E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

نویسندگان

  • Sonia Mansoldo Dainesi
  • Moisés Goldbaum
چکیده

INTRODUCTION The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. METHODS Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. RESULTS The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. CONCLUSION Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

A Survey on the Observance rate of Research Ethics Principles in Approved Proposals at Ilam University of Medical Sciences, Ilam, Iran

Introduction: Considering the ever-increasing developments in medical research, especially the use of human subjects in research projects, the implementation of such research according to the ethical principles and criteria of creditable national and international declarations is of great significance. The present study aimed to investigate the rate of observance of research ethics in proposals...

متن کامل

Evaluation of clinical trials by Ethics Committees in Germany - Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA)

The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12(th) Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or ...

متن کامل

Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?

BACKGROUND The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. METHODS With a grant from the Bill and Melinda Gates Foundation, the A...

متن کامل

Review of policies for injuries to research participants in India.

BACKGROUND As there is little Indian data about severity, frequency and types of research related injuries, costs involved and policies regarding compensation, this study was conducted to review the present Indian scenario. METHODS The study was carried out in three parts; a questionnaire-based survey, in-depth interviews, and a review of informed consent and insurance documents of projects s...

متن کامل

نظری برکمیته‌های اخلاق در پژوهش در جهان و ایران

Medicine and ethics have increasingly more links caused by considerable progresses in biotechnology in different fields of medical diagnosis, treatment and prevention. The issue of research ethics is one of the most important subjects which have been emphasized by international and regional organizations, policy-makers, medical and religious professions, scientists and researchers in different ...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • Revista brasileira de epidemiologia = Brazilian journal of epidemiology

دوره 15 4  شماره 

صفحات  -

تاریخ انتشار 2012