Clinical Research Regulatory and/or Ethics
Consultation Request Form
To request a clinical research regulatory and/or ethics consultation, please complete the
information below and email the completed form to reg_spt_center@wusm.wustl.edu.
If you have not been contacted by a member of the consulting team within two (2) business days,
please call us at (314) 362-5626 or email us at reg_spt_center@wusm.wustl.edu.
CONTACT INFORMATION
First Name:
Last Name:
Degree(s):
Title:
Email:
Phone:
Department:
Institutional Affiliation:
Mailing Address:
PROJECT INFORMATION
Title/Topic:
Multi-Center Study:
YES
NO
Investigator-Initiated:
YES
NO
Type of Study:
Clinical trial
Genetic research
Social science study (e.g., survey or focus group)
Use of existing data or chart review
Community health research
Program evaluation or quality improvement research
Other (specify)
Current Stage of Project:
Planning study to apply for funding
Preparing for scientific review, pre-funding
Preparing for scientific review, post-funding
Responding to scientific review
Preparing for IRB initial review
Responding to IRB initial review
12-22-2011
Preparing for IRB continuing review
Responding to IRB continuing review
Responding to adverse event or complaint report
Enrolling/conducting research
Data analysis
Responding to manuscript review
Other/unsure
Please describe the timeline for the project:
Areas of Service Requested (check all that apply):
Subject selection/recruitment/retention
Investigational New Drug (IND) application
Investigational Device Exemption (IDE) application
Monitoring of regulatory documents and subject-level study data
Study Budget development/negotiation with sponsor
Informed consent
Confidentiality
ACT, RCT, or PCT issues (e.g., randomization, use of placebo, rescue provisions, standard of
care)
Financial considerations regarding subjects, such as payments to participants or expenses to
be incurred by participants
Vulnerable populations
International research
Genetic, gene therapy, or genomics research issues
Disclosure of study data or results
Investigator or Institutional Conflicts of Interest/Commitment
Sensitive research (e.g., stigmatizing conditions such as HIV, addiction, or psychiatric
illness)
Safety/Unknown risks
Other (specify)
Other Comments or Information:
How did you hear about the clinical research regulatory and/or ethics consultation service?
12-22-2011