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Policies & Procedures

office for research protections

The Policy for the Protection of Human Research Participants is available. In addition, a Standard Operating Procedures for Researchers is has been created as a companion document to the Policy. It contains a wealth of information concerning protocol submission and approval as well as coverage of many special topics.

  


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 you feel 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. It is ultimately the responsibility of ORP staff to make valid human research determinations and decide which level of review is required. 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 21 CFR 50 and 56.  Research that is eligible for exemption may only be exempted by the IRB administration not the investigator.

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.

What is required for exempt review?

  1. Complete the IRB application in CyberIRB marking the "exempt" category.  
  2. Complete the integrated research summary in CyberIRB.
  3. Upload any supporting documents into the supporting documents grid (informed consent, surveys, recruitment materials, instruments, site permission letters, IRB approvals from other institutions, etc)
  4. The training completion certificates for all research staff interacting with data.  See the Training Policy on our main page for guidance and any exceptions.
  5. Via Cyber, sign the application and, if applicable, send it to the faculty research supervisor or Chair/Dean for signature. 

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. 

What is required for expedited review

1. Complete the IRB application in CyberIRB marking.
2. Complete the integrated research summary in CyberIRB.
3. Upload any supporting documents into the supporting documents grid (informed consent, surveys, recruitment materials, instruments, site permission letters, IRB approvals from other institutions, etc.).
4. The training completion certificates for all research staff interacting with data.  See the Training Policy on our main page for guidance and any exceptions.
5. Via Cyber, sign the application and, if applicable, send it to the faculty research supervisor or Chair/Dean for signature.

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 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, you may contact ORP for guidance.

Full board materials should be submitted via CyberIRB. You should follow the procedures for what is required for expedited review. Once your IRB application has been submitted, you will work closely with ORP staff on the next steps.

The IRB meets once a month on every 3rd Wednesday of the month. All materials must be submitted to ORP 10 business days prior to an IRB meeting date to be included in the agenda.  If the materials are submitted and the application is incomplete, the protocol will not be able to be reviewed at that month's meeting. Instead, it will have to be revised by the PI and re-submitted for consideration of the next month's IRB meeting. No research may begin until final IRB approval has been granted.