*Individuals who have NIH funding may complete the NIH training (http://www/bu.edu/irb/home/required-training).

Initial Certification

New Researchers:

• As of September 1, 2012, all individuals who have not submitted as the Principal Investigator and/or been listed as a co-investigator/study staff on an approved CRC IRB protocol, will be required to complete the CITI program for both initial certification and recertification.

Current Researchers:

• Individuals who previously completed CITI: Individuals who have submitted as the Principal Investigator and/or have been listed as a co-investigator/study staff on an approved CRC IRB protocol will be required to complete recertification within 3 years of when they completed their initial CITI certification. If it has been more than 3 years since you completed the CITI course you have one year (by September 1, 2013) to complete the initial certification.
• Individuals who previously completed NIH or other training: Individuals who have submitted as the Principal Investigator and/or have been listed as a co-investigator/study staff on an approved CRC IRB protocol will be required to complete recertification within 3 years of when they completed their initial NIH or other training certification. If it has been more than 3 years since you completed the NIH or other course you have one year (by September 1, 2013) to complete the initial certification.

Recertification

Investigators and study staff must complete a recertification course every 3 years. Recertification includes completing Refresher Modules in the CITI program. Individuals who completed the CITI for initial certification will receive expiration reminders from CITI via email 30 days and 7 days before his/her certification expires.

Individuals who completed NIH for Initial Certification: Individuals who completed the NIH training for the initial training will need to complete the CITI Basic Course module for their first re-certification. Subsequent recertification will be done by completing the Refresher Modules as described in the paragraph above.

The online CITI Program can be accessed at: www.citiprogram.org.

If you have any questions, please contact the IRB at 617-358-6115 or irb@bu.edu.

• The classroom activity is not designed to develop or contribute to generalizable knowledge. The only purpose of the activity is to teach research methodology
• Activities are not considered to be generalizable because either:
  • The results of the activity will not leave the classroom (e.g. the data/results will NOT be published or presented at meetings) OR
  • The activity involves collecting data from or about a company, organization, or agency and the data/results will only be shared with that company, organization, or agency to be used internally for the purpose of quality assurance or quality improvement
• The activity is limited to surveys/questionnaires, interviews, observations of public behavior, conducting non-invasive biomechanical measurements (e.g. placing sensors on the skin), or standard educational exercises directly related to the class assignment for the official Boston University course.

It is the responsibility of the faculty member to determine if the assignment meets the criteria above.  If the faculty member is unsure if the activity meets the criteria, he/she should contact the IRB office for consultation.

If the classroom activity does not meet the criteria listed above, contact the IRB office for consultation.  Federal regulations require that research projects involving human subjects be reviewed by an Institutional Review Board (IRB).  The IRB must approve the project prior to the start of any research activities.  The IRB cannot provide approval or determinations for research that has already been conducted.

If you have any questions, please contact the IRB at 617-358-6115 or irb@bu.edu.

Effective May 16, 2012, certain approved documents (e.g. consent form, flyers, letters, questionnaires, etc.) will include an electronic IRB approval stamp as seen below:

Important note – there is no action needed of you at this time.

You should continue to use your currently valid and approved documents. The IRB will issue documents with the new stamps when re-approval is required for these documents (i.e. amendment or progress report approval).

Please call our office if you have questions.

Approximate time from submission to IRB decision:
For new protocols, progress reports, and protocol amendments that modify the research–4-6 weeks
Staff amendments –4 working days

These turnaround times assume that investigators respond promptly to IRB queries.  For reviews that require full-board attention, turnaround could be affected by the timing of full-board meetings. Please visit our meeting date guidance page for more information.

Please submit your protocol to irb@bu.edu or to our address: Institutional Review Board, Room 157, 25 Buick Street, Boston, MA 02215.  Please be sure to email your informed consent document(s) in electronic word document format.

Please find the complete list of templates here: Consent Form Templates