IRB Resources

Researchers

Researchers

CITI Training Requirement

Starting January 1, 2016, all investigators conducting human subjects research sponsored by the University of St. Thomas are required to complete a short, online course and become "certified" in human subjects protections through the Collaborative Institutional Training Initiative (CITI) Program. This course must be completed prior to Institutional Review Board approval of new or continuing projects. Some investigators with funding sources (e.g. NSF, NIH, etc.) may be required to do additional training.

For more information on CITI Program training requirements click here.

Useful Resources for Human Subjects Research

Federal Regulations

Code of Federal Regulations (45 CFR 46)

Federal Registrar

Ethical Codes for Human Subjects Research  

Belmont Report

Declaration of Helsinki

Nuremberg Code

Additional Websites

Office for Human Research Protections (OHRP)

National Institutes of Health (NIH) (Biomedical Research use)

Application for Initial Review‌

Please note that the Application for Initial Review and all supporting application documents, such as consent forms, are available on IRBNet. Applications must be submitted through IRBNet.

Informed Consent Resources & Templates

Informed Consent Checklist for Investigators

Guide for Writing Consent Forms

General Consent Form

Parent Guardian Consent Form

Child Assent Form Ages 7-12

Child Assent Form Ages 13-17

Photography and Video Recording Permission

Photography and Video Recording Consent Form

Adverse Events and Unanticipated Problems Reporting Form

Adverse Event and Unanticipated Problem Reporting Form

All adverse events or unanticipated problems must be reported to the Institutional Review Board by investigators within one business day of the occurrence or investigator's knowledge of the event whenever possible.

Faculty Resources‌

Faculty Guidelines for Research with Students

Sample Forms and Letters

Sample Letter of Permission

Research Assistants and Transcribers

Research Assistants and Transcribers

Collaborative Institutional Training Initiative (CITI)

For more information regarding the CITI Program Education Requirement click here.

Research Assistant Confidentiality Agreement

Transcriber Confidentiality Agreement

Study Participants

Study Participants

As a study participant you have the right to know...

  • Why the research is being conducted;
  • What you will be asked to do as a research subject;
  • What types of questions you will be asked during study participation;
  • What risks are associated with the research study and what safeguards are in place to minimize any risk you;
  • What benefits there are to study participation, including if you will be compensated for your participation (financially or otherwise);
  • What will happen to the data that is collected during the study;
  • How your personal information will be kept confidential;
  • Who will have access to research data, including confidential information;
  • Who you can contact with concerns about the research study you are participating in.

As a study participant you have the right to…

  • Decide whether or not to participate in a research study;
  • Sufficient time to review and fully understand the consent form;
  • Ask questions at any time;
  • Drop out of a study without penalty;
  • Keep a copy of the consent form for your records (recommended).

Frequently Asked Questions

Who should I contact with concerns about the study I am participating in?

Study participants are encouraged to discuss any concerns with the principal investigator of the research study. However, if study participants do not feel comfortable directly communicating with the principal investigators concerns may be brought to the attention of Sarah Muenster-Blakley, Director of the Institutional Review Board at muen0526@stthomas.edu or (651)-962-6035.

Who reviews the research study prior to my participation?

All human subjects research studies sponsored by the University of St. Thomas are reviewed, approved, and monitored by the University’s Institutional Review Board (IRB).

Board Members

Institutional Review Board Members

Collaborative Institutional Training Initiative (CITI) Program

More information on CITI training requirements for board members can be found here.

Protocol Review

Reviewer Worksheet

Useful Resorces for Human Subjects Research

Federal Regulations

Code of Federal Regulations (45 CFR 46)

Federal Registrar

Ethical Codes for Human Subjects Research

Belmont Report

Declaration of Helsinki

Nuremberg Code

Additional Webstites

Office for Human Research Protections (OHRP)

National Institutes of Health (NIH) (Biomedical Research use)