The Methodist Hospital Research Institute

1
The Methodist Hospital Research Institute

• Clinical Research Education Session
• TMHRI IRB

2
Topics

• Brief Overview
• TMHRI Administrative Review and Approval
  Credentialing
• TMHRI IRB forms/processes

3
TMHRI Administrative Review and Approval Form
TMHRI Credentialing Form

• Required for full committee approval of any study
  (IRB, IACUC, IBC)
• Submit original hard copy to TMHRI Office of
  Research Protection (ORP)

4
How to Access the Forms From the Internal Website
5
How to Access the Forms From the Internal Website
6
How to Access the Forms From the Internal Website
7
How to Access the Forms From the External Website
8
How to Access the Forms From the External Website
9
How to Access the Forms From the External Website
10
TMHRI Administrative Review and Approval (ARAF)

• What type of research is going on at TMH?
• Completed with each new study proposed
• Institutional Account automatically created
• ARAF Approval letter sent out to PI
• Electronic with IRB submission

11
TMHRI Credentialing

• Who is doing research at TMH?
• Required for all research personnel listed on a
  protocol
• Additional layer of protection/patient safety
• TMH badge issued for non-TMH employees
• Only required to be filled out once
• Submit any changes to TMHRI
• Keep Human Subjects Training current

12
TMHRI IRB

• Overview of IRB Structure
• Internal IRB Membership
• Internal IRB Meeting/Submission Dates
• Fees?
• Forms How to Access

13
TMHRI IRB Structure
14
TMHRI IRB Membership
15
Meeting Dates Submission Deadlines
16
Fees?

• Investigator-originated no fees
• Industry-Sponsored Clinical Trials
• 2500 - one-time-only
• 10 if small budget (lt 10,000)

17
TMHRI IRB Forms

• Initial Submission - Full IRB Review
• Initial Submission - Expedited IRB Review
• Initial Submission - Exemption Form 
• Informed Consent Template
• Waiver of Consent Form
• Waiver for Use of PHI 
• Protocol Amendment Form
• Emergency Use of Drug/Device Form 
• Adverse Event Form
• Adverse Events Table

18
How to Access the forms from the Internal Website
19
How to Access the forms from the Internal Website
20
How to Access the forms from the Internal Website
21
Contact Information

• Office of Research Protection
• Michelle Haynes, Analyst 713.441.5847 or
  mhaynes_at_tmhs.org (for questions regarding TMHRI
  IRB)
• Jennifer Santini, Analyst 713.441.7887 or
  jlsantini_at_tmhs.org (for questions regarding PAC
  IRB, TMHRI IBC, or IACUC)
• Lee Seabrooke, Director 713.441.7548 or
  lseabrooke_at_tmhs.org