Chapter 6 (Lesson 1)

Question 1

_____ advances the understanding of science and promotes human health.

_____ are established for clinical research to:
1.) _____
2.) _____

Researchers must take PRECAUTIONS in the planning, implementation, and follow-up of studies to protect participants.

Answer 1

Clinical research
1. Protect patient volunteers
2. Preserve the integrity of the science.

Ethical guidelines

Question 2

_____ is defined as an activity that inquires into a PARTICULAR SUBJECT with the aim to contribute to generalizable knowledge (theories, principles and relationships) or any accumulation of information using scientific methods, observation, inference and analysis.

The scope of _____ entails any social science, biomedical or epidemiologic activity that entails SYSTEMATIC COLLECTION OR ANALYSIS OF DATA with the intent to generate new knowledge in which human beings are exposed to manipulation, intervention, observation or other interaction with investigators either directly or through alteration of their environment or become individually identifiable through investigator’s collection, preparation, or use of biological material or medical or other records. (WHO, 2019)

_____ is a framework applying BROAD ETHICAL PRINCIPLES to the responsible conduct of research and to the use of any outcomes resulting from research.

Answer 2

Research

Health Research in Human

Ethics in Research

Question 3

Importance of Adhering to Ethical Norms in Research

Ethical norms serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. Here are several reasons why it is important to adhere to ethical norms in research:
1. PROMOTES THE AIM OF RESEARCH, such as knowledge, truth, and avoidance of error.
2. PROMOTES THE VALUES ESSENTIAL TO COLLABORATIVE WORK (e.g., trust, accountability, mutual respect, and fairness), as research involves cooperation among many different people.
3. Helps to ensure that RESEARCHERS CAN BE HELD ACCOUNTABLE TO THE PUBLIC.
4. Helps to BUILD PUBLIC SUPPORT FOR RESEARCH.
5. Promotes a variety of other important MORAL AND SOCIAL VALUES, such as social responsibility, human rights, animal welfare, compliance with the law, and public health

Answer 3

Ethical norms are basically the rules that guide what’s right and wrong when doing research. Following them is very important because research often involves people, animals, or communities, and we have to make sure no one gets harmed or treated unfairly.

Here’s why it’s important to follow ethics in research:
1. To find the truth and avoid mistakes.
When researchers are honest and careful, the results of their study are more accurate and reliable. If someone cheats or makes up data, the research becomes useless and can even cause harm.
2. To work well with others.
Research is teamwork. Everyone involved — from nurses to scientists — must show trust, respect, and fairness so the project runs smoothly. Ethical behavior helps prevent conflicts and misunderstanding.
3. To be accountable to the public.
Researchers must be responsible for their actions. Following ethical rules shows that they can be trusted and that their work can be checked or questioned if needed.
4. To gain public trust and support.
If people believe that researchers act honestly and protect participants, they’ll be more willing to take part in studies or support medical research.
5. To protect moral and social values.
Ethics remind researchers to care for people, respect rights, follow laws, protect animals, and promote public health and safety. It’s about doing what’s right, not just what’s smart.

Question 4

The Researcher’s Responsibility

• The VIGILANT and CONSCIENTIOUS RESEARCHER has ultimate RESPONSIBILITY and ACCOUNTABILITY for the ETHICAL SOUNDNESS of the research.
• In conducting CLINICAL INVESTIGATION, the INVESTIGATOR should demonstrate the same CONCERN and CAUTION for the WELFARE, SAFETY, and COMFORT of the person involved as is required of a PHYSICIAN who is furnishing MEDICAL CARE to a patient independent of any clinical investigation.

Answer 4

The VIGILANT and CONSCIENTIOUS RESEARCHER has ultimate RESPONSIBILITY and ACCOUNTABILITY for the ETHICAL SOUNDNESS of the research.

Question 5

RESEARCH ETHICS: THREE FUNDAMENTAL PRINCIPLES
Research ethics are based on THREE FUNDAMENTAL PRINCIPLES, which are also the core principles of the BELMONT REPORT:

1. _____
   - Treating people as AUTONOMOUS AGENTS.
   - Protecting people with DIMINISHED AUTONOMY.

INVOLVES:
- Respecting their PRIVACY and keeping their private information CONFIDENTIAL.
- Respecting their RIGHT TO CHANGE THEIR MIND and to WITHDRAW WITHOUT PENALTY.
- Informing them of NEW INFORMATION that might emerge (which could change their assessment of RISKS/BENEFITS).
- MONITORING THEIR WELFARE, ensuring APPROPRIATE TREATMENT for ADVERSE REACTIONS, and when necessary, REMOVAL FROM THE STUDY.
- Informing them about what was LEARNED FROM THE RESEARCH.

Answer 5

RBJ

RESPECT FOR PERSONS

Question 6

RESEARCH ETHICS: THREE FUNDAMENTAL PRINCIPLES
Research ethics are based on THREE FUNDAMENTAL PRINCIPLES, which are also the core principles of the BELMONT REPORT:

2. _____
   - ACTION DONE FOR THE BENEFIT OF OTHERS.
   - This principle states that research should:
   - DO NO HARM.
   - MAXIMIZE BENEFITS for participants and MINIMIZE RISKS for participants.

Answer 6

BENEFICENCE

Question 7

RESEARCH ETHICS: THREE FUNDAMENTAL PRINCIPLES
Research ethics are based on THREE FUNDAMENTAL PRINCIPLES, which are also the core principles of the BELMONT REPORT:

3. _____
   - This principle deals with the concept of FAIRNESS IN DISTRIBUTION or “WHAT IS DESERVED”, regarding who ought to receive the BENEFITS OF RESEARCH and bear its BURDENS.

INCLUDES:
- FAIR RECRUITMENT: Researchers should consider what is FAIR in terms of RECRUITMENT and LOCATION. People should not be included merely because they are EASY TO ACCESS, AVAILABLE, VULNERABLE, or LESS ABLE TO DECLINE PARTICIPATING.
- RELEVANT TESTING: An EXPERIMENTAL STRATEGY likely to be used by many types of people should be TESTED IN THE POPULATIONS LIKELY TO USE IT, to ensure it is SAFE, EFFECTIVE, and ACCEPTABLE for all potential users.
- RELEVANCE OF QUESTIONS: QUESTIONS IN TRIALS should be of RELEVANCE TO THE COMMUNITIES participating in the study.

Answer 7

JUSTICE

Question 8

_____
- Introduced in_____, after the NUREMBERG TRIALS (where NAZI DOCTORS were convicted of CRIMES COMMITTED DURING HUMAN EXPERIMENTS on CONCENTRATION CAMP PRISONERS).
- Attempted to give CLEAR RULES about what was LEGAL and what was NOT when conducting HUMAN EXPERIMENTS.
- Aimed to PROTECT HUMAN SUBJECTS from enduring the CRUELTY and EXPLOITATION the prisoners endured.

Answer 8

NUREMBERG CODE
- AUGUST 1947

Question 9

THE 10 ELEMENTS OF THE NUREMBERG CODE:

1. VOLUNTARY CONSENT is essential.
   The results of any experiment must be for the GREATER GOOD OF SOCIETY.
2. HUMAN EXPERIMENTS should be based on PREVIOUS ANIMAL EXPERIMENTATION.
3. Experiments should be conducted by AVOIDING PHYSICAL/MENTAL SUFFERING AND INJURY.
4. No experiments should be conducted if it is believed to cause DEATH OR DISABILITY.
5. The RISKS should never exceed the BENEFITS.
6. ADEQUATE FACILITIES should be used to protect subjects.
7. Experiments should be conducted only by QUALIFIED SCIENTISTS.
8. SUBJECTS should be able to END THEIR PARTICIPATION AT ANY TIME.
9. The SCIENTIST IN CHARGE must be prepared to TERMINATE THE EXPERIMENT when INJURY, DISABILITY, or DEATH is likely to occur.
10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur.

Question 10

_____

• Developed by the WORLD MEDICAL ASSOCIATION (WMA) as a STATEMENT OF ETHICAL PRINCIPLES to provide GUIDANCE TO PHYSICIANS AND OTHER PARTICIPANTS in MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (including research on IDENTIFIABLE HUMAN MATERIAL OR DATA).
• The WMA encourages other participants in MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS to ADOPT THESE PRINCIPLES.

_____: Any LIVING PERSON from whom a researcher obtains DATA, including data obtained through INTERACTION with the person and IDENTIFIABLE INFORMATION about the person or their OPINION.

Answer 10

DECLARATION OF HELSINKI
- HUMAN SUBJECT

Question 11

PRINCIPLES FOR ALL MEDICAL RESEARCH (SELECTED KEY POINTS):

1. PHYSICIAN’S DUTY: Protect the LIFE, HEALTH, DIGNITY, INTEGRITY, RIGHT TO SELF-DETERMINATION, PRIVACY, and CONFIDENTIALITY of personal information of research subjects.
2. SCIENTIFIC BASIS: Must conform to GENERALLY ACCEPTED SCIENTIFIC PRINCIPLES, be based on THOROUGH KNOWLEDGE OF LITERATURE, and ADEQUATE LABORATORY/ANIMAL EXPERIMENTATION.
3. RESEARCH PROTOCOL: Design and performance must be CLEARLY DESCRIBED IN A PROTOCOL, which includes ETHICAL CONSIDERATIONS, FUNDING, CONFLICTS OF INTEREST, INCENTIVES, and PROVISIONS FOR TREATING/COMPENSATING SUBJECTS who are harmed.
4. ETHICS COMMITTEE REVIEW (MANDATORY): The protocol must be submitted to a RESEARCH ETHICS COMMITTEE (independent of the researcher/sponsor) for CONSIDERATION, COMMENT, GUIDANCE, and APPROVAL before the study begins. The committee must MONITOR ONGOING STUDIES.
5. QUALIFICATIONS AND SUPERVISION: Must be conducted only by individuals with APPROPRIATE SCIENTIFIC TRAINING AND QUALIFICATIONS, under the supervision of a COMPETENT AND APPROPRIATELY QUALIFIED PHYSICIAN OR HEALTH CARE PROFESSIONAL.
6. RESPONSIBILITY FOR PROTECTION: Must always rest with the PHYSICIAN OR HEALTH CARE PROFESSIONAL, and NEVER THE RESEARCH SUBJECTS, even if they have given consent.
7. VULNERABLE POPULATIONS: Research is only justified if it is RESPONSIVE TO THEIR HEALTH NEEDS AND PRIORITIES and if there is a REASONABLE LIKELIHOOD THEY STAND TO BENEFIT.
8. RISK ASSESSMENT: Must be preceded by CAREFUL ASSESSMENT of PREDICTABLE RISKS AND BURDENS compared with FORESEEABLE BENEFITS.
9. REGISTRATION: Every CLINICAL TRIAL must be REGISTERED IN A PUBLICLY ACCESSIBLE DATABASE before recruitment of the first subject.
10. STOP STUDY: Physicians must IMMEDIATELY STOP A STUDY when the RISKS OUTWEIGH THE POTENTIAL BENEFITS or when there is CONCLUSIVE PROOF OF POSITIVE AND BENEFICIAL RESULTS.
11. VOLUNTARY PARTICIPATION AND INFORMED CONSENT (CRUCIAL):
    - Participation by COMPETENT INDIVIDUALS must be VOLUNTARY.
    - Each potential subject must be ADEQUATELY INFORMED of the AIMS, METHODS, FUNDING, CONFLICTS OF INTEREST, RISKS, BENEFITS, and the RIGHT TO REFUSE OR WITHDRAW CONSENT at any time WITHOUT REPRISAL.
    - INFORMED CONSENT must be sought, PREFERABLY IN WRITING.
    - For INCOMPETENT SUBJECTS, informed consent must be sought from the LEGALLY AUTHORIZED REPRESENTATIVE. DISSENT SHOULD BE RESPECTED if the subject is able to assent.
12. PRIVACY AND CONFIDENTIALITY: Every precaution must be taken to PROTECT THE PRIVACY and CONFIDENTIALITY OF PERSONAL INFORMATION.
13. PUBLICATION: Authors have a DUTY TO MAKE PUBLICLY AVAILABLE the RESULTS OF THEIR RESEARCH (including NEGATIVE/INCONCLUSIVE RESULTS) and DECLARE FUNDING, AFFILIATIONS, and CONFLICTS OF INTEREST. Reports NOT IN ACCORDANCE WITH THE DECLARATION should NOT BE ACCEPTED FOR PUBLICATION.

Answer 11

1. Physician’s Duty
   The main responsibility of the physician or researcher is to protect the participant’s life, health, dignity, and privacy. The person in the study should always feel respected and safe.
   
   2. Scientific Basis
      The study should be based on solid scientific knowledge, not just guesses. Researchers should review past studies and do lab or animal tests first before involving people.
   3. Research Protocol
      Every study must have a clear plan (protocol). This includes details about how the research will be done, the ethical rules to follow, the funding, any possible conflicts of interest, and what will be done if someone gets harmed during the study.
   4. Ethics Committee Review (Mandatory)
      Before starting, the research plan must be checked and approved by an ethics committee — a group that’s independent from the researcher or sponsor. They review if the study is safe and fair, and they keep monitoring it as it goes on.
   5. Qualifications and Supervision
      Only trained and qualified people should conduct research. It must be supervised by a competent doctor or health professional to ensure safety and proper care.
   6. Responsibility for Protection
      Protecting the participants is always the duty of the researcher or physician, not the participants. Even if a person gives consent, the researcher must still make sure they are safe.
   7. Vulnerable Populations
      If the study involves people who are more at risk (like children, pregnant women, or people with disabilities), the research should only be done if it truly helps their health needs and they are likely to benefit from it.
   8. Risk Assessment
      Before starting, researchers should carefully weigh the possible risks and benefits. The benefits must always be greater than the risks.
   9. Registration
      Every clinical trial should be registered in a public database before it starts. This helps keep the research transparent and prevents hidden or fake studies.
   10. Stop the Study When Needed
       If the study starts to cause harm or if there’s already enough proof of good results, the physician must stop it immediately.
   11. Voluntary Participation and Informed Consent (Very Important!)
   • People should join voluntarily, not by force or pressure.
   • They must be fully informed about the purpose, risks, and benefits of the study, and they can withdraw anytime without punishment.
   • Consent should be written whenever possible.
   • If the participant can’t decide for themselves (like a child or unconscious person), consent must come from their legal guardian, but their wishes should still be respected.
   12. Privacy and Confidentiality
       Researchers must keep all personal information private and protect it from being shared without permission.
   13. Publication
       After the study, researchers should share the results honestly, whether positive, negative, or uncertain. They must also be transparent about who funded or supported the study. Research that violates ethical standards should not be published.

Question 12

ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE:

1. JUSTIFIED COMBINATION: Only to the extent that the RESEARCH IS JUSTIFIED by its POTENTIAL VALUE and participation will NOT ADVERSELY AFFECT THE HEALTH of the patients.
2. TESTING AGAINST BEST INTERVENTION: New intervention must be tested against the BEST CURRENT PROVEN INTERVENTION, except when:
   - No current proven intervention exists (PLACEBO IS ACCEPTABLE).
   - PLACEBO is SCIENTIFICALLY NECESSARY to determine efficacy/safety, and patients won’t be subject to SERIOUS OR IRREVERSIBLE HARM (EXTREME CARE MUST BE TAKEN TO AVOID ABUSE).
3. POST-STUDY BENEFITS: Patients are entitled to be INFORMED ABOUT THE OUTCOME and to SHARE ANY BENEFITS that result (e.g., access to BENEFICIAL INTERVENTIONS).
4. PATIENT-PHYSICIAN RELATIONSHIP: REFUSAL TO PARTICIPATE OR WITHDRAWAL must NEVER INTERFERE with the PATIENT-PHYSICIAN RELATIONSHIP.
5. UNPROVEN INTERVENTIONS: May be used when PROVEN INTERVENTIONS DON’T EXIST OR ARE INEFFECTIVE, after seeking EXPERT ADVICE and INFORMED CONSENT, if the physician judges it offers HOPE OF SAVING LIFE, RE-ESTABLISHING HEALTH, or ALLEVIATING SUFFERING. This intervention should, where possible, be MADE THE OBJECT OF RESEARCH.

Answer 12

1. Justified Combination
   Research can only be combined with patient care if it’s worth it — meaning the study has real potential to improve knowledge or treatment, and it won’t harm the patient’s health.
   
   2. Testing Against the Best Intervention
      Any new treatment or medicine should be compared with the best treatment currently available.
      • If there’s no proven treatment yet, using a placebo (a fake treatment) is allowed.
      • A placebo can also be used when it’s the only way to know if a treatment really works — but only if it won’t seriously harm patients. Researchers must be very careful to prevent abuse.
   3. Post-Study Benefits
      After the research, patients have the right to know the results and to benefit from any helpful discoveries — for example, continuing access to a new medicine that proved effective.
   4. Patient–Physician Relationship
      If a patient refuses or decides to leave the study, it should never affect their care or the relationship with their doctor. The patient should still be treated with the same respect and quality of care.
   5. Unproven Interventions
      If there’s no proven treatment available, and the patient’s condition is serious, a doctor may try an unproven intervention — but only after:
      • Asking for expert advice,
      • Getting informed consent from the patient, and
      • Believing that it offers real hope of saving a life, restoring health, or relieving suffering.
      If possible, that unproven treatment should later be studied properly in research so that others can benefit too.

Question 13

Declaration of Helsinki: Basic Principles (Summary Points)

• Conform to accepted scientific principles.
• Design formulated in experimental protocol, reviewed by IEC (Institutional Ethics Committee).
• Conducted by qualified and trained persons.
• Importance in proportion to inherent risk.
• Assessment of risks vs. benefits.
• Safeguard subject’s integrity (privacy).
• Abstain unless hazards are predictable.
• Preserve accuracy when publishing.
• Adequately inform or right to withdraw.
• Obtain true informed consent in writing.
• Reliance on legal guardian (for incompetent subjects).
• State compliance with Declaration.

Question 14

_____
- Written by the NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH.
- The COMMISSION was created as a result of the NATIONAL RESEARCH ACT OF 1974.
- Charged with IDENTIFYING THE BASIC ETHICAL PRINCIPLES that should underlie RESEARCH INVOLVING HUMAN SUBJECTS and DEVELOPING GUIDELINES.
- Serves as an ETHICAL FRAMEWORK FOR RESEARCH.

Answer 14

BELMONT REPORT

Question 15

THE 3 MAJOR COMPONENTS (ETHICAL PRINCIPLES):

1. RESPECT FOR PERSONS
   - Individuals should be treated as AUTONOMOUS AGENTS.
   - Persons with DIMINISHED AUTONOMY are entitled to PROTECTION.
   - Divided into two moral requirements: ACKNOWLEDGING AUTONOMY and PROTECTING THOSE WITH DIMINISHED AUTONOMY.
2. BENEFICENCE
   - Treated ethically by RESPECTING DECISIONS, PROTECTING FROM HARM, and making efforts to SECURE WELL-BEING.
   - Understood as an OBLIGATION.
   - Complementary expressions: (1) DO NOT HARM, and (2) MAXIMIZE POSSIBLE BENEFITS AND MINIMIZE POSSIBLE HARMS.
3. JUSTICE
   - Focuses on FAIRNESS IN DISTRIBUTION OF BENEFITS AND BURDENS (“WHAT IS DESERVED”).
   - An INJUSTICE occurs when an ENTITLEMENT IS DENIED WITHOUT GOOD REASON, or a BURDEN IS IMPOSED UNDULY.
   - “EQUALS OUGHT TO BE TREATED EQUALLY.”

FORMULATIONS OF JUST DISTRIBUTION:
1. To each person an EQUAL SHARE.
2. To each person according to INDIVIDUAL NEED.
3. To each person according to INDIVIDUAL EFFORT.
4. To each person according to SOCIETAL CONTRIBUTION.
5. To each person according to MERIT.