IRB FAQ

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. (Title 45)

Does my project need to be reviewed?

The IRB is only charged with reviewing research that involves people as research participants. Your project needs to be reviewed if it meets the following criteria: 1) The research is a systematic investigation (including development, testing, and evaluation) designed to discover or contribute to a body of generalizable knowledge. 2) It involves human participants. Human participants include those who are actively involved in the research process (being interviewed, filling out surveys, etc.). They also include those who may not be in front of us: those who provided medical samples, left records of their activities through applying for marriage licenses, etc. The IRB reviews research that involves living individuals (1) about whom “an investigator conducting research obtains data through intervention or interaction with the individual” or (2) which obtains “identifiable private information”(Title 45 CFR, Part 46.102.f). Secondary data analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB.

Can I begin my research before I receive IRB approval?

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

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

Please contact an IRB Compliance Administrator: Stephanie Thomas (Phone: 713-348-3586 | Email: irb@rice.edu)

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

CITI Online Training (Collaborative Institutional Training Initiative)

What are the types of IRB review?

There are three types of IRB review: Exempt, Expedited and Full Board. The level of review depends on the risk to the human participants. The IRB makes the determination of what level of review your project will receive. - Exempt: Studies that meet explicit criteria set forth by the federal regulations. - Expedited: Studies that involve minimal risk and meet explicit criteria set forth in federal regulations. - Full: Studies that do not meet criteria for Exempt or Expedited Review and are usually greater than minimal risk are reviewed by the Full Board. Examples are studies that involve vulnerable populations or questions of a sensitive nature.

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

The Full Board meets monthly during the academic year to review protocols that are above minimal risk. Expedited Reviewers review protocols that meet the criteria for Exempt or Expedited status with an average turnaround time of three (2) weeks. 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.

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

You can 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.

Do students’ academic research projects require IRB approval?

If human subjects are involved, yes. Student research that involves human subjects, whether of a biomedical or social‐scientific nature, requires approval or granting of exemption by the IRB prior to initiation. Please note: student researchers are required to work with a faculty advisor (who serves as the Principal Investigator) for each research project.

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.

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 mentally incapable of consenting on his or her own behalf requires consent by a legal representative. This can be a parent, court appointed guardian or individual with power of attorney. When minors participate in research consent must be given by a parent or legal guardian and often assent must be given by the minor.

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

Study participants must be given a copy of the consent to be used as a reference document and to reinforce their understanding of the study. Regulations require that the consent document must be in language understandable to the participant. When the prospective participant is fluent in English, the consent document should be in English. However, when the participant is non‐English‐speaking, the PI should submit a translated consent form for IRB review. While a translator may be used to facilitate conversation with the participant, routine ad hoc translation of the consent document may not be substituted for a written translation.

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 a signature of a witness to the consent process and signature of the person conducting the consent interview. Investigators should not enroll participants who may not truly understand what they have agreed to do.

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

Yes. Any changes to your protocol must be reviewed and approved by the IRB prior to the implementation of those changes. You will need to submit a modification package in IRBNet for the applicable project you are amending.

Does the IRB continue to review projects once they have been approved?

Yes. The IRB is required by law to conduct continuing review of research. Requests for Continuing Review must be filed each year. Projects that were reviewed by exempt review have to be renewed every 5 years.

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.

What happens if I conduct human research without IRB approval?

You will be out of compliance with Federal requirements for human subject research. This can result in Federal or Rice University actions that will prevent you from conducting human subject research and will jeopardize the Rice human research certification. In addition, many publications will not publish materials that have not undergone the appropriate IRB approval process.