IRB meeting dates and submission deadlines
MCP IRB committee meets every 2nd Wednesday of each month from 12:00 PM to 1:00 PM. Per regulations, IRB members must be provided with research materials sufficiently in advance to allow review of the material to prepare for any deliberation and voting. Per local policy, this is generally one week before the meeting. Therefore, the submission deadline is ten (10) business days before each IRB meeting to allow for any changes and to meet the review timeline. Submit materials following the IRB submission checklist and instructions on each applicable form.
Below is a schedule of IRB meetings and submission deadlines for Initial, continuing and amendment (modification) applications that involve greater than minimal risk to subjects. Submit all documents via IRBNet. For all IRB submissions, an original signature is not required. The Principal Investigator must sign all packages before they are submitted for IRB review.
| IRB Meeting Date | Submission Deadline |
|---|---|
| October 13, 2021 | September 29, 2021 |
| November 10, 2021 | October 27, 2021 |
| December 08, 2021 | November 24, 2021 |
| January 12, 2022 | December 29, 2021 |
| February 09, 2022 | January 26, 2022 |
| March 09, 2022 | February 23, 2022 |
| April 13, 2022 | March 30, 2022 |
| May 11, 2022 | April 27, 2022 |
| June 08, 2022 | May 25, 2022 |
| July 13, 2022 | June 29, 2022 |
| August 10, 2022 | July 27, 2022 |
| September 14, 2022 | August 31, 2022 |
| October 12, 2022 | September 28, 2022 |
| November 09, 2022 | October 26, 2022 |
| December 14, 2022 | November 30, 2022 |
| January 11, 2023 | December 28, 2022 |
*Note: Submissions received on the deadline date must be complete and review ready to be placed on the Agenda for review at next convened board meeting.
Training and education
MCP IRB will accept evidence of completion for Human Subject Protection training or any Good Clinical Practice training that is mutually acceptable by TransCelerate BioPharma, Inc. member companies. Examples of acceptable training include, but are not limited to:
- PHRP Online - Protecting Human Research Participants (PHRP) eLearning Course. This course is available for a cost of $39.99.
- CITI Program - The Collaborative Institutional Training Initiative (CITI) Human Subject Research or additional applicable course offerings. There is a cost associated with each course. However, if you are affiliated with an organization, that has a membership with CITI Program; training may be available to you at no cost.
- ACRP Program – Association of Clinical Research Professionals (ACRP) “Ethics and Human Subject Protection” is available at no cost to you. To access the course, you would need to register and choose “Pricing Without Contact Hours”. Follow the prompts to complete the course.
- OHRP – Human Research Protection Training – Office of Human Research Protections (OHRP) offers comprehensive training based on the revised Common Rule. This training takes approximately 4.5 hours to complete.
- Medical City Health employees may complete the course “Introduction to Good Clinical Practice” in HealthStream [accessible only from an internal computer]. This training takes about 2 hours to complete.
- MCP IRB will consider other forms of education in protection of human subjects on a case-by-case basis.
Average completion time for each course is different. You do not have to complete an entire course in one sitting. You can log in and out of a course to complete it at your convenience.
Certificates evidencing completion of training must be submitted via IRBNet for IRB review. If training was completed at another institution, please submit a copy of the training certificate to determine if it meets MCP IRB training requirements.
Unless otherwise specified, training must be renewed every three (3) years as long as the study team member is involved in an active study under IRB oversight.