Re-orientation of Ethics Review Committee

The Ethics Review Committee (ERC) and Institutional Ethics Review Committee (IERC) Members ERC and IERC members met last March 19, 2016 for the Re-orientation of Ethics Review Member.

Dr. Lloyd V. Orduña, (Vice-President for Administration and the Chairperson of the IERC) gave a talk on the topics:  What is Ethics and why is it importantEthical Norms in Research, Principles of Ethical Conduct of Research and on Determining Research Risks.

The following are the highlights of Dr. Orduña’s talk:

Ethics in Research and its importance

The Do’s

  1. Do unto others or The Golden Rule
  2. Do no harm or the Code of Ethical Conduct or Hippocratic Oath
  3. Do not kill or the religious creed found in the 10 commandments.
  4. Do the wise aphorisms of following Confucius sayings.

Ethical Norms in Research

  1. To promote the aims of research is to improve and to simplify life, to avoid error and to promote the truth.
  2. To promote values that involves a great deal of cooperation, sharing of ideas among different people in disciplines and institutions.
  3. To be accountable to the public as researchers deal a lot of time to study human subjects and animals.
  4. To help build public support in research, as people or different agencies are more likely to fund a research if the project per se has quality and integrity.
  5. To promote moral and social values variedly that greatly involves social responsibility, human rights, animal welfare, law compliance, and public health and safety.

A brief historical background was discussed so as to give reference why human research subjects need protection. The 13047713_1160929923939071_4747342296473232074_o observance of ethics in researches involving human participants was rooted on the Nazi Experiments when Nazi doctors tortured and carried out atrocious experiments over the inmates in a freezing concentration camp even killing the subjects in order to study them all in the glorious name of science. In that case, the ethical principles for experimentation of human subjects was formulated and now known as the Nuremberg Code.

The Belmont Report was formulated on 1978 and the Common Rule was established on 1991. The principles of the Belmont Report govern all research.  The ethical principles outlined in the report are the basis for subsequent regulations designed to ensure protection of human subjects in research.

The Basic Principles of the Belmont Report

  1. Respect for Persons where researchers should treat individuals as autonomous agents. Never use people as a means to an end. Allow people/subject to choose for themselves and to provide extra protections to those with diminished autonomy (i.e., Prisoners, Children, Cognitively Impaired, etc.)
  2. Beneficence is defined as an act of charity, mercy, and kindness with a strong connotation of doing good to others including moral obligation. The two general rules formulated from the principle of beneficence are: first, do no harm and second, maximize possible benefits and minimize risks.
  3. Justice is to treat people fairly and fair sharing of burdens and benefits of the research. An injustice occurs when benefits to which a person is entitled are denied without good reason, or burdens are imposed unduly.

Rules Derived used in Research

 On Respect for persons which involves Informed Consent Process and Respect for Privacy of the subject or the respondents. With the principle of Beneficence it helps us to make a good research design with competent investigators/researchers and favorable risk-benefit analysis. Lastly, with the principle of Justice, it helps us to have an equitable selection of subjects.

The Common Rule. It is the set of regulations which were developed to ensure compliance with the principles of the Belmont Report.  The regulations fall under the Department of Health and Human Services.  Protective mechanisms established by The Common Rule are the Institutional assurances of compliance and the review of research by an IERC with the informed consent of subjects.

The last topic of Sir Lloyd was focused on determining a research risk.  Different risks were defined and the role of the IERC in identifying risks was discussed. The risks to which research subjects may be exposed have been classified as physical, psychological, social and economic. Points to consider are:

  • Are both risks and anticipated benefits accurately identified, evaluated, and described?
  • Are the risks greater than minimal risk? Has the IERC taken into account any special vulnerability among prospective subjects that might be relevant to evaluating the risk of participation?
  • If the research involves the evaluation of a therapeutic procedure, have the risks and benefits of the research interventions been evaluated separately from those of the therapeutic interventions?
  • Has due care been used to minimize risks and maximize the likelihood of benefits?
  • Are there adequate provisions for a continuing reassessment of the balance between risks and benefits? Should there be a data and safety monitoring committee?