Institutional Review Board

IRB Chair

Tony Kiszewski
JEN 226
ga_irb@bentley.edu
781.891.2954

Institutional Official

Mystica Alexander, Associate Provost for Research and Faculty
MOR 301
malexander@bentley.edu
781.891.2202

Committee Members AY 2020 - 2021

Gary David, Department of Sociology
Jonathan Ericson, Information Design and Corporate Communication Department
Kelly Giardullo, Office of Institutional Research and Planning
Jean Goldsberry, Community Member
Jeff Gulati, Department of Global Studies
Marianne Kulow, Department of Law, Taxation and Financial Planning
Fred Ledley, Department of Natural and Applied Sciences
Helen Meldrum, Department of Natural and Applied Sciences
Shelle Santana, Department of Marketing
David Szymanski, Department of Natural and Applied Sciences
Jay Thibodeau, Department of Accounting

Review Process

How do I know if my project needs IRB review?

Bentley University relies on OHRP Guidance OHRP Chart 1: Is An Activity Research Involving Human Subjects Covered by 45 CFR46 to determine when an IRB review is required. Once you consult the OHRP Chart and determine that project meets the definition of research and qualifies for research with human subjects, your project will fall into one of three categories of IRB review: exempt, expedited or full board (more than minimal risk). The determination of level of IRB review required is made by the IRB Chair.

If you have any questions about making a valid human research determination or which level of review your project qualifies for, please contact the IRB Chair at ga_irb@bentley.edu.  Kindly note that you must submit the funding proposal for all federally sponsored research with your protocol application.

Exemption Review

Some research may be eligible for an exemption from IRB review according to the rules stated in

45 CFR 46.101(b) and for FDA governed research in 21 CFR 50 and 56. Only IRB administration can exempt research from review, not the investigator.

Only minimal risk research qualifies for exemption from IRB review.  Research that is officially exempted from IRB review requires no further interaction with the IRB unless the PI would like to change study procedures or adverse events occur.

What is required for exempt review?

1. Complete the IRB application, marking the “exempt” category.
2. Submit the application and any supporting documents (informed consent, surveys, recruitment materials, instruments, site permission letters, IRB approvals from other institutions, etc.) via email to the IRB Chair at ga_irb@bentley.edu.
3. Complete the Collaborative Institutional Training Initiative (CITI) training course on human research subjects protection and submit your certificate of completion with your application.
4. All research staff interacting with data must also complete the training and submit certificates.

Expedited Review

All research studies submitted for IRB review are screened for the level of IRB review required.  Minimal risk research that includes procedures outlined in the Expedited Categories, will be reviewed by one or two IRB members.

What is required for expedited review?

1. Complete the IRB application, marking the “expedited” category.
2. Submit the application and any supporting documents (informed consent, surveys, recruitment materials, instruments, site permission letters, IRB approvals from other institutions, etc.) via email to the IRB Chair at ga_irb@bentley.edu.
3. Complete the Collaborative Institutional Training Initiative (CITI) training course on human research subjects protection and submit your certificate of completion with your application.
4. All research staff interacting with data must also complete the training and submit certificates.

Full Committee Review

Any research activities that pose greater than minimal risk to participants must be reviewed at a convened IRB meeting.  These reviews are referred to as Full Board reviews.  In some cases, these studies require additional procedures to reduce risk.  If you are planning a research study that may be of greater than minimal risk, you may contact the IRB Chair for guidance.

Full board materials should be submitted to the IRB Chair.  You should follow the procedures required for an expedited review.  Once your IRB application has been submitted, you will work closely with the IRB on the next steps.  No research may begin until final IRB approval has been granted.

What is the IRB?

The Bentley University Institutional Review Board (IRB) serves as the primary institutional body to protect the rights and welfare of individuals recruited to participate in research conducted at Bentley University or by affiliates of the University. The IRB is a federally mandated board (45 CFR part 46, the "Common Rule". 1991) that prospectively reviews and approves research that involves human beings as research subjects. Each research study that proposes interactions with human subjects must be prospectively reviewed and approved by the Institutional Review Board (IRB) or exempted from IRB review by the administration prior to the onset of data collection. All human subjects research, even if found exempt from IRB review, must follow the Bentley University policies for the protection of human research subjects.

What needs IRB review?

All data collected by an interaction or intervention with human subjects generally should be reviewed and approved by the Bentley University IRB or be exempted by the administration BEFORE the project begins. This applies to ALL data collection involving human subjects conducted at Bentley or by Bentley agents, including data collection in the humanities and behavioral and social sciences, whether the research is externally funded or not.  If unsure, please the IRB Chair, by email at GA_IRB@bentley.edu or by phone at 781.891.2954.
    
How do I know if my project needs IRB review?

1. Does your project involve human subjects?
As an investigator, will you interact or intervene with a human subject or any identifiable private information on individuals? If yes, see #2 below. If no, then no IRB review is required.

2. Is your project "research" as defined under the Common Rule (45 CFR 46)?
Is your project a systematic investigation designed to contribute to "generalizable" knowledge? This means the data will be made publicly available either through presentation or publication of some sort (e.g., Web sites, tapes, archives, forum, publications, etc.)? If the answer is yes, then your study involves "human subject research". The project must be reviewed by the IRB or exempted from IRB review by the administration prior to human subject interaction or intervention.

What is the definition of research?

Federal regulation 45 CFR §46.102 defines research as:
"A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Virtually all federally funded research with human subjects is governed by this definition. In addition, all human subjects research conducted under a Federwide Assurance (which Bentley University has) is also governed by this definition.

If I know my project is exempt, may I begin interacting or intervening with human subjects?

NO. ONLY THE HUMAN PROTECTIONS ADMINSTRATION MAY EXEMPT A STUDY FROM IRB REVIEW IN STRICT ADHERENCE TO THE COMMON RULE 45 CFR 46. Forms to request an exemption from IRB review are available on this web site. As soon as you receive a written notification of Exemption from IRB review, you may begin your research.

May I begin to recruit human subjects before I receive approval for my protocol?

The answer is no. No research or recruiting can commence until PI's have received an approval letter for their protocol. The same holds true for amendments and continuing review applications.

Does oral history research need IRB review?

It depends. If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the Bentley IRB before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they do not wish any or all of the oral history archived.

Where do I submit IRB materials?

Please submit your IRB materials via email to the IRB Chair at GA_IRB@bentley.edu

How long will it take to get approval for my project?

How long a project takes to be approved depends on how complete the application is, what level of review the project qualifies for and how long it takes for a protocol to be revised and returned to IRB.

How long is IRB approval valid?

IRB approval for expedited and full board protocols are valid for one year. The expiration date can be found on the approval letter.  If a PI would like to continue with the research for an additional year, the PI must seek IRB approval by submitting a Continuing Review application sixty days prior to the expiration date of the protocol. Protocols that are not renewed will expire and be closed. A PI may not work on an expired protocol. IRB will issue a continuing review reminder letter to PI's so the protocol can be renewed and this can be avoided.

How long is my human subjects training certificate valid?

Training certificates obtained through the CITI program are valid for three years from the date of the training.  If the training certificate is due to expire, PIs should complete either the CITI refresher course or the NIH training course prior to the expiration date of their training.

All research staff without proper training certificates on file with the IRB, or with expired training certificates, should be removed from a study until they have updated their training.

If I am submitting a proposal for external funding, do I need to have IRB approval before submitting the proposal?

In most cases (NIH, NSF, Dept. of Education) you will be submitting the approval information "just in time", when you receive a fundable score, or when the agency requests the IRB approval information. All of these time frames occur prior to the release of the award to the Office of Sponsored Programs. For the most accurate information, the PI should consult the agency for guidelines for the use of human subjects.