Human Subjects -- Guidelines for Research Protocol

Introduction

The purpose of the research protocol is to provide a clear and complete description of the purpose and benefits of the research, the methodology involved, the informed consent process, and any questionnaires, surveys, interview schedules, or other materials to be used. Be advised that some of the individuals reviewing your proposal may be entirely unfamiliar with the field of study involved. The protocol should be written in the tense (past, present, future) that is accurate at the time of submission of the protocol. Thus, future tense should be most common as the research should not have been initiated prior to obtaining the Institutional Review Board's approval. It is very important for researchers to review carefully Cal Poly's Policy for the Use of Human Subjects in Research for clarification of items mentioned here (e.g., the use of informed consent, vulnerable groups, experimental procedures) and to ensure that your practices are in keeping with those guidelines.

It is not necessary to submit an entire senior project or master's thesis proposal to the IRB. In particular, the IRB does not normally need to see your literature reviews, although a concise summary of the need for your research, its potential benefits, and your hypotheses is requested. You may submit the method section and relevant appendices from a senior project or thesis proposal. If they do not contain all the information requested below, however, you must add that information to the research protocol you submit to the Board.

The Research Protocol should contain:

  • Title of the research
  • Name and department/affiliation of the primary investigator(s) and faculty advisor, if applicable
  • Statement of purpose, benefits, and hypotheses
    This section need not be lengthy. In most cases, one or two paragraphs is likely to be sufficient.
  • Methods:
    • Subjects: Source (e.g., introductory psychology classes at Cal Poly), selection and exclusion criteria (if applicable), approximate number, whether prospective subjects are members of a vulnerable group or not (see Specific Ethical Criterion #6 in Cal Poly's Policy for the Use of Human Subjects in Research for a discussion of vulnerable groups such as children and disabled persons), expected age range, other descriptors that might be relevant (e.g., gender, ethnicity)
    • Experimenter(s): Identity of individual(s) who will administer the study; relevant qualifications of experimenter(s) (such as medical training when conducting physical tests)
    • Materials and Procedures*: Copies of any questionnaires, surveys or interview questions; description of other materials or apparatus that will be used; location of the study; chronological description of the procedures that will be followed in collecting the data; how participants will be debriefed.
      * Required Procedures for Experiments Involving Vigorous Exercise, or Exercise of Subjects at Risk: During these exercise protocols, at least two persons must be present at all times, one of whom is certified in CPR (cardiopulmonary resuscitation) techniques. Both persons should be prepared to call for appropriate medical assistance in the event that a subject requires it. Emergency telephone numbers should be posted in a clearly visible place in a testing facility.
      In addition, prospective subjects must fill out a standard health-screening questionnaire, such as the PAR-Q (Physical Activity Readiness Questionnaire), and these or similar criteria should be used to determine whether candidates may be enrolled in the study and/or whether a medical evaluation (release) should be required for participation.
  • Informed Consent Form**: Include identification of the activity as research, purpose(s) of the study, expected duration of the subject's participation, summary of the procedures, notification of any experimental procedure(s) that may be used (meaning procedures not yet accepted as standard practice such as experimental drugs), foreseeable risks or discomforts (physical, psychological, social, or economic as described in Specific Ethical Criterion #1 in Cal Poly's Policy for the Use of Human Subjects in Research), benefit(s) to subject or others, disclosure of alternative treatments (if applicable), how confidentiality will be protected, recourse if injury occurs (if the study is deemed of greater than minimal risk), referral for questions or to report harm or to obtain a summary of the study's results (e.g., the name and campus phone number of the faculty member conducting or supervising the project), indication that their participation is voluntary and that no penalty or loss of benefits will result from their refusal to participate or their discontinuing their participation once initiated, referral(s) to services that might assist them with any distress generated by their participation (e.g., a referral to the campus Psychological Services for those answering a questionnaire on sexual assault), offer of a copy of the consent form, and contact information for the Chair of the IRB and the Dean of Research. Sample Informed Consent Forms can be found in the Forms link.
    ** A separate signed informed consent form may not be appropriate in studies in which the only link between the data and the subject's identity would be the signed consent form. In this case, the informed consent information should still be presented, though not on a signed form.

Reporting Adverse Effects of Research on Human Subjects

Researchers are required to report adverse effects of their study to the Cal Poly IRB. Serious or life-threatening adverse effects should be reported to the Chair of the IRB or the Dean of Research as soon as possible after they occur or become known to the researcher. When a research protocol may be responsible for serious adverse effects, it should be discontinued until such time as an evaluation has been conducted and the protocol has been re-approved by the Cal Poly IRB.

Examples of adverse effects requiring immediate notification of the Cal Poly IRB include death and serious injuries. Examples of adverse effects which should also be reported include moderate injuries, loss of income, moderate or severe psychological trauma, etc.

Duration of Human Subjects Approval and Application for Renewal

Proposals submitted to the Cal Poly IRB for review are approved, unless otherwise specified, for a period of one year. If work with human subjects will occur more than one year following the date of original approval, the investigators must submit an application for renewal to the IRB via Debbie Hart (Office of Research and Economic Development, (805) 756-1508, dahart@calpoly.edu). This can be done by delivering a request that includes:

  1. A description of work accomplished to date;
  2. Description of any proposed modifications to the original procedures, and the rationale for the modifications; and
  3. Listing of any adverse effects on human subjects that have occurred, with a description of procedures established to prevent or reduce the subsequent risks.

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