State of clinical research ethics in Pakistan

Abstract The role of research ethics consultants in biomedical research has increased to the point that they have an advisory capacity at all research institutes. For such professionals, we have established an educational system, which includes teaching materials, training methods, and nationwide educational workshops. These workshops have served to examine the developed system’s usefulness and to provide realistic training for consultant candidates. In addition, we have used the current workshop to encourage clinical research investigators (and related personnel) to participate. Subsequently, we examined its usefulness as an opportunity to provide exposure to research ethics. In October 2019, we held a 1-day pilot workshop in Tokushima, Japan, which included a basic lecture in research ethics. During the lecture, two sets of materials were used for case discussion: case 1, covering issues related to a clinical trial, and case 2, covering issues related to human biological specimens. At the end of the workshop, a 30-item self-reporting anonymous questionnaire was provided. Of the 13 total participants, 9 (70%) were clinical research investigators and related personnel, while 6 (46%) had no direct intention to act as consultants. Respondents indicated that case 2 was more difficult than case 1. However, both cases were generally accepted as educational materials; thus, satisfaction was expressed in relation to both. As the evaluations of the cases were generally positive, we will further examine the usefulness of participation in the workshop in the cultivation of research ethics in the investigator community.

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Should Research Ethics Committees Be Observing the Law or Working by Ethical Principles?

Research Ethics ◽

10.1177/174701610500100105 ◽

2005 ◽

Vol 1 (1) ◽

pp. 23-26 ◽

Cited By ~ 4

Author(s):

Charles Warlow

Keyword(s):

Clinical Research ◽

Research Ethics ◽

Public Interest ◽

Ethics Committees ◽

Unintended Consequences ◽

Research Ethics Committees ◽

Individual Interest ◽

The Public ◽

The Law ◽

The Individual

Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.

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Clinical Research Ethics in Respiratory Medicine

Archivos de Bronconeumología (English Edition) ◽

10.1016/s1579-2129(06)60121-3 ◽

2006 ◽

Vol 42 (2) ◽

pp. 74-80

Author(s):

E. Fernández de Uzquiano ◽

R. Álvarez-Sala

Keyword(s):

Clinical Research ◽

Research Ethics ◽

Respiratory Medicine

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Research Oversight through New Lenses: The Consortium to Examine Clinical Research Ethics

IRB Ethics and Human Research ◽

10.2307/3564407 ◽

2003 ◽

Vol 25 (1) ◽

pp. 9 ◽

Cited By ~ 3

Author(s):

Jeremy Sugarman ◽

Lisa A. Eckenwiler ◽

Ezekiel J. Emanuel

Keyword(s):

Clinical Research ◽

Research Ethics ◽

Research Oversight

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The Hennepin Ketamine Study Investigators’ Reply

Prehospital and Disaster Medicine ◽

10.1017/s1049023x19000219 ◽

2019 ◽

Vol 34 (02) ◽

pp. 111-113

Author(s):

Jeffrey D. Ho ◽

Jon B. Cole ◽

Lauren R. Klein ◽

Travis D. Olives ◽

Brian E. Driver ◽

...

Keyword(s):

Emergency Medicine ◽

Social Media ◽

Informed Consent ◽

Clinical Research ◽

Emergency Medical Services ◽

Research Ethics ◽

Public Controversy ◽

Future Studies ◽

Strongly Agree ◽

Recent Editorial

We read with interest the recent editorial, “The Hennepin Ketamine Study,” by Dr. Samuel Stratton commenting on the research ethics, methodology, and the current public controversy surrounding this study.1 As researchers and investigators of this study, we strongly agree that prospective clinical research in the prehospital environment is necessary to advance the science of Emergency Medical Services (EMS) and emergency medicine. We also agree that accomplishing this is challenging as the prehospital environment often encounters patient populations who cannot provide meaningful informed consent due to their emergent conditions. To ensure that fellow emergency medicine researchers understand the facts of our work so they may plan future studies, and to address some of the questions and concerns in Dr. Stratton’s editorial, the lay press, and in social media,2 we would like to call attention to some inaccuracies in Dr. Stratton’s editorial, and to the lay media stories on which it appears to be based.Ho JD, Cole JB, Klein LR, Olives TD, Driver BE, Moore JC, Nystrom PC, Arens AM, Simpson NS, Hick JL, Chavez RA, Lynch WL, Miner JR. The Hennepin Ketamine Study investigators’ reply. Prehosp Disaster Med. 2019;34(2):111–113

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