Module 2

Ethico-Legal Considerations in Nursing Research

Module Content

Philippine National Health Research System (PNHRS)

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).

Philippine Health Research Ethics Board (PHREB)

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. Formulate/update guidelines for the ethical conduct of human health research;

2. Develop guidelines for the establishment and management of ethics review
committees and standardization of research ethics review;
3. Monitor and evaluate the performance of institutional ethics review committees in
accordance with procedures outlined in a prior agreement;
4. Promote the establishment of functional and effective ethics review committees;
5. Provide advice and make recommendations to the PNHRS Governing Council and
other appropriate entities (including the Food and Drugs Administration[FDA])
regarding programs, policies, and regulations as they relate to ethical issues in human
health research;
6. Initiate and contribute to discourse and discussions of ethical issues in human health
research; and
7. Network with relevant local, national and international organizations.
 Fig. 1 Philippine Structural Framework for Human Protection for Health Research

Source: Philippine Health Research Ethics Board (2015)

Importance of Ethics in Research (Resnik, 2007)

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.

1. Beneficence - imposes a duty on researchers to minimize harm and maximize

benefits. Human research should be intended to produce benefits for participants or
a situation that is more common for others. The principle covers multiple dimensions:
A. Right to Freedom from Harm and Discomfort. Researchers have an
obligation to avoid, prevent, or minimize harm (nonmaleficence) in studies
with humans. Participants must not be subjected to unnecessary risks of harm
or discomfort, and their participation must be essential to achieving
scientifically and societally important aims that could not otherwise be
realized.

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

Major Potential Benefits

•Access to a potentially beneficial intervention that might otherwise be unavailable to them.

•Comfort in being able to discuss their situation or problem with a friendly, objective person.
•Increased knowledge about themselves or their conditions, either through opportunity for
introspection and self-reflection or through direct interaction with researchers.
•Escape from normal routine, excitement of being part of a study.
•Satisfaction that information they provide may help others with similar problems or conditions.
•Direct monetary or material gains through stipends or other incentives.

Major Potential Risks

•Physical harm, including unanticipated side effects.

•Physical discomfort, fatigue, or boredom.
•Physiological or emotional distress resulting from self-disclosure, introspection, fear of the
unknown, discomfort with strangers, fear of eventual repercussions, anger or embarrassment at
the type of questions being asked.
•Social risks, such as the risk of stigma, adverse effects on personal relationships, loss of status.
•Loss of privacy.
•Loss of time.
•Monetary costs (e.g., for transportation, child care, time lost from work)

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.

Key Elements of Informed Consent (Fain, 2009)

A basic responsibility of researchers is to ensure that potential subjects understand

the implications of practicing in a research study and recognize that they have the freedom
to decide whether they want to participate.

Subjects give informed consent before participating in a study by signing a written

consent form, which also signed by the researcher and a witness. The researcher discusses
the proposed research study with subjects to provide feedback in response to subjects’
questions, concerns, or both. Consent forms should be divided into sections with headings.
Medical jargon should be avoided for purposes of clarity and readability; sentences should
be short, margins should be reasonably wide, and the pages should not be overcrowded with
too much text. The following information should be conveyed to potential subjects:

a. Title of the study

b. Personnel engaged in the study (name of researchers/investigators)
 c. Invitation to participate in the study (e.g., “You are invited to participate in a
research study”; not “requested”, “chosen,” or “eligible”).
d. Reason the particular subject is being invited to participate.
e. Clear description of the purpose of the study.
f. Detailed description of procedures of the study
g. Potential risks to subjects, including psychological, social, and physical risks
h. Potential benefits of the study
i. Economic considerations
j. Confidentiality considerations
k. Freedom of subjects to ask questions and withdraw from the study at any time
without penalty.

KEY POINTS:

1. Ethics refers to ‘the rules of conduct in preserving human life’.

2. Nursing research uses human beings as subjects hence, the researcher must exercise
caution to protect the rights of the subjects against undue impositions.
3. Ethical principles and guidelines for nurse researchers include informed consent, the
power of free choice to voluntarily consent to or decline participation in the study.