(Q37217591)

19 August 2017

First-in-human trial participants: not a vulnerable population, but vulnerable nonetheless (English)

1 reference

19 August 2017

1

Rebecca Dresser

1 reference

19 August 2017

1 January 2009

1 reference

Journal of Law, Medicine, and Ethics

19 August 2017

1 reference

19 August 2017

37

1 reference

19 August 2017

1

1 reference

19 August 2017

38-50

1 reference

The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research

19 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Bench to bedside: mapping the moral terrain of clinical research.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

First-in-Man (FIM) clinical trials post-TeGenero: a review of the impact of the TeGenero trial on the design, conduct, and ethics of FIM trials

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Ethics at phase 0: clarifying the issues

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Clinical trials and medical care: defining the therapeutic misconception

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Staunch protections: the ethics of haemophilia gene transfer research

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Risks and benefits associated with novel phase 1 oncology trial designs

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Identifying and hurdling obstacles to translational research

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Oncology of companion animals as a model for humans. an overview of tumor histotypes

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Strategies to minimize risks and exploitation in phase one trials on healthy subjects

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Legitimate requests and indecent proposals: matters of justice in the ethical assessment of phase I trials involving competent patients

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Gene therapy progress and prospects: bringing gene therapy into medical practice: the evolution of international ethics and the regulatory environment

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Artificial sweeteners--do they bear a carcinogenic risk?

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Pet models in cancer research: general principles.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Evolution of a gene therapy clinical trial. From bench to bedside and back

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Safety issues in cell-based intervention trials.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Translational Medicine: A two-way road

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Ethics of phase 1 oncology studies: reexamining the arguments and data

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Emergency medicine animal research: does use of randomization and blinding affect the results?

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Moving research from the cage to the bedside: the need for IACUC/IRB cooperation

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Recommendations for standards regarding preclinical neuroprotective and restorative drug development

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Fifty years later: the significance of the Nuremberg Code

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

The Northwick Park tragedy--protecting healthy volunteers in future first-in-man trials

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Practice-based research--"Blue Highways" on the NIH roadmap

14 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Phase I cancer trials. A collusion of misunderstanding.

14 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Reality testing in cancer treatment: the phase I trial of endostatin

26 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Justice in translation: from bench to bedside in the developing world.

26 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Clinical trials and SCID row: the ethics of phase 1 trials in the developing world

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Risks and benefits of phase 1 oncology trials, 1991 through 2002.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Ethics in human subjects research: do incentives matter?

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Uncertain benefit: investigators' views and communications in early phase gene transfer trials

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

High-profile research & the media. The case of the AbioCor artificial heart.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Repeat Participation Among Normal Healthy Research Volunteers: Professional Guinea Pigs in Clinical Trials?

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Consent forms for oncology trials.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Phase I trials in cancer treatment. The maximum tolerated dose: a barbarian guideline.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Protecting research subjects--the crisis at Johns Hopkins

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

To screen new drugs for safety, Lilly pays homeless alcoholics: it's 'quick cash' to habitues of Indianapolis shelters; it vanishes quickly, too.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Policy forum: human genetics. Ethical considerations in leaping from bench to bedside.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

What's the price of a research subject? Approaches to payment for research participation.

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Consent forms and the therapeutic misconception: the example of gene transfer research

3 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Descriptions of benefits and risks in consent forms for phase 1 oncology trials

20 October 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Stable ethics: enrolling non-treatment-refractory volunteers in novel gene transfer trials

20 October 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects

4 December 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Ethical standards in phase 1 trials of neuroprotective agents for stroke therapy

4 December 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=2692671

Translational and clinical science--time for a new vision

4 December 2018

1 reference

12 December 2020

Exploiting a research underclass in phase 1 clinical trials

1 reference

12 December 2020

Risks and benefits of phase 1 clinical trials evaluating new anticancer agents: a case for more innovation

1 reference

12 December 2020

The changing landscape of human experimentation: Nuremberg, Helsinki, and beyond

1 reference

12 December 2020

Translation of research evidence from animals to humans

1 reference

12 December 2020

Guinea-pigging: healthy human subjects for drug safety trials are in demand. But is it a living?

1 reference

12 December 2020

Phase 1 clinical trials in oncology

1 reference

12 December 2020

Trials and tribulations

1 reference

12 December 2020

Injury to research volunteers--the clinical-research nightmare

1 reference

12 December 2020

Industry, FDA warm to "adaptive" trials

1 reference

12 December 2020

Participants in phase 1 oncology research trials: are they vulnerable?

1 reference

12 December 2020

10.1111/J.1748-720X.2009.00349.X

Identifiers

DOI

1 reference

19 August 2017

1 reference

PMC publication ID

2692671

19 August 2017

PubMed publication ID

19245601

1 reference

PMC publication ID

2692671