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 is the communication process of providing a potential research subject with adequate information for consideration of participant.
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:
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:
The consent form is the communication mechanism to provide potential research subjects with adequate information for consideration of participating.
A minimum of one of the following examples are required for projects involving adult subjects:
Both of the following consents are required for projects involving minor-aged subjects
Common Templates available for IRB use.
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.
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:
When research involves a deceptive technique like those mentioned above, you are required to "debrief" subjects after their involvement in the research.
Current forms available for submission regarding a human subjects research study.
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.
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.
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.
If a study is complete and ready for closure, a Final Report form must be submitted prior to the expiration date.
Other information that may be helpful for your study are included here.
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: