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Ethics and Regulations in Clinical Research [MCTS 5101S (3 credits)]

Course Director: Anna Petrova M.D., Ph.D., MPH

Professor of Pediatrics

Child Health Institute of New Jersey (CHINJ), 89 French Street, Room 1355,

New Brunswick, NJ 08901

Date / Instructor / Topic / Comments
09.04.12
4:30-7:30 / Anna Petrova MD, PhD, PH
Professor, Pediatrics
/

Introduction to the MCTS 5101S, requirements, description, and historical perspective of ethics and regulation in clinical research

Description of the UMDNJ/RWJMS web-based CITI /HIPAA Training http://www.umdnj.edu/hsweb/Education/ / CITI Training Exams must be completed by 11.29. 2011
09.11.12
4:30-7:30 / Anna Petrova MD, PhD, MPH
Professor, Pediatrics
/

Advanced Notice of Proposed Rulemaking (ANPRM): Enhancing Protections for Research Subjects & Reducing Burden, Delay & Ambiguity for Researchers

/ Assignment: Term Paper
09.18.12 / Anna Petrova MD, PhD, MPH
Professor, Pediatrics
/ Ethics and regulation in conducting the randomized clinical trials
09.25.12 / Ambarina Faiz MD, PhD
Instructor, Hematology
/ Ethics and regulation in research on vulnerable population
10.2.12 / Jeffrey L Carson MD
Professor, Internal Medicine

Anna Petrova MD, PhD, MPH
Professor, Pediatrics /

Ethics and Regulation in Organization of Multicenter Clinical Trials (Dr. Carson)

Potential ethical conflicts associated with the conduct of human subjects research (Case presentation) / Distribution of Articles for Journal Club Discussion
10.9.12 / Amisha Malhotra MD
Assistant Professor, Pediatrics
Anna Petrova MD, PhD, MPH
Professor, Pediatrics /

Ethics in clinical research on subjects with different conditions:

a. Ethical aspects for enrolment of HIV infected subjects (Dr. Malhotra)
1. Ethical aspects for advertisement of participation in RCT (Dr. Petrova)
10.16.12 / John Crombie, Ph.D.
Ethicon, Inc.
/ Ethics and regulation for using medical devices in clinical research
( Crombie)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm
10.23.12 /

Marc Sturgill, Pharm.D.

Pediatric CRC /

FDA regulations to perform pediatric drug research (Dr. Sturgill)

10.30.12 / Anna Petrova MD, PhD, MPH
Professor, Pediatrics / Ethics and regulation in clinical data collection and storage
11.6.12 / Donna Hoagland, LPN, BS, CIP, CCRC, Director, IRB RWJMS

Petrova MD, PhD, MPH
Professor, Pediatrics
/ Requirements for approval of clinical research by the local IRB
(Hoagland)

Preliminary presentation and discussion of Term Paper (Dr. Petrova)

11.13.12 / Donna Hoagland, LPN, BS, CIP, CCRC
Director, IRB RWJMS / 1. Analysis of Research Protocol from Ethical Point of View According to IRB criteria
2. Informed Consent: ethics and issues
11.20.12 / Terry Kinzy PhD (Move 11/01)
Professor
/

Misconduct, fraud, and integrity in clinical research

(Dr. Kinzy)
11.27.12 / Vivien Hsu, M.D.
Associate Professor, CRC Director
/ Subject selection, recruitment, inducement and coercion, exploitation (Dr. Hsu)
RCT stakeholders: Role and responsibilities of clinical trial staff (Dr. Hsu)
12.4.12 / Anna Petrova MD, PhD, MPH
Professor, Pediatrics / Discussion the published articles in association with fundamental ethical principals / Journal Club.
12.11.12 / Anna Petrova MD, PhD, MPH
Professor, Pediatrics
/ 10 minute for presentation (PowerPoint) and 5 min for discussion / Term Paper Presentation

Recommended Material

1. CITI Training/HIPAA Training http://www.umdnj.edu/hsweb/Education/

To enroll for CITI training:

Students should go to http://www.citiprogram.org/ to enter the training.

They will have to enter several questions to be able to enter CITI

They should select UMDNJ as their participating institution. Anyone can select any institution as their affiliated institution. They need to answer three questions:

1) Answer "YES. I would like to take the CITI Basic Course required by UMDNJ"

2) They have to select a "group". The options are noted below:

(a) Biomedical/Clinical Research Investigators...

(b) Social/Behavioral/Epidemiologic Research Investigators...

(c) Data & Specimen only Research Investigators...

(D) IRB MEMBER AND PROFESSIONAL HSP/IRB PROGRAM STAFF

(e) Fogarty Global Infectious Disease Fellowship Residents

(f) Reference Resources

Select “Biomedical/Clinical Research Investigator” which should be the first option.

3) Answer "I have NOT previously completed a UMDNJ-approved CITI Basic Course"

Once you have finished the basic course, you can always go back into CITI and in the reference section review modules from any of the other options. There is a wealth of information there, so it is a valuable resource.

2. Robert J Levine. Ethics and Regulation of Clinical Research. Urban & Schwarzenberg. Two Editions (1981, 1988)

3. Fost, N. and Levine, R.L. (2007). The Dysregulation of Human Subjects Research. Journal of the American Medical Association,298(18),2196-2198

4. Levine, R.J. (2008). The Nature, Scope and Justification of Clinical Research: What is Research? Who is a Subject?. in E.J. Emanuel, C. Grady, R. A. Crouch, R. Lie, F. Miller and D. Wendler,The Oxford Textbook of Clinical Research Ethics(pp.211-221). Oxford:Oxford University Press.

Evaluation will be based on the followings:

1)  Term paper (30%)

2)  Class participation (25%)

3)  Journal Club presentation (25%)

4)  Completion of CITI/HIPAA training (20%)

Updated 10/3/12 – 9.50 am