Research Resources
Regulatory Support
Regulatory Support services to investigators and clinical researchers
in both the pre-award and post-award process include the following offerings.
As our program continues to expand and develop please check back to this
site or contact us directly to find out about the latest services.
Regulatory Compliance Consultation
An important function of the RSB core is to assist investigators
in meeting their regulatory and ethical obligations as required by federal,
state, and institutional policies. We offer assistance in pre-reviewing
IRB and other regulatory applications to ensure they are complete and
ready for formal submission. We also provide guidance on filing for
an IND, consent/assent form review, and protocol development.
During the course of the study, we will periodically review regulatory
documents to ensure they are in order and send out helpful reminders
for renewal deadlines and educational newsletters on compliance issues relevant
to researchers. If you have any questions or concerns about your study please
don't hesitate to contact our office for assistance.
Study Coordinator Support
Within the RSB core is a group of study coordinators and a research nurse
dedicated to providing assistance and training to investigators and study staf
with research study start-up, implementation, and close-out. We offer a menu of
different support activities including IRB application preparation, consent form
development, specimen collection, chart reviews, etc. For a complete list of the
coordinator services offered and availability, please contact us.
Clinical Research Education and Training
The assurance of ethical and quality conduct of clinical research is a primary
focus of the RSB core. We provide training and mentoring support for investigators and research staff. Currently a free half-day class on the Fundamentals of Clinical trials is taught quarterly. Short courses are also available on topics such as Working with Investigational Drug Services, Overview of the IRB Process, and Study Documentation. Additional courses are planned and suggestions are welcomed. Personalized training and mentoring based on the research study protocol is also available. If you are interested in registering for one of our classes or would like one-on-one assistance please contact us.
Data and Safety Monitoring Plan Development
An important component of every trial and one that will be looked at closely by IRBs and other review committees is the Data and Safety Monitoring Plan (DSMP). The DSMP is a set of detailed procedures for how the study will be monitored to assure continued safety of the participants and the integrity of the data collected. Our expert staff can help investigators develop and implement a DSMP that is appropriate to the level of risk associated with a given study. We have templates for DSMPs and Data Monitoring Committee (DMC) [aka Data Safety Monitoring Board (DSMB)] charters [if applicable] for investigators to use. For assistance with your DSMP,
please contact us early in the development of your protocol.
Research Participant and Consent/Assent Consultation
We are happy to respond to general questions from people who are considering enrolling in a clinical trial at the ITHS or those who have already enrolled. At the request of the investigator or participant, we are available to observe the informed consent conference and provide guidance and feedback as appropriate. Please contact us if you would like more information
To place a request or obtain more information
about any of the above services, please contact us at:
(206) 598-6477 or
rsbcore@u.washington.edu
Who we are
Ann Melvin, MD, MPH.
ann.melvin@seattlechildrens.org
Office: 206-987-2535
Director, RSB core, Associate Professor, Pediatrics - Infectious Diseases
Monica Jarrett, PhD, RN.
jarrett@u.washington.edu Office: 206-543-2348
Research Coordinator Mentoring and Training, Associate Professor,
Biobehavioral Nursing and Health Systems
Jason Malone
jmmalone@u.washington.edu Office: 206-598-4734 (UW)
ITHS Clinical Compliance Officer
206-987-3694 (Children's)
Leonard Sanchez
leonards@u.washington.edu
Office: 206-598-6477
RSB Program Coordinator
206-987-3694 (Children's)