UNIT III

Question 1

_______ are fundamental to conducting responsible and credible nursing research. These
considerations ensure that research is performed with integrity and respect for participants’ rights while
adhering to legal requirements.

Answer 1

Ethico-legal considerations

Question 2

The process by which participants voluntarily agree to participate in a study after being fully
informed about its purpose, procedures, risks, and benefits.

Answer 2

Informed consent

Question 3

Key Points: Disclosure: Provide comprehensive information about the study. Understanding: Ensure participants comprehend the information. Voluntariness: Participation must be free from coercion or undue influence. Documentation: Obtain written consent before participation.
Example: Before starting a study on pain management, provide participants with a consent form detailing the
study’s aims, procedures, potential risks, and benefits.

Answer 3

Informed Consent

Question 4

Protecting participants’ personal and medical information from unauthorized access or disclosure.

Answer 4

Confidentiality and Privacy

Question 5

Key Points: Data Protection: Use secure methods for storing and handling data. Anonymity: Avoid identifying participants in reports or publications. Access Control: Limit access to data to authorized personnel only. Example: Use coded identifiers instead of names in data analysis and store all research data in password- protected files.

Answer 5

Confidentiality and Privacy

Question 6

The process of obtaining approval from an ethics review board or institutional review board (IRB) before starting a research study.

Answer 6

Ethical Approval

Question 7

Key Points:
Submission: Submit a detailed research proposal for review.
Review: The board evaluates the research for ethical concerns and adherence to guidelines. Compliance: Adhere to any recommendations or conditions set by the board.
Example: Submit your research proposal on the effects of a new intervention in chronic illness management to the IRB for review and approval.

Answer 7

Ethical Approval

Question 8

Ensuring that the research benefits outweigh any potential harm to participants and that no harm is intentionally inflicted.

Answer 8

Beneficence and Non-Maleficence

Question 9

Key Points:
Risk Assessment: Identify and minimize potential risks.
Benefit Maximization: Ensure that the research has the potential to benefit participants or advanceknowledge in a meaningful way.
Harm Prevention: Take measures to prevent physical, emotional, or psychological harm. Example: Assess and mitigate any potential side effects of a new treatment being tested and provide support to participants experiencing discomfort.

Answer 9

Beneficence and Non-Maleficence

Question 10

Recognizing and respecting participants’ rights to make their own decisions regarding their involvement in research.

Answer 10

Respect for autonomy

Question 11

Key Points:
Informed Decision: Ensure participants have all necessary information to make an informed choice. Right to Withdraw: Participants can withdraw from the study at any time without penalty. Respect: Honor participants’ decisions and preferences.
Example: Clearly inform participants that they can withdraw from the study at any point without affectingtheir care or relationship with the research team.

Answer 11

Respect for Autonomy

Question 12

Definition: Adhering to laws and regulations governing research activities.

Answer 12

Legal Compliance

Question 13

Key Points:
Regulations: Follow local, national, and international research regulations and standards. Documentation: Maintain accurate and complete records for legal and compliance purposes. Reporting: Report any adverse events or violations to relevant authorities.
Example: Ensure compliance with data protection laws like GDPR for research involving participants fromtheEuropean Union.

Answer 13

Legal COmpliance

Question 14

Definition: Identifying and managing any personal, financial, or professional conflicts that could influence the research.

Answer 14

Conflict of Interest

Question 15

Key Points:
Disclosure: Fully disclose any potential conflicts of interest.
Management: Implement strategies to manage or mitigate conflicts.
Transparency: Maintain transparency about funding sources and potential biases.
Example: Disclose any financial ties to companies whose products are being studied in the research.

Answer 15

Conflict of Interest

Question 16

also known as the “Philippine National Health Research System Act of 2013,”establishes a comprehensive framework for strengthening the health research system in the Philippines.

Answer 16

RA 10532

Question 17

Republic Act No. 10532, also known as the ___________________,”establishes a comprehensive framework for strengthening the health research system in the Philippines.

Answer 17

“Philippine National Health Research System Act of 2013

Question 18

This act aims to enhance the country’s capacity for health research and development to improve public health outcomes. It promotes the integration and coordination of health research activities and ensures that research is aligned with national health priorities.

Answer 18

RA 10532 OR PHILIPPINE NATIONAL HEALTH RESEARCH SYSTEM ACT OF 2013

Question 19

To create a unified and coordinated approach to health research in the Philippines. Structure: Includes various stakeholders such as government agencies, academic institutions, and privateorganizations.

Answer 19

Establishment of the Philippine National Health Research System (PNHRS)

Question 20

Function: To oversee and ensure ethical standards in health research, including reviewing and approvingresearch protocols to protect human subjects.
Mandate: To establish guidelines and ensure compliance with ethical practices in health research.

Answer 20

Creation of the National Health Research Ethics Board (NHREB):

Question 21

Development: Formulate a national health research agenda that aligns with the country’s health prioritiesand needs.
Implementation: Ensure that research efforts are focused on addressing key health issues and improvinghealth outcomes.

Answer 21

Health Research Agenda:

Question 22

Support: Allocate financial resources to support health research initiatives and infrastructure. Management: Manage and distribute funds effectively to promote high-quality research.

Answer 22

Funding and Resource Allocation:

Question 23

Training: Enhance the skills and capabilities of researchers through training and education programs. Partnerships: Foster collaboration among various research institutions, government agencies, andinternational organizations.

Answer 23

Capacity Building and Collaboration:

Question 24

Application: Promote the use of research findings to inform policy and practice in health care.
Dissemination: Ensure that research results are effectively communicated to stakeholders and the public.
Impact: RA 10532 aims to create a robust health research system that supports evidence-based decision- making, advances health knowledge, and contributes to the overall improvement of public health in the Philippines. It provides a structured approach to health research, emphasizing ethical practices, strategic alignment with national health priorities, and effective utilization of research findings.

Answer 24

Research Utilization and Dissemination:

Question 25

The research should have the potential to benefit society or contribute to knowledge in a meaningful way.

Answer 25

Social Value

Question 26

Ensures that the research addresses significant problems and has the potential to improvehealth outcomes or advance understanding in a relevant field.

Answer 26

Social Value

Question 27

Example: Studying new interventions for chronic diseases that can improve patient quality of life.

Answer 27

Social value

Question 28

The process of providing potential participants with comprehensive information about theresearch, allowing them to make an informed decision about their participation.

Answer 28

Informed Consent

Question 29

Protects participants' autonomy and ensures they are fully aware of what their participation entails.

Answer 29

Informed consent

Question 30

Example: Providing a detailed consent form outlining the study’s purpose, procedures, risks, and benefits.

Answer 30

Informed consent

Question 31

Recognizing and addressing the special needs or risks associated with certain groups who may be more susceptible to coercion or harm

Answer 31

Vulnerability of Research Participants:

Question 32

Ensures that vulnerable populations are protected and that their participation is handled with additional care.

Answer 32

Vulnerability of Research Participants

Question 33

Example: Providing extra safeguards when researching vulnerable populations like children or individualswith cognitive impairments.

Answer 33

Vulnerability of research participants

Question 34

Evaluating the potential risks and benefits of the research and ensuring measures are in place to protect participants' safety.

Answer 34

Risk, Benefits, and Safety

Question 35

Balances the potential benefits of the research with the risks to ensure ethical conduct.

Answer 35

Risks, Benefits, and Safety

Question 36

Example: Implementing procedures to minimize physical or psychological harm and monitoring participants' well-being throughout the study.

Answer 36

Risk, Benefits, and Safety

Question 37

Protecting participants' personal information and ensuring that it is not disclosed without consent.

Answer 37

Privacy and Confidentiality

Question 38

Importance: Maintains trust and complies with legal and ethical standards.

Answer 38

Privacy and confidentiality

Question 39

Example: Using coded identifiers instead of personal information and secure storage methods for data.

Answer 39

Privacy and confidentiality

Question 40

Ensuring that the benefits and burdens of research are distributed fairly among all participants.

Answer 40

Justice

Question 41

Importance: Prevents exploitation and ensures equitable treatment and access to the benefits of research.

Answer 41

Justice

Question 42

Example: Ensuring that research benefits are accessible to all participants and that no group is unfairlyburdened.

Answer 42

justice

Question 43

Clearly communicating research processes, findings, and potential conflicts of interest

Answer 43

Transparency

Question 44

Importance: Enhances credibility and allows for proper scrutiny and accountability.

Answer 44

Transparency

Question 45

Example: Disclosing all funding sources and potential conflicts of interest in research publications.

Answer 45

Transparency

Question 46

The study of moral principles guiding research conduct to ensure integrity, respect, and fairness.

Answer 46

Ethics and Research

Question 47

Focus: Understanding ethical guidelines and principles to design and conduct research responsibly. Example: Familiarizing yourself with ethical guidelines from institutions like the IRB or ethics committees.

Answer 47

Ethics and research

Question 48

Involves informed consent and respecting participants' autonomy.

Answer 48

Respect for Persons

Question 49

Obligation to minimize harm and maximize benefits.

Answer 49

Beneficence

Question 50

Fair distribution of research benefits and burdens.

Answer 50

Justice

Question 51

Providing clear information and obtaining written consent.

Answer 51

Informed consent process

Question 52

Implementing secure data handling and storage practices.

Answer 52

Confidentiality measures

Question 53

Regularly assessing and addressing any potential risks or adverse effects.

Answer 53

Monitoring and safety procedures

Question 54

it is a process that was established to ensure the ethical and responsible conduct of research

Answer 54

research ethics review

Question 55

these reviews are conducted by a research ethics committee

Answer 55

research ethics review

Question 56

it involves the application of fundamental ethical principles to research activities which include the design and implementation of research, respect towards society and others, the use of resources and research outputs, scientific misconduct and the regulation of research

Answer 56

research ethics

Question 57

Researchers must design and conduct studies with respect for participants' rights and welfare, including obtaining informed consent, minimizing risks, and safeguarding confidentiality.

Answer 57

Design and implementation

Question 58

Ethical research entails responsibly utilizing resources, maximizing benefits, and minimizing negative impacts. Researchers must disseminate findings transparently, promoting knowledge advancement and societal benefit.

Answer 58

Use of resources and research outputs

Question 59

Researchers must respect the dignity, autonomy, and diversity of individuals and communities involved in the research, considering cultural sensitivities, avoiding exploitation, and addressing conflicts of interest.

Answer 59

Respect toward society and others

Question 60

Researchers must uphold integrity by avoiding misconduct such as plagiarism, falsification, and fabrication. They should also disclose any conflicts of interest arising from their research.

Answer 60

scientific misconduct

Question 61

Research activities are regulated by institutions, funding agencies, and governmental bodies to ensure ethical conduct, legal compliance, and scientific integrity.

Answer 61

regulation of research

Question 62

Projects which involve the collection data from public available databases or public documents are exempted from review.

Answer 62

Exempted Review

Question 63

Projects posing minimal risk to research subjects go through expedited reviews. The RASD and the REO Director decide consensually on whether a research project would qualify for expedited review.

Answer 63

expedited review

Question 64

Research projects which pose a more than “minimal risk” to research participants or subjects are subjected to a full review by the Research Ethics Review Pannel (RERP).

Answer 64

Full review

Question 65

Steps in critically appraising the ethical aspects of the study

Answer 65

1. evaluate social value 2. review informed consent procedures 3. assess measures for vulnerable populations 4. analyze risk-benefit ratio 5. check privacy and confidentiality 6. examine justice and fairness 7. verify transparency