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Scientists and Subjects

Seminar description


The seventh annual SAS Online Seminar will meet via the World Wide Web and e-mail January 9-March 19 2006.

Although online seminars have many advantages, they are not for everyone. The success of this seminar is wholly dependent on the active and appropriate participation of all seminar members. In this case, participation consists entirely of online communication. Participants are expected to be able to understand and follow written directions, have enough time to write adequate responses, be comfortable communicating in this medium, and consistently meet deadlines. Please do not register unless you believe that you will be able to meet these expectations. Seminar members who do not meet these expectations will be removed from the seminar.

The online seminar will utilize a simple, user-friendly Web-based bulletin board system (BBS). Before registering, prospective seminar members should read the seminar guidelines and visit http://poynter.indiana.edu/sas_bbs/sas.cgi to try the BBS. All seminar members will have the option of subscribing to have messages posted to the seminar BBS sent to them via e-mail. Only limited technical assistance will be available during the seminar; registrants and seminar members are expected to be adept at using the World Wide Web and e-mail.

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.

Six 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. Seminar members are expected to have access to the World Wide Web throughout the ten-week seminar period.

The seminar syllabus can be found at http://poynter.indiana.edu/sas/syl2006.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). The four substantive units are:

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

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). The seminar guidelines have more details on expectations.

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 guidelines will be dropped 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 1: 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 2: 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 3: 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 4: 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, 2004, and 2005, 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 (59%) reported spending from 2 to 4 hours on the seminar each week. The raw and adjusted data in the table below show that on average seminar members reported spending about 2.6 hours per week on the seminar.

On average, I spent approximately _____ hours per week on the seminar.
Actual responses Averaged responses Number of responses
1 1 1
2 2 7
2.5 2.5 1
2-3 2.5 2
2-4 3 1
3 3 6
3-4 3.5 1
3-5 4 1
4 4 6
4-5 4.5 3
5 5 4
5-8 6.5 1
6-8 7 1
7 7 1
8 8 4
10 10 1
10-15 13 1
12 12 1
14 14 1
Total 112.5 44
Average reported time commitment: 2.6 hours per week

Registration and fee

The registration form must be completed online; see http://poynter.indiana.edu/sas/reg.php.

The registration fee is $200. An additional $50 processing fee is required for registrants who wish to apply for Continuing Medical Education credit.

Registration information and fees must be received by Friday, December 9, 2005. Send your contact information (name, address, daytime telephone number, and e-mail address) and $200 (or $250 if you wish to receive CME credit) in the form of a purchase order or check (payable to "Poynter Center-SAS") to Scientists and Subjects, Poynter Center, Indiana University, 618 East Third Street, Bloomington IN 47405-3602. We regret that we cannot process credit cards.

No more than 17 participants will be accepted on a first-come, first-served basis. If fewer than 8 registrations are received by December 9, the seminar will be cancelled and a full refund will be made to registrants. A full refund will be made to any registrant who cancels by December 30; a 50% refund will be made if cancellation is received by January 13, 2006; after January 13, no refund will be made.


Seminar facilitator

Kenneth D. Pimple, Ph.D., Director of Teaching Research Ethics Programs, Poynter Center, Indiana University. Pimple brings to this project more than thirteen years of experience in organizing faculty workshops on ethics and research ethics, including six prior Scientists and Subjects online seminars and twelve 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/


Next: Seminar guidelines (contributing to the seminar, ground rules, stylistic guidelines)


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Last updated: 18 August 2005
URL: http://poynter.indiana.edu/sas/seminar.html
Comments: pimple@indiana.edu
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