Human Subjects Research Frequently Asked Questions (FAQs)

Topics

Research Administration Portal (RAP)

General Information

Human Subjects Education Requirement (CITI)

Working with other institutions and individuals outside University of Oregon.

Single IRBs (sIRB)

Research Administration Portal (RAP)

Why isn’t CITI training showing up for an investigator?

  • Check the investigator is listed under Local Study Team Members.
  • Confirm the investigator has completed the correct courses. There are only a limited number of courses that will satisfy human subjects training requirements.
  • Verify that the investigator name and email in CITI are an exact match to what is listed in the RAP. To integrate properly, the individual's first name in their CITI profile must match the preferred first name as listed in DuckWeb. The last name and email address as must match what is listed in the University of Oregon database (Banner). CITI training information will not populate if all three do not match. If an individual has listed a preferred name in DuckWeb, the preferred name will display in the RAP.
    • Once you have updated your CITI profile to match what is listed in the RAP, it may take several days for CITI training to populate into the RAP.

Can I have a lab assistant create a submission?

Anyone can start and complete an initial submission and list someone else as the principal investigator. However, the principal investigator or an assigned PI proxy must “submit” the study to begin the review process. Once the study is submitted, anyone listed on the research team may access the protocol and create follow-on submissions (i.e., modifications and continuing review), but only the PI and PI proxies are able to submit an application to the IRB.

Can I enter more than one principal investigator?

Only one principal investigator is allowed per study. You may add additional co-investigators on the “Local Study Team Members” page. After all the study team members are entered, the Principal Investigator can assign the co-investigator(s) as PI proxy(ies).

Where should I be uploading forms and attachments such as the application, research plan, consent form, instruments, etc.?

Instructions for where to upload materials is located in each application. Additionally, RCS has created a table of where to upload attachments which can be found in the guidance library.

I am unable to locate my department, funding agency, research location, etc. from the drop-down lists. Do you have any tips to help search?

When selecting from drop-down lists, use the percentage sign (%) as a wildcard to maximize your search results. For example, “%geography” will bring up sources with “geography” anywhere in the name.

I’m conducting on-line research. How do I answer the questions of which campus research locations the research activities will be conducted or overseen by the local investigator?

When conducting remote research, use the location you will be analyzing the data or doing the work. This may be the investigator’s office or an on-campus lab. If you are not physically on campus, use your office as the location where research will be overseen.

I finished entering the information and clicked "finish", do I need to do anything else?

When you are satisfied with the application and are ready to submit the study for IRB review, you must choose "Submit" from the menu options on the left of the main workspace. While anyone can create a submission, only the principal investigator or a PI proxy can submit studies to the RAP module of the IRB. If you have created an initial review submission on behalf of someone else, the person listed as principal investigator must access the RAP using their DuckID and submit the study or assign a PI Proxy who then can submit the study on their behalf. The study will appear in the IRB module of RAP for the principal investigator and everyone listed as a study team member will be able to view the study, but only the PI and PI Proxies may submit an application for review.

Do you have guidance materials for the IRB module of the RAP?

A list of guidance documents can be found in our library. Once logged into the RAP, the guidance materials can all be found in the Help Center.

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General Information

Why is human subject research review important?

Ethical and responsible conduct of human subject research is essential for excellence and public trust in science. The review of human subject research is ethically important to protect the rights and welfare of individual participants and ensure research integrity. The regulations that govern human subject research are based on ethical principles and guidelines that arise from issues that have occurred historically from the conduct of research with human subjects. For more information about regulations and ethical standards, see our Regulations and UO Policy webpage.

I have already completed research for a class. Now I want to use this research more broadly. What do I do?

If the initial project was intended for in-class purposes only (e.g., for a class assignment) and you now want to use information obtained for a broader purpose, the intent has shifted. If your work meets the definition of both “human subject” and “research”, you must apply for IRB review or an exempt determination. For additional information, including the definition of “human subjects research” see our Determine if your Project Requires IRB Review webpage.

I am not sure if my study needs to go through review. What should I do?

Research that meets the definition of “human subjects research” requires review. In order to determine if your research meets this definition, please complete the Human Subjects Determination Worksheet available on our Determine if your Project Requires IRB Review webpage. If you still have questions or would like formal documentation that your study is not considered human subjects research, please submit the completed form (including the last page) to Research Compliance Services via the research administration portal (RAP).

I think my research qualifies as exempt. Does that mean I do not need to submit a protocol for review?

In addition to both federal and institutional requirements, basic ethical standards apply to exempt research. Exempt research must be submitted to Research Compliance Services to verify the exempt determination and ensure these standards are met. For information on applying for an exempt determination, see our Application for Research with Human Subjects webpage.

How do I know what to submit and if I have everything?

A checklist of materials that are either required or may need to be submitted can are included within each application. Please refer to the applications and email ResearchCompliance@uoregon.edu with any questions.

If I am applying for funding when should I submit to the IRB?

Ideally, a protocol should be submitted when sufficient information about the human subjects activities covered by the grant can be included in the submission. However, some funders require documentation from the IRB that proposed human subjects activity meets federal regulatory criteria and that the investigator is aware of their obligations. In cases when the protocol activities are in development, the funder may accept documentation such documentation via an Approval-in-Principle. Research Compliance Services will work with individual investigators to ensure that appropriate review and documentation of review is available as a part of the grant application process. For additional information, see our Approval-in-Principal webpage.

What considerations do I need to make regarding informed consent?

Before involving a human subject in research, it is ethical to obtain informed consent in most cases. Unless certain criteria are met for a waiver when conducting non-exempt human subject research, informed consent is required. It is important to remember that informed consent is a process, not just a form. The process should be free of coercion or undue influence and provide information in a language understandable to the participant with sufficient opportunity for the potential participant to make an informed decision about whether to participate in the research. For more information about informed consent, including the informed consent process and documentation requirements, see our  Informed Consent webpage

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Human Subjects Education Requirement (CITI)

Who must complete humans subjects training requirements and how can that requirement be fulfilled?

All research personnel working with participants and/or identifiable participant data, as well as those unaffiliated with the University of Oregon and faculty members advising students, must be listed on the protocol and maintain current human subjects training. This requirement can be satisfied by completing either the Biomedical Researchers or the Social-Behavioral-Educational Researchers learners groups offered through CITI. These learner groups can be found under the Protection of Human Research Subjects training curriculum.

Please note, there are a wide variety of courses offered through CITI, but only the Biomedical Researchers or the Social-Behavioral-Educational Researchers courses will satisfy the training requirement for University of Oregon researchers. For more information, see our Human Subjects Education Requirement webpage.                                             

How do I access or affiliate my already existing CITI account with UO?

UO faculty, students, and staff can access the CITI Program using their DuckID through the Single Sign On. It is important to note that for the research administration portal (RAP) to access CITI training, the name and email address found on the CITI website must be an exact match to that used in the RAP.

For individuals not affiliated with the University of Oregon, CITI accounts can be created and accessed through the CITI website. Once logged in, users can select "Affiliate with an Institution" to either select or add the University of Oregon to their user profile.

If you have previously completed CITI training under another institutional affiliation, any courses in common with the UO requirement will automatically count towards completion of the UO requirement. You will need to affiliate with the University of Oregon on the CITI website and update your CITI profile with your UO email. Verify that your name and email in CITI match to what is listed in the RAP (preferred first name, last name, and UO email). For the RAP to integrate properly, the individual's first name in their CITI profile must match the preferred first name as listed in DuckWeb. The last name and email address as must match what is listed in the University of Oregon database (Banner). If you are having trouble accessing your existing CITI account, please contact the CITI Program Support Center directly at https://about.citiprogram.org/en/contact-us/.

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Working with other institutions and individuals outside University of Oregon.

I’m working with a professor at another institution and the research has already been approved by their IRB. Do I need to obtain approval from Research Compliance Services?

It is possible that the University of Oregon enter into an agreement with another institution to rely on their IRB review. If you would like to request that the University of Oregon rely on the IRB review of another intuition, see our Collaboration in Research webpage.

I have an approved protocol and would like to collaborate with an individual not affiliated with the University of Oregon. Can I add them to my protocol?

If the collaborator is affiliated with an institution has its own IRB, we will need either (a) to enter into an agreement that allows their institution to rely on University of Oregon’s IRB review, or (b) documentation of review approval from their IRB.

If the collaborator is unaffiliated with an IRB, then they will have to sign an Individual Investigator Agreement (IIA).

In either case, you will have to submit an amendment application and update any applicable protocol materials. For more information, see our Collaboration in Research webpage.

Do collaborators not affiliated with the University of Oregon need to complete CITI training?

If the individual is affiliated with an intuition that has an IRB, the University of Oregon will accept current training in accordance with their instuitional policies. If the individual is unaffiliated, they will have to complete University of Oregon CITI training requirements. Collaborators can login to the CITI website, affiliate with the University of Oregon, and complete the training required by University of Oregon researchers. Investigators do not need a university ID or email to affiliate with the University of Oregon on the CITI website. For more information, see our Human Subjects Education Requirement webpage.

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Single IRBs (sIRB)

What is a single IRB?

A single IRB (sIRB) is the IRB of record that oversees the ethical review for all sites participating in a multisite study.

When is the use of a sIRB required?

Effective January 25, 2018, studies wholly or partially funded by the NIH require the use of an sIRB for the review of all non-exempt, multi-site, domestic, human subjects research. Additionally, effective January 20, 2020, under the revised Common Rule, most federally supported or conducted cooperative studies that meet the criteria for non-exempt human subjects research and involve more than one site require sIRB review, unless:

  • Cooperative research for which more than a single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
  • Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

I have an existing NIH grant. Is that subject to the new sIRB policy?

The NIH sIRB requirement applies to all competing grant application, including new, renewal, revision or resubmission, submitted on or after January 25, 2018.

I am currently developing a protocol that involves multiple sites. How do I determine which site should serve as the sIRB of record?

This depends on a multiple number of factors including the experience and expertise of the IRB reviewing the research and funder requirements. Research Compliance Services can help determine which IRB will be the best fit for your research.

What is the SMART IRB and can I use it?

The SMART IRB is a service designed to streamline IRB review for multisite studies. The platform allows investigators and institutions to request, track, and document reliance agreements on a study-by-study basis. Although it is not a requirement, University of Oregon will use the SMART IRB agreement when possible. To learn more about the SMART IRB reliance agreement and confirm whether your collaborators have signed on, please visit www.smartirb.org.

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