(F) Research Ethics

Question 1

A state of optimal physical, mental, and social well-being and the ability to function at the individual level.

Answer 1

Health

Question 2

• Refers to the development of knowledge to understand health challenges and mount an improved response to them.

Answer 2

Research in relation to Health

Question 3

ESEARCH IN RELATION TO HEALTH

Full spectrum of research in five generic
areas of activity, except:

A. Measuring the problem.
B. Understanding its effect/s
C. Elaborating solutions
D. Translating the solutions or evidence into policy, practice and products
E. Evaluating the effectiveness of solutions

Answer 3

B. dapat causes

Question 4

• Seeks to understand the impact of processes, policies, actions, or events originating in any sector on the well-being of individuals and communities; and
• To assist in developing interventions that will help prevent or mitigate their negative impact, and in so doing, contribute to the achievement of health equity and better health for all.

Answer 4

Health research

Question 5

Those outside of the description for health research, but where the research procedures and outcomes can affect the well-being of the participants and the community.

Answer 5

HEALTH-RELATED RESEARCH

Question 6

HARM IN RESEARCH

1. probability of harm
2. pain, discomfort, illness, injury, death, disability, side effects, withholding treatment ex. Tuskegee and Nazi
3. anxiety, fright, embarrassment, shame, guilt, self doubt, feeling betrayed ex. Tuskegee, Nazi, Milgram, Tearoom, Havasupai, Wakefield
4. Includes loss of job, uncovered expenses, lost time, ex. Tuskegee, Nazi, Milgram, Tearoom, Havasupai
5. loss of privacy, breach of confidentiality, damaged
   standing in the community or family ex. Tearoom, Havasupai, and Wakefield experiments

Answer 6

1. risk
2. physical
3. psychological
4. economic
5. social

Question 7

• an activity, a performance of a behavior.
• involves asking questions, obtaining answers to generate knowledge.
• There are right ways and wrong ways in conducting research activities

Answer 7

Research

Question 8

• Moral principles that govern a person’s behavior or the conducting of an activity (Oxford languages)
• Involves systematizing, defending, and recommending concepts of right and wrong behavior (Internet Encyclopedia of Philosophy)

Answer 8

Ethics

Question 9

WHAT RESEARCH IS NOW…

1. Knowledge generation (research) is ———–
2. Generating knowledge involves ———–
3. There are ———– in conducting
   research activities
4. We need a ———– way of telling right ways from wrong ways of doing research (ethics)

Answer 9

1. Good
2. Harm
3. right and wrong ways
4. systematic

Question 10

• In Tagalog it is known as “pakinabang”
• Doing good for the benefit of others to:
• Work towards a desired outcome
• Prevent or remove harm
• To improve the situation
• Usually directed to the participants and the community
• BENEFITS: direct, indirect, intentional, unintentional, actual, potential; physical, psychological, social, economic, spiritual

Answer 10

Beneficence

Question 11

Beneficence

TOF.
1. Research involves harm, or at least the risk of it, to participants.
2. To outweigh the harm, participants should benefit by excluding theirselves from the research
3. If there is no direct benefit to the participants, the community should at least benefit
4. You CANNOT make a study that do not have beneficence

Answer 11

1. T
2. F (joining)
3. T
4. T

Question 12

MAXIMIZING BENEFIT (BENEFICENCE)

1. Research should have social value; results should be potentially useful. Potential use should be explicit in significance of the study; Research should be technically sound; bad science may result to bad ethics
2. Information about the outcome; Access to best proven interventions; Reimbursements and tokens
3. Anchored in goals and research agenda of the
   discipline, community, nation; Direct or indirect benefits should include sustained healthcare, improved local structures, capacity building

Answer 12

1. Motive
2. Participants should become better by joining the study
3. Community condition should be improved

Question 13

• Embodies the principle “PRIMUM NON NOCERE” which
  means “first, do no harm”
• Do not harm, do not put participants at risk of harm
• Risk must be minimized, must be reasonable
• INDEPENDENT of consent
• Usually directed to participants, community, and researchers

Answer 13

Non maleficence

Question 14

Non maleficence

TOF.
2. Participants are optional in research
1. In and of itself, research already involves harm or at least the risk of it
1. Do not add to the risk of harm that is already present
2. Participants can be worse off by joining the research

Answer 14

1. F (needed)
2. T
3. T
4. F (cannot)

Question 15

MINIMIZING HARM (Non-Maleficence)

TOF. Sound scientific protocol.

1. ○ Some protocols, if it is not scientifically sound, then it is already unethical.
2. Exhaustive background of harms involved.
3. Minimum participants, but adequate to arrive at a useful conclusion
4. Safeguards, correction, and compensation for complications, adverse events, injuries, any harmful events
5. Allow for participant withdrawal at any point in the research

Answer 15

True all

Question 16

MINIMIZING HARM (Non-Maleficence)

Backups are required if the team are still group of
students who conducts the research—so that we can
have someone read the results. Therefore, you must
have RMTs with you.

Answer 16

Appropriate, qualified research team

Question 17

Enumerate MINIMIZING HARM

Answer 17

1. Sound scientific protocol
2. Appropriate, qualified research team
3. Peer review, ethics review, community participation
4. Manage conflict of interest

Question 18

WHAT AN INFORMED CONSENT IS NOT

TOF.
1. A self-administered document
2. They should not be asked to sign on that day even if they don’t understand it.
3. only basis that makes research ethically acceptable
4. one-size-fits all process
5. Given verbally

Answer 18

1. T
2. F (give them time ot study it all night)
3. T
4. T
5. T

Question 19

COMPONENTS OF FREE AND INFORMED CONSENT

TOF.
1. Adolescents (minor) cannot decide by themselves.
2. 18-year-old person with mental disability or psychological issues, and bedridden patients as they are considered to have the competence to make a proper decision

Answer 19

1. T
2. F

Question 20

COMPONENTS OF FREE AND INFORMED CONSENT

1. proceeding from free will, produced by an act of choice
2. complete, correct, relevant; all that a reasonable person needs or wants to decide
3. expression of permission
4. term used for an agreement made by an individual who is not yet competent to give a full consent

Answer 20

1. Freedom and voluntariness
2. Information on the research
3. Consent
4. Assent

Question 21

• Being fair to research participants
• Giving to, or not depriving, others their due
• Not exploiting the vulnerable
• Not excluding, without good reason, those who may
  benefit from participation
• Usually directed to participants, community, and researchers

Answer 21

Justice

Question 22

Justice

TOF.

1. Benefits and burdens should be distributed fairly
2. If they are needed to be hospitalized, the researcher
   should provide for that.

Answer 22

both true

Question 23

JUSTICE IN RESEARCH

TOF.

1. Practicing all the other principles—beneficence, non maleficence, respect, is a form of justice
2. Reduce inequalities or at least do not increase
3. Fair recruitment, sampling, assignments
4. Do not include those who may benefit from the results
5. Benefit sharing

Answer 23

1. T
2. T
3. T
4. F
5. T

Question 24

1. benefiting the participants and the society
2. not allowing harm to happen and minimizing or removing harm
3. respecting the rights of participants, honoring the choices and decisions of participants, and protecting those with diminished autonomy
4. being fair to everyone concerned, and providing or not depriving others of their due

Answer 24

1. Beneficence
2. Non-maleficence
3. Respect
4. Justice

Question 25

* Duly-designated body that reviews and approves research protocols, and monitors the conduct of research among humans * Essential component of a human protection system in research

Answer 25

RESEARCH ETHICS COMMITTEES (REC)

Question 26

* The research protocol must be submitted for consideration, guidance, and approval of the concerned research ethics committee before the study begins * The committee must take into consideration the laws and regulations of the country or countries in which the research is to be performed, as well as applicable international norms and standards.

Answer 26

Declaration of Helsinki Provision 23

Question 27

The use of animals for research shall comply with the?

Answer 27

Animal Welfare Act of 1998 (RA 8485) ## Footnote its Implementing Rules and Regulations through the Department of Agriculture AO No. 40 series of 1998, and the Code of Practice for the Care and Use of Laboratory Animals in the Philippines, 2nd edition, 2002 developed by the Philippine Association for Laboratory Animal Science (PALAS).

Question 28

Research involving biological and hazardous materials, including those that involve genetic modification and manipulation of microorganisms and animal and plant tissue cells, must be reviewed, and approved by a biosafety committee, the?

Answer 28

National Committee of Biosafety of the Philippines (NCBP)

Question 29

What organization identified seven categories that meet DURC which is also known as the Biosecurity Risk Category

Answer 29

National Science Advisory Board for Biosecurity (NSABB)

Question 30

Biosecurity Risk Category | familiarize

Answer 30

the Biosecurity Risk Category: 1. Enhances the harmful consequences of a biological agent or toxin. 2. Disrupts the immunity or the effectiveness of immunization without clinical and/or agricultural justification. 3. Confers to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies. 4. Increases the stability, transmissibility, or the ability to disseminate a biological agent or toxin. 5. Alters the host range or tropism of a biological agent or toxin. 6. Enhances the susceptibility of a host population. 7. Generates a novel pathogenic agent or toxin or reconstitutes an eradicated or extinct biological agent.

Question 31

# EXPERTISE THRESHOLD Levels of risk based on the knowledge and experience of the researcher 1. The researchers that conducted the study were in the graduate level. 2. The researchers that conducted the study have year-long specialized experience 3. Students, and those that require low-level technology

Answer 31

2 3 1

Question 32

Levels of risk based on the technologies used in the laboratory. 1. Water bath, Stove or any equipment that may be used for boiling 2. Evolis Twin Plus System, microplate processor, and Sysmex for CBC. 3. Process highly infectious specimens 4. Autoclave, incubator, culture, and sensitivity and biosafety cabinet.

Answer 32

1. 1 2. 3 3. 2 and 3 4. 2