Ethics in research with human beings: from knowledge to practice

Area of Science:

• Medical Ethics
• Research Compliance

Background:

• Brazilian Resolution 196/96 and its amendments govern human research ethics.
• Ensuring participant rights, respect, and dignity is paramount in research.

Purpose of the Study:

• To evaluate the adherence of Free Communications (FC) presented at the XVIII Pernambucan Cardiology Congress to Resolution 196/96.
• To identify ethical compliance gaps in presented research abstracts.

Main Methods:

• A cross-sectional study involving interviews with FC authors.
• Assessment of FC abstracts to determine the necessity of prior Research Ethics Committee (REC) approval.
• Data collection on the use of Free and Informed Consent Forms (FICF).

Main Results:

• Only 23.1% of 90 FCs were submitted to a REC; 15.4% used FICF.
• 65.6% of authors not submitting to REC deemed it unnecessary; 18% were unaware of the requirement.
• 80% of authors had not read Resolution 196/96, with significantly higher REC submission rates among those who had (p=0.005).
• FC design and institutional authorization significantly influenced REC submission (p < 0.001).

Conclusions:

• A significant majority of FCs presented at the congress did not comply with Brazilian research ethics regulations.
• Lack of awareness and perceived necessity of ethical review contribute to non-compliance.
• Strengthening adherence to Resolution 196/96 is crucial for ethical research conduct in Brazil.