Q: Do I need to use information sheet, cover letter, assent, parental permission form, etc for my study?


Not all pages may be required for every study. Consult with the IRB Chair, faculty advisor, committee chair or committee members to see what is needed for your study. For example some studies, implied consent may be appropriate.


Q: Do I need to use the example sheets word for word?


No, the wording examples are shown in red in the example sheets. Prior to submission and use with participants, items in red should be changed to black font type. The color is used in the electronic version to assist the PI in identifying the items.


The following are examples and samples for contact and/or consent. They should be modified to fit your individual project.  Items in bolded italics and other sections should be modified for your project or deleted if not appropriate. In some cases, you may need to add information. For example, if the project is conducted in a class, there should be information added that participation is not part of the grade.


Q: When is a cover letter needed?


Cover Letter- usually used for surveys and when recruitment is done at a distance, such as through the mail.


Q: When should an information sheet be used?


Information Sheet- may be used when recruitment is done face-to-face, such as in a classroom. If a signed Consent Form is required, an Information Sheet (which is the Consent Form without a signature) can be given to the participant to take with them should there be any questions in the future.


Q: When should a consent form be used?


Consent Form- must be used for all projects posing greater than minimal risk to participants. 


Q: What is an Assent form and when should it be used?


Assent- If minors (under the age of 18 years in South Dakota) are included as participants, they cannot provide legal consent. Instead, investigators should obtain assent from these participants. The format must follow the general ideas of the consent form, and should be written in language appropriate to the age of the participant. Readability statistics are available on most word processing programs, and should be included in the submission.


Q: When should a parental permission form be used?


Parental Permission Form- to be used when a participant is under 18 years of age and can be modified for use with other vulnerable populations.


Q: Do I need to be present during full committee review?


No, you do not need to be present. However, it may help to make arrangements through telephone conferencing or other means if you would like to be present.