Dealing with Compliance: Research on Human Subjects
J.D. Practicum 1016
| 3 credit hours
Through a combination of class sessions and field work, this course will introduce students to the issue of regulatory compliance as it arises in the context of research on human subjects. The course will also call upon students to consider general issues that relate to regulatory compliance in a variety of fields, by offering chances to compare research regulation with financial and safety regulation.
Readings will cover the history and practice of legal and institutional oversight of scholarly research on human subjects.
The fieldwork for the course will entail working with the Georgetown University Institutional Review Board (IRB), specifically the Board dealing with social scientific and humanistic research on human subjects. Students will become acquainted with the obligations of the IRB and the gaps in the understanding between the law and the IRB and, more concretely, between the IRB and the general research community. Students will work with the IRB to perform its work reviewing research proposals. They will perform reviews in conjunction with the IRB chair and they will attend at least one meeting of the full IRB. Students will also be expected to develop improved means of communication between the IRB and the research community. These measures will take the form of written recommendations; additions to or revision of the IRB website; presentations that can be reused for communicating with the research community; and other forms approved by the professor. Students will have the option of, and will be strongly encouraged to, work collaboratively on these projects. All students will be expected to present their ideas to the group as a whole for discussion and feedback. Whatever form they take, the final measures will be submitted for evaluation for the course.
The plan for the course includes a number of guest speakers who practice in fields where regulation and compliance play a major role.
Prerequisites: Students must complete the required first-year program prior to enrolling in this course (part-time and interdivisional transfer students may enroll prior to completing Criminal Justice, Property, or their first-year elective).
Students may not concurrently enroll in this practicum course and a clinic (except Street Law) or another practicum course. Students may concurrently enroll in this practicum course and an externship.
Students who wish to receive credit for the Externship Seminar and a practicum course that has the same field placement may do so only if: (1) the practicum course is taken in a semester following the Externship Seminar; and (2) the student receives permission from the Assistant or the Associate Dean for Clinical Programs. To receive such permission, the student must explain in writing how the practicum course field work would serve substantially different learning goals than did their externship field placement.
THIS IS A PRACTICUM COURSE.
This is a 3 credit course. One credit will be awarded for the 2-hour weekly seminar and 2 credits will be awarded for approximately 10 hours of supervised work per week, for a minimum of 11 weeks.
Note: The seminar component of this practicum course will meet for seven Monday sessions on the following dates in the Spring 2013 semester: January 14, 28; February 4, 11; April 15 and 22. There will be an additional class meeting to be scheduled at a later date.
Students who enroll in this course will be automatically enrolled in both the seminar and practicum components and may not take either component separately. A student wishing to withdraw from the course will be withdrawn from both the seminar and field work components.
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