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Related Concept Videos

Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
Nurses' Legal Responsibilities I01:27

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Ethical Standards II01:23

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Transportation of samples from the collection point to the laboratory, as well as storage and preservation techniques, are crucial for maintaining sample integrity and ensuring accurate and reliable test results.
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Working with Human Tissues for Translational Cancer Research
07:48

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Published on: November 26, 2015

Informed consent and research with stored biological samples.

Cristiano Guedes Duque1, Daniela Maria de Paula Ramalho, José Cláudio Casali-da-Rocha

  • 1Instituto Nacional de Câncer - INCA MS/HC1, Rio de Janeiro, RJ, Brazil.

Revista Da Associacao Medica Brasileira (1992)
|December 15, 2010
PubMed
Summary

Obtaining patient consent for retrospective cancer research via mail is feasible, with most patients agreeing to participate. This method, however, involves significant costs and logistical challenges.

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Area of Science:

  • Oncology
  • Clinical Research Ethics
  • Health Services Research

Background:

  • Retrospective studies are crucial for understanding disease progression and treatment outcomes.
  • Obtaining informed consent for retrospective studies involving patient data and biological samples presents unique challenges.
  • Compliance with ethical guidelines, such as Resolution 196/96 in Brazil, is mandatory for research involving human subjects.

Purpose of the Study:

  • To detail the practical experience and feasibility of obtaining informed consent from patients for a retrospective colon cancer study.
  • To evaluate the effectiveness of a combined phone and mail approach for consent acquisition.
  • To identify the costs and challenges associated with this consent process.

Main Methods:

  • A retrospective study was designed to review medical records and analyze paraffin blocks of colon cancer patients treated between 2000 and 2004.
  • Initial attempts to obtain consent in person were limited.
  • A strategy involving phone contact followed by mailing information sheets, consent forms, and prepaid return envelopes was implemented.

Main Results:

  • Out of 155 mailed consent forms, 115 (74%) were returned, with 111 patients providing consent.
  • Phone contact success rate was 37.5% (60 out of 160 attempts).
  • The median return time for consent forms was 10 days, with an overall mailing cost of R$ 1,004.40.

Conclusions:

  • Acquiring patient consent for retrospective clinical studies through phone and mail is a viable approach.
  • The majority of patients were responsive and willing to participate, supporting the feasibility of this method.
  • Researchers must acknowledge and plan for the associated costs and potential risks involved in mail-based consent procedures.