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Ethics and Infectious Diseases
  Human Subject Research
Ethical Principles
 General Reports
 Whistleblowing
 Volunteers
 Conflicts of Interests
 Falsification of Data  
Informed Consent
 Eligibility
 Randomization
 Underpowered Trials
Resource-Limited Countries
 Cross-Cultural Research
 Prison Research
 Pediatric Research
 Perinatal Research
 Vaccine Research
 Microbicide Research
 Epidemiological Research
 HIV/STI Prevention
 
Ethics Main Page Main New and Noteworthy Home Page
Last Update:  February 04, 2012
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General Reports
 

  Journal Papers, Abstracts, and Commentaries

 
HIV/AIDS Research Conducted in the Developing World and Sponsored by the Developed World:
Reporting of Research Ethics Committee Review in Two Countries.
Chin LJ, Rifai-Bashjawish H, Kleinert K, et al J
Empir Res Hum Res Ethics. 2011 Sep;6(3):83-91.
 Abstract

Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the
National Institutes of Health.
Neaton JD, Babiker A, Bohnhorst M, et al
Clin Trials. 2010 Aug 20
 Abstract

Ethical considerations in industry-sponsored Multiregional clinical trials.
Ibia E, Binkowitz B, Saillot JL, et al
Pharm Stat. 2010 Sep 7
 Abstract

Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical
prevention research.
Nelson RM, Lewis LL, Struble K, Wood SF.
 J Acquir Immune Defic Syndr. 2010 Jul 1;54 Suppl 1:S18-24.
 Abstract

Treatment Needs in HIV Prevention Trials Using Beneficence to Clarify Sponsor-Investigator
Responsibilities  
Stobie M, Slack C.
 Dev World Bioeth. . [Epub ahead of print]
 Abstract

Assessing social risks prior to commencement of a clinical trial: due diligence or
ethical inflation?
Burris S, Davis C.
 Am J Bioeth. 2009 Nov;9(11):48-54.
 Abstract

Compensation for Incarcerated Research Participants: Diverse State Policies Suggest a New
Research Agenda.
Smoyer AB, Blankenship KM, Belt B. 
Am J Public Health. 2009 Aug 20.
 Abstract

Protecting vulnerable subjects in clinical research: children, pregnant women, prisoners,
and employees.
Schwenzer KJ.
Respir Care. 2008 Oct;53(10):1342-9
 Abstract
 
Ethics issues for HIV/AIDS researchers in international settings - perspectives from the
Canadian experience.
 Gahagan J, Sweeney E, Worthington C, et al 
 Int J Infect Dis. 2008 Sep 29.
Abstract
 
A WEEK IN REVIEW FEATURED REPORT
Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials.
 Fisher JA.
 Soc Sci Med. 2008 Mar 17
 Abstract
 
Ethics committees and the legality of research.
Douglas TM.  
J Med Ethics. 2007 Dec;33(12):732-6
 Abstract
 
Fraud and deceit in published medical research.
 Lohsiriwat V, Lohsiriwat S.
 J Med Assoc Thai. 2007 Oct;90(10):2238-43.
 Abstract
 
FULL TEXT PDF ARTICLE
 Health, human rights, and the conduct of clinical research within oppressed populations.
Mills EJ, Singh S. 
Global Health. 2007 Nov 8;3(1):10
Paper
 
Ethical issues in stopping randomized trials early because of apparent benefit.
Mueller PS, Montori VM, Bassler D, et al
Ann Intern Med. 2007 Jun 19;146(12):878-81.
Abstract
 
The obligation to provide antiretroviral treatment in HIV prevention trials.
Lo B, Padian N, Barnes M. 
AIDS. 2007 Jun;21(10):1229-1231.
 Abstract
 
Bench-to-bedside review: Human subjects research - are more standards needed?
Huang DT, Hadian M 
Crit Care. 2006 Dec 15;10(6):244
Abstract
 
Exploring the Ethics of Clinical Research in an Urban Community.
Grady C, Hampson LA, Wallen GR, et al
m J Public Health. 2006 Oct 3
 Abstract
 
"It's Like Tuskegee in Reverse": A Case Study of Ethical Tensions in Institutional Review
Board Review of Community-Based Participatory Research.
Malone RE, Yerger VB, McGruder C, Froelicher E. 
Am J Public Health. 2006 Oct 3;
 Abstract
 
FULL-TEXT ARTICLE
 The Declaration of Helsinki: an update on paragraph 30
Blackmer J, Haddad H
CMAJ  October 25, 2005; 173 (9).
 Commentary
 
Ethical issues in HIV/AIDS research.
Muthuswamy V
 Indian J Med Res. 2005 Apr;121(4):601-10.
 Abstract
 
Trust and confidence: towards mutual acceptance of ethics committee approval of
multicentre studies.
Sarson-Lawrence M, Alt C, Mok MT, et al 
Intern Med J. 2004 Nov;34(11):598-603.
Abstract
 
Research Ethics Committees: can they contribute to the improvement of clinical
research in Europe?
Liberati A.
 J Ambul Care Manage. 2004 Apr-Jun;27(2):154-65
 Abstract
 
Ethics in human experimentation: the two military physicians who helped develop
the Nuremberg Code.
Temme LA.
Aviat Space Environ Med. 2003 Dec;74(12):1297-300
 Abstract

HIV-AIDS: ethics in healthcare, research, and access to treatments
Hirsch E. 
Med Sci (Paris). 2003 Jun-Jul;19(6-7):753-60.
 Abstract

Scientific and ethical considerations in trial design for investigational agents for
the treatment of human immunodeficiency virus infection.
Feinberg J, Japour AJ.
Clin Infect Dis 2003 Jan 15;36(2):201-6
 Abstract
 
    Conference Reports, Abstracts, and Posters
 
 
POSTER
 The critical role of people living with HIV in shaping biomedical prevention research
G. Caswell, J. Beloqui, S. Bukiki, et al
 (XVIII International AIDS Conference)
PDF Poster     Abstract
 
Biogeneric development : when trade secret law clashes with research ethics
K. Elouardighi
 (XVIII International AIDS Conference)
 Abstract
 
An analysis of dual IRB disclosure in published HIV/AIDS collaborative research between developed
and developing countries
L. Chin, H. Rifai-Bishjawish, K. Kleinert, et al
 (XVIII International AIDS Conference)
 Abstract

Research ethics issues for HIV/AIDS researchers in international settings –
Perspectives from CanadianExperience
 J. Gahagan  , E. Sweeney  , C. Worthington, et al
(XVII International AIDS Conference)
 Abstract
 
How ethical are our studies – an examination of the built in provisions for ethical issues
in field research studies
 R. Gopal
 (XVII International AIDS Conference)
 Abstract
 
Ethics in experimentation of neo-traditional treatments for HIV/AIDS in Benin, Burkina Faso and Senegal
relativism vs. universalism
 E. Simon, M. Egro A. Traore, E. Sambieni
 (XVII International AIDS Conference)
 Abstract
 
Ethical misrecognition: reframing community perspectives and debates on clinical trial conduct
 K. Peterson  , M. Folayan
(XVII International AIDS Conference)
 Abstract
 

Influencing legislative processes and policy development in order to improve research
ethics
Fischer H., Fabrice P. 
(XVI International AIDS Conference)
 Abstract

Civil society and HIV/AIDS research ethics: development of a code of conduct for HIV/AIDS
research to reinvigorate dialogue between north and south
Gahagan J., Worthington C., Nadeau J., Prince B. 
(XVI International AIDS Conference)
 Abstract
Whistleblowing
 

    Journal Papers, Abstracts, and Commentaries
 
  Whistleblowing in academic medicine
Rhodes R Strain JJ J
Med Ethics 2004;30:35-39
 Abstract
   
  Supporting whistleblowers in academic medicine: training and respecting the
courage of professional conscience
Faunce T, Bolsin S, W-P Chan W-P
J Med Ethics 2004;30 40-43
 Abstract
Volunteers 
 

    Journal Papers, Abstracts, and Commentaries

 
How ethical is ethical research? Recruiting marginalized, vulnerable groups into
health services research.
Smith LJ.
J Adv Nurs. 2008 Apr;62(2):248-57
Abstract

Infectious disease experimentation involving human volunteers.
Rosenbaum JR, Sepkowitz KA.
Clin Infect Dis 2002 Apr 1;34(7):963-71
 Abstract
Conflicts of Interests
 

    Journal Papers, Abstracts, and Commentaries

  FULL-TEXT PAPER
Disclosure of financial competing interests in randomised controlled trials: cross
sectional review
Gross CP, Gupta AR,  Krumholz HM  
BMJ 2003;326:526-527
Paper
 
FULL-TEXT ARTICLE
 Ethics of undisclosed payments to doctors recruiting patients in clinical trials 
Rao JN , Sant Cassia L J
BMJ 2002;325 36-37
Paper

Managing conflicts of interest in the conduct of clinical trials.
Morin K, Rakatansky H, Riddick FA Jr, et al.
JAMA 2002 Jan 2;287(1):78-84
Abstract

 		 
Falsification of Data
 
     Journal Papers, Abstracts, and Commentaries
 
 
Fraud and deceit in published medical research.
Lohsiriwat V, Lohsiriwat S.
J Med Assoc Thai. 2007 Oct;90(10):2238-43.
 Abstracts

FULL-TEXT ARTICLE
 Institutional corruption in medicine
 Wilmshurst P   
BMJ 2002;325 1232-1235
Paper

  
Eligibility Criteria/Subject Selection
 

     Journal Papers, Abstracts, and Commentaries

  Selecting subjects for participation in clinical research: one sphere of justice.
Weijer C
J Med Ethics 1999 Feb;25(1):31-6
Abstract
Research in Resource-Limited Countries 
 

    Journal Papers, Abstracts, and Commentaries

 
FULL-TEXT ARTICLE
 Establishing ethical trials for treatment and prevention of AIDS in  developing countries
Lo B, Bayer R  
BMJ 2003;327 337-339
 Paper

Ethical Oversight of Public Health Research: Can Rules and IRBs Make a
Difference in Developing Countries?
London L
 Am J Public Health 2002; 92: 1079-1084.
 Abstract

AIDS research in developing countries: Do the ends justify  the means?
Clark PA.
Med Sci Monit 2002 Sep;8(9):ED5-16
 Abstract

 Ethical issues in HIV research in poor countries.
J Nurs Scholarsh 2001;33(2):111-4
Abstract
 

  
    Conference Reports, Abstracts, and Posters
 
  How to limit the coercive effect of the provision of care and treatment in clinical trials in
resource poor settings
 M. de Cenival, M. Ukpong, X. Anglaret
 (XVI International AIDS Conference)
 Abstract
 
Ethics in experimentation of neo-traditional treatments for HIV/AIDS in Benin, Burkina Faso and
Senegal: relativism vs. universalism
 E. Simon, M. Egrot, A. Traore,  et al
 (XVI International AIDS Conference)
 Abstract
 
Ethical misrecognition: reframing community perspectives and debates on clinical trial conduct
 K. Peters, M. Folayan
 (XVI International AIDS Conference)
 Abstract
 
Civil society implication in HIV/AIDS research issues: Cameroon experience
 C. Talom Yomgne
(XVI International AIDS Conference)
 Abstract
 
Civil society involvement in HIV related research
 S. Kabore , A. Ouaré , E. Fleutelot, et al
 (XVI International AIDS Conference)
 Abstract
Informed Consent
 

     Journal Papers, Abstracts, and Commentaries

  Voluntary consent in correctional settings: do offenders feel coerced to participate in research?
Edens JF, Epstein M, Stiles PG, Poythress NG Jr.
Behav Sci Law. 2011 Nov;29(6):771-95.
 Abstract

Factors influencing parental consent in pediatric clinical research.
Rothmier JD, Lasley MV, Shapiro GG.
Pediatrics 2003 May;111(5 Pt 1):1037-41
 Abstract

The centennial of the Yellow Fever Commission and the use of informed
consent in medical research.
Guerena-Burgueno F.
Salud Publica Mex 2002 Mar-Apr;44(2):140-4
 Abstract

Ethical issues in ethnographic nursing research with children and
elderly people.
 Jokinen P, Lappalainen M, Merilainen P, Pelkonen M.
 Scand J Caring Sci 2002 Jun;16(2):165-70
 Abstract

FULL-TEXT ARTICLE  
 Attitudes of the Japanese public and doctors towards use of archived information
and samples without informed consent: Preliminary findings based on focus group interviews
 Asai A, Ohnishi M, Nishigaki E, et al.
BMC Med Ethics 2002; 3: 1
 Paper

Patients' perceptions of information provided in clinical trial.
Ferguson PR
J Med Ethics 2002;28:45-48
 Abstract

  

     Conference Reports, Abstracts, and Posters

 
Improving informed consent in HIV/AIDS research: a conceptual framework and supportive
materials
C Woodsong, Q Abdool Karim, A Coletti, et al
 (15IAC)
 Abstract
 
Pediatric/Adolescent Research
 

    Journal Papers, Abstracts, and Commentaries    

 
What do research ethics committees say about applications to conduct research involving
children?
Angell E, Biggs H, Gahleitner F, Dixon-Woods M.
Arch Dis Child. 2010 Jun 23
 Abstract

A review of the ethics in research on child abuse.
 Veena AS, Chandra PS.
Indian J Med Ethics. 2007 Jul-Sep;4(3):113-5.L
 Abstract
 
Ethical issues in research with homeless youths.
Ensign J, Ammerman S.  
J Adv Nurs. 2008 May;62(3):365-72.
 Abstract
 
The legal ethics of pediatric research.
 Coleman DL.
 Duke Law J. 2007 Dec;57(3):517-624
 Abstract
 
Ethical concerns regarding guidelines for the conduct of clinical research
on children
 Edwards SDMcNamee MJ
J Med Ethics 2005;31
Abstract
 
Children in Medical Research: balancing protection and access: has the pendulum swung too far?
Ross LF.
Perspect Biol Med. 2004 Fall;47(4):519-36.
 Abstract
 
Overcoming ethical barriers to childhood tuberculosis research in developing countries.
Sina BJ, Molyneux E.
Int J Tuberc Lung Dis. 2004 May;8(5):683-6.
 Abstract
 
FULL-TEXT ARTICLE
Youth health research ethics: time for a mature-minor clause?
Sanci LA, Sawyer SM, Weller PJ, et al 
Med J Aust. 2004 Apr 5;180(7):336-8
 Paper

Ethical principles and operational guidelines for good clinical practice in paediatric research.
Recommendations of the Ethics Working Group of the Confederation of European Specialists
in Paediatrics (CESP).
Gill D.
Eur J Pediatr. 2004 Jan 10
Abstract
 
Ethical issues in qualitative health research with homeless youths.
Ensign J.  
J Adv Nurs. 2003 Jul;43(1):43-50.
Abstract

Ethical considerations in psychopharmacological research involving
children and adolescents.
Vitiello B.
Psychopharmacology (Berl) 2003 Apr 4;
Abstract

 Is it in a neonate's best interest to enter a randomised controlled trial?
Allmark P, Mason S, Gill AB, Megone C.
J Med Ethics 2001 Apr;27(2):110-3
 Abstract

  
Perinatal Research
 

    Journal Papers, Abstracts, and Commentaries

 
Reflections on the use of a placebo in international research. The example of trials relative to
the vertical perinatal transmission of the HIV virus
Delfosse ML.
 J Int Bioethique. 2007 Dec;18(4):59-67, 77
 Abstract 

Ethical framework for observational studies of medicinal drug exposure in pregnancy.
Koren G.
Teratology 2002 Apr;65(4):191-5 
Abstract 

Randomised placebo-controlled trials and HIV-infected pregnant women in developing
countries. Ethical imperialism or unethical exploitation?
de Zulueta P.
Bioethics 2001 Aug;15(4):289-311
Abstract

 Ethics and HIV research in Zimbabwe.
Bhagat K, Nyazema NZ
Cent Afr J Med 2000 Apr;46(4):105-7
Abstract

  
Prison Health Research
 
     Books
  FULL-TEXT BOOK
 Ethical Considerations for Research Involving Prisoners.
 Institute of Medicine (US) Committee on Ethical Considerations for Revisions to DHHS
Regulations for Protection of Prisoners Involved in Research; Gostin LO, Vanchieri C, Pope A, editors.
Washington (DC): National Academies Press (US); 2007.
 Book

    Journal Papers, Abstracts, and Commentaries

 
The prisoner as model organism: malaria research at Stateville Penitentiary.
Comfort N.   
Stud Hist Philos Biol Biomed Sci. 2009 Sep;40(3):190-2
 Abstract

Research involving prisoners: consensus and controversies in international
and European regulations.
Elger BS.
Bioethics. 2008 May;22(4):224-38.
 Abstract
 
Forensic psychiatry ethics: expert and clinical practices and research on prisoners
Taborda JG, Arboleda-Florez J.
Rev Bras Psiquiatr. 2006 Oct;28 Suppl:s86-92.
Abstract

HIV clinical trials in correctional settings: right or retrogression?
De Groot AS, Bick J, Thomas D, Stubblefield E.
AIDS Read 2001 Jan;11(1):34-40
 Abstract

  

    Conference Reports, Abstracts, and Posters

 
POSTER
 Updated ethics guidance for HIV prevention research
S. Rennie, J. Sugarman, Q. Abdool Karim, Ethics Working Group,
HIV Prevention Trials Network
 (XVIII International AIDS Conference)
PDF Poster     Abstract

Ethical issues in conducting researchers with prisoners
PJ Kelly
(135 APHA)
 Abstract
Vaccine Research
 

     Journal Papers, Abstracts, and Commentaries

 
FULL-TEXT PDF ARTICLE
 Convergent ethical issues in HIV/AIDS, tuberculosis and malaria vaccine trials in Africa:
Report from the WHO/UNAIDS African AIDS Vaccine Programme's Ethics, Law and
Human Rights Collaborating Centre consultation, 10-11 February 2009, Durban, South Africa.
Mamotte N, Wassenaar D, Koen J, Essack Z.
 BMC Med Ethics. 2010 Mar 9;11(1):3
 Paper

Strategies and ethical considerations for the recruitment of young men who have sex with men:
challenges of a vaccination trial in Mexico.
Gutierrez-Luna A, Angeles-Llerenas A, et al  
Clin Trials. 2009 Jul 22
 Abstract

Views of the process and content of ethical reviews of HIV vaccine trials among members of
US institutional review boards and South African research ethics committees.
 Klitzman R. 
Dev World Bioeth. 2008 Dec;8(3):207-18.
 Abstract
 
A WEEK-IN-REVIEW FEATURED REPORT
FULL-TEXT ARTICLE
 Enrolling Women into HIV Preventive Vaccine Trials: An Ethical Imperative but a Logistical
Challenge
Mills E,  Nixon S, Singh S, et al
 PLoS Medicine  Vol 3, No 3. March 2006
 Paper
 
FULL-TEXT ARTICLE
 Ethical and Legal Issues in AIDS Vaccine Trials
 Shapiro RS, Stein RE
Human Rights Magazine Fall 2004
 Paper
 
FULL-TEXT PDF ARTICLE
 Ethical Issues in Using a Cocaine Vaccine to Treat and Prevent Cocaine Abuse and
Dependence
Hall  W, Carter L
J Med Ethics Advanced Publications June 02, 2004
 Paper

Ethical considerations in international HIV vaccine trials: summary of a consultative
process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS).
Guenter D, Esparza J, Macklin R
J Med Ethics 2000 Feb;26(1):37-43
 Abstract

Live attenuated vaccine trials in medically informed volunteers: a special case?
Pinching AJ
J Med Ethics 2000 Feb;26(1):44-6
Abstract

  
Microbicide Research
 
   Journal Papers, Abstracts, and Commentaries
 
  FULL TEXT ARTICLE
Microbicide research in developing countries: have we given the ethical concerns due
consideration?
Moodley
BMC Medical Ethics 2007, 8:10 (19 Sep 2007)
 Paper
HIV/STI Prevention
 
     Journal Papers, Abstracts, and Commentaries
 
 
Ethical issues in the NIMH Collaborative HIV/STD Prevention Trial.
NIMH Collaborative HIV/STD Prevention Trial Group. 
AIDS. 2007 Apr;21 Suppl 2:S69-80.
 Abstract
 
Tenofovir trials raise ethical issues.
Mills E. 
HIV AIDS Policy Law Rev. 2005 Aug;10(2):31-2.
 Abstract

FULL-TEXT ARTICLE
 Ethics guidance for HIV prevention trials
MacQueen KM,  Karim QA, Sugarman J.
BMJ 2003;327 340
 Paper
Underpowered Research
 
   Journal Papers, Abstracts, and Commentaries
 
  The continuing unethical conduct of underpowered clinical trials.
Halpern SD, Karlawish JH, Berlin JA.  
JAMA 2002 Jul 17;288(3):358-62
 Abstract		  
Randomization
 

      Journal Papers, Abstracts, and Commentaries

  Estimating a treatment effect in survival studies in which patients switch treatment.
Branson M, Whitehead J.
Stat Med 2002 Sep 15;21(17):2449-63
 Abstract		  
Cross-Cultural Research
 
     Journal Papers, Abstracts, and Commentaries
 
  Ethical issues in ethnographic nursing research with children and elderly people.
 Jokinen P, Lappalainen M, Merilainen P, Pelkonen M.
 Scand J Caring Sci 2002 Jun;16(2):165-70
 Abstract

Some ethical issues in international collaborative research in developing countries.
Robison VA
Int Dent J 1998 Dec;48(6):552-6
Abstract

  
Epidemiological Research
 
      Journal Papers, Abstracts, and Commentaries
 
  FULL-TEXT PDF ARTICLE
 Ethical issues in epidemiologic research and public health practice.
Coughlin SS.
 Emerg Themes Epidemiol. 2006 Oct 3;3(1):16
Paper		  

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