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Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School of Public Health Director, Human Research Administration HSPH, Harvard Medical School September 6, 2013

Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School

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Page 1: Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School

Responsible Conduct of Research - Course Overview

Delia Y. Wolf, MD, JD, MSCI

Assistant Dean, Regulatory Affairs and Research Compliance

Harvard School of Public Health

Director, Human Research Administration

HSPH, Harvard Medical School

September 6, 2013

Page 2: Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School

Instructor & Course Coordinator

Delia Wolf, MD, JD, MSCI 90 Smith St. 3rd Floor Email: [email protected] Phone: (617) 432-2148

Staci Landis 90 Smith St. 3rd Floor Email: [email protected] Phone: (617) 432-2157

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Page 3: Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School

Reading Materials Required reading:

“On Being a Scientist, A Guide to Responsible Conduct in Research,” 3rd Edition, by National Academy of Sciences, National Academy of Engineering, and Institute of Medicine http://www.nap.edu/openbook.php?record_id=12192&page=8

ORI Introduction to the Responsible Conduct of Research http://ori.dhhs.gov/documents/rcrintro.pdf

Additional reading materials will be posted on course iSite

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Page 4: Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School

Course Requirements & Grading Class participation

Attend at least 6 lectures (you can miss two)

Written assignments (12 short cases) Submit to the “drop-box” or hand-in a hard copy in

class

Course evaluation Grading

Pass/fail – 1.25 credits Certificate of Completion - all students who meet

course requirements

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Page 5: Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School

Will this course benefit you?

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Spring 2013 FAS RCR Course Evaluation

Did you feel that the time you spent on this course will benefit you?

AnswerOptions ResponsePercent ResponseCount

Yes82.8% 53

No9.4% 6

No Opinion7.8% 5

If no, explain:8

AnsweredQuestion 64

SkippedQuestion 0

Page 6: Responsible Conduct of Research - Course Overview Delia Y. Wolf, MD, JD, MSCI Assistant Dean, Regulatory Affairs and Research Compliance Harvard School

Certificate of CompletionHarvard School of Public Health

HPM 548, 1.25 Credit Hours (16 Contact Hours)

Responsible Conduct of ResearchThis is to certify that

Participanthas successfully completed the above course on October 25, 2013. This course meets training requirements

for all NIH Institutional Research Training Grants, Individual Fellowship Awards, Career Development Awards, Research Education Grants, Dissertation Research Grants, or other grant programs with a training

component that requires instruction in responsible conduct of research.

Delia Y. Wolf, MD, JD/Course Instructor