Protocol and Forms

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.

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.

Federal regulations around human subject research (45 CFR Part 46) require that researchers provide prospective participants with the information that a reasonable person would want to have to make an informed decision about whether to participate. This information is provided in an informed consent form or through implied consent (e.g., on the first page of an electronic survey). The minimal elements of the informed consent form should include:

1. A statement making it clear to the participant the project involves research.
2. An explanation of the purpose of the research.
3. A description of the process or procedures the participant will follow.
4. The expected duration of the participant’s time in the project.
5. A description of any reasonably expected benefits from the research to the individual participant (including if none should be expected) and to a broader target population.
6. A description of any reasonably foreseeable risks or discomforts to the participant, even if only to say that the research should involve no risks beyond what someone would encounter in their daily life.
7. A statement about how the participant’s data will either be anonymous (no identifiable participant data are collected) or confidential (identifiable data will be collected but not presented in a manner that easily identifies them) and how that will be achieved.
8. If collecting identifiable private information, a statement about how data could be used for future research or distributed to other researchers (and whether, when, and how identifiers will be removed from data).
9. If collecting data from voice, digital, video, or image recordings, include a statement specifying how those recordings will be used or include a supplemental Audio-Visual Release Form.
10. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits, and the subject may discontinue participation at any time without penalty.
11. Contact Information (including faculty advisor information when appropriate) with an explanation of whom to contact for answers to pertinent questions about the research, research subject rights, research-related injuries (if applicable), and research results.
12. If you offer compensation, a statement on when the participant will receive the compensation. If in a class and the student is receiving extra credit, include a statement on how non-participants will receive the opportunity to earn the same extra credit.There should be documentation of the participant's acceptance to participate.
13. There should be documentation of the participant's acceptance to participate.
    1. An adult's written informed consent form should have a signature and date line for the participant to consent to participate.
    2. A written informed consent form for a minor or individual with a legal guardian should have a signature and date line for the parent or guardian to consent and a place for the participant to sign to give their assent (when possible and if cognitively able to provide assent).
    3. For an electronic implied consent form, there should be a statement indicating that by continuing with the electronic study, the participant is giving their consent (e.g., “By completing this online survey, I confirm that I have read this informed consent form, am a legal adult, and voluntarily agree to participate in this research study.”)

Informed 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:

• Adult Informed Consent Example

Projects Including Minor-Aged Subjects

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

• Child/Minor Assent Example

This form should be used as a template to obtain permission from participants when your research project involves the use of audio, photographs, or video.

This form can be used in conjunction with the consent form.

Only the item(s) selected on the form by the participant may be used in the research.

• SCSU Audio/Photograph/Video Release Template

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.

• Debriefing Template
• Debriefing Example

A collaborative study involving human subjects research with an external lead investigator in which St. Cloud State is relying upon approval by their institution/organization, requires submission of an Authorized Agreement form.  This is needed in order for St. Cloud State's IRB to ensure we are safeguarding human subjects' rights and welfare and can rely upon the single IRB approval pursuant to state and federal guidelines.

Authorized Agreement Form

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, the Protocol Revision or Modifications Form must be submitted prior to implementing the proposed changes to the protocol or study documents.

Protocol Revision/Modifications Form

If a study is ongoing and an extension is needed beyond the expiration date, a Continuing Review Form must be submitted prior to the expiration date.

Continuing Review Form

If a study is complete and ready for closure, a Final Report form must be submitted prior to the expiration date.

Final Report Form

Letters of cooperation for any external research site or cooperating organization or agency will be required. A letter of cooperation serves as documentation from the external entity that it understands the nature of the researcher’s work, outlines its commitment to the project, and states approval of the study as it relates to its involvement. The letter is generally signed by someone in authority at the external entity. When working with other colleges and universities, it is strongly suggested that researchers check with central administration as these institutions may have specific processes for oversight of research occurring on or with their campuses.

Letters of cooperation may be obtained before or after SCSU IRB approval, depending on the policies of the cooperating organization. If it is the organization’s policy to write letters of cooperation only after SCSU IRB approval, the study approval letter will indicate that the approval is pending with respect to the involvement with the cooperating organization until the letter of cooperation is received by the SCSU IRB.

Recruitment materials used in human subject research must be reviewed by the IRB. Content should be limited to the information the prospective participants need to determine their eligibility and interest.

It is generally acceptable to include basic study information in recruitment materials, including:

• The title of the research study
• The purpose of the research
• A brief summary of the protocol
• Basic eligibility criteria
• Study location
• Name and contact information of the primary investigator
• Time or other commitment required of participants

• Promise or imply a benefit beyond what is explained in the informed consent
• Use language that is unduly coercive
• Advertise compensation using bigger or bolder font than the rest of the messaging