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 other types of reviews that may need to be conducted to enable me to begin my work?

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?

What is a cultural consultant and when is one required to review 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?

The Brown HRPP offers comprehensive guidance and resources to help you determine if your project requires IRB review. Please visit our page, "Does my Project Need IRB Review?" to help you make this determination.

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.  Since completion of required training must be in place before the IRB may approve or grant exemption for your study, the Brown HRPP strongly encourages you to complete any requisite training before submitting an application to the Brown IRB. In fact, completing the training *should* help you write a stronger IRB application which will lead to a faster review! Please review our CITI Instructions and Policy on Education in the Conduct of Human Subject Research for more information.

Are there any other types of reviews that may need to be conducted at Brown by other offices or committees to enable me to begin my work?

Yes! There are other committees that review research at Brown.

The Institutional Biosafety Committee (IBC) oversees research involving human source material, including blood, body fluids, tissues and/or cell lines, infected clinical specimens or biologically contaminated specimens. If this applies to your human subject research activities, then you will need to submit a Biological Research Authorization to the IBC in addition to obtaining IRB approval. To learn more about the IBC and access its application(s), please click here.

The Radiation Safety Committee (RSC) oversees research involving the use of radiation at Brown. To learn more about the RSC and access its application, please click here.

The Athletics Department reviews research involving Brown's student athletes. When your study involves this special population, contact Colleen Kelly ([email protected]), Assistant Director of Athletics for Admission and Financial Aid. All research studies must be submitted by the last day of each month to ensure they are reviewed by the Athletics Department Compliance Office on the 2nd Monday of the following month.

Brown's Computing and Information Services (CIS) requires that all data be categorized in accordance to its Data Risk Classifications. When completing an IRB Application, you will need to identify the corresponding Risk Level of your data and ensure that the environment in which you plan to maintain your data meets CIS' Minimum Security Standards for Servers (included on the Data Risk Classifications webpage).

If your data are classified as Risk Level 2 or 3, when your IRB Application is received the HRPP will forward it to CIS for a security review. CIS will follow up with you directly with any questions. If you intend to use a Mobile App or select "Web-Based Other" in your IRB Application and CIS has not previously reviewed the app or the web-based tool, then your Application will be forwarded to CIS for its review. As such, we encourage you to work proactively with CIS before you submit your IRB Application, or contemporaneous with your submission, to facilitate the CIS review and approval process. Of note, currently the HRPP/IRB will not withhold or delay IRB approval while awaiting CIS' review. However, if CIS' review results in re-categorization of Risk Level to a higher Risk Level than what was approved in your IRB Application, it is the PI's responsibility to contact the HRPP and amend the study application accordingly.

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

Yes. The Expedited/Full Board IRB Application is the application to use for new, non-exempt research studies. The Application for Exemption must be used for studies that meet the criteria for an Exempt submission.  The Amendment form must be used for modifications to Expedited and Full Board studies. Looking to relinquish IRB review to another study site or have them cede review to Brown? Use our IAA Application.  Undergraduate work should be submitted using our Undergraduate Project Application if determined necessary after you review our Guidance on Undergraduate Work Involving Human Subjects.

Please ensure you download application forms from the Forms & Templages web page EACH time you submit. All forms are periodically reviewed to meet changing regulatory or other requirements.  Submissions using forms that are outdated will not be accepted.​

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 participants 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.

The investigator has 45 calendar days from the date of the last communication from the HRPP with review comments to respond. If no response is received within 45 calendar days of that communication OR the response received is incomplete (i.e., the response doesn't address all review comments received), then the application will be withdrawn by the HRPP. It is the PI's responsibility to then submit as a new IRB Application using the HRPP's current application forms. Limited exceptions to this policy may be considered under extenuating circumstances. 

For additional information about review turn-around time, please visit our landing page for the latest information regarding our current protocol review times. Dates are updated every Friday by the end of the day.

What is a cultural consultant and when is one required to review my study?

If your research will take place in a foreign country or will take place in the U.S. but involve a unique population (for example, Little Haiti in Florida), your study will be reviewed by a cultural consultant. The HRPP will identify an appropriate cultural consultant during its review; you are welcome to recommend an appropriate consultant for the HRPP's consideration if you know of one. (You are also encouraged to contact the HRPP if you would like to volunteer to serve as a cultural consultant on others' studies!)

The cultural consultant will assess the study's sensitivity and awareness of the national, cultural, and/or linguistic group of the study site and population. Sensitivity can be shown through knowing the local language, using an appropriate manner of communication, and being attentive to cultural norms and mores, religious beliefs and practices, family structures and dynamics, community decision-making patterns, and class consciousness and socioeconomic realities.

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. Undergraduate work should be submitted using our Undergraduate Project Application if determined necessary after you review our Guidance on Undergraduate Work Involving Human Subjects.

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. Please visit our Exemption Categories web page to learn more about which categories meet exempt criteria.

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.

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 our IRB Guidance & Policies page for NIH Policy on Single IRB (sIRB) Review.

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 our IRB Guidance & Policies page for Preparing a Complete IRB Protocol Sections III & IV and our Forms & Templates page for our 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 our IRB Guidance & Policies page for Does my Project Need IRB Review? Section I(B) 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.