Institutional Review Board (IRB)

Protocol and Forms

Protocol Application Form

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Protocols

A protocol is the precise and detailed design for conducting a research study; specifically, it is the study plan submitted to an IRB for review. The protocol is the application mechanism to request IRB review and approval.

Participant recruitment and data collection cannot begin until you receive an approval letter from the IRB.

Informed Consent

Informed consent is the communication process of providing a potential research subject with adequate information for consideration of participant.

The consent process

The process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.

The consent process is one of the most important elements of all research studies involving human subjects. If consent is not properly obtained, then the rights of the individual research subject have been violated.

Upon IRB approval, the informed consent process can begin and it is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study.

Types of informed consent

The informed consent process can take on various forms:

  • Signed informed consent: used most commonly, signed informed consent allows prospective participants to document their agreement to take part in research activities by signing and dating the consent document.
  • Implied consent: by completing a research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research.

Required information in consent form

The minimal elements of the consent form include:

  1. Background Information and Purpose: a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. Procedures, a description of the expectation of the subjects including description of any reasonably foreseeable risks or discomforts to the subject and benefits to the subject or to others which may reasonably be expected from the research;
  3. Confidentiality Statement,: a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  4. Research Results, how participants can access results of the study;
  5. Contact Information (when applicable faculty advisor contact), an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
  6. Voluntary Participation/Withdrawal, and a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
  7. Acceptance to Participate

Consent form template and examples

Informed Consent Form

Consent Form

The consent form is the communication mechanism to provide potential research subjects with adequate information for consideration of participating.

Projects Including Adult Subjects

A minimum of one of the following examples are required for projects involving adult subjects:

Projects Including Minor-Aged Subjects

Both of the following consents are required for projects involving minor-aged subjects:

Protocol Modifications/Continuing Reviews/Final Report

If there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team for an already approved protocol. If a final report is required, the Continuing Review/Final Report Form must be submitted upon project completion.

Modification/Continuing Review/Final Report Form

Projects deemed EXEMPT are not required to file the Continuing Review/Final Report.

Deception and Debriefing Templates

There may be times when, in order to accomplish research objectives, investigators must deliberately mislead subjects during the research by withholding information or even providing false information. As a result, subjects are not fully informed about the research when they consent to participate. For example, you might:

  • stage an emergency, assault, or other situation
  • provide false feedback about a subject's performance
  • hide the true purpose of the research
  • conceal the identity of another researcher

When research involves a deceptive technique like those mentioned above, you are required to "debrief" subjects after their involvement in the research.