Questions?

Our staff are happy to assist you!

Lara Kuhn
Assistant Director, Research Integrity

Marissa Wick
Senior Research Integrity Administrator

(781) 736-8133

irb@brandeis.edu

Frequently Asked Questions

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GENERAL QUESTIONS

What is Human Subjects Research?

For your project to qualify as human subjects research, it must meet the Federal Regulations definitions of both research and human subject:

Research is a systematic investigation designed to develop or contribute to generalizable knowledge.

A Human Subject is a living individual about whom an investigator obtains one or both of the following:

  1. Data through intervention or interaction with the individual

  2. Identifiable private information about the individual.

 For more details (including pertinent definitions) regarding what human subject research is, see the IRB’s Defining Human Subjects Research page

May I start any research activities before I receive approval from the Brandeis University IRB?

No. You absolutely may not begin any research activities until you have received Brandeis University IRB approval. This includes recruitment of subjects, data collection, data analysis (including anonymous data), and pilot studies where the investigator plans to use the pilot study data for future research projects.

 Note that if you are collaborating with another institution that has received IRB approval, you still may not begin any research related activities until you have received Brandeis University IRB approval. 

What is the difference between anonymous and confidential data?

Anonymous data are recorded in such a way that no identifier of any kind exists which link a subject’s research data to that subject. When data is recorded anonymously, not even the investigator can link the subject with the subject’s research data.

Confidential data are recorded in such a way that identifiers of some kind do exist which link a subject’s research data to that subject. When data are recorded confidentially, the investigator (and/or others) can (or could) identify the subjects, such as through a code and master list that links that code to the subject’s identity. This applies even when the code and master list are stored in a secure location, such as encrypted files. 

Am I allowed to use deception in my human subjects research?

Yes. However, the use of deception must be justifiable – a complete explanation of why deception is required for your research must be included in your protocol. In addition, the use of deception requires additional precautions such as debriefing of the subjects once the participation of the subject or the research project is complete.

Note that no research involving deception can qualify for exempt status or expedited review, but must undergo a full committee review. 

Can my research be retroactively approved by the IRB?

No. Any subject recruitment, data collection, data analysis (including anonymous data), or pilot studies completed before IRB approval may not be used for your project. 

What should I do if my research involves rDNA, biological materials (e.g. infectious agents, allergens, blood, fluids, tissues, or cell lines from humans or animals), or other potentially hazardous agents?

If your research involves any of these, it will require approval from the Institutional Biosafety Committee (IBC) before you can submit it for IRB review. For more information regarding the IBC and its procedures and processes, see the IBC website. Be sure to give yourself enough time for your application to go through both committees before your research will begin. 


TRAINING REQUIREMENTS

Are there any training requirements for conducing human subjects research at Brandeis University?

Yes. Training is an important part of the IRB’s Human Subjects in Research program at Brandeis and we are pleased to offer a convenient, customized online training program through the University of Miami’s Collaborative Institutional Training Initiative (CITI).

Undergraduate students, graduate students, and postdoctoral fellows are required to complete the online CITI training program prior to the IRB’s review of their protocol. 

See the IRB’s Training page for more details. 

I’ve already completed CITI training for another institution – do I need to repeat it before I can do research at Brandeis University?

Yes and no. If you have completed the CITI training for another institution, go to the CITI training site and change your affiliation to Brandeis University; any portions of your previous training that overlap with the Brandeis training modules will be noted as “complete” and you will not be required to complete them.

For more information on the CITI training and how to complete it, see the IRB’s Training page

Does the IRB office offer any additional training opportunities to faculty, staff, and students?

Yes. The IRB office offers a workshop series to which all students, staff, and faculty members are invited. The workshop guides participants through the steps of assembling an IRB protocol, and participants will have the opportunity to have specific questions answered.

In addition, IRB office staff are available to visit undergraduate and graduate classes and provide information to students regarding human subject research and the IRB review process.

Finally, the IRB staff are always available to answer any questions you have – feel free to call (781-736-8133) or email (irb@brandeis.edu) with questions or to set up a time to meet individually. 


DOES MY RESEARCH REQUIRE IRB REVIEW...?

How do I know if my project qualifies as human subjects research?

Your project qualifies as human subject research if it meets OHRP’s definitions for both research and human subjects:

Research is a systematic investigation designed to develop or contribute to generalizable knowledge.

A Human Subject is a living individual about whom an investigator obtains one or both of the following:

  1.  Data through intervention or interaction with the individual
  2.  Identifiable private information about the individual.

For more details (including pertinent definitions) regarding what human subject research is, see the IRB’s Defining Human Subjects Research page

How do I know if my project requires IRB approval?

Your project requires IRB approval if it:

    1) Is being conducted under the auspices of Brandeis University

                          —and—

    2) It meets the Federal Regulations definitions of both research and human subjects:

Research is a systematic investigation designed to develop or contribute to generalizable knowledge.

A Human Subject is a living individual about whom an investigator obtains one or both of the following:

    1) Data through intervention or interaction with the individual

    2) Identifiable private information about the individual.

For more details (including pertinent definitions) regarding what human subject research is, see the IRB’s Defining Human Subjects Research page

My research is not being funded – does it still require IRB approval?

Yes. All human subject research conducted at Brandeis University or by Brandeis University representatives (faculty, staff, postdoctoral fellows, or students) must be reviewed by the Brandeis University IRB. 

My research is being funded by a private foundation – do I still need IRB approval?

Yes. All human subject research conducted at Brandeis University or by Brandeis University representatives (faculty, staff, postdoctoral fellows, or students) must be reviewed by the Brandeis University IRB. 

Do class projects require IRB approval?

Generally speaking, class assignments (excepting dissertations and masters or honors theses) will not meet the definition of human subject research. If the data collected will not be shared outside of class, IRB review is not necessary. Note that this data may at no time be presented or published outside of the class and that IRB approval is never retroactive – if a student hopes to present his/her findings in, for example, a poster session, s/he will need to have IRB approval before beginning the research project. 

Does my thesis/dissertation human subject research require IRB approval?

Yes. It is generally assumed that theses and dissertations will meet the Federal Regulations definition of research (a systematic investigation designed to develop or contribute to generalizable knowledge) and as such, will require IRB approval. 

My research consists only of the use of a survey – does it require IRB approval?

Yes. A survey is an example of an intervention or interaction. 

My research will not involve the collection of identifying information – does it require IRB approval?

It may, if your research involves an intervention or interaction with the subjects.

For help in determining whether your project is human subjects research requiring IRB review, see the IRB's IRB Review Determination Tree. If still in doubt, contact the IRB office for help. 

My research involves only the use of existing data – does it require IRB approval?

It may, if the identities of the human subjects can be ascertained in the data, documents, records, or pathological specimens you receive (regardless of whether you record the data in such a way that the identities of the subjects can not be ascertained).

If the data you receive has been stripped of all identifying information prior to your receiving it and you have no way of re-identifying the information, it does not qualify as human subject research and does not require IRB approval.

For help in determining whether your project is human subjects research requiring IRB review, see the IRB's IRB Review Determination Tree. If still in doubt, contact the IRB office for help.

My research involves collaboration with a colleague at another institution – is IRB approval required at both institutions?

Generally speaking, when an investigator engages in human subject research, IRB approval is required from that investigator’s institution, regardless of where the research takes place. However, if the investigator is collaborating with a colleague from another institution, either IRB may, in certain situations, cede review and approval to the collaborating institution. In this case, an Institutional Authorization Agreement (IAA) may be arranged to establish one IRB as the designated IRB of record. 

My research will take place outside of the United States – is IRB approval required from Brandeis University?

Yes. When an investigator engages in human subject research, IRB approval is required from that investigator’s institution, regardless of where the research takes place. Note that your research may require IRB approval from the IRB (or its local equivalent) used by the international site in addition to Brandeis University’s IRB approval. Please contact the IRB office for guidance on how to proceed.

I believe my research falls under the exempt category of IRB review – does this mean I do not have to receive IRB approval to conduct my research?

No. Investigators may not make the determination that their own research is exempt – only the IRB can make the determination that research is exempt from IRB review.  Investigators engaged in human subject research that qualifies for exempt status must still complete an Exempt Research Form (as well as a Modification Form when appropriate, and a Final Report and Termination Form at the conclusion of their research). 

For a list and explanation of exempt categories see the IRB’s Research Review Categories page.


THE APPLICATION

I am an undergraduate student, graduate student, or postdoctoral fellow – may I serve as a Principle Investigator?

No. All human subject research conducted by undergraduate students, graduate students, and postdoctoral fellows require a faculty or staff member to serve as Principle Investigator. This faculty or staff member serves as research advisor and certifies s/he will provide direct supervision and guidance and assume final responsibility for the conduct of the research. 

What is a research protocol?

A research protocol is a detailed plan for conducting research and makes up the bulk of your IRB application. For detailed information of what is included in a research protocol, see the IRB’s IRB Initial Application Guide & Checklist.

What is involved in putting together an IRB application?

The Brandeis University IRB office has put together an IRB Initial Application Guide and Checklist that will walk you through the assembling of your application.

You can find more detailed information, as well as the necessary forms, at the IRB’s Forms and Instructions page. 

How do I submit my research application to the IRB?

All forms are available on the IRB’s Forms and Instructions page and should be filled out online. Once you have compiled all the necessary elements, they should be submitted (as a single pdf file) to the IRB electronically via email (to irb@brandeis.edu). In addition, a hard copy with required signatures must be submitted to the Office of Research Administration (Bernstein-Marcus, room 121 or MS 116). 

Are there any specific criteria the IRB uses for review of research applications?

Yes. The IRB will pay close attention to whether the risks are sufficiently minimized and reasonable relative to the anticipated benefits, the equitability of the subject selection, the informed consent procedures and documentation, the safety of your data storage plan, the provisions for the privacy of subjects and confidentiality of data, whether appropriate safeguards are in place if your subjects include a vulnerable population.

For a more detailed answer, see the IRB’s Criteria for Review page

I am applying for grant funding to conduct my research – should I wait until my funding has been awarded before submitting an application to the IRB?
No. The research protocol should be written in conjunction with the grant proposal and submitted simultaneously. Funding agencies will often not officially award a grant before IRB approval has been obtained.
Are there any guidelines on what to do with my data once it has been collected?

Yes. Brandeis University has issued the Brandeis University Information Security Plan. All human subjects investigators should make themselves familiar with this plan and follow the recommendations for how to handle and store collected data. 

How do I know which review category my research falls under?

For a detailed description of the review categories, see the IRB’s Review Categories page

How do I submit my application for review?

For an application to be considered submitted, you must 1) send a complete application (as a single pdf file) to the IRB office at irb@brandeis.edu and 2) either bring a signed hard copy of the complete application to the IRB office in the Bernstein-Marcus Administration building, room 121 or send it via campus mail to MS 116. Note that the IRB office must receive both copies for the application to be considered submitted.


INFORMED CONSENT

What does “informed consent” mean?

Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research. The primary purpose of informed consent is to protect the prospective human subject.

For more information on informed consent, see the IRB’s Informed Consent page

How do I write an informed consent form?

The informed consent form documents the information regarding the research which the subject has been given, and his/her agreement to participate in the research. 

For guidelines on how to create an informed consent form, see Elements of Informed Consent and Sample Informed Consent Form.

Must I always use an informed consent form?

No. A waiver of documented informed consent may be granted by the IRB in certain circumstances. However, in such cases, must give verbal informed consent and an information sheet similar to the informed consent form is often required.

For more information on informed consent requirements, see the IRB’s Informed Consent page

What is the difference between consent and assent?

Minors (non-emancipated individuals <18 years old) may not give legal informed consent. In research involving minors informed consent must be obtained from the minor’s parent or guardian. This does not mean that the minor has no say in whether they participate in the research, however. In cases where the minor is able to understand what his/her participation would entail, informed assent must be obtained from the minor.

For further guidance on informed consent and research involving minors, see the IRB’s Informed Consent page


THE IRB REVIEW

When is the next deadline for submitting my IRB application?

To see all submission deadlines and meeting dates, please see the IRB’s Dates and Deadlines page.

Note that only protocols that involve greater than minimal risk are subject to these deadlines. All other protocols are reviewed on a rolling basis and may be submitted for review at any time.

What does exempt research mean?

The term exempt means the research is exempt from some of the Federal Regulations. Note that exempt research continues to be subject to state laws, institutional policies, and the requirements for ethical research. If your research falls under one of the six exemption categories, your application will not require full committee review and will be reviewed on a rolling basis.

For a list and explication of the review categories, see Categories of Review

What does expedited research mean?

The term expedited means the research does not require full-committee review and can therefore be reviewed on a rolling basis by a subset of the IRB committee. Note that it does not mean the application will be fast-tracked.

For a list and explication of the review categories, see Categories of Review

What happens after I submit my application?

IRB staff will initially inform you of their receipt of your application after it has been submitted both electronically and as hard copy. Your protocol will be pre-reviewed by IRB staff, who may contact you with required revisions. Once these revisions are complete, the application will be reviewed by the IRB committee. IRB staff will inform you if your protocol has been approved or requires further revisions. Note that you may not begin your research project until after final IRB approval has been received.

For more detailed information regarding the review process see the IRB’s Research Review Process page

I have submitted my application – how long will the review take?

From submission to approval, this process usually takes between two and three weeks for exempt* and expedited* research, though if extensive revisions are required, this timeline could be extended.

*Note that exempt does not mean the application does not require IRB review, and that expedited does not mean the application will be fast-tracked; they simply do not require full committee review and can be therefore be reviewed on a rolling basis.  

For applications that require full committee review, the length of time will also depend on whether your application was received before the deadline for the next IRB meeting (see the IRB's Dates and Deadlines page). If it has, the process usually takes between four and five weeks. 


POST-APPROVAL ISSUES

My IRB approval has an expiration date– what must I do if my research is continuing beyond the expiration date?

If your research will continue beyond the IRB approval’s expiration date, you must submit a continuation request. Note that your request must be approved before the initial/former approval form’s expiration date or your research must cease until IRB approval of your continuation request – be sure to submit your continuation request with this in mind.

If you continue to recruit subjects, collect data, or analyze data after the expiration date and before your request has been approved you will be out of compliance.

You can find more detailed information, as well as the necessary forms, at the IRB’s Forms and Instructions page. 

What happens if I am making changes to my research plan as outlined in my approved protocol?

If you plan to make changes to your research plan as outlined in your approved protocol, you must submit a modification request. Note that this request must be approved before the implementation of the changes (except where changes are necessary to eliminate apparent immediate hazards to subjects) – be sure to submit your modification request with this in mind. If you implement changes before IRB approval, you will be out of compliance.

You can find more detailed information, as well as the necessary forms, at the IRB’s Forms and Instructions page. 

What are examples of changes to my research plan (as outlined in my approved protocol) that require IRB approval?

Some examples of changes include (note that this list is by no means exhaustive):

  • Change in PI
  • Addition or removal of personnel
  • Change in number of enrolled participants
  • Changes to the procedures or study design
  • Changes to the study instruments (surveys, questionnaires, etc.)
  • Changes to the Informed Consent Document or procedures
  • Changes to recruitment materials
  • Changes in location of research or agency
  • Changes in funding sources
If my modification request is approved by the IRB, is my expiration date automatically extended?

No. You must still submit a continuation request by the expiration date noted on the approval of your initial application or most recent continuation approval.

What do I do if issues arise that increase the risks to my research subjects?

If a serious problem occurs while conducting your research, you must report it to the IRB promptly after becoming aware of the problem.

I have concluded all research related activities – must I inform the IRB?

Yes. When your research is complete (when all participants have completed all research related interventions, all analysis of identifiable data is completed, and all funding and contracting issues have been completed) you must complete a termination report. Note that this report must be submitted regardless of review level. 

You can find more detailed information, as well as the necessary forms, at the IRB’s Forms and Instructions page.