M2_L2: GUIDELINES FOR ETHICAL CONDUCT IN THE CARE AND USE OF ANIMALS AND HUMAN SUBJECTS

Research involving ___ is essential to the advancement of pharmacy, medicine, and the health sciences.

human participants and animals

___ help determine whether medicines are safe and effective in people, while ___ may provide important information about ___.

Clinical studies

animal studies

pharmacology, toxicity, pharmacokinetics, and biological mechanisms

___ does not automatically justify a research procedure.

scientific importance

Researchers have an ethical responsibility to ensure that:

 Human participants are treated with ___

 Animals are treated ___

 ___ are minimized

 Research has sufficient ___ to justify its procedures

 Appropriate ___ is obtained before the study begins

 Research findings are reported ___

dignity, respect, and fairness

humanely and responsibly

Risks

scientific value

ethical review

honestly and transparently

In the Philippines, human health research ethics is guided by the ___ and its ___.

Philippine Health Research Ethics Board (PHREB)

National Ethical Guidelines for Research Involving Human Participants

___ is responsible for developing ethical guidelines and standards for research ethics committees and monitoring their performance.

Philippine Health Research Ethics Board (PHREB)

For animal research, Philippine requirements operate within the ___, as amended by ___, together with implementing rules and institutional animal-care requirements.

Animal Welfare Act of 1998 (RA 8485)

RA 10631

The ___ is a national body established within the ___ to promote the ethical conduct of human health research.

Philippine Health Research Ethics Board (PHREB)

Philippine National Health Research System

It sets national standards and accreditation guidelines for all ___ in the Philippines to protect human participants in health research.

Philippine Health Research Ethics Board (PHREB)

Research Ethics Committees (RECs)

Among PHREB responsibilities are:

1) Formulate and update guidelines for ethical human health research

2) Set standards for establishing and managing RECs

3) Monitor and evaluate REC performance through mandatory reports and reviews

4) Provide policy advice to the Food and Drug Administration (FDA) and other national bodies

The current major reference is the ___

National Ethical Guidelines for Research Involving Human Participants 2022 (NEGRIHP)

 The research question is scientifically and socially valuable

 Risks are reasonable

 Participants will be adequately informed

 Informed consent is appropriate

 Privacy and confidentiality will be protected

 Vulnerable participants are protected

 The selection of participants is fair

Scientific research involving humans must protect the ___ of participants.

rights, safety, dignity and welfare

checklist of recommendations designed to improve transparency, reliability, and scientific reproducibility in published animal research. They are primarily concerned with how animal research is designed and reported so that readers can evaluate its quality, reliability, and reproducibility.

ARRIVE guidelines 2.0

ARRIVE guidelines 2.0 are developed by the ___

NC3Rs (National Centre for the Replacement, Refinement and Reduction of Animals in Research)

ARRIVE Essential 10

Study design

Sample size

Inclusion and exclusion criteria

Randomisation

Blinding

Outcome measures

Statistical methods

Experimental animals

Experimental procedures

Results

details of experimental groups and control

Study design

number of animals used and how it was calculated

Sample size

rules for data omission

Inclusion and exclusion criteria

how animals or samples were allocated to experimental groups

Randomisation

whether personnel were aware of group assignments during the study or analysis

Blinding

clear definitions of primary and secondary measurements

Outcome measures

details of analytical approaches used

Statistical methods

species, strain, sex, age and genetic background

Experimental animals

exact details of how, when, and where interventions occurred

Experimental procedures

outcome data and estimation of effect sizes

Results

an institutional body responsible for reviewing and overseeing research and other activities involving animals.

IACUC (Institutional Animal Care and Use Committee)

Core responsibilities of IUCAC

Protocol review

Facility inspections

Program oversight

The Three Rs

Evaluates and approves, modifies, or rejects research proposals involving live vertebrate animals before any work begins.  Facility inspections

Protocol review

Inspects animal housing facilities and laboratories at least twice a year to ensure regulatory compliance

Facility inspections

Monitors institutional animal care programs, investigates concerns or complaints, and has the authority to suspend non-compliant

Program oversight

Promotes ___ (using non-animal alternatives), ___ (minimizing animal numbers), and ___ (lessening pain or distress)

The Three Rs

Replacement

Reduction

Refinement

The IACUC operates under the Philippine animal welfare laws and administrative guidelines:

1) ___ (Animal Welfare Act of 1998)

2) ___ (Rules and Regulations on the Conduct of Scientific

Procedures Using Animals)

3) The ___ set by the Philippine Association for Laboratory Animal Science

Republic Act No. 8485

Department of Agriculture (DA) Bureau of Animal Industry (BAI) Administrative Order No. 40 - 99

PALAS Code of Practice

An ___ - also called an ___ or ___ - is an independent committee that reviews and monitors research involving human participants to ensure their rights, safety, and well-being are protected.

Institutional Ethics Review Board (IERB)

Institutional Review Board (IRB)

Research Ethics Committee (REC)

Key functions of IERB

Protocol review

Protection of vulnerable groups

Ongoing monitoring

Decision authority

Evaluates research plans and consent forms before a study starts to make sure risks are low and balanced by benefits

Protocol review

Gives extra care to protect people who cannot easily protect themselves, such as children or patients

Protection of vulnerable groups

Checks active studies regularly for safety issues, changes, or rule-breaking

Ongoing monitoring

Has the legal and administrative power to approve, change, or reject any research project under its authority

Decision authority

The IERB committee examines the research protocol, including:

 Scientific rationale

 Research methodology

 Risk-benefit assessment

 Participant selection

 Informed consent

 Privacy and confidentiality

 Protection of vulnerable participants

 Compensation and management of research-related injury

 Data management

___ is the physical and emotional well-being and quality of life of non- human animals under human care. It focuses on humane treatment, proper management, and reducing suffering.

Animal welfare

Important Components of Animal Welfare

Proper housing

Proper nutrition

Veterinary care

Pain and distress management

Humane endpoints

Appropriate euthanasia

Space, ventilation, lighting, sanitation, bedding

Proper housing

Food, water, feeding schedules, nutritional support

Proper nutrition

Receive appropriate monitoring and veterinary attention when necessary

Veterinary care

Anticipate potential pain and establish appropriate interventions

Pain and distress management

A predefined point at which an animal is removed from an experiment, treated, or euthanized to prevent unnecessary suffering

Humane endpoints

When euthanasia is necessary, it must be conducted using an accepted humane method consistent with applicable standards and the approved protocol.

Appropriate euthanasia

Primary law in the Philippines protecting animal welfare and regulating facilities like kennels, pet shops, zoos, and veterinary clinics

Animal Welfare Act of 1998 (R.A. No. 8485)

The foundational US federal law regulating the transport, sale, and use of animals in research and exhibition.

Animal Welfare Act of 1966

An international body that develops global standards for animal health and welfare

World Organization for Animal Health (WOAH)