Medical Advocates
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
Substance Abuse Research
Vaccine Research
Microbicide Research
Epidemiological Research
HIV/STI Prevention
 

Ethics Main Page Main New and Noteworthy Home Page

Last Update:  July 20, 2016
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General Reports
 

  Journal Papers, Abstracts, and Commentaries

 
Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers Through Evidence-Based Ethics.
Fisher CB, Arbeit MR, Dumont MS, et al
 
J Empir Res Hum Res Ethics
. 2016 Mar 7.
Abstract

Ethics, research and HIV: lessons learned: a workshop report.
Reznik DA, Croser D, Kadrianto TH, Lavanya R. 
Oral Dis. 2016 Feb 11.
Abstract

The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics.
Fisher CB, Yuko E.
J
Empir Res Hum Res Ethics
. 2015 Dec;10(5):470-80.
Abstract

Prisoners as research participants: current practice and attitudes in the UK.
Charles A, Rid A, Davies H, Draper H
.
J Med Ethics
. 2014 Jun 23.
Abstract

Ethical considerations in HIV cure research: points to consider.
Lo B, Grady C; on behalf of the Working Group on Ethics of the International AIDS Society.

Curr Opin HIV AID
S
. 2013 Feb 15.
Abstract

Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research.
Haire BG
J Med Ethics. 2012 Nov 22.
 
Abstract

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
 
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
 


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   
B
MJ 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

 

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

 

Pediatric/Adolescent Research
 

    Journal Papers, Abstracts, and Commentaries    

 
Ethical Issues in Adolescent HIV Research in Resource-Limited Countries.
Bekker LG, Slack C, Lee S,  et al
J Acquir Immune Defic Syndr
. 2014 Jan 1;65 Suppl 1:S24-8.
Abstract

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
Y
outh 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

 
Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy.
Cohen JA, Mastroianni AC, Macklin R.
Int J Gynaecol Obstet. 2014 Jul 22

Abstract

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

 
A WEEK-IN-REVIEW FEATURED REPORT
Ethical Challenges in Conducting HIV/AIDS Research in Correctional Settings.
Eldridge GD, Robinson RV, Corey S, et al  
J Correct Health Care
. 2012 Sep 5.
Abstract

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

 

Substance Abuse Research
 

   Journal Papers, Abstracts, and Commentaries
 
  The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics.
Fisher CB, Yuko E.J
Empir Res Hum Res Ethics
. 2015 Dec;10(5):470-80.
Abstract

Participant and Staff Experiences in a Peer-Delivered HIV Intervention with Injection Drug Users.
Kostick KM, Weeks M, Mosher H.

J Empir Res Hum Res Ethic
s
. 2014 Feb;9(1):6-18
Abstract

Ethical issues in mHealth research involving persons living with HIV/AIDS and substance abuse.
Labrique AB, Kirk GD, Westergaard RP, Merritt MW.
AIDS Res Treat. 2013;2013:189645.

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
 

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 to Consider in the Design of HIV Prevention Trials Involving Transgender People.
Singh JA.
J Acquir Immune Defic Syndr. 2016 Aug 15;72
Abstract

Design Issues in Transgender Studies.
Hughes JP, Emel L, Hanscom B, Zangeneh S.

J Acquir Immune Defic Syndr
. 2016 Aug 15;72 Suppl 3:S248-S251.
Abstract

Ethical issues for late-stage trials of multipurpose prevention technologies for HIV and pregnancy.
Cohen JA, Mastroianni AC, Macklin R.
Int J Gynaecol Obstet. 2014 Jul 22

Abstract

HIV Prevention Research Ethics.
Fisher CB.

J Empir Res Hum Res Ethics
. 2014 Feb;9(1):1-5.
Abstract

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. 2
005 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
I
nt 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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