IRB FAQ

1. What is the Institutional Review Board (IRB)?

The IRB is a diverse group of scientific and non‐scientific individuals who conduct the initial and ongoing review of research studies in order to ensure the protection of the rights, safety, and well‐being of human subjects participating in those studies. The federal code of regulations governs the composition and conduct of the IRB.

2. Does my project need to be reviewed?

Research

Per Rice Policy 326, determination of whether your research project requires IRB oversight has to be made by the IRB, not by the investigator overseeing the project. The requirement for OHRP-based IRB oversight can be triggered by the following criteria: 1) A systematic investigation (including development, testing, and evaluation) designed to discover or contribute to a body of generalizable knowledge and 2) “an investigator conducting research obtains data through intervention or interaction with the individual” or "an investigator obtains identifiable private information or identifiable biospecimens about human research participants".

Additionally the US FDA mandates IRB oversight can be triggered by the following criteria: 1) The involvement of one or more human research participants, 2) the study or analysis of a test article, and 3) either plans to submit data to the FDA for supporting licensure of the test article or the test article in question is a new drug or an investigative medical device.

Class Activities

Activities that are being performed in classrooms for the purposes of teaching students may or may not require IRB oversight. Instructors have been authorized to make this determination on their own. Rice IRB Staff have developed a new guidance form to help them with this process, it can be found here.

Broadly speaking, the simplest way to make this determination is by answering the questions:

1. Is my classroom activity intended to generate new information and knowledge that will be published/disseminated to people outside of the class?
2. Will my classroom activity involve human participants and/or private, identifiable information?

Your activity is likely to require IRB oversight only if the answer to both questions is yes. If the answer to either question is no, we recommend putting information into your syllabus to inform students that any information gained from human subjects cannot be shared outside of the class. Additionally, we recommend that any students interacting with human subjects and/or private information receive appropriate CITI training.

IRB Administrators are always available to help with this determination by emailing or calling 713-348-3586.

3. Can I begin my research before I receive IRB approval?

No. Research must be approved by the IRB before research can be conducted.

4. Who do I talk to if I’m not sure if my project needs to be reviewed?

Please contact an IRB Compliance Administrator (Phone: 713-348-3586 | Email: irb@rice.edu). We are happy to help you make the appropriate choice.

5. Where do I get training in the ethical treatment of human research participants?

CITI Online Training (Collaborative Institutional Training Initiative)

6. What are the types of IRB review?

IRB review generally takes one of three forms, on the basis of federal legislation. The IRB makes the determination of what level of review your project will receive.

Protocols that are Exempt are limited to minimal risk (i.e., cannot expose participants to risk beyond their daily lives). These protocols generally do not have a pre-determined continuing review period and generally do not require approval for modifications (a FAQ describing the conditions that may trigger conversion to non-Exempt status and would require pre-approval can be found here).

Expedited review is a faster review pathway (than Full Board Review) that was developed by the federal government to simplify IRB review. These protocols generally receive a 5 year approval period, but require official approval for any modification. (Please note that this is a regulatory category. Requesting that your research be reviewed on an expedited basis will not speed the review; all matters are reviewed in order of receipt.)

Full Board Review is for the most complicated and risky studies or studies that may not meet criteria for Exempt or Expedited Review. These protocols generally require annual continuing review.

7. What is the average turnaround time for a protocol to be reviewed?

IRB protocols are reviewed on an ongoing basis. Protocols that meet criteria for an Exempt or Expedited status are typically reviewed by an IRB Administrator within approximately 1 week. Provided that the protocol is complete, it will be submitted to a member of the IRB for review. This typically occurs within about 5-7 business days. Protocols that must be reviewed at a convened meeting of the IRB are typically scheduled for the next appropriate convened IRB meeting. Meetings occur monthly during academic year and on an ad hoc basis during the summer. Please note that turn‐around time is dependent on the completeness of the application submitted and the PI’s responsiveness to questions and requests from the reviewers.

All timelines are approximate. Review times may be slower during times of high submission volume, staff vacation, and official university closures. All material submitted to the IRB (emails, responses to requests for additional information, initial studies, modifications, continuing reviews, etc) is reviewed in the order received.

Although the IRB may be able to meet short deadlines to accommodate funding or course-related issues, this can not be guaranteed. Complete, well-written protocols (i.e., those that include all required documents and that address all scientific and research ethics issues and hence do not require requests for additional information or clarification) will be reviewed more quickly.

8. If I submit a grant proposal, do I have to propose and submit a protocol?

You may submit an IRB protocol at the time you submit a grant proposal. Depending upon the sponsor, you may also wait until you know if you will receive the award. Please note that the Office of Sponsored Research (OSR) will not release the funding until there is an approved protocol. You will also need to include your research plan/scope of work submitted with the grant proposal with your IRB application as well.

9. Do students’ academic research projects require IRB approval?

Student research projects require oversight on the same case-by-case basis as other research (see Question 2, above). If the project involves human subjects, whether of a biomedical or social‐scientific nature, approval by the IRB prior to initiation is likely necessary. Please note that student researchers generally do not qualify for PI status under Rice Policy 301, so they must work with a faculty advisor (who serves as the Principal Investigator) for each research project.

10. Why do you talk about “human research participants”? Is this the same as “human subjects”?

The phrases “human subjects” and “human research participants” can be used interchangeably. “Participant” is the preferred term, as it reflects the perspective that research participants are partners in the review process.

11. Who can sign the consent form on behalf of a minor or other subject incapable of giving consent?

A minor participant or a participant considered incapable of providing meaningful consenting on his or her own behalf requires consent by a legal representative. This can be a parent, a court-appointed guardian, or an individual with power of attorney. When minors participate in research, consent must generally be given by a parent or legal guardian and typically the minor must give assent.

12. Is an English consent document acceptable when enrolling non‐English‐speaking subjects?

Regulations require that participants receive an Informed Consent in a language that they can understand so that they can provide meaningful consent. As such, it will depend on the nature of the protocol and the research in question. Generally, regulations require at least an automated translation should be provided in the participant's preferred language, and they should also be provided with an English copy for their reference. If the prospective participant is fluent in English, the consent document should be in English. Translated consent and assent fomrs, as well as surveys, interview questions, etc., must be submitted for IRB review. Use of a translator is allowed to facilitate conversation with the participant, but ad hoc translation of the consent document is not permissible as a substitution for a written translation.

13. How do you obtain consent from someone who speaks and understands English but cannot read?

Illiterate persons may have the consent form read to them and “make their mark.” Regulations require the signature of a witness to the consent process and the signature of the person conducting the consent interview. In this case, investigators need to take extra care only to enroll who have evidenced clear understanding and are giving meaningful consent.

14. If I make any changes in my protocol does the IRB have to review and approve it again?

It depends.

For protocols that are Exempt, changes to personnel or research do not require a modification to be filed unless it will result in your protocol becoming non-Exempt. An FAQ has been prepared and can been accessed here for assistance in determining whether changes would render the protocol non-Exempt.

For non-Exempt protocols, modifications are always required and must be filed in Cayuse IRB. For these protocols, any changes to your protocol must be reviewed and approved by the IRB prior to the implementation of those changes.

15. How does IRB review of modifications work? Do you review my whole protocol?

The IRB and IRB Administrators comprehensively review IRB protocols, both when modifications are submitted and potentially at other times as well. This is done to ensure that the protocols remain consistent with changes to regulatory requirements, IRB practices and policies, and to ensure that research remains consistent with the principles of The Belmont Report. As such, IRB Administrators may require changes to parts of your IRB protocol that you have not changed recently. We will endeavor to ensure clear justification for requiring these changes when you are contacted about making the changes.

16. Is IRB research subject to ongoing review?

Yes. Federal regulations require that certain research protocols be subject to what is known as Continuing Review. In these cases, the IRB reviews the status of the research, comprehensively looks at any incident reports that have been filed, and re-evaluates the risks and benefits of the research to ensure that it continues to meet approval criteria. Additionally, IRB regulations require evaluation of any incidents that occur during the research practice. Finally, IRB regulations are subject to legislative changes. These changes may necessitate reconsideration of previous review of IRB protocols. Federal regulations also provide IRBs with the authority to observe, or direct the observation by a third party, of consent and research practices, at their discretion.

17. Do I need IRB approval if my work will be conducted outside of the campuses? Do I need IRB approval if my study is already approved by another IRB?

Yes. To ensure that investigators comply with federal and university regulations, it is important that the university, through the IRB, be aware of where and by whom such research is being done, even if it is done in a foreign country. Formal approval still must come from a human subjects review panel in the host institution or country. This approval must then be received and approved by the Rice IRB. Be mindful of any laws or federal regulations that may govern human subjects research in foreign countries.

18. What happens if I conduct human research without IRB approval?

Many journals will not publish materials that have not undergone the appropriate IRB approval process, which may limit your ability to publish your research. Additionally, you will be out of compliance with Rice University and federal requirements for human subject research. This can result in university and/or federal sanctions that will prevent you from conducting human subject research and may jeopardize Rice's human research certification.

19. Who should I contact if I have a problem?

The first point of contact is usually an IRB Administrator by email or by phone (713-348-3586). If this does not address your concern, you may contact the IRB Chair, the Associate Vice President for Research Integrity, or the Executive Vice President for Research.