Journal of Reproduction & Infertility

Journal of Reproduction & Infertility

Designing and compiling a generic informed consent form for human volunteers participating in research

Authors
Ali Yousefinejad Ostadkelayeh 1
Bagher Larijani 2
Seyyed Reza Majdzadeh 3
Asadollah Madadi 1
Morteza Zabihyean 4
Aliraza Parsapour 4
Hasan Tamini 5
Hojjatallah Soleimani 1
Ghasem Zamani 3
Alireza Nikbakht 6
1 Research Deputy , Tehran university of medical sciences, Tehran, Iran
2 Department of Internal Medicine, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
3 Epidemiology Department, Faculty of Publi Health, Tehran Medical Sciences University, Tehran, Iran
4 Tehran University of Medical Sciences, Tehran, Iran
5 Faculty of Rehabilitation ,Tehran University of Medical Sciences, Tehran, Iran
6 Department of Internal Medicine & Surgery, Faculty of Midwifery and Nursing, Tehran University of Medical Sciences and Health Services, Tehran, Iran
Abstract
Introduction: Performing research on (human) volunteers may involve useful or harmful effects. To preserve the volunteers' dignity, numerous world associations have issued declarations such as Nurembergs, Helsinkis, Belmonts report, etc. One of the four ethical principles in research is respecting volunteers' rights and the most obvious aspect of this respect materializes in obtaining the volunteers informed consent. Materials & Methods: This informed consent form has been compiled by a Delphi quality study which 15 experts have participated in its designation and compilation. At first, the experts replied the questions posed by the researchers on the frame and contents of the form. Then, the replies were summarized and once again were sent to the experts for a second revision. Eventually, the final form was edited by a Persian language expert. Results: The final result of this research is an informed consent form which includes three main parts: introduction, body and places provided for signatures. Conclusion: Compilers of this form find it a suitable and useful way to obtain volunteers in-formed consent. This form has been prepared for all researchers in different fields of medical science and the authors welcome any comments, suggestions or criticisms by professors and specialists.
Keywords
Human subjects
informed consent
Research
Volunteer
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Journal of Reproduction & Infertility
Volume 6, Issue 5
Winter 2006
Pages 553-562