IRB FAQs

How do I know if I'm conducting human subjects research?

Are there any training or education requirements before conducting human subjects research?

Are there any forms or templates I can use for submissions?

How long will it take for me to obtain approval to do my study?

When may I begin my study?

Do projects conducted by Brown students (undergraduate, graduate, or medical) need IRB approval?

I've heard that the federal regulations make certain categories of research exempt.  If my research fits into one of these categories, does this mean that I don't need to submit anything to the IRB for review?

Do I always have to obtain the informed consent of the research participants?

What is an IRB Authorization Agreement (IAA) or Reliance Agreement?

What steps do I need to take for IRB approval as an Advance-CTR award recipient?

What does it mean for an institution or organization to be “engaged” in a study?

What do the terms “consent,” and “assent” mean? Are they the same thing?

My research will be done in another country. Do I have to obtain IRB review and approval from Brown?

Is it true that I need IRB review even if I am only conducting interviews or surveys, analyzing data, or simply observing people, instead of a medical experiment?

Do I need IRB approval if my research does not have funding or is funding through Brown?

What's the best way to keep track of my approved consent documents?

 

How do I know if I'm conducting human subjects research?

In order for your project to be considered human subjects research, and thus require IRB review, both definitions of “research” and “human subjects” must be met.

Research is defined by federal regulations at 45 CFR 46.102 (Protection of Human Subjects 2009), as "a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

  • Researchers need to have constructed a research plan with ideas about what they want to learn and how best to do that. 
  • The potential publication of results is sometimes used, inaccurately, as the main indicator that a project meets the definition of research. It is the intent and design of the project that matters.

A Human Subject, according to the federal regulations at 45 CFR 46.102 (Protection of Human Subjects 2009), is a "living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

  • Research about deceased people does not meet the definition of research with human subjects.
  • Some research that involves interactions with living individuals does not meet the regulatory definition of research with human subjects because the focus of the investigation is not on the opinions, characteristics, or behavior of the individual. Instead, the individual is asked to provide information about something; “About What” questions rather than “About Whom” questions.

For additional information about human subjects research and these definitions, please visit Does My Project Need IRB Review?.

Are there any training or education requirements before conducting human subjects research?

Yes. All principal investigators, advisors on graduate/medical student projects, and research staff who interact with human participants or have access to identifiable private information must have active certification in the Brown University Education Program in the Protection of Human Research Participants.  Brown uses the Collaborative Institutional Training Initiative (CITI) for this certification.  Although certification is not required before submission of your protocol, certification must be in place before the IRB may approve or grant exemption for a study. This certification must remain active during the entire life of the study.  Continuing education is required every 3 years.

For additional information regarding Brown’s training requirements, please visit the Brown Human Research Protections educational requirements page.

Are there any forms or templates I can use for submissions?

Yes. The IRB Form #1 and Protocol Checklist are the cover pages for the submission of all new, non-exempt research studies. The IRB Form #2, Application for Exemption is a fillable form for studies that are believed to be exempt from the regulations.  The Amendment form is the cover page for all amendment submissions.

Check the HRPP website often for new forms and templates, as they will be added when available and may be revised periodically.

How long will it take for me to obtain approval to do my study?

Turnaround time depends on several factors, including the completeness of the submission, the nature of the study, and the characteristics of the people to be included in the study.  The speed at which the investigator responds to HRPP/IRB questions and requests also has a big impact on the turnaround time.  Our goal is to review and respond to all submissions within two weeks of receipt.  Turnaround time may also vary depending on the time of year and the number of submissions in the queue.

For additional information about review turn-around time, please visit When will I hear from the IRB about my study?.

When may I begin my study?

You must receive written documentation of approval or determination of exemption from the IRB/HRPP before beginning any human subjects activities including participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRB approval or exemption.

Do projects conducted by Brown students (undergraduate, graduate, or medical) need IRB approval?

It depends on whether the student project is intended to be an educational exercise or a project that fits the definition of research with human subjects. Brown University considers graduate thesis and dissertation work to meet the definition of “research,” and requires IRB review if they involve human subjects. Undergraduate thesis work may or may not meet the definition of research, depending on the intent and design of the project.

Please visit Do Undergraduate projects need IRB review?

I've heard that the federal regulations make certain categories of research exempt.  If my research fits into one of these categories, does this mean that I don't need to submit anything to the IRB for review?

No. Federal regulations are clear that it is not up to the investigator alone to determine if a project is exempt. Brown University policy requires that all human subjects research receive IRB review. However, in January of 2017, the Brown University HRPP released a new policy and application form for research that may be exempt from the federal regulations.  This new application procedure should reduce the burden of investigators conducting minimal risk research that meets the criteria for exemption under university policies and federal regulations.

For additional information regarding exempt research, please visit Categories of EXEMPT REVIEW and Exempt Determinations.

Do I always have to obtain the informed consent of the research participants?

In general, yes, but there are some exceptions. The IRB has the authority to waive some or all federal requirements for informed consent in certain circumstances.  The Brown IRB is responsible for ensuring that basic ethical principles are followed.  The expectation that informed consent of research participants is obtained is based upon the Belmont principle of respect for persons, and regarded as extremely important in conducting ethical research.

Please visit Consent Form Template and Guidance

What is an IRB Authorization Agreement (IAA) or Reliance Agreement?

An IAA is an agreement between IRBs or ethics committees when a study involves more than one engaged institution. This agreement is used to reduce PI burden by submitting to as few review committees as possible. If your study involves more than one IRB, you can request an IAA with your submission or contact HRPP to discuss the possibility of an IAA.

Please visit What about IAAs (Reliance Agreements) for collaborative research?

What steps do I need to take for IRB approval as an Advance-CTR award recipient?

It is a shared goal among all Advance-CTR collaborating sites to minimize duplicate review of human subject research protocols.  This is currently accomplished via the facilitation of IRB Authorization Agreements (IAAs). The Brown University IRB (and as applicable, other collaborating site IRB(s)] will subsequently accept the review and approval by the partner IRB, cede oversight of the research to the collaborating IRB (affirming that the partner IRB is the "IRB of record"), and formally document this acceptance via an IAA, thereby circumventing time-intensive duplicate review by multiple IRBs. 

If you are already conducting human subject research in accordance with an existing IRB-approved protocol at the time when the Advance-CTR funding is awarded, you must decide whether the more appropriate approach is to amend an existing protocol or submit a new protocol, to enable the newly funded activities to be approved by the IRB and a grant congruency review conducted by the human research protection office.

If the new funding from Advance-CTR does not align with the aims of an existing protocol, or the project is intended to be a pilot study, submitting a new IRB protocol may result in faster review and approval. It may be that while the existing IRB approval requires full board or expedited review, a new protocol for a pilot study may qualify for an exempt determination (or even be non-human subject research).  

What does it mean for an institution or organization to be “engaged” in a study?

An “engaged” institution or organization is one that receives federal funding and/or is involved in any human subjects research activity. Research activities can range from enrolling participants to direct interaction with participants or receiving potentially-identifiable data or materials.

Visit this link to review the Office of Human Research Protections (OHRP) guidance on the Engagement of Institutions in Human Subjects Research (2008).

What do the terms “consent,” and “assent” mean? Are they the same thing?

Sometimes the word “consent” is used to include consent and assent. In research involving adults, “consent” is obtained from the participant to participate in the study. In research involving minors, a parent must consent to allow their child to participate in the research, and children who are able to understand information about participation are asked to “assent” or agree to participate as well. Assent documents can also be used for participants with cognitive impairments.

Please visit Consent Process for further clarification; Children in Research as well as Consent Templates

My research will be done in another country. Do I have to obtain IRB review and approval from Brown?

Yes. You must get Brown IRB approval if you are conducting your research under the auspices of your role at Brown, regardless of where the research takes place. You should also be aware that your project may need approval from an IRB or ethics committee in the international setting. An international review may add significant time to the approval process. You can contact HRPP if you are unsure if your international research site requires IRB review.

Is it true that I need IRB review even if I am only conducting interviews or surveys, analyzing data, or simply observing people, instead of a medical experiment?

Yes, as long as your research involves collecting data or information from and/or about living individuals, you need to have it reviewed by the IRB.

Please visit Data about living individuals through intervention or interaction

Do I need IRB approval if my research does not have funding or is funded through Brown?

Yes, all research involving human subjects conducted under the auspices of Brown University must be approved by the IRB regardless of funding source.

What's the best way to keep track of my approved consent documents?

HRPP staff scans and uploads your approved consent documents into Coeus Lite, in the Other Attachments tab. When consent or assent documents are revised with an amendment request, we replace the previous version with the most recently approved version.  Principal investigators have automatic access to their protocols in Coeus Lite and they can delegate access to research staff.  Besides having ready access to the most recently approved consent documents, PIs have access to all their other protocol information, including approval and expiration dates and actions taken on the protocol (amendments, renewals, etc.).

Please visit the Coeus IRB Protocols page for additional information and instructions.