Dates and 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.

*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.

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. NOTE: If your research involves investigational drugs and/or devices, then MCP IRB requires that all investigators and key research personnel complete The International Council for Harmonisation (ICH) E6 – Good Clinical Practice (GCP)(R2). Examples of acceptable training include, but are not limited to:

• PHRP Online - Protecting Human Research Participants (PHRP) eLearning Course.
• 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 only free for new registered users accessing the training course for the first time. To access the course, you would need to register and choose “Pricing Without Contact Hours”. Follow the prompts to complete the course. There will be a cost for individual learners attempting to retake this course, please visit ACRP’s website for further details.
  • NOTE: If you are an HCA Healthcare employee then please contact the IRB Office for access to the ACRP course without occurring a cost to you.
• HCA Healthcare employees may complete the following courses in HealthStream [accessible only when connected to the server];
  • Introduction to Good Clinical Practice This training takes about 2 hours to complete.
  • Human Subjects Training: IRB Members and Research Staff
  • Research Ethics and Protection of Human Subjects (An excellent history of research ethics presented by a leading expert).
  • GME – Scholarly Presentation and Publication (Note that this session is a bit outdated as it references studies that need to go through an IRB that no longer need to do so under the revised 2019 exempt regulations)
• Other Training From Reputable Sources: These are generally free unless you desire contact hours.
  • HHS Office for Human Research Protections: Lesson 2: What is Human Subjects Research?
  • HHS Office for Human Research Protections: Lesson 3: What are IRBs?
  • Association of Clinical Research Professionals: Ethics and Human Subject Protection: A Comprehensive Introduction
• 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.