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Research at Boston College

IRB Review Process

Review Process:

How do I know if my project needs IRB review?
Boston College administration relies on OHRP Guidance “OHRP Chart 1: Is An Activity Research Involving Human Subjects Covered by 45 CFR 46” to make determinations on IRB review requirements. Once you have consulted the OHRP Chart and determined that your 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). Ultimately, all research studies that are submitted for IRB review are screened by OPR staff for the level of IRB review required.

If you have any questions about making a valid human research determination or which level of review your project qualifies for. please contact ORP. ORP staff would be pleased to assist you by phone at 617.552.4778 or email at irb@bc.edu.

Note about Funded Research:  For externally funded research, please wait until funds have been awarded before submitting a protocol application to the IRB. 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 21CFR 50 and 56.  Research that is eligible for exemption may only be exempted by the IRB administration not the investigator.

To Request an exemption from IRB review, please complete the IRB Exemption Form and submit the “Documents Required for Exemption” listed below.  Investigators must be aware that 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 or the Office of Human Research Participant Protection unless the PI would like to change study procedures or adverse events occur.

Documents Required for Exemption

  1. Memo that lists the contents of your application
  2. IRB Exemption Form (Signed manually or electronically using Adobe)
  3. Research Summary
  4. Research Documents (informed consents, surveys, interview guides, advertisements, data collection tools, etc)
  5. The training completion certificates for all research staff interacting with data.  See the Training Policy on our main page.
  6. Combine all the above materials into one continuous PDF document and submit to irb@bc.edu.

The IRB no longer requires hard copies of all IRB materials.  The IRB requires all documents to be submitted via e-mail (irb@bc.edu).  Digital signatures are acceptable if you use the Adobe format.  If you are unable to provide a digital signature, fax (617.552.0498) or scan the manually signed signature page (not the ENTIRE Application) to the ORP (IRB Office). Investigators without access to a scanner or fax may mail (US Mail or Campus Mail) the signature page to:

Boston College
Office for Research Protections
140 Commonwealth Ave., Waul House
Chestnut Hill, MA 02467

Please indicate the IRB Protocol Number (for continuing reviews or amendments) or the title of your study on all materials.


Expedited Review:

All research studies that are 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 on an ongoing basis. 

Documents required for IRB Review

  1. Memo that lists the contents of your application
  2. Initial IRB Form (Signed manually or electronically using Adobe)
  3. Research Summary
  4. Research Documents (informed consents, surveys, interview guides, advertisements, data collection tools, etc)
  5. The training completion certificates for all research staff interacting with data.  See the Training Policy on our main page. 
  6. Combine all the above materials into one continuous PDF document and submit to irb@bc.edu.
     

Full Committee Review:

Any research procedures that are not found in the Expedited Categories or pose greater than minimal risk to participants, must be reviewed at a convened IRB meeting.  These reviews are called Full Board reviews.  In some cases these studies require additional procedures to reduce risk.  If you are planning a research study that may be greater than minimal risk, please contact ORP for guidance.

The IRB no longer requires hard copies of IRB materials.  All materials are submitted via e-mail (irb@bc.edu).  All Applications must be signed in order to be processed for review.  Applications may be digitally signed using Adobe and submitted along with e-mailed materials.  If you are unable to sign digitally,  manually sign the last page of the application and fax (617-552-0498) scan (include with e-mailed materials) or mail the signed signatory page only ORP (Waul House, Chestnut Hill Campus). 

The IRB meets once a month on every 3rd Wednesday of the month. All materials must be submitted to ORP 10 days prior to an IRB meeting date to be included in the agenda.  All materials must also be submitted electronically by e-mail to the IRB at irb@bc.edu.  Please note that no research may begin until final IRB approval has been granted.
 
All materials must also be sent electronically as an E-mail attachment to the IRB at irb@bc.edu.  Please note that the research must not begin until final IRB approval has been granted.