Module 2 Ethico-Legal Considerations in Nurisng Research
Module 2 Ethico-Legal Considerations in Nurisng Research
Module 2 Ethico-Legal Considerations in Nurisng Research
Module Content
The Philippine National Health Research System Act of 2013 (RA 10532)
institutionalized the memorandum of understanding among the DOST, DOH, CHED and UP
Manila to work towards “improving the health status, productivity and quality of life of
Filipinos by (a) ensuring that health research is linked to the health system needs; (b)
ensuring that investments in health research yield the most benefit; (c) promoting good
governance among health research organizations through efficient, effective, transparent
and ethical health research management system ; (d) engaging in national and international
partnerships and networks for health research development and (e) ensuring sustainability
of resources for health research.” It was generally assumed that research ethics was
embedded in objectives (a), (b) and (c) (Philippine Health Research Ethics Board, 2015).
The more explicit provision that referred to research ethics was in Section 12 of the
law that adopted the DOST Special Order No. 091 s 2006 that created the Philippine Health
Research Ethics Board (PHREB) to “ensure adherence to the universal principles for the
protection of human participants in research” and shall, among other things:
1. Ethics promotes the pursuit of knowledge and truth and the avoidance of error. In
promotes the values that are essential in collaborative work.
2. Many of the ethical norms help to ensure that researchers are held accountable to the
public.
3. Adherence to ethical principles helps build public support for research. People are
more likely to fund research that promotes a variety of important moral and social
values such as social responsibility, human rights, animal welfare, health, and safety.
Ethical Codes and Policies for Research (Cristobal & Cristobal, 2009)
1. Honesty. Maintain honesty in all communications, e.g., when reporting data, results
and procedures. Never fabricate, falsify or misrepresent data.
2. Objectivity. Avoid biases in the experimental design, data analysis, interpretation,
expert testimony and other aspects of research.
3. Integrity. Keep promises and agreement. Act with sincerity and strive for consistency
of thought and action.
4. Care. Avoid careless errors and negligence. Critically examine your own work and the
works of your peers. Keep good records of research activities.
5. Opennes. Share data, results, ideas and resources. Be open to criticism and new ideas.
6. Respect for intellectual property. Honor patents and copyright. Do not use
published and unpublished data, methods or results without permission. Give credit
where credit is due. Give proper acknowledgement.
7. Confidentiality. Protect confidential communications and documents.
8. Responsible publication. Publish in order to advance research and scholarship.
Avoid wasteful and duplicative publication.
9. Responsible mentoring. Help educate, mentor and advise students.
10. Respect for colleagues. Treat peers fairly.
11. Social responsibility. Strive to promote social good and prevent social harm.
12. Non-discrimination. All those eligible to participate in the research must be allowed
to do so.
13. Competence. Maintain and improve your own professional competence.
14. Legality. Know and obey relevant laws and institutional and government policies.
15. Human subjects protection. Minimize harm and risk to human lives; instead,
maximize benefits and respect human dignity, privacy and autonomy.
Ethical Principles for Protecting Study Participants (Polit & Beck, 2012)
The Belmont Report articulated three (3) broad principles on which standards of
ethical conduct in research are based: beneficence, respect for human dignity, and
justice.
Protecting human beings from physical harm may be straightforward, but the psychological
consequences of study participation are usually subtle and require close attention and sensitivity.
Potential Benefits and Risks of Research to Participants
B. Respect for Human Dignity. This principle includes the right to self-
determination and right to full disclosure.
1) Right to Self-Determination. Humans should be treated as
autonomous agents, capable of controlling their actions. Self-
determination means that prospective participants can voluntarily
decide whether to take part in a study, without risk of prejudicial
treatment. It also means that people have the right to ask questions,
to refuse to give information, and to withdraw from the study. A
person’s right to self-determination includes freedom from coercion,
which involves threats of penalty from failing to participate in a study
or excessive rewards from agreeing to participate.
2) Right to Full-Disclosure. People’s right to make informed, voluntary
decisions about study participation requires full disclosure. Full
disclosure means that the researcher has fully described the nature
of the study, the person’s right to refuse participation, the
researcher’s responsibilities, and likely risks and benefits.
The right to self-determination and the right to full disclosure are the two
major elements on which informed consent is based.
C. Justice. The third principle concerns justice which includes participants’
right to fair treatment and their right to privacy.
1) The Right to Fair Treatment. One aspect of justice concerns the
equitable distribution of benefits and burdens of research.
Participant selection should be based on study requirements and not
on a group’s vulnerability. The principle of justice imposes particular
obligations toward individuals who are unable to protect their own
interests (e.g., dying patients) to ensure that they are not exploited.
The right to fair treatment means that researchers must treat people
who decline to participate (or who withdraw from the study after
initial agreement) in a nonprejudicial manner; that they must honor
all agreements made with participants; that they demonstrate beliefs,
habits, and lifestyles of people from different backgrounds or
cultures; that they give participants access to research staff for
desired clarification; and that they afford participants courteous and
tactful treatment at all times.
2) The Right to Privacy. Most research with humans involves
intrusions into personal lives. Researchers should ensure that their
research is not more intrusive than it needs to be and that
participant’s privacy is maintained continuously. Participants have
the right to expect that their data will be kept in strictest confidence.
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