Four forward-looking guidance points

Ruth Macklin

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too 'aspirational' and not sufficiently 'pragmatic'.

Original languageEnglish (US)
Pages (from-to)121-133
Number of pages13
JournalDeveloping World Bioethics
Volume1
Issue number2
StatePublished - Nov 2001
Externally publishedYes

Fingerprint

vaccines
Research
Vaccines
Helsinki Declaration
bioethics
AIDS Vaccines
Bioethics
biomedical research
Biomedical Research
HIV
Guidelines
pragmatics
criticism
Control Groups
Guidance
Population
Group
Vaccine
AIDS/HIV

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Social Sciences(all)
  • Arts and Humanities(all)

Cite this

Four forward-looking guidance points. / Macklin, Ruth.

In: Developing World Bioethics, Vol. 1, No. 2, 11.2001, p. 121-133.

Research output: Contribution to journalArticle

Macklin, R 2001, 'Four forward-looking guidance points', Developing World Bioethics, vol. 1, no. 2, pp. 121-133.
Macklin, Ruth. / Four forward-looking guidance points. In: Developing World Bioethics. 2001 ; Vol. 1, No. 2. pp. 121-133.
@article{73615e8a6b2d4f99980bd250788783c8,
title = "Four forward-looking guidance points",
abstract = "Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too 'aspirational' and not sufficiently 'pragmatic'.",
author = "Ruth Macklin",
year = "2001",
month = "11",
language = "English (US)",
volume = "1",
pages = "121--133",
journal = "Developing World Bioethics",
issn = "1471-8731",
publisher = "Wiley-Blackwell",
number = "2",

}

TY - JOUR

T1 - Four forward-looking guidance points

AU - Macklin, Ruth

PY - 2001/11

Y1 - 2001/11

N2 - Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too 'aspirational' and not sufficiently 'pragmatic'.

AB - Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on similar issues in the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should potentially benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too 'aspirational' and not sufficiently 'pragmatic'.

UR - http://www.scopus.com/inward/record.url?scp=0037778766&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037778766&partnerID=8YFLogxK

M3 - Article

C2 - 12870520

AN - SCOPUS:0037778766

VL - 1

SP - 121

EP - 133

JO - Developing World Bioethics

JF - Developing World Bioethics

SN - 1471-8731

IS - 2

ER -