ETHICAL ASPECTS OF HEALTH RESEARCH Ethics Definition It

ETHICAL ASPECTS OF HEALTH RESEARCH

Ethics Definition: (It has several meanings is common use it refers to). It refers to, a method of inquiry that helps people to understand the morality of human behaviour the practices or beliefs of a certain group and the expected standards of moral behaviour of a particular group as described in the groups’ formal code of professional ethics. Bioethics is ethics as applied to life

Contd… The need for ethical guidelines Ø To protect the rights of the human beings Ø Historical background Ø The Nazi medical experiments of the 1930’s and 1940’s Ø In USA Tuskegee syphilis study Ø In Jewish chronic disease hospital, Brooklyn Ø 1993, Atomic Energy commission, a US Federal Agency. Ø

Ethical dilemmas in conducting research § Does a new medication prolong life in cancer patients? Codes of ethics § Nuremberg code § Declaration of Helsinki -1964 by the World Medical Assembly § Belmont report

Ethical Principles in Research – The principles of beneficence – The principles of respect for human dignity – The principles of justice

The principle of beneficence v v v Freedom from harm Freedom from exploitation Benefits from research The risk /benefit ratio Major potential benefits to participants Access to an intervention Increased knowledge Escape from normal routine Share the information with others Chance to discuss their problems Direct monetary or material gains

Major potential costs to participants o o o Physical harm Physical discomfort, fatigue or boredom Psychological or emotional distress Loss of privacy Loss of time Monetary costs

The principle of respect for human dignity Respect for human dignity includes n The right to self determination are the two major elements n The right to full disclosure on which informed consent is based n

The right to self determination Meaning: The right to self determination means that prospective participants have the right to decide voluntarily on Ø To participate in a study Ø To terminate their participation Ø To refuse to give information Ø To ask for clarification

The right to full disclosure Meaning: Full disclosure means that the research has fully described the nature of the study • The participant’s right to refuse participation, > the researcher’s responsibilities • The likely risks and benefits

Issues relating to the principle of respect § Inability to make well informed to certain individuals § Researcher’s feeling on violation for the research to field meaningful information. § When full disclosure poses the risk of biased results § The researchers sometimes use covert data collection or concealment or use deception

The principle of justice § This principle includes § The right to fair treatment § The right to privacy

Features of fair treatment n n n n The fair and non discriminatory selection of participants The non prejudicial treatment of individual The honoring of all agreements made between the researcher and the participant Participants’ access to research personnel at any point of time Participant’s access to appropriate professional assistance Debriefing or clarifying issues Respectful and courteous treatment at all times

The right to privacy This can occur either through n Anonymity n Confidentiality procedures n Steps to be followed to safeguard the participants n Obtain identifying information only when needed n Assign an identification number and attach this rather than other identifiers

Contd… n n n Maintain any identifying information and lists of ID numbers in a locked file Restrict access to identifying information Enter no identifying information onto computer files Destroy identifying information as quickly as is feasible Get the sign of all research personnel on the pledge of confidentially Report research information in the aggregate

Informed consent Meaning: It means that participants have adequate information regarding the research, are capable of comprehending the information, and have the power of free choice, enabling them to consent to or decline participation in the research voluntarily. n n n The content of informed consent Participant status Study purpose Type of data Nature of the commitment Sponsorship

Contd… v Participant selection v Procedures v Potential risks or costs v Potential benefits v Confidentially pledge v Voluntary consent v Right to withdraw v Alternatives v Contact information

Vulnerable subjects Children Ø Mentally or emotionally disabled people Ø Physically disabled people Ø The terminally ill Ø Institutionalized people Ø Pregnant women Ø

External reviews and the protection of human rights Human subjects committees or research advisory panel § Institutional review board § Research critique is not just a review or summary of a study, rather it is a careful critical appraisal of strengths and limitations of piece of research §

Steps in critical appraisal of an article Purpose: n To develop a balanced evaluation of the study’s contribution to knowledge n Guidelines to consider on research critique n Be sure to comment on the study’s strengths as well as its limitations.

Contd… n n n Give specific example of the study’s strengths and limitations Try to justify your criticism Be as objective as possible Be sensitive in handling negative comments Suggest realistic alternatives that the researcher might want to consider Evaluate all aspects of the study

Elements of a research critique • • Substantive dimensions Methodologic dimensions Interpretive dimensions Presentational and stylistic dimensions

Steps • • • Critiquing research problems research questions and hypotheses Critiquing research literature reviews Critiquing research theatrical and conceptual frameworks Critiquing research designs Sampling designs Data collection procedures Critiquing data quality and analyses and interpretation Critiquing ethical aspects of a study Critiquing the presentation of a research report.