No, it is to protect participants. Participants still retain their legal rights.
Yes, as new areas of research and new issues arise, regulations change or are added accordingly.
Training is required. See FAQ question about CITI training for more information.
Individuals required to complete CITI training:
- Anyone involved in the direct collection of data from human subjects (including interviewers, focus group facilitators, transcribers, etc., whether they are U of I faculty, staff or students).
- The PI or direct supervisor of individuals who are involved in data collection from human subjects (includes faculty sponsor or advisor, if individual is a student).
- The PI or lead investigator for the human subjects component of an interdisciplinary project.
- Anyone who analyzes or examines data which can be linked to individual study participants.
- The lead PI on interdisciplinary grants in which there is a human subjects component of a project, even if the lead PI is not the researcher overseeing the human subjects component of the research.
Individuals not required to complete CITI training:
- Individuals who only analyze secondary data (such as published U.S. Census Bureau data or other agency data) that is publicly available and where individuals cannot be identified.
- Co-PI’s (whether at U of I or not), other than the grant’s lead PI, on interdisciplinary projects that may have a human subjects component where the human subjects component is being overseen and/or conducted by a PI who does have IRB training. [Example: on a project examining the agronomic, environmental, and sociological factors surrounding the use of conservation practices in agriculture, the sociologist and his/her team should have IRB training, the grant’s lead PI (whether the sociologist or not) should have IRB training, but the hydrologist analyzing water quality data is not required to complete the training.]
- The lead PI on a grant awarded to another university or agency where a) the lead PI is not a U of I employee, and b) U of I is the subcontractor and the U of I PI does have IRB training.
U of I IRB Protocols
Most protocols qualify for exempt certification or expedited review. Only protocols that do not meet the exemption or expedited categories or have been determined to be above minimum risk are reviewed by the IRB full board.
All research activities with human participants pose some level of risk. In some instances the level of risk may be considered minimal but for all nonexempt research these risks need to be listed and tied to appropriate risk mitigation measures.
While there are many measures that can be taken to protect confidentiality, U of I is a state institution and data collected by faculty, staff and students can be requested through the State Public Records Act and the federal Freedom of Information Act (FOIA).
In some cases (phone survey, anonymous survey, illiterate populations), other forms of consent may be better.
No, participants can withdraw at any time without penalty.
The University of Idaho reviews protocols for U of I faculty/staff/students only. If you are an outside investigator and your planned activities will engage U of I in your research, you will need to seek a U of I collaborator to submit your protocol to the U of I IRB for review and approval. For activities that do not engage U of I in your research, e.g., contacting individuals associated with U of I to recruit for your Human Subjects Research project, no U of I IRB approval is required or provided.
Note: Please refer to the following guidance document as to whether your planned activities will engage U of I in your research activities: HHS Guidance on Engagement.
- All internal and external personnel must take CITIProgram.org training for "IRB Investigators and Student Researchers," "Good Clinical Practice," and "Responsible Conduct of Research."
- Determine if the research meets the NIH definition of a Clinical Trial or an Applicable Clinical Trial by using the information provided at the IRB FAQ. (See: Clinical Trials). If so, follow the instructions in that section as well as those below.
- Additional information about changes to the NIH data sharing policy effective Jan. 25, 2023 is here: https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-sharing-policy/data-management-and-sharing-policy-overview
- Submit your Data Management & Sharing Plan for NIH funded research and submit this with your IRB application. Templates are available here: https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/writing-a-data-management-and-sharing-plan. Some resources to consider for long-term data storage and sharing are: https://data.nkn.uidaho.edu and https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html although Principle Investigators can utilize any NIH-approved option.
- Use the "Consent Form Template - Standard - NIH (For non-exempt federally-funded protocols). This specialized consent form lets participants know their data will be shared.
- If you will require a Data Transfer and Use Agreement (Data Sharing Agreement) to share the data. Submit this form to the IRB along with the IRB application in VERAS. Please note that these agreements must be signed for each data recipient by Director, Office of Technology Transfer, since that office is the University of Idaho's authorized signatory. Principle Investigators may not sign these agreements.
- Manage and share data as per the Data Management & Sharing Plan submitted to the NIH.
- Principle Investigators are responsible for ensuring that all NIH and ClinicalTrials.gov requirements are met.
Download and fill out the required materials, complete the CITI course and email your materials to your faculty sponsor. If acceptable, the faculty sponsor will forward the materials to the IRB for review.
Class projects may be exempt from IRB review when they meet all the guidelines provided in the “Research Practica” because the activities do not meet the definition of research. However, class projects that meet the definition of human participant research would require IRB review, e.g., class projects involving human participants that are part of a masters or doctorate thesis require IRB review because the activity meets the definition of research.
Research with Minors
It is necessary, but not sufficient. You must also have assent of child participant (>3 yrs.):
- verbal assent (3-7 yrs.)
- written assent (>7yrs.)
Yes, you must provide this permission as part of the IRB submission package.
Yes. PIs may pay research subjects as an incentive to increase recruitment and compensate them for their time, effort and unreimbursed expenses incurred as a result of participating in the study. The IRB must approve the payment scheme prior to implementation.
Yes. If a PI is conducting human subjects research and intends to pay research subjects, then the PI must get IRB approval of the payment scheme prior to implementing the study. PIs can seek approval by outlining the payment scheme details in an IRB protocol and submitting it to the IRB. PIs should include details such as the payment type and amount, how and when the payment will be made, and what conditions the subjects must meet before qualifying for payment. PIs also must include these details within the informed consent documentation.
PIs must ensure that payments will not coerce or unduly influence a research subject to participate in the study such that the subject’s participation is not truly voluntary. PIs must consider the vulnerabilities of the subject population, what types and amounts of payment are appropriate in light of the demands of the study, what subjects must do in order to receive the payment, and the conditions under which the payment offer will be made. Additionally, in instances where PIs must collect personal information for tax purposes (see IRB Payments to Research Subjects Policy), PIs must consider how the information will be collected, stored and shared with Accounts Payable, and how the payment will be recorded.
PIs who need to make a change to a previously approved payment scheme must submit an amendment request to the IRB. The PI may not implement any change until the IRB approves the amendment. The PI also should talk with Accounts Payable to be sure that the changes in the payment scheme can be implemented pursuant to Accounts Payable’s policies and procedures.
Yes, but the method of payment may be subject to certain restrictions. If the IRB determines during the review of a protocol that individuals who do not qualify as “research subjects” (see definition in IRB Payments to Research Subjects Policy) are going to be paid in connection with the study, the IRB will refer the matter to the Office of Sponsored Programs, who will work with the PI and U of I’s Finance Division to determine the appropriate payment mechanism. The determination of whether an individual involved in the project is a “research subject” or “nonresearch subject” is not always clear and must be made on a case-by-case basis in close consultation with the PI. For example, individuals involved in community-based participatory research projects generally will be deemed “research subjects” if they are not only participating in the design or implementation of the project, but also are in some way a source of data that is the focus of the project. However, individuals who merely provide a service in support of the project likely will be deemed employees, contractors or subrecipients; those individuals must be compensated through the payroll or contracting processes.
Subject to IRB approval and following the procedures in the IRB Payments to Research Subjects policy, PIs may provide research incentives to subjects via any of the following methods:
- gift cards/gift certificates
- university checks
- noncash tangible items
- extra course credit
Note that monetary payments to nonresident alien individuals may be made by university check only, and PIs must issue those individuals a Form W-8. For monetary payments to U.S. tax residents in the amount of $50.01 or more, PIs must issue the subjects a Form W-9.
It depends. If a PI pays a U.S. tax resident $50 or less and the PI does not reasonably expect that aggregate payments to that person will exceed $600 in a calendar year, then the PI is not required to collect personal information from that subject. If a PI pays a U.S. tax resident $50.01 or more, reasonably expects that the aggregate payments to that person will exceed $600 in a calendar year, or pays any amount to a nonresident alien individual, then the PI is required to collect personal information from that subject. See the IRB Payments to Research Subjects policy for detailed guidance.
Contact Accounts Payable prior to starting the research project and making any payments to determine the appropriate mechanism for receiving reimbursement or a cash advance. Accounts Payable will identify the documentation that PIs must produce in order to receive the reimbursement or cash advance.
No. P-cards may not be used to purchase any research incentive including, but not limited to, gift cards, gift certificates or noncash tangible items.
Recruitment for Medical Studies
ResearchMatch.org is a nationwide registry of potential research volunteers sponsored by the National Institutes of Health. This site can help with feasibility analysis. It can also be used for medical research recruitment for University of Idaho IRB approved studies. The service is free for U of I researchers to list their study and contact registered volunteers. To begin, create an account and select “University of Idaho” as your institutional affiliation.
Federal regulations FDAAA 801, Final Rule and the University of Idaho require that all Applicable Clinical Trials (ACTs) be registered on ClinicalTrials.gov—a database maintained by the National Institutes of Health (NIH).
Investigators can also use ClinicalTrials.gov to recruit participants and potential volunteers can learn more about your research study. Another recruitment site is ResearchMatch.org, and additional information is available on this page under Recruitment for Medical Studies.
If your study is a NIH-funded interventional clinical trial, it must also be registered. This includes studies that may not be Applicable Clinical Trials such as behavioral, surgery, and drug and device studies. For additional information about this requirement see NIH-Funded Trials. You must also have all members of the research team complete Responsible Conduct of Research and Clinical Trials and Good Clinical Practice training. Learn more about training requirements on IRB's training page.
Most medical journals follow the International Committee of Medical Journal Editors guidelines which recommend that all clinical trials be registered publicly as a condition of publication.
Important steps and deadlines are:
- Apply for your ClinicalTrials.gov account by emailing email@example.com
- Register the trial at ClinicalTrials.gov
- Submit your IRB protocol for review and approval. In no event may you register a participant for the study without having IRB approval and a completed registration at ClinicalTrials.gov.
- You have 1 year to post results after the study primary completion date (see definition) or to submit a certification for delayed submission of results to ClinicalTrials.gov. Be sure to check qualification requirements for a delayed submission of results well in advance as they are limited.
- The IRB recommends setting calendar reminders in advance of IRB Protocol expiration dates and ClinicalTrials.gov deadlines.
FDA Civil Money Penalties for not meeting these deadlines can be substantial and can include fines of up to $10,000. If you have questions regarding the study registration process, or additional requirements, please contact the IRB Coordinator at firstname.lastname@example.org.