Human Subjects Protection

IRB applications are submitted through Cayuse IRB, USD's online submission system. Please see the instructions and guidance below. The system provides guidance to new users; however, office staff is available if you need assistance. Contact the IRB office at 605-658-3743 or humansubjects@usd.edu to ask questions or schedule a training.

Office Staff

Linda Rupp: IRB Coordinator
Linda.Rupp@usd.edu, 605-658-3743

Jackie Stelling, M.B.A.: Reviewer
Jackie.Stelling@usd.edu, 605-658-3763

Marc Guilford, J.D.: Director
Marc.Guilford@usd.edu, 615-658-3767

Determination

If you are unsure if your study requires IRB review, please submit a determination application. Follow the below steps for “New Protocol.”

New Protocol

• New users, request an account.
• Existing users, login to Cayuse
• For USD affiliates, the username is your full USD email address and associated password.
• Click on Cayuse IRB.
• Short, helpful tutorials for how to use Cayuse IRB can be accessed by clicking on “Menu” then “Help.”

Resources

• USD IRB Standard Operating Procedures
• USD IRB Standard Operating Procedures – Pre-2018 Revised Common Rule

CITI Training

• GRP 1 Biomedical Research Investigators and Key Personnel, Basic Course.
• GRP 2 Social Behavioral Research for Investigators and Key Personnel, Basic Course. 

The University of South Dakota utilizes a board that meets at the  Sanford School of Medicine in Sioux Falls, South Dakota. The Institutional Review Board (IRB) typically reviews research applications that involve more than minimal risk. Many studies that are considered no more than minimal risk can be reviewed without convened IRB review.

IRB Meeting

The board meets the second Thursday of every month. Submission deadline is the 25th day of the month preceding the meeting date. Contact the Office of Human Subjects Protection with any questions about the meeting dates or submission deadlines at 605-658-3743 or  HumanSubjects@usd.edu.

Fees

The OHSP is happy to review human subject research for investigators not affiliated with USD for a one-time fee. This fee covers the initial review as well as any continuations, amendments, and adverse event reports. The fee is based on the level of review required. Call the Office of Human Subjects Protection at 605-658-3743 to determine if a fee will apply.

IRB review at a convened meeting:  $1,791.76
Expedited Review:  $895.88
Exempt Review:  $298.62
Continuation, amendment, etc.:  No fee

USD consent templates contain the required regulatory elements, IRB contact information and guided wording for various study elements. Studies that do not require a signature on the consent form may use either the "Consent Statement Template" or the "Cover Letter Template." Research with children or cognitively impaired subjects should include both a parental consent form and an assent form.

Please submit Word versions of consent forms. No PDFs.

(Need remediated documents for the below)

• Survey Consent Statement - For studies involving a survey that does not collect identifying information.
• Interview Consent Statement - For studies involving interviews that will not retain (i.e.. recordings transcribed and deleted) any identifying information.
• Consent Statement Template - For studies that do not collect identifying information.
• Cover Letter Template - For studies that do not collect identifying information.
• Phone Script Consent Template
• Addendum to Informed Consent - For re-contacting subjects or seeking additional consent.
• Addendum to Informed Consent - HIPAA Authorization

Non-Medical

• Non-medical Informed Consent Template
• Non-medical Parental Informed Consent Template
• Assent for minors and cognitively impaired

Medical

• Medical Informed Consent Template
• Medical Parental Informed Consent Template
• Assent for minors and cognitively impaired
• Informed consent template for humanitarian use device

Other

• Statement of radiation risk
• Tissue and Blood Storage for possible future use with identifiers
• Tissue and Blood Storage for possible future use without identifiers

Why is training necessary?
In recent years, reports by the Office of the Inspector General (OIG) and enforcement actions taken by the Office for Human Research Protections (OHRP) against a number of prominent universities have called attention to serious problems related to compliance with Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) regulations for the protection of human subjects. Accordingly, national bodies including the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) have called for formal training of personnel involved in the conduct of human subject's research.

What type of training is offered?
To meet the requirements the University of South Dakota has elected to use an Internet-based human subject education program sponsored by the University of Miami. The Collaborative Institutional Training Initiative (CITI) course consists of modules for both the social / behavioral and biomedical researcher. The CITI modules encompass the history of the IRB, regulations governing human subject research and topics specific to areas of particular importance, controversy or complexity.

Who must be trained?
All personnel who interact with research subjects will be required to turn in a Certificate of Completion with each study/project/protocol submission to the IRB. These personnel include:

• Institutional Review Board members
• Institutional Review Board Staff
• Principal investigators
• Co-investigators
• Sub-investigators
• Project directors
• Faculty
• Students
• All research staff, including study coordinators, study nurses, residents, and individuals who obtain informed consent, administer surveys, or collect identifiable private information
• All other employees listed on protocols that involve the use of human subjects in research
• All research staff who do not work directly with human subjects, but analyze data and/or biological specimens obtained from subjects or patients

Will this institution accept certification of training from other institutions for new USD employees?
The only certificates of training which will be accepted are those from institutions who utilize the same training program as this institution. The University of South Dakota must be assured that all personnel involved in human subject's research have at least equivalent training. USD will also accept the NIH training certificate.

Will the IRB review an initial application if all key personnel are not trained and certified?
Yes, the application will be reviewed but will not be granted final approval until all research personnel have appropriate training. You may remove untrained personnel from your research team and add them in an amendment after their training is complete.

Are training and certification of all key personnel required for continuing review?
The Principal Investigator should ensure that all key personnel are certified prior to submission of the IRB Application for Continuing Review.

Does the training requirement apply to expedited and full board research conducted by students or staff?
Yes, research conducted by students or staff must maintain the same high ethical standard as research conducted by faculty.

Does the training requirement apply to students doing exempt research?
Yes, the training requirement applies for students doing exempt projects. Students must complete the Social-Behavioral or Biomedical course.

How long will certification be valid?
Certification is valid for 3 years.

How do I access the required CITI training program?
Go to citiprogram.org

How long will it take to complete the training?
The time required to complete each module varies between 10 minutes and 30 minutes. The total time required is estimated to be 3-6 hours. The course does not have to be completed in one sitting, and personnel can enter the course at any time.

Where are the test data maintained and what about confidentiality?
Your individual quiz scores are confidential. The webmaster and staff supporting the distance learning software at the University of Miami where the data are processed and stored have access to individually identifiable quiz scores. However, each of these staff members have signed confidentiality pledges and will not disclose individually identifiable quiz results nor aggregate institutionally identifiable results. Aggregate, anonymous quiz data will be used by course faculty to help improve course content and quiz questions. Absolute confidentiality will be maintained.

Is there a minimum passing score required in order to be certified?
The passing score is 70 percent. The score will be based on the overall score from all the required modules. The quizzes are open book.

How do I receive a certificate of completion?
Once you complete and score a 70 percent passing score (based on the overall score from all required modules), the CITI site will send you an e-mail.

If I encounter a problem or have a question, whom do I contact?
Contact: humansubjects@usd.edu or call the Office of Human Subjects Protection 605-677-6184.