BIOST/STAT 578A • Spring 2011 

Ethical Issues for Biostatisticians

Readings and Assignments Page

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Syllabus 

Class Meetings Materials

 Readings and Assignments

 Resources

Assignments:  (Note: Expect updates throughout the quarter)
[3/30]   Introduction and overview
  1. Review for 3/31:  
      2. Familiarize yourself with the Belmont Report
      Look over the ASA ethical guidelines and the ISI Ethics Declaration
      Read David Resnik's page on What is ethics in research and why is it important?
  2. Additional optional readings for 3/30 and 3/31: 
      3. vanBelle's Rule 1.1. (4 questions) from van Belle G.  Statistical Rules of Thumb, Second Edition.  2008.
      pp 699-first column on 702 of the Cornand paper in Science on "The Code of the Scientist and Its Relationship to Ethics"
      UW Medical School Vendor Interaction Policy
      Univ Michigan Policy Statement on the Integrity of Scholarship

[3/31]   Guest lecture on human subjects protections (Sharon Elsayed, UW IRB)
  1. Read for today:  Assignments listed under 3/30
  2. Additional optional readings for today:  See Human subjects research links on the course resources page, both 
[4/13]   Remune story preparation
  1. Read for today:  

Kahn JO, Cherng DW, Mayer K, Murray H, Lagakos S  Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10(6)/L CD4 cell counts: A randomized controlled trial.  JAMA. 2000 Nov 1;284(17):2193-202.

Churdboonchart, V., C. Sakondhavat, S. Kulpradist, B. Isarangkura Na Ayudthya, V. Chandeying, S. Rugpao, C. Boonshuyar, W. Sukeepaisarncharoen, W. Sirawaraporn, D. J. Carlo, and R. Moss. 2000. A double-blind, adjuvant-controlled trial of human immunodeficiency virus type 1 (HIV-1) immunogen (Remune) monotherapy in asymptomatic, HIV-1-infected Thai subjects with CD4-cell counts of >300. Clin. Diagn. Lab. Immunol. 7:728-733

Glidden D, Kim S, Lagakos S.  Effectiveness of Remune.  Clin Diagn Lab Immunol. 2001 Mar;8(2):468-9.

  1. Prepare for class discussion:  Write two short reviews and think about a variety of questions (see 4/13 homework assignment)
[4/14]   Guest lecture on the Remune story (Dave Glidden, UCSF)
  1. Read additional materials related to the Remune story (see the Remune link on the resources page)
  2. Optional additional reading:  Dave sent this Grant et al 2010 NEJM paper about another AIDS trial he worked on and I expect he will discuss this in class in the context of pressure to publish
[4/21]   Guest lecture on conflict of interest (Bruce Psaty)  NOTE:  Room today is F648
  1. Read for today:
DeAngelis 2000 JAMA editorial on conflict of interest and the public trust with discussion of the Kahn et al Remune study

Psaty 2009 JAMA editorial on conflict of interest, disclosure, and trial reports

DeAngelis & Fontanarosa 2008 JAMA editorial on the adverse effects of industry influcence on research following up on the apparent misrepresentation of Vioxx results and proposing 11 changes to the analysis and reporting of clinical trials.
  1. Prepare for class discussion:  See 4/21 homework assignment
  2. Optional additional reading:  Korn (2000) JAMA editorial on "Conflict of Interest in Biomedical Research"
[4/27]   General discussion and processing your impressions from the previous class meetings
  1. Today we will discuss your impressions from the previous two classes
  2. I will introduce a multi-week homework project I want to assign later in the quarter and we will discuss the FIFRA 10(g) form you will need to sign in order to get access to the materials
[5/5]     Guest lecture on bias for positive findings (Tom Fleming)
  1. Read for today:  
    2. Tom Fleming's 2010 paper "Clinical Trials:  Discerning Hype from Substance"
    Noel Weiss's 2008 commentary on reporting subgroup effects
  2. Hand in 5/5 homework assignment  
[5/11]   Ethical issues in epidemiological research
  1. Project topics handout for discussion in class
  2. Sign the FIFRA 10(g) form and bring it to class to prepare for your next homework assignment

 [5/12]   Guest lecture on low-dose lead and residual confounding (Bruce Lanphear, SFU (faculty page))
  1. Read for today:  
    2. Bruce Lanphear's 2005 paper on a pooled analysis of low level lead exposure
    Bruce Lanphear's 2008 paper on the conundrum of unmeasured confounding
    One and preferably all of the following policy-related papers:
        The conquest of lead poisoning: a pyrrihc victory
        Trials and tribulations of protecting children from environmental hazards
        Childhood lead poisoning: the tortuous path from science to policy
  2. Hand in 5/12 homework assignment  

[5/18]   No Class

[5/19]   Guest lecture on Vioxx (Dick Kronmal)
  1. Hand in first phase of the multi-week homework assignment
  2. Make sure you have discussed your project topic with Lianne and scheduled a time to speak if you will be giving an oral presentation  
  3. Read for today:
Bombardier C, Laine L, Reicin A, et al.  Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.  New England Journal of Medicine 2000; 343:1520-8.  (Vigor study results)
Concerns about the Vigor study:  Curfman et al (2005) expression of concern; Bombardier et al (2006) response; Curfman et al (2006) reaffirmation of expression of concern
Psaty B, Kronmal RA.  Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment:  A case study based on documents from rofecoxib litigation.  Journal of the American Medical Association 2008; 299:1813-1817.
          Optional additional reading:
Letters to editor and authors’ replies (on the revelations about the reporting of mortality findings). JAMA 2008;300:900-906.

[5/25]   No Class

 [5/26]   Guest lecture on ROC and DSMBs (Scott Emerson)  Note:  Class will start at 1 p.m. today and end at 2:50 p.m.  Same room
  1. Hand in the second part of the multi-week homework assignment
  2. Optional additional reading:  Hicks et al (2007) paper "A primer on data safety monitoring boards:  mission, methods, and controversies"
  3. Read for today:
Goodman (2007):  Rashomon revisited:  two views of monitoring the Women's Health Initiative trials
A view from the Clinical Coordinating Center (Anderson et al 2007)
A view from the DSMB (Wittes et al 2007)

[6/1]     Student presentation meeting
 
[6/2]     Course wrap-up and discussion
  1. Hand in the third part of the multi-week homework assignment and be prepared to discuss it in class today
  2. For your final homework assignment, please share some parting thoughts (please hand in by June 1 so I can incorporate your thoughts into today's discussion)