• We have made minor revisions to our Training Policy. See below.
• We are now requiring certification for research conducted during an unapproved period. See below.
• Please use the correct name of our office for consent forms.If you are using an old form or an online sample form, please delete the Office for Human Research Participant Protection and use the Office for Research Protections.
• Please note that Stephen Erickson, not Christina Booth Steele, is the current Director of ORP and all submissions, consent forms and correspondence should reflect this change. 
  
  
  
  
   
  

• The CITI, NIH or any other accepted training certificates will be regarded as being active for three years from the date recorded on the certificate. Please refer to our website for details.
  

• If you plan on continuing with your research past the  expiration date on your approval notice, you must complete a BC IRB Continuing Review Form/Study Completion report. If the study is not renewed/closed prior to the expiration date, you and the University will not be in compliance with either federal regulations or Boston College policy. Data that is collected during an unapproved period, no matter how short that period may be, may not be used in the project. Participants should not be recruited or consented during an unapproved period. However, if participants have been recruited and/or have given their informed consent during the unapproved period (which is subject to review and audit), they must be re-consented after the next protocol approval date. If this occurs, you will be asked to complete a certificate agreeing to the foregoing requirements.
  
  

Protocols:

• We have been receiving an extraodinarily high number of amendments in a short period of time. ORP asks that you carefully consider whether changes and revisions can be combined into a single amendment.
• Please remember to accept the track changes in any documents created in Word prior to sending them to ORP.
• Expedited and full board protocols require yearly IRB review. Please remember to submit your continuing review application well in advance (60 days) of the expiration date listed on your approval notice.
• Student protocols must be signed by the PI and his/her faculty advisor. Faculty and staff protocols must be signed by the Dean/Chair of the department.If you are unable to create a digital signature, please fax the signature page to us at x20498.
• Please combine your application and supporting materials (consent forms, site permission letter etc.) into one PDF document before emailing it to the IRB.
• Protocols involving minors as participants do not qualify for exempt review.
• Protocols with special subject populations (e.g. prisoners) require full board review at a fully convened IRB meeting. See 45 CFR 46 Subparts B-D. Only greater than minimal risk research is reviewed at a convened IRB meeting.
• For federally funded protocols or federal subaward sponsored projects, PIs should submit the latest version of the sponsored project proposal, not the grant.

Training: