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.org. 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|
|January 9, 2019||December 26, 2018|
|February 13, 2019||January 30, 2019|
|March 13, 2019||February 27, 2019|
|April 10, 2019||March 27, 2019|
|May 8, 2019||April 24, 2019|
|June 12, 2019||May 29, 2019|
|July 10, 2019||June 26, 2019|
|August 14, 2019||July 31, 2019|
|September 11, 2019||August 28, 2019|
|October 9, 2019||September 25, 2019|
|November 13, 2019||October 30, 2019|
|December 11, 2019||November 27, 2019|
|January 8, 2020||December 25, 2019|
|February 12, 2020||January 29, 2020|
|March 11, 2020||February 26, 2020|
|April 8, 2020||March 25, 2020|
|May 13, 2020||April 29, 2020|
|June 10, 2020||May 27, 2020|
|July 8, 2020||June 24, 2020|
|August 12, 2020||July 29, 2020|
|September 9, 2020||August 26, 2020|
|October 14, 2020||September 30, 2020|
|November 11, 2020||October 28, 2020|
|December 9, 2020||November 25, 2020|
*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 requires all individuals involved in the conduct of human subjects research to complete human subjects protection training and to ensure that training is current for every year while the study is under active IRB oversight. IRB approval will be withheld if these training requirements are not met.
These requirements apply to all persons with a significant role in the research, such as those designated as:
- Principal Investigator and Co-investigators,
- Individuals named on a study grant or contract proposal,
- Individuals listed on an FDA form 1572 for the conduct of the research at MCP or at an affiliate institution,
- Individuals named as a contact person in the informed consent document(s) or recruitment materials for research,
- Individuals who obtain informed consent from prospective participants in research, and
- Individuals who obtain individually identifiable health information under a Business Associate Agreement.
Medical City Plano 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.
- 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 two (2) hours. 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.