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IRB Frequently Asked Questions

What is the IRB?

What needs IRB review?

How is “research” defined?

What is the definition of a “Human Subject” for research purposes?

Do researchers need special training?

How long does the NIH training for Human Research Protection take?

How long does it take for my study to be approved by the IRB?

Once my study has been approved by the IRB, how long does my approval last?

What if I make some changes to my research after it was approved by the IRB?

What if my study’s risk level changes?

What happens after my study is completed, i.e. all data have been collected and reports are written?

Are there sample forms available?

What happens if I do not get IRB approval prior to starting my study?

Is there someone who can help me?

Where do I submit my IRB proposal?




What is the IRB?

The Institutional Review Board (IRB) is a federally mandated board that prospectively reviews and approves research involving human beings as research subjects. The MassBay 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 MassBay or its domestic and international affiliates. Each research study that proposes interactions with human participants must be reviewed and approved by the IRB, or exempted from IRB review to data collection. All federal grants and most other grants typically require that research proposals be approved by the institution proposing the grant.
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What needs IRB review?

All research involving human subjects conducted at MassBay or by MassBay affiliates, including data collection in the Humanities, STEM, and Social Sciences and Professional Studies, and Transportation and Energy divisions, whether the research is externally funded or not must be approved by the MassBay IRB or be exempted by the board BEFORE the project begins. This includes faculty classroom projects that are not part of the regular coursework and requirements, as well as independent research conducted by faculty associated with MassBay.  All research conducted by non-faculty members, including students and staff, are also subject to review and approval. In addition, course projects conducted by students that include interaction with human subjects at MassBay or a local agency must also be reviewed and approved.
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How is “research” defined?

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 Federal wide Assurance is also governed by this definition.
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What is the definition of a “Human Subject” for research purposes?

45 CFR §46.102 defines a human subject as:

“A living individual(s) about whom an investigator (whether professional or student) conducting research obtains: data through intervention or interaction with the individual, or identifiable private information.”

Interaction includes communication or interpersonal contact between investigator and subject.
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Do researchers need special training?

Yes. All researchers must take the free federal National Institutes of Health’s training on Protecting Human Subject Research Participants. To log on to the training site, go to.

http://phrp.nihtraining.com/users/login.php. All MassBay researchers must provide evidence of successful completion of the training with their research proposals.
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How long does the NIH training for Human Research Protection take?

The NIH training module takes approximately two hours to complete. When you sign on you will create a password (please write down the password) that will allow you to revisit the site and complete the training in segments or all at once.
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How long does it take for my study to be approved by the IRB?

You will be notified in writing of the IRB’s decision to approve, request modification (or additional information), or disapprove your protocol.  Within seven (7) days of submission, you will receive confirmation of receipt from the IRB Administrator. If your application is missing sections, you will also be notified at that time. Since the IRB meets monthly, within four weeks you will receive a decision about your proposal.

You may not begin recruitment or any other interactions with potential participants until you receive written notification of approval of your proposal from the IRB.  
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Once my study has been approved by the IRB, how long does my approval last?

Initial protocol approval is typically granted for one year.  Approximately three months before the expiration of the approval, the IRB Administrator will send you a reminder to complete the Continuing Review Report. At the completion of the project, the investigator is expected to complete a Final Report. Exempt protocols are not subject to annual review.
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What if I make some changes to my research after it was approved by the IRB?

Any modifications to an approved protocol (e.g., recruitment process, administering materials, collecting data, gaining consent, changing participants) must be approved by the IRB using the Study Modification Form.
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What if my study’s risk level changes?

You must submit a Study Modification Form to make the IRB aware of this.
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What happens after my study is completed, i.e. all data have been collected and reports are written?

Upon completion of your project, you will need to submit a Final Report to the IRB Administrator.
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Are there sample forms available?

Yes. Click on the appropriate links below for sample forms:

Initial Application Form

 

* All Principal Investigators, researchers, and coordinators must submit an IRB certificate indicating that they have completed the online training at the time they submit the initial IRB application.

IRB Continuing Review Form

IRB Final Report

Protocol Modification Form

Sample Audio Recording Consent Form
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What happens if I do not get IRB approval prior to starting my study?

You may have to start your study all over again. It is better to consult with the IRB prior to beginning your study.
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Is there someone who can help me?

Yes. Call the Office of Institutional Planning, Research and Assessment at (781) 239-3160.
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Where do I submit my IRB proposal?

You may submit electronic applications to institutional.research@massaby.edu or to the address below:


IRB

c/o Office of Institutional Planning, Research and Assessment

 MassBay Community College

50 Oakland Street

Wellesley Hills, MA 02481


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