Students sitting around a table talking

Investigator Responsibilities

All University of Idaho individuals whose activities meet both the definition of “human subjects” and of “research” are required to submit a Human Subjects Application Form to the Institutional Review Board and obtain approval or exempt certification prior to engaging in human subjects/participants research activities.

In order to submit a Human Subjects Application Form (also referred to as a protocol) to the IRB committee for review, the investigator must complete the following:

  1. Review the exempt application questions within the form.
  2. After reviewing these questions, identify which form applies to the research activities.
  3. Download any additional specialized forms you require for your study. For resources related to studies involving children, click here. For resources related to studies involving prisoners, click here. For forms related to the testing of food, drugs, cosmetics, or medical devices, click here.
  4. Fill out the forms which are required for your study. Make sure to save any changes which you make to the document.
  5. Create a consent form (if applicable) and debriefing document/statement (if applicable) and save these files as either a .doc or .pdf file.  You should also include any questionnaires, interview questions/topics, surveys, text-based stimulus materials or other materials to which participants will be asked to respond. If these measures are not available in their entirety or are not textual they should be described in such a way that it is clear what participants will experience.

  6. Complete the NIH Course and when you pass the course, save a copy of the Course Certificate. All individuals involved in “intervention” or “interaction” with human subjects must complete this course and provide a copy of the certificate to the IRB before approval may be granted.

   
Students
If the applicant is a student, you must email your materials to your faculty sponsor for review. If acceptable, the faculty sponsor will then forward the material to the IRB for review. The faculty sponsor must indicate their review and approval of the project by  emailing to irb@uidaho.edu

Adjunct Faculty or other U-Idaho employees
If the applicant is an adjunct faculty member or other U-Idaho employee, please email your materials and completed IRB form to the UI faculty sponsor. Once reviewed and finalized, the sponsor  submits the form and materials via email to irb@uidaho.edu 

Additional Investigator Responsibilities Include:
1. Adherence to the Belmont Principles Ethical Code.

2. Understanding and following the Federal, State and Local regulations and University of Idaho policies and procedures governing human subjects research.

3. Continuing responsibilities that human researchers have include:

  • Enrolling only those subjects that meet IRB approved inclusion and exclusion criteria,
  • Properly obtaining and documenting informed consent,
  • Informed consent (a primary ethical requirement of human research and reflects the basic principle of “respect for persons”):
    • (a.) Is an ongoing process, not just a signed consent form,
    • (b.) Must take into account cultural differences among subjects ,
    • (c.) Informed consent requires three components:
        • (i.) The subject must understand the information,
        • (ii.) Consent must be voluntary and continuing,
        • (iii.) The subject must be capable of making decisions,
  • Obtaining prior approval for any deviation from the approved protocol, 
  • Keeping accurate records,
    • Records relating to research which is conducted shall be retained for at least 3 years after completion of the research
  • Promptly reporting to the IRB any unanticipated problems and adverse events involving risks to subjects or others.

   
Upon the completion of all of the requirements listed above, please submit your forms electronically to irb@uidaho.edu.