
      a. the project does not meet the criteria for peer review; or
      b. the peer review committee identifies any reason that the project cannot be or should not be reviewed by peer review.
      The results of peer review must be filed in a central location within the department, so that these results are easily accessible. Peer review committees must file the following items for each research project that is reviewed: (a) a completed “Application for Review of Investigations Involving Human Subjects”; (b)the “Peer Review Form” which indicates whether the project was approved or referred to the IRB; (c)the research proposal, if applicable, and (d)any supporting information that may have been submitted or collected.
  10. Student Research
    • At Truman State University, all student investigators must have a University supervisor who is responsible for ensuring that the research is carried out according to the procedures that were approved. The faculty supervisor should thoroughly review the student’s project before it is submitted to the IRB or to a Peer Review Committee, and only after doing so should sign the student’s application certifying that the project will be carried out under his/her supervision.
    • Class projects may be reviewed as one proposal at the discretion of the instructor. If the entire class is not using the same procedure each student or group of students using a different procedure must submit the required information, but the class project will still be considered one proposal. Instructors may obtain approval for a class project before the semester begins if: (1) all of the students are using the same procedures and the instructor has established written guidelines explaining the procedures, or (2) the instructor submits a list of alternative procedures for approval and the students are to choose one from the list.
    • Projects conducted as instructional demonstrations where subjects are not solicited from outside the classroom generally do not need to be reviewed. Care should be taken, however, to protect the rights and welfare of students who act as subjects.