Human Subjects Review

 

Application Process

The Institutional Review Board requires that all IRB submissions be transmitted electronically as a single attachment to an email with the Human Subjects Research Application as the first page and Collaborative Institutional Training Initiative (CITI) certificate (see Reponsible Conduct of Research) as a second page.

  • Email to your advisor, if applicable, for evaluation
  • Request advisor to evaluate and forward via email to department chair with a cover email stating decision
  • If advisor evaluation is not required go to next step
  • Email to your department chair for evaluation
  • Request department chair to evaluate and forward via email, with a cover email stating decision, to IRB@usm.edu

An IRB committee member will review your submission. If a revision or further documentation is required you will be notified via email by the IRB administrator.

Upon approval you will receive an approval letter from the IRB committee chair via email.  

Human Subjects Review

Human Subjects Review Application

Human Subjects Application Enclosure Checklist


Attach your Collaborative Institutional Training Initiative (CITI) Certificate. (See Integrity Assurance Program (formerly RCR)

Applications should contain all information using the following
format. Attach a typed narrative that includes the following. Do not omit any sections.

  1. Brief statement of project goals (two or three sentences).
  2. Protocol:
      • Describe procedures.

      • Number and age range of subjects. (Federal law requires that any research conducted involving the use of any person under the age of 18 must obtain parental consent prior to the research taking place. Organizations, such as public schools, may provide a blanket consent for observational or limited direct participation when risks are minimal or nonexistent. This is provided the parents or guardians are given proper notification prior to the research being conducted and are given the opportunity to exclude their child from participation. NOTE...Lower level [first year - 100 level] college courses may have minors in attendance. If your project includes a lower-level course, please prescreen the audience for minors, or be prepared to use a parental consent form.)

      • Describe subject population, criteria for subject selection, and recruitment procedures. From where will subjects be obtained? (The composition of any study group should be based on science, not merely on the convenience of the investigator. Efforts to include representation from racial or ethnic groups and both genders are strongly encouraged, unless inclusion is impossible or is inappropriate with respect to the purpose of the research. In cases where exclusion is necessary, provide rationale.)

      • How long will the procedures take? How much time will be required of subjects?

      • Where will the procedures be done? Where will the study be conducted? (For survey research, how will the survey be conducted?)

      • Name and describe the data gathering tool (attach a copy).

      • Describe any special situations. (Example: Full disclosure of procedure to subjects is not feasible because biased data will result.)

      • If data collection is done in class, explain what students who do not participate will be doing.

      • Attach letter of approval from any organizations that will be involved with the research project (regardless of the terms or extent of participation). The letter must be on official letterhead and signed by an authorized official of the organization.
  3. Benefits: Describe the potential benefits to the subject or to others. (If class credit will be given for participation, describe what other options exist for nonparticipants to receive the same amount of credit.)
  4. Risks:
      • Describe the possible risks, discomforts, and inconvenience to the subject and the precautions that will be taken to minimize them. This includes physical, psychological, and social risks. Describe appropriate controls, screening methods, debriefing or follow-up procedures designed to prevent residual physical, psychological, or social damage to the subject.

      • Describe the conditions under which subjects will be terminated from study before its completion.

      • Describe your method for maintaining subject confidentiality or anonymity.

      • How will confidentiality of data be maintained? (Where will data be kept? Who will have access to it?)

      • Detail the final disposition of data. (What will be done with questionnaires, inventories, videotapes, and/or audiotapes?)
  5. Informed Consent: Samples and Tips

    Informed consent is a process, not just a form. The dialogue between subject and investigator is the essence of informed consent, and the written consent form is its documentation. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. The procedures used in obtaining informed consent should be designed to educate members of the subject population in terms that they can understand. Therefore, informed consent language and its documentation must be written in "lay" language. Any suggestion of undue inducement, fraud, or coercion must be strictly avoided. Research involving minor subjects (under the age of 18) must include provisions to obtain the minor subject's assent as well as the legal consent of the minor subject's parent or guardian. (Revised 01/01)

Minimum information required for informed consent includes the following:

  1. Statement that the study involves research, the general purpose of the research, and a description of procedures.
  2. The amount of time required of the subject.
  3. Statement that participation is completely voluntary and that participation may be discontinued at any time without penalty or prejudice to the subject.
  4. Confidentiality of data and final disposition of data.
  5. The opportunity to ask questions and/or the name and phone number of whom to contact for answers to questions about the research.
  6. The statement: "This project has been reviewed by the Human Subjects Protection Review Committee, which ensures that research projects involving human subjects follow federal regulations. Any questions or concerns about rights as a research subject should be directed to the chair of the Institutional Review Board, The University of Southern Mississippi, 118 College Drive #5147, Hattiesburg, MS 
    39406-0001, (601) 266-6820."

The above information should be provided even for anonymous surveys/questionnaires.

For other types of research, one or more of the following elements may be required:

  1. Description of reasonably foreseeable risks, inconvenience, or discomforts.
  2. Description of benefits to the subject or to others.
  3. Disclosure of appropriate alternative procedures.
  4. Documentation of informed consent.

In addition, when appropriate, more information may need to be provided, including the following:

  1. Explanation as to whether compensation or treatment will be provided if injury occurs and whom to contact in the event of a research-related injury.
  2. Statement that the procedure may involve risks that are currently unforeseeable.
  3. Circumstances under which the subject’s participation may be terminated by the investigator.
  4. Any additional costs to the subject.
  5. Consequences of and procedures for withdrawal from the research.
  6. Statement that new findings, which may affect the subject’s willingness to participate, will be provided.
  7. Approximate number of subjects.

Consent forms:

Short Form and Oral Presentation: The oral presentation must be accompanied by a short consent form unless this requirement is waived. The short consent form and oral presentation are appropriate when procedures are simple or the research involves minimal risk. Minimal risk is ultimately determined by the HSPRC, but generally means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The oral presentation, used with a short consent form, must cover the same elements of informed consent as those required in the long form. If an oral presentation is planned, include the content of the presentation in your application. The oral presentation must be witnessed each time it is read to a group of subjects. The date and signature of the auditor witness and of the person explaining the study is needed on the oral presentation form. The auditor witness shall sign both the short consent form and the oral presentation form. Provide subjects with a copy of the oral presentation and a copy of the short consent form.

Long Form: The long consent form is required when studies have a longitudinal perspective and require the subjects' ongoing participation or if the research procedures are complex and difficult to understand or involve more than minimal risk. Consecutively number the pages in the lower left corner. Denote total number of pages (e.g., page 1 of 6). Provide a space in the lower right corner for the subject to initial each page. Provide a copy to the subject or the subject’s legally authorized representative.

Waiver of Consent Forms: At the request of the investigator, the HSPRC may waive the requirement to obtain a signed consent form for some or all subjects if it finds either:

  1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
  2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required when performed outside of the research context.

In cases in which the consent form requirement is waived, the HSPRC may require the investigator to provide subjects with a written statement regarding the research.

Other Considerations: If the consent document or oral presentation is administered in a language other than English, include a copy in the language of the participants and a copy in English. A signed statement, from someone other than the researcher, attesting to the accuracy of the translation should also be included.

Projects with an exercise or a diet component should contain the following statement: "Before beginning this or any exercise or health program, participants should consult a physician."