Medical University of South Carolina
Protocol Guidelines
(Adapted from the DHHS research grant application guide PHS 398)

This is an outline of content requirements for protocols. The actual “Protocol form” on the IRB Forms web page should be completed and uploaded to the IRB application.

These requirements are for investigator initiated studies only. Existing protocols which meet certain criteria may be acceptable. See the IRB Application for details.

1. SPECIFIC AIMS
   List the broad, long-term objectives and the goal of the specific research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.
   
2. BACKGROUND AND SIGNIFICANCE
   Briefly sketch the background leading to the present application, critically evaluate existing knowledge, and specifically identify the gaps that the project is intended to fill. State concisely the importance and health relevance of the research described in this protocol by relating the specific aims to the broad, long-term objectives. If the aims of the study are achieved, state how scientific knowledge or clinical practice will be advanced.
   
3. PRELIMINARY STUDIES
   Provide an account of the principal investigator's preliminary studies pertinent to this protocol and/or any other information that will help to establish the experience and competence of the investigator to pursue the proposed project.
   
4. RESEARCH DESIGN AND METHODS (including data analysis)
   Describe the research design and the procedures to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted and specify what statistical methods will be used. Describe any new methodology and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or time-table for the project. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.
   
5. PROTECTION OF HUMAN SUBJECTS
   1. RISKS TO THE SUBJECTS
      1. Human Subjects Involvement and Characteristics
         • Describe the proposed involvement of human subjects.
         • Describe the characteristics of the subject population, including their anticipated number, age range and health status.
         • Identify the criteria for inclusion or exclusion of any subpopulation.
         • Explain the rationale for the involvement of special classes of subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. Note that 'prisoners' includes all subjects involuntarily incarcerated (for example, in detention centers) as well as subjects who become incarcerated after the study begins.
         • If you propose to exclude any sex/gender or racial/ethnic group, include a compelling rationale for the proposed exclusion. For example, 1) the research question addressed is relevant to only one gender or 2) evidence from prior research strongly demonstrates no difference between genders.
         • Provide either a description of the plans to include children or, if children will be excluded from the proposed research, then you must present an acceptable justification for the exclusion. For example, 1) the condition is rare in children as compared to adults or 2) insufficient data are available in adults to judge risk in children.
         • List any collaborating sites where human subjects research will be performed, and describe the role of those sites in performing the proposed research.
      2. Sources of Materials
         • Describe the research material obtained from living human subjects in the form of specimens, records, or data.
         • Describe any data that will be recorded on the human subjects involved in the project.
         • Describe the linkages to subjects, and indicate who will have access to subject identities.
         • Provide information about how the specimens, records, or data are collected and whether material or data will be collected specifically for your proposed research project.
      3. Potential Risks
         • Describe the potential risks to subjects (physical, psychological, social, legal, or other), and assess their likelihood and seriousness to the subjects.
         • Where appropriate, describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures to participants in the proposed research.
           
   2. ADEQUACY OF PROTECTION AGAINST RISKS
      1. Recruitment and Informed Consent
         • Describe plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent.
         • Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent.
      2. Protection against Risk
         • Describe planned procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness.
         • Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects.
         • Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects in Section 4 below.
   3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS
      • Discuss the potential benefits of the research to the subjects and others.
      • Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.
   4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
      • Discuss the importance of the knowledge gained or to be gained as a result of the proposed research.
      • Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.

      NOTE: Test articles (investigational new drugs, devices, or biologicals) including test articles that will be used for purposes or administered by routes that have not been approved for general use by the Food and Drug Administration (FDA) must be named. State whether the 30-day interval between submission of applicant certification to the FDA and its response has elapsed or has been waived and/or whether use of the test article has been withheld or restricted by the Food and Drug Administration, and/or the status of requests for an IND or IDE covering the proposed use of the test article in the research plan.

5. SUBJECT SAFETY AND MINIMIZING RISKS (Data and Safety Monitoring Plan)
   Studies that involve *clinical trials (see description below) must include a description of the plan for subject safety and minimizing risks of the research, including data monitoring and adverse event reporting to ensure the safety of subjects. The complexity of the plan should be determined by the level of risk to subjects. The plan should specify: 1) what will be monitored, 2) how frequently the monitoring will occur, 3) who will be responsible for the monitoring, and 4) study endpoints.
   
   *Clinical Trials
   A clinical trial is a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
   Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits these criteria of a clinical trial. Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision-making for the subject or the test itself imposes more than minimal risk for subjects.
   

6. REFERENCES/LITERATURE CITATIONS
   List all references. Each reference must include the title, names of all authors, book or journal, volume number, page numbers, and year of publication. The reference should be limited to relevant and current literature. It is important to be concise and to select only those literature references pertinent to the proposed research.
   
7. CONSULTANTS
   Where applicable, attach electronic versions of appropriate letters from all individuals confirming their roles in the project. Go to the application under “additional uploads” to attach this information.
   
8. FACILITES AVAILABLE
   Describe the facilities available for this project including laboratories, clinical resources, etc.
   
9. INVESTIGATOR BROCHURE (if applicable)
   If applicable, attach the electronic version of the investigator brochure. Go to the application under “additional uploads” to attach this information.
   
10. APPENDIX
    Attach any additional information pertinent to the application, such as surveys or questionnaires, diaries or logs, etc. Go to the application under “additional uploads” to attach this information.