Scientists and Subjects Seminar description

About the project (historical and cultural context, benefits to seminar members and to others) Seminar description (description, objectives and outcomes, time commitment, registration and fee, seminar facilitator) Expectations (expectations, ground rules, guidelines) Enrollment status The online forum (overview, trying the forum) Registration form

Description

The eighth SAS Online Seminar is scheduled to meet via the World Wide Web and e-mail February 25-May 4, 2008.

Seven years of experience offering the Scientists and Subjects seminar has allowed us to develop an intensive, focused curriculum addressing core issues in human subjects research. To maximize interaction and attention to each seminar member's concerns, each cohort will be limited to 17 members.

While the discussion of the current regulatory climate cannot be avoided, the focus of the seminar will be on the ethical and moral foundations of research with human subjects rather than existing regulations and laws.

The schedule of assignments can be found at http://poynter.indiana.edu/sas/sched2008.pdf.

The online seminar will consist of a one-week introductory orientation followed by four units of two weeks each and one week for evaluation (ten weeks total):

1. Introductions
2. Justifying human experimentation
3. The Belmont Report and implementing the three principles articulated therein
4. Informed consent, including issues associated with research with children, at-risk and vulnerable populations, and cognitively or emotionally impaired individuals
5. Therapeutic obligations in research, including in non-therapeutic research
6. Evaluation

Units will typically consist of an article-length reading, a short writing assignment analyzing or reacting to the reading, and guided, asynchronous discussion. All readings will be available to seminar members via the World Wide Web in HTML or PDF format.

The nature of the seminar makes it possible to address the needs, interests, and concerns of seminar members.

Although members will be expected to meet weekly deadlines, they will be able to fit the work into their own schedules. Registrants should be prepared to work on the seminar twice a week for several hours (see time commitment).

Seminar members who complete all assignments on time will receive a Certificate of Completion. Members who do not actively contribute, who fail to meet deadlines, or fail to adhere to the seminar ground rules and guidelines will be removed from the seminar.

Objectives and outcomes

Objectives

1. Overall: After successfully completing the seminar, participants will be able to describe and discuss the moral foundations and ethical frameworks of research with human subjects.
2. Unit II: After successfully completing this unit, participants will be able to describe and discuss the moral arguments articulated by Hans Jonas in his article, "Philosophical Reflections on Experimenting with Human Subjects," particularly those arguments concerning the individual versus society, recruiting human subjects, the limits of informed consent, and the ideal of identification.
3. Unit III: After successfully completing this unit, participants will be able to describe and discuss the principles and guidelines for the protection of human subjects of research as articulated in The Belmont Report, particularly the distinction between research and practice, the three principles (respect for persons, beneficence, and justice), and their three applications (informed consent, risk-benefit analysis, and justice).
4. Unit IV: After successfully completing this unit, participants will be able to describe and discuss the topic of informed consent in greater depth, particularly the ethical justification of requiring informed consent, the four key components of informed consent, and situations in which obtaining informed consent may not be necessary or morally desirable.
5. Unit V: After successfully completing this unit, participants will be able to describe and discuss the therapeutic obligation in biomedical research, particularly the moral constraints placed on research by the therapeutic obligation and the limits of the therapeutic obligation.

Outcomes

As a result of meeting these objectives, participants will be able to

1. identify and analyze moral issues in research with human subjects.
2. interpret and implement policies and regulations concerning human subject protections in accordance with the ethical principles underlying them.
3. design or aid the design of ethically sound research protocols and informed consent documents.
4. serve effectively on an Institutional Review Board (IRB).

Time commitment

In post-seminar evaluations for 2003-2006, seminar members who successfully completed the seminar have reported spending an average of 1 to 14 hours per week on the seminar. Most seminar members (78%) reported spending from 1 to 5 hours on the seminar each week; on average, seminar members reported spending about 4.6 hours per week on the seminar.

Registration and fee

• The seminar fee for the 2008 seminar is $300.
• The registration form must be completed online by February 8, 2008.
• The full seminar fee must be received by Friday, February 15, 2008.
  • To pay by check or purchase order, send your contact information (name, address, daytime telephone number, and e-mail address) to Scientists and Subjects, Poynter Center, Indiana University, 618 East Third Street, Bloomington IN 47405-3602. Checks must be drawn on U.S. dollars and made payable to Indiana University-Bloomington
  • Credit card payments must be made via the World Wide Web at https://uisapp2.iu.edu/tpp-prd/guest/GotoIndex.do. Note the following details:
    • for Department Code, enter POYC
    • for Description, enter SAS and the name of the person who will participate in the seminar
    • for CVC Number, enter the non-embossed number on the back of the card (click the ? icon on the Web form for help)
  • We will also be happy to send an invoice at your request. Please allow at least 2 business weeks for invoice processing.
• No more than 17 participants will be accepted on a first-come, first-served basis.
• If fewer than 8 paid registrations are received by February 15, 2008, the seminar will be cancelled and a full refund will be made to registrants.
• A full refund of the seminar fee will be made to any registrant who provides a written notification of withdrawal by February 22, 2008; a 50% refund will be made if a written notification of withdrawal is received by March 5, 2008; after March 5, no refund will be made.
• We regret that no scholarships or reductions in the seminar fee are available.

Seminar facilitator

Kenneth D. Pimple, Ph.D., Director of Teaching Research Ethics Programs, Poynter Center, Indiana University. Pimple brings to this project more than fifteen years of experience in organizing faculty workshops on ethics and research ethics, including seven prior Scientists and Subjects online seminars and fourteen years of the Teaching Research Ethics Workshop. He has worked as a consultant for the National Research Council and the Institute of Medicine (among others) and has been invited to make presentations on the responsible conduct of research and on teaching research ethics in a wide variety of venues, including the (Norwegian) National Committee for Research Ethics in the Social Sciences and the Humanities; the national meeting of Public Responsibility in Medicine and Research (PRIM&R); the Whitaker Foundation Biomedical Engineering Research Conference; and the Slovak Republic's Institute of Preventive and Clinical Medicine. He has used electronic conferences in several courses. For more on Pimple, see http://mypage.iu.edu/~pimple/

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Last updated: 21 February 2008
URL: http://poynter.indiana.edu/sas/sasos.php
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