PHA 056 Student Activity Sheet #7 PDF

Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: _____________________...

Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ Lesson title: Preclinical phase; Ethical Considerations in Human Materials: and Animal Experimentation {Pen, highlighters, & students Lesson Objectives: activity sheet} At the end of the lesson, you should be able to: References: 1. Determine the three R’s in animal research and in designing 1. National Research Council (US) humane animal research studies Committee for the Update of the 2. Identify the different types of animal models; Guide for the Care and Use of 3. Discuss the guidelines, rules & regulations on the conduct of Laboratory Animals. Guide for the scientific procedures using animals & Human beings. Care and Use of Laboratory Animals. 8th edition. Washington (DC): National Academies Press (US); 2011. 3, Environment, Housing, and Management. Available from: https://www.ncbi.nlm.nih.gov/books /NBK54046/ https://www.officialgazette.gov.ph/1 998/02/11/republic-act-no-8485/ 2.https://cioms.ch/publications/prod uct/international-ethical-guidelines-f or-health-related-research-involving -humans/ Productivity Tip: 2 Timothy 1:7 For God gave us a spirit not of fear but of power and love and self-control. Make sure to remind yourselves that everything you`re doing right now serves a purpose. Do it for the people you love. Make sure to set unimportant things aside and focus on your goal. Do not do it later but right now. A. LESSON PREVIEW/REVIEW Introduction ( 3 mins) Laboratory animals (also referred to as animals) are generally defined as any vertebrate animal (i.e., traditional laboratory animal, agricultural animals, wildlife, and aquatic species) produced for or used in research, testing, or teaching. Animal use is defined as the proper care, use, and humane treatment of laboratory animals produced for or used in research, testing, or teaching. Human experimentation has to follow strict rules & In order to be ethically permissible, health-related research with humans, including research with samples of human tissue or data, must have social value. The scientific and social value of research can be difficult to quantify, but it is generally grounded in three factors which will be discuss as in the main lesson. Page | 1 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ Activity 1: What I Know Chart, part 1 (5 mins) Answer only the first column, “What I know”. Leave the third column “What I Learned” blank at this time. What I Know Questions: What I Learned (Activity 4) 1. What is the meaning of the word Euthanasia? 2. What is the definition of the term minimal-risk standard? 3. What is the purpose of Animal Welfare Act of 1998? B.MAIN LESSON Activity 2: Content Notes (66 mins) Laboratory animals (also referred to as animals) are generally defined as any vertebrate animal (i.e., traditional laboratory animal, agricultural animals, wildlife, and aquatic species) produced for or used in research, testing, or teaching. Animal use is defined as the proper care,use, and humane treatment of laboratory animals produced for or used in research, testing, or teaching. THE THREE Rs Three Rs have become an internationally accepted approach for researchers to apply when deciding to use animals in research and in designing humane animal research studies. 1. Replacement a. Refers to methods that avoid using animals. b. The term includes absolute replacements (i.e., replacing animals with inanimate systems such as computer programs) as well as relative replacements (i.e., replacing animals such as vertebrates with animals that are lower on the phylogenetic scale). 2. Refinement a. Refers to modifications of husbandry or experimental procedures to enhance animal well-being and minimize or eliminate pain and distress. b. While institutions and investigators should take all reasonable measures to eliminate pain and distress through refinement, IACUCs should understand that with some types of studies there may be either unforeseen or intended experimental outcomes that produce pain. c. These outcomes may or may not be eliminated based on the goals of the study. 3. Reduction a. involves strategies for obtaining comparable levels of information from the use of fewer animals or for maximizing the information obtained from a given number of animals (without increasing pain or distress) so that in the long run fewer animals are needed to acquire the same scientific information. Page | 2 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ b. This approach relies on an analysis of experimental design, applications of newer technologies, the use of appropriate statistical methods, and control of environmentally related variability in animal housing and study areas. Refinement and reduction goals should be balanced on a case-by-case basis. Principal investigators are strongly discouraged from advocating animal reuse as a reduction strategy, and reduction should not be a rationale for reusing an animal or animals that have already undergone experimental procedures especially if the well-being of the animals would be compromised. Studies that may result in severe or chronic pain or significant alterations in the animals’ ability to maintain normal physiology, or adequately respond to stressors, should include descriptions of appropriate humane endpoints or provide science-based justification for not using a particular, commonly accepted humane endpoint. Veterinary consultation must occur when pain or distress is beyond the level anticipated in the protocol description or when interventional control is not possible. ANIMAL MODELS The term animal model became increasingly important as a means by which disease processes occurring in humans could be investigated. Some specific strains and stocks of animals have biological and pathologic process bearing similarities to humans, and their study can lead to a better understanding of these mechanisms. The definition of a true animal model of a particular disease, is one in which the disease in the animal is reproducible and more important, is predictable. Animal Models are classified as follows: 1. Experimental Model - one in which the experimentally reproduced condition mimics a human disease (i.e., Leprosy in armadillos). 2. Negative Model - (Non-Model) – is an animal species in which a particular disease cannot be produced. These are used to study why this animal is resistant to a particular disease, i.e., wood rat - immune to snake bite; opossum - resistant to rabies. 3. Spontaneous Model - is an animal species that has a disease which occurs naturally and "mimics" a human disease at least in some way (i.e., Stumptailed macaques - baldness; Doberman Pinscher - VonWillebrands Disease - Factor A Hemophilia). 4. Orphan Model - is an animal disease that does not "mimic" a human disease. Even though the animal disease pathogenesis is well understood, the similar human disease is not, therefore, the animal disease model may not be recognized as a true model. In selecting an animal model, the investigator is required to establish his experimental objectives and determine that there is not an alternative technique to animal use. Once this is accomplished, the animal model should be selected based on the following considerations: 1. Species availability. 2. Facilities availability. Page | 3 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ 3. Husbandry and technical expertise availability. 4. Space and caging availability. 5. Special environmental requirements. 6. Genetic characteristics. 7. Nutritional requirements. 8. Microbial ecology of the animal. 9. Reproductive, anatomic, physiological, behavioral considerations. 10. Lifespan 11. Biohazard control. 12. Knowledge of comparative biology. 13. Literature survey. HEALTH MONITORING As in any field of science, the merit of animal experiments depends on the rigid adherence to principles of scientific method. By following these principles, data produced will be both reliable and reproducible. However, living organisms are complex and can be subject to wide variations in biological response to apparently insignificant influences. Disease prevention should be a prerequisite of any animal experiment for three reasons: 1. For animal welfare: Infectious agents have the ability to cause ill health and possibly death thus compromising the welfare of the animals. Even sub-clinical infection can introduce greater variation between individuals thereby increasing the numbers of animals required to produce statistically significant results. 2. For scientific quality: Overt or sub-clinical infection is likely to affect experimental results, so reducing reliability and reproducibility of the research. 3. For safety: To safeguard health of laboratory and research staff as some animal pathogens are transmissible to humans. ENVIRONMENT, HOUSING, AND MANAGEMENT The design of animal facilities combined with appropriate animal housing and management are essential contributors to animal well-being, the quality of animal research and production, teaching or testing programs involving animals, and the health and safety of personnel. An appropriate Program provides environments, housing, and management that are well suited for the species or strains of animals maintained and takes into account their physical, physiologic, and behavioral needs, allowing them to grow, mature, and reproduce normally while providing for their health and well-being. RULES AND REGULATIONS ON THE CONDUCT OF SCIENTIFIC PROCEDURES USING ANIMALS Republic Act No. 8485, otherwise known as the “Animal Welfare Act of 1998” Page | 4 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ o The purpose of these rules and regulations is to institute the basic systems, organizations and practices in all laboratory animal care and use establishments to safeguard the welfare of animals used in scientific procedures. o The intention is to grant authorization to conduct scientific procedures using animals to any concerned entity based mainly on the acceptability of their Animal Care and Use Program and the existence of an Institutional Animal Care and Use Committee (IACUC). o There is no intention to evaluate or review individual scientific procedures or protocols at the Animal Welfare Committee level. Such evaluation or review is best assumed by the IACUC in adherence to the principles of self-regulation. The following shall be exempted from the requirements: o A clinical test on animals for evaluating a veterinary product in accordance with regulatory requirements or standard procedures. o The conduct of recognized veterinary procedures such as any therapy, prophylaxis, diagnostic or disease surveillance procedures directly necessary or desirable for the welfare of the animal or animal population. Examples are: ▪ giving established medicines (e.g., antibiotics, anthelmintics, analgesics) orally or by injection ▪ anesthetizing or sedating prior to further therapy (e.g., surgery) or diagnostic evaluation (e.g., x-ray) ▪ performing corrective surgical procedures ▪ vaccinating against rabies, distemper or other infectious diseases ▪ taking blood or other tissue samples for diagnosis/ disease testing o The conduct of recognized agricultural practices such as castration, genetic engineering or embryo manipulation, unless they form part of an experiment. AUTHORIZATION/REGISTRATION/CERTIFICATION The following are requirements for the authorization of animal use: o Description of the Animal Care and Use Program (ACUP) signed by the duly licensed veterinarian representing the entity. o Animal Care and Use Program Accreditation Certificate issued by a duly recognized body or association such as the Philippine Association for Laboratory Animal Science (PALAS). o Animal Technician Training Program on laboratory animal care and use. o Certification of Assurance that an Institutional Animal Care and Use Committee (IACUC) is in existence in the establishment. Institutional Animal Care and Use Committee (IACUC) o The IACUC shall be composed of at least three (3) members: ▪ a licensed veterinarian (preferably with sufficient training and experience in laboratory animal science or medicine or in the use of the species in question) ▪ one experienced in scientific procedures involving animals Page | 5 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ ▪ a public member not affiliated with the institution and preferably with concern for animal welfare ▪ Any additional member may be appointed provided he/she possesses the aforementioned qualifications. o The functions and obligations of the IACUC shall be to: ▪ evaluate and approve the ACUP and the protocols of scientific procedures ▪ Monitor and review the implementation of the ACUP and scientific procedures through the conduct of facility inspections. ▪ Submit an annual report on the status and implementation of the ACUP to the BAI. EUTHANASIA o Euthanasia is defined as the process of inducing painless death to pets. It has rapidly gained acceptance in many aspects of scientific procedures. It should be done rapidly and humanely and must occur with the least fear, anxiety, pain and distress to the animals. Consideration must be given to how the animal is handled immediately prior to and during the procedure. GUIDELINES IN THE CONDUCT OF SCIENTIFIC PROCEDURES USING HUMAN FOR HEALTH-RELATED RESEARCH. GUIDELINE 1: SCIENTIFIC AND SOCIAL VALUE AND RESPECT FOR RIGHTS General considerations o In order to be ethically permissible, health-related research with humans, including research with samples of human tissue or data, must have social value. o The scientific and social value of research can be difficult to quantify, but it is generally grounded in three factors: the quality of the information to be produced, its relevance to significant health problems, and its contribution to the creation or evaluation of interventions, policies, or practices that promote individual or public health. o It is essential to the social value of health-related research that its design is scientifically sound and that it offers a means of developing information not otherwise obtainable. o For example, so-called “seeding trials” violate this requirement if their purpose is to influence clinicians who participate in the study to prescribe a new medication rather than to produce knowledge about the merits of these interventions. Social value o Refers to the importance of the information that a study is likely to produce. Information can be important because of its direct relevance for understanding or intervening on a significant health problem or because of its expected contribution to research likely to promote individual or public health. o The importance of such information can vary depending on the significance of the health need, the novelty and expected merits of the approach, the merits of alternative means of addressing the problem, and other considerations. Page | 6 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ o Researchers, sponsors, research ethics committees and relevant health authorities, such as regulators and policy-makers, must ensure that a study has sufficient social value to justify its associated risks, costs and burdens. In particular, there must be sufficient social value to justify risks to participants in studies that lack the prospect of potential individual benefit to them. Scientific value o Scientific value refers to the ability of a study to produce reliable, valid information capable of realizing the stated objectives of the research. The requirement of scientific value applies to all health-related research with humans, regardless of funding source or degree of risk to participants. o Ensuring that studies uphold high scientific standards is essential for maintaining the integrity of the research enterprise and its ability to fulfil its social function. Qualification of research personnel o Sponsors, researchers, and research ethics committees must ensure that all research personnel are qualified by virtue of their education and experience to perform competently and with integrity. This includes receiving appropriate ethics education and training. Qualifications of research personnel must be adequately described in the materials submitted to the research ethics committee. Respect for rights and welfare. o Although the social value of research is a necessary condition for its ethical acceptability, it is not sufficient. All research with humans must be carried out in ways that show respect and concern for the rights and welfare of individual participants and the communities in which research is carried out. This respect and concern is manifest in requirements for informed consent, ensuring that risks are minimized and are reasonable in light of the importance of the research, and other requirements discussed in this document. Dissemination of results of research. GUIDELINE 2: RESEARCH CONDUCTED IN LOW-RESOURCE SETTINGS General considerations o This Guideline pertains to settings in which resources are so limited that the population may be vulnerable to exploitation by sponsors and investigators from wealthier countries and communities. o The ethical standards applied should be no less stringent than they would be for research carried out in high-resource settings. To ensure that people in low-resource settings receive equitable benefit from their participation in health-related research, this Guideline demands that local social value be created. Low-resource settings should not be interpreted narrowly as low-resource countries. These settings might also exist in middle- and high- income countries. o Moreover, a setting can change over time and no longer be considered low-resource. Responsiveness of research to health needs or priorities Page | 7 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ o The responsiveness requirement can be met by demonstrating that research is needed to provide new knowledge about the best means of addressing a health condition present in that community or region. o Where communities or policy-makers have determined that research on particular health needs constitutes a public health priority, studies that address such needs seek to provide social value to the community or population and are therefore responsive to their health needs. Responsibilities and plans o When the research has important potential individual benefits to the population or community, the responsibility to make any intervention or product developed available to this population is shared among researchers, sponsors, governments, and civil society. o For this reason, the negotiation among stakeholders must include representatives in the community or country, including, where appropriate, the national government, the health ministry, local health authorities, relevant scientific and ethics groups, as well as members of the communities from which persons are drawn, patent-holders if they are other than the sponsor, and nongovernmental organizations such as health advocacy groups. o The negotiation must address the health-care infrastructure required for safe and appropriate use of any intervention or product developed. Post-trial availability for communities and populations o Even if research addresses a question that has social value for the community or population where it is carried out, the community or population will not benefit from successful research unless the knowledge and interventions that it produces are made available to them and products are reasonably priced. Additional benefits to the population or community o Benefits other than those associated with study participation may accrue to the community or population, especially in resource-poor settings. Such benefits can include improving the health infrastructure, training laboratory personnel, and educating the public about the nature of research and the benefits resulting from a particular study. Community engagement o From the inception of research planning, it is important to ensure full participation of communities in all steps of the project, including discussions of the relevance of the research for the community, its risks and potential individual benefits, and how any successful products and possible financial gain will be distributed, for example through a benefit-sharing agreement. GUIDELINE 3: EQUITABLE DISTRIBUTION OF BENEFITS AND BURDENS IN THE SELECTION OF INDIVIDUALS AND GROUPS OF PARTICIPANTS IN RESEARCH General considerations o The equitable distribution of benefits and burdens in the selection of study populations requires that the benefits of research be distributed fairly and that no group or class of persons bears more than its fair share of the risks or burdens from research participation. Fair distribution of research benefits o Equity in the distribution of the benefits of research requires that research not disproportionately focus on the health needs of a limited class of people, but instead aims to address diverse health needs across different classes or groups. Page | 8 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ Fair distribution of research burdens. o Research with human participants typically requires that some persons or groups are exposed to risks and burdens in order to generate the knowledge needed to protect and promote people’s health. o Equity in the distribution of burdens of research requires special care to ensure that individuals, communities or populations that are already disadvantaged or marginalized are not over-represented in research. o When research is concentrated in disadvantaged or marginalized groups, it may be easier to expose participants to unreasonable risks or undignified treatment. Furthermore, research results obtained from disadvantaged populations may not be appropriately extrapolated to the general population. GUIDELINE 4: POTENTIAL INDIVIDUAL BENEFITS AND RISKS OF RESEARCH Evaluation of individual research interventions and procedures o To evaluate the risks and potential individual benefits of a research study, researchers, sponsors, and research ethics committees must first assess the risks and potential individual benefits of each individual research intervention and procedure, and then judge the aggregate risks and potential individual benefits of the study as a whole. o Taking these successive steps is important because overall judgments of the risk-benefit profile of a study as a whole are more likely to be inaccurate because they may miss concerns raised by individual interventions. Potential individual benefit o Research has a range of potential individual benefits. It generates the knowledge necessary to protect and promote the health of future patients. o Potential clinical benefits to participants can be maximized by targeting populations who stand to benefit most from the intervention under study. Measures to maximize potential individual benefits need to be carefully balanced with competing considerations. Risks to research participants o This can involve ensuring that plans and procedures exist to adequately manage and reduce risks, for example by: ▪ monitoring the study and providing mechanisms for responding to adverse events; ▪ establishing a Data Safety and Monitoring Committee (DSMC) to review and decide on data on harms and benefits as a study progresses; ▪ instituting clear criteria for stopping a study; ▪ installing safeguards to protect the confidentiality of sensitive personal data; ▪ seeking exemptions, where possible, from requirements to report information about illegal activities of study participants (such as sex work in countries where prostitution is forbidden by law); ▪ avoiding unnecessary procedures (for example, by performing laboratory tests on existing blood samples instead of drawing new blood, where scientifically appropriate); and Page | 9 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ ▪ excluding participants who are at a significantly increased risk of being harmed from an intervention or procedure. The minimal-risk standard o The minimal-risk standard is often defined by comparing the probability and magnitude of anticipated harms with the probability and magnitude of harms ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. o The purpose of these comparisons is to determine the level of acceptable research risk by analogy with the risks of activities in other areas of life: when the risks of an activity are considered acceptable for the population in question, and the activity is relatively similar to participating in research, then the same level of risk should be considered acceptable in the research context. o These comparisons typically imply that research risks are minimal when the risk of serious harm is very unlikely and the potential harms associated with more common adverse events are small. Risks to groups o In order to achieve the social and scientific value of research, results must be made public However; research results in certain fields (for example, epidemiology, genetics, and sociology) may present risks to the interests of communities, societies, families, or racially or ethnically defined groups. Risks to researchers o In addition to participants, investigators themselves can be exposed to risks that result from research activities. For example, research involving radiation can expose researchers to risks and studies on infectious disease can pose risks to laboratory staff who are handling samples. GUIDELINE 5: CHOICE OF CONTROL IN CLINICAL TRIALS General considerations for controlled clinical trials o The conduct of controlled clinical trials is methodologically essential in order to test the relative merits of investigational interventions. To obtain valid results in a controlled trial, researchers must compare the effects of an experimental intervention on participants assigned to the investigational arm (or arms) of a trial with the effects that a control intervention produces in persons drawn from the same population. o Randomization is the preferred method for assigning participants to the arms of controlled trials. Assignment to treatment arms by randomization tends to produce study groups comparable with respect to factors that might influence study outcomes, removes researcher bias in the allocation of participants, and helps to ensure that the study results reflect the effects of administered interventions and not the influence of extraneous factors. GUIDELINE 6: CARING FOR PARTICIPANTS’ HEALTH NEEDS Page | 10 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ It is generally inappropriate to require researchers or sponsors to take on the role of a country’s health systems. Nevertheless, research with humans often involves interactions that enable researchers to detect or diagnose health problems during recruitment and the conduct of research. Similarly, clinical research often involves care and preventive measures in addition to the experimental interventions. In some cases, participants may continue to need the care or prevention provided during the research after their participation in the study has ended. This may include access to an investigational intervention that has demonstrated significant benefit. In all these situations, researchers and sponsors must show care and concern for the health and welfare of study participants. GUIDELINE 7: COMMUNITY ENGAGEMENT Proactive and sustained engagement with the communities from which participants will be invited to participate is a way of showing respect for them and the traditions and norms that they share. Community engagement is also valuable for the contribution it can make to the successful conduct of research. In particular, community engagement is a means of ensuring the relevance of proposed research to the affected community, as well as its acceptance by the community. GUIDELINE 8: COLLABORATIVE PARTNERSHIP AND CAPACITY-BUILDING FOR RESEARCH AND RESEARCH REVIEW Governmental authorities in charge of health-related research involving human participants have to ensure that such research is reviewed ethically and scientifically by competent and independent research ethics committees and is conducted by competent research teams. GUIDELINE 9: INDIVIDUALS CAPABLE OF GIVING INFORMED CONSENT Researchers have a duty to provide potential research participants with the information and the opportunity to give their free and informed consent to participate in research, or to decline to do so, unless a research ethics committee has approved a waiver or modification of informed consent. Informed consent should be understood as a process, and participants have a right to withdraw at any point in the study without retribution. Researchers have a duty to: o seek and obtain consent, but only after providing relevant information about the research and ascertaining that the potential participant has adequate understanding of the material facts; o refrain from unjustified deception or withholding of relevant information, undue influence, or; o ensure that the potential participant has been given sufficient opportunity and time to consider whether to participate; and o as a general rule, obtain from each potential participant a signed form as evidence of informed consent. Researchers must justify any exceptions to this general rule and seek the approval of the research ethics committee. With the approval of the research ethics committee, researchers must renew the informed consent of each participant if there is a substantive change in the conditions or procedures of the research, or if Page | 11 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ new information becomes available that could affect the willingness of participants to continue. In long-term studies, researchers should ensure at pre-determined intervals that each participant is willing to stay in the study, even if there are no changes in the design or objectives of the research. GUIDELINE 10: MODIFICATIONS AND WAIVERS OF INFORMED CONSENT Researchers must not initiate research involving humans without obtaining each participant’s individual informed consent or that of a legally authorized representative, unless researchers have received explicit approval to do so from a research ethics committee. Before a waiver of informed consent is granted, researchers and research ethics committees should first seek to establish whether informed consent could be modified in a way that would preserve the participant’s ability to understand the general nature of the investigation and to decide whether to participate. A research ethics committee may approve a modification or waiver of informed consent to research if: o the research would not be feasible or practicable to carry out without the waiver or modification; o the research has important social value; and o the research poses no more than minimal risks to participants. GUIDELINE 11: COLLECTION, STORAGE AND USE OF BIOLOGICAL MATERIALS AND RELATED DATA When biological materials and related data, such as health or employment records, are collected and stored, institutions must have a governance system to obtain authorization for future use of these materials in research. Researchers must not adversely affect the rights and welfare of individuals from whom the materials were collected. When human biological materials are left over after clinical diagnosis or treatment (so-called “residual tissue”) and are stored for future research, a specific or broad informed consent may be used or may be substituted by an informed opt-out procedure. This means that the material is stored and used for research unless the person from whom it originates explicitly objects. The informed opt-out procedure must fulfil the following conditions: 1) Patients need to be aware of its existence 2) Sufficient information needs to be provided; 3) Patients need to be told that they can withdraw their data; and 4) A genuine possibility to object has to be offered. GUIDELINE 12: COLLECTION, STORAGE AND USE OF DATA IN HEALTH-RELATED RESEARCH Page | 12 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ When data are stored, institutions must have a governance system to obtain authorization for future use of these data in research. Researchers must not adversely affect the rights and welfare of individuals from whom the data were collected. When data are collected and stored for research purposes, either specific informed consent for a particular use or broad informed consent for unspecified future use must be obtained from the person from whom the data were originally obtained. The ethical acceptability of broad informed consent relies on proper governance. When data are used that were collected in the context of routine clinical care, an informed opt-out procedure must be used. This means that the data may be stored and used for research unless A person explicitly objects. However, a person’s objection is not applicable when it is mandatory to include data in population-based registries. The informed opt-out procedure must fulfil the following conditions: 1) Patients need to be aware of its existence; 2) Sufficient information needs to be provided; 3) Patients need to be informed that they can withdraw their data; and 4) A genuine possibility to object has to be offered. GUIDELINE 13: REIMBURSEMENT AND COMPENSATION FOR RESEARCH PARTICIPANTS Research participants should be reasonably reimbursed for costs directly incurred during the research, such as travel costs, and compensated reasonably for their inconvenience and time spent. Compensation can be monetary or non-monetary. The latter might include free health services unrelated to the research, medical insurance, educational materials, or other benefits. Compensation must not be so large as to induce potential participants to consent to participate in the research against their better judgment (“undue inducement”). A local research ethics committee must approve reimbursement and compensation for research participants. GUIDELINE 14: TREATMENT AND COMPENSATION FOR RESEARCH-RELATED HARMS Sponsors and researchers must ensure that research participants who suffer physical, psychological or social harm as a result of participating in health-related research receive free treatment and rehabilitation for such harms, as well as compensation for lost wages, as appropriate. Such treatment and compensation are owed to research participants who are harmed physically, psychologically or socially, as a consequence of interventions performed solely to accomplish the purposes of research, regardless of fault. In the case of death resulting from research participation, the participant’s dependents are entitled to compensation. Participants must not be asked to waive the right to free treatment and compensation for research-related harms. Research ethics committees must determine whether there is an adequate arrangement for treatment and compensation for research-related injuries. GUIDELINE 15: RESEARCH INVOLVING VULNERABLE PERSONS AND GROUPS Page | 13 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ When vulnerable individuals and groups are considered for recruitment in research, researchers and research ethics committees must ensure that specific protections are in place to safeguard the rights and welfare of these individuals and groups in the conduct of the research. According to the Declaration of Helsinki, vulnerable groups and individuals “may have an increased likelihood of being wronged or of incurring additional harm.” This implies that vulnerability involves judgments about both the probability and degree of physical, psychological, or social harm, as well as a greater susceptibility to deception or having confidentiality breached. It is important to recognize that vulnerability involves not only the ability to provide initial consent to participate in research, but also aspects of the ongoing participation in research studies. In some cases, persons are vulnerable because they are relatively (or absolutely) incapable of protecting their own interests. Some characteristics can make it reasonable to assume that certain individuals are vulnerable, for example: o Capacity to consent. One widely accepted criterion of vulnerability is limited capacity to consent or decline to consent to research participation. o Individuals in hierarchical relationships. The characteristic of vulnerability in this case is the possibility of diminished voluntariness of the consent of potential participants who are in a subordinate relationship. o Institutionalized persons. Residents of nursing homes, mental institutions, and prisons are often considered vulnerable because in a confined setting they have few options and are denied certain freedoms that non-institutionalized persons enjoy. o Women. Although women in general must not be considered vulnerable, specific circumstances in which women could be vulnerable in research include: studies with female or transsexual sex workers; research on sexual and intimate partner violence; studies with trafficked women, refugees and asylum seekers; studies of abortion in jurisdictions where abortion is illegal; and research with women who live in a cultural context where they are not permitted to consent on their own behalf for participation in research, but require permission from a spouse or male relative o Pregnant women. Pregnant women must not be considered vulnerable simply because they are pregnant. Specific circumstances, such as risks to the fetus, may require special protections. o Other potentially vulnerable individuals. Among members of groups that have traditionally been considered vulnerable, the following are frequently mentioned: people receiving welfare benefits or social assistance and other poor people and the unemployed; people who perceive participation as the only means of accessing medical care; some ethnic and racial minorities; homeless persons, nomads, refugees or displaced persons; people living with disabilities; people with incurable or stigmatized conditions or diseases; people faced with physical frailty, for example because of age and co-morbidities, individuals who are politically powerless; and members of communities unfamiliar with modern medical concepts. Furthermore, in some contexts vulnerability might be related to gender, sexuality and age. GUIDELINE 16: RESEARCH INVOLVING ADULTS INCAPABLE OF GIVING INFORMED CONSENT Page | 14 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ Adults who are not capable of giving informed consent must be included in health-related research unless a good scientific reason justifies their exclusion. As adults who are not capable of giving informed consent have distinctive physiologies and health needs, they merit special consideration by researchers and research ethics committees. At the same time, they may not be able to protect their own interests due to their lack of capacity to provide informed consent. Specific protections to safeguard the rights and welfare of these persons in research are therefore necessary. Before undertaking research with adults who are not capable of giving informed consent, the researcher and the research ethics committee must ensure that: o a legally authorized representative of the person who is incapable of giving informed consent has given permission and this permission takes account of the participant’s previously formed preferences and values (if any); and o The assent of the subject has been obtained to the extent of that person’s capacity, after having been provided with adequate information about the research at the level of the subject’s capacity for understanding this information. If participants become capable of giving informed consent during the research, their consent to continued participation must be obtained. In general, a potential participant’s refusal to enroll in the research must be respected, unless, in exceptional circumstances, research participation is considered the best available medical option for an individual who is incapable of giving informed consent. If participants have made advance directives for participation in research while fully capable of giving informed consent, the directives should be respected. For research interventions or procedures that have the potential to benefit adults who are incapable of giving informed consent, the risks must be minimized and outweighed by the prospect of potential individual benefit. For research interventions or procedures that have no potential individual benefits for participants, two conditions apply: o the interventions and procedures should be studied first in persons who can give consent when these interventions and procedures target conditions that affect persons who are not capable of giving informed consent as well as those who are capable, unless the necessary data cannot be obtained without participation of persons who are incapable of giving informed consent; and the risks must be minimized and no more than minimal. When the social value of the studies with such research interventions and procedures is compelling, and these studies cannot be conducted in persons who can give informed consent, a research ethics committee may permit a minor increase above minimal risk. GUIDELINE 17: RESEARCH INVOLVING CHILDREN AND ADOLESCENTS Children and adolescents must be included in health-related research unless a good scientific reason justifies their exclusion. As children and adolescents have distinctive physiologies and health needs, they merit special consideration by researchers and research ethics committees. However, their distinctive physiologies and emotional development may also place children and adolescents at increased risk of being harmed in the conduct of research. Moreover, without appropriate support, they may not be able to protect their own interests due to their evolving capacity to give informed consent. Specific protections to safeguard children’s rights and welfare in the research are therefore necessary. Page | 15 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ Before undertaking research involving children and adolescents, the researcher and the research ethics committee must ensure that: o a parent or a legally authorized representative of the child or adolescent has given permission; and o the agreement (assent) of the child or adolescent has been obtained in keeping with the child’s or adolescent’s capacity, after having been provided with adequate information about the research tailored to the child’s or adolescent’s level of maturity. If children reach the legal age of maturity during the research, their consent to continued participation should be obtained. In general, the refusal of a child or adolescent to participate or continue in the research must be respected, unless, in exceptional circumstances, research participation is considered the best medical option for a child or adolescent. For research interventions or procedures that have the potential to benefit children or adolescents, the risks must be minimized and outweighed by the prospect of potential individual benefit. For research interventions or procedures that have no potential individual benefits for participants, two conditions apply: o the interventions and procedures should be studied in adults first, when these interventions and procedures target conditions that affect adults as well as children and adolescents, unless the necessary data cannot be obtained without participation of children or adolescents; and o The risks must be minimized and no more than minimal. When the social value of the studies with such research interventions and procedures is compelling, and these studies cannot be conducted in adults, a research ethics committee may permit a minor increase above minimal risk. GUIDELINE 18: WOMEN AS RESEARCH PARTICIPANTS Women must be included in health-related research unless a good scientific reason justifies their exclusion. Women have been excluded from much health-related research because of their child-bearing potential. As women have distinctive physiologies and health needs, they merit special consideration by researchers and research ethics committees. Only the informed consent of the woman herself should be required for her research participation. Since some societies lack respect for women’s autonomy, in no case must the permission of another person replace the requirement of individual informed consent by the woman. Women of child-bearing potential must be informed in advance of the possibility of risks to the fetus should they become pregnant during their research participation. When participation in research might be hazardous to a fetus or a woman if she becomes pregnant, sponsors and researchers must guarantee access to pregnancy tests, effective contraceptive methods before and during the research and to safe, legal abortion. GUIDELINE 19: PREGNANT AND BREASTFEEDING WOMEN AS RESEARCH PARTICIPANTS Pregnant and breastfeeding women have distinctive physiologies and health needs. Research designed to obtain knowledge relevant to the health needs of the pregnant and breastfeeding woman Page | 16 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ must be promoted. Research in pregnant women must be initiated only after careful consideration of the best available relevant data. In no case must the permission of another person replace the requirement of individual informed consent by the pregnant or breastfeeding woman. For research interventions or procedures that have the potential to benefit either pregnant or breastfeeding women or their fetus or infant, risks must be minimized and outweighed by the prospect of potential individual benefit. For research interventions or procedures that have no potential individual benefits for pregnant and breastfeeding women: o the risks must be minimized and no more than minimal; and o The purpose of the research must be to obtain knowledge relevant to the particular health needs of pregnant or breastfeeding women or their fetuses or infants. When the social value of the research for pregnant or breastfeeding women or their fetus or infant is compelling, and the research cannot be conducted in non-pregnant or non-breastfeeding women, a research ethics committee may permit a minor increase above minimal risk. Short-term and long‐term follow-up of the fetus and the child may be required in research involving pregnant and breastfeeding women depending upon the study intervention and its potential risks. As a general rule, health-related research involving pregnant women that has the potential for harm to the fetus should be conducted only in settings where women can be guaranteed access to a safe, timely and legal abortion in the event that participation in the research makes the pregnancy unwanted. Research designed to obtain knowledge relevant to the health needs of pregnant and breastfeeding women should be promoted in the following areas: o interventions for conditions resulting from pregnancy; o interventions for conditions that affect the general population and are reasonably expected to be used without adequate evidence during pregnancy (for example off-label use of medications); and o interventions for conditions that affect the developing fetus GUIDELINE 20: RESEARCH IN DISASTERS AND DISEASE OUTBREAKS Disasters arising from events such as earthquakes, tsunamis or military conflicts, and disease outbreaks, can have a sudden and devastating impact on the health of large affected populations. In order to identify effective ways of mitigating the health impact of disasters and disease outbreaks, health-related research should form an integral part of disaster response. However, the conduct of research must not unduly impact the response to the victims of a disaster. In the conduct of research in disasters and disease outbreaks, it is essential to uphold the ethical principles embodied in these Guidelines. Conducting research in these situations raises important challenges such as the need to generate knowledge quickly, maintain public trust, and overcome practical obstacles to implementing research. These challenges need to be carefully balanced with the need to ensure the scientific validity of the research and uphold ethical principles in its conduct. Page | 17 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ Researchers, sponsors, international organizations, research ethics committees and other relevant stakeholders should ensure that: o studies are designed so as to yield scientifically valid results under the challenging and often rapidly evolving conditions of disasters and disease outbreaks; o the research is responsive to the health needs or priorities of the disaster victims and affected communities and cannot be conducted outside a disaster situation; o participants are selected fairly and adequate justification is given when particular populations are targeted or excluded, for example health workers; o the potential burdens and benefits of research participation and the possible benefits of the research are equitably distributed o the risks and potential individual benefits of experimental interventions are assessed realistically, especially when they are in the early phases of development; o communities are actively engaged in study planning in order to ensure cultural sensitivity, while recognizing and addressing the associated practical; o the individual informed consent of participants is obtained even in a situation of duress, unless the conditions for a waiver of informed consent are; and o research results are disseminated, data are shared, and any effective interventions developed or knowledge generated are made available to the affected communities Research in disasters and disease outbreaks should ideally be planned ahead. Health officials and research ethics committees should develop procedures to ensure appropriate, expedient and flexible mechanisms and procedures for ethical review and oversight. For example, research ethics committees could pre-screen study protocols in order to facilitate and expedite ethical review in a situation of crisis. Similarly, researchers and sponsors could make pre-arrangements on data- and sample-sharing that research ethics committees review in advance. Sponsors and research ethics committees should evaluate and seek to minimize the risks to researchers and health professionals conducting research in a disaster context. Sponsors should include in the protocol a plan for mitigating adverse events. Furthermore, appropriate resources for mitigation measures should be included in the protocol budget. GUIDELINE 21: CLUSTER RANDOMIZED TRIALS In advance of initiating a cluster randomized trial, researchers, sponsors, relevant authorities, and research ethics committees should: o Determine who are the research participants and what other individuals or groups are affected, even though they are not directly targeted; o Determine whether it is required or feasible to obtain informed consent from patients, health care workers, or community members in certain studies; o Determine whether requiring informed consent and allowing refusal to consent may invalidate or compromise the research results; o Determine whether a no-intervention group is ethically acceptable as a comparator in a particular cluster randomized trial; and o Decide whether permission must be obtained from a gatekeeper. GUIDELINE 22: USE OF DATA OBTAINED FROM THE ONLINE ENVIRONMENT AND DIGITAL TOOLS IN Page | 18 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ HEALTH-RELATED RESEARCH When researchers use the online environment and digital tools to obtain data for health related research they should use privacy-protective measures to protect individuals from the possibility that their personal information is directly revealed or otherwise inferred when datasets are published, shared, combined or linked. Researchers should assess the privacy risks of their research, mitigate these risks as much as possible and describe the remaining risks in the research protocol. They should anticipate, control, monitor and review interactions with their data across all stages of the research. Researchers should inform persons whose data may be used in the context of research in the online environment of: o the purpose and context of intended uses of data and information; o the privacy and security measures used to protect their data, and any related privacy risks; and o The limitations of the measures used and the privacy risks that may remain despite the safeguards put in place. In case of a refusal by the person approached, researchers should refrain from using the data of this individual. This informed opt-out procedure must fulfil the following conditions: 1) Persons need to be aware of its existence; 2) Sufficient information needs to be provided; 3) Persons need to be told that they can withdraw their data; and 4) A genuine possibility to object has to be offered. Researchers collecting data on individuals and groups through publicly accessible websites without direct interaction with persons should, at a minimum, obtain permission from website owners, post a notice of research intent, and ensure compliance with published terms of website use. Researchers must describe in the protocol how data obtained from online environments and digital tools will be treated, along with the potential risks of the research and how the potential risks are mitigated. GUIDELINE 23: REQUIREMENTS FOR ESTABLISHING RESEARCH ETHICS COMMITTEES AND FOR THEIR REVIEW OF PROTOCOLS All proposals to conduct health-related research involving humans must be submitted to a research ethics committee to determine whether they qualify for ethical review and to assess their ethical acceptability, unless they qualify for an exemption from ethical review (which may depend upon the nature of the research and upon applicable law or regulations). The researcher must obtain approval or clearance by such a committee before beginning the research. The research ethics committee should conduct further reviews as necessary, for example, when there are significant changes in the protocol. Research ethics committees must review research protocols according to the principles set out in these Guidelines. Research ethics committees must be formally established and given adequate mandate and support to ensure timely and competent review according to clear and transparent procedures. Committees must Page | 19 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ include multidisciplinary membership in order to competently review the proposed research. Committee members must be duly qualified and regularly update their knowledge of ethical aspects of health-related research. Research ethics committees must have mechanisms to ensure independence of their operations. Research ethics committees from different institutions or countries should establish efficient communication in cases of externally sponsored and multi-center research. In externally sponsored research, ethical review must take place in both the host and the sponsoring institution. Research ethics committees should have a clear procedure for researchers or sponsors to make legitimate appeals against the decisions of research ethics committees. GUIDELINE 24: PUBLIC ACCOUNTABILITY FOR HEALTH-RELATED RESEARCH Public accountability is necessary for realizing the social and scientific value of health related research. Therefore, researchers, sponsors, research ethics committees, funders, editors and publishers have an obligation to comply with recognized publication ethics for research and its results. Researchers should prospectively register their studies, publish the results and share the data on which these results are based in a timely manner. Negative and inconclusive as well as positive results of all studies should be published or otherwise be made publicly available. Any publication or report resulting from a research study should indicate which research ethics committee has authorized the study. Researchers and sponsors should also share information about and data from past research. GUIDELINE 25: CONFLICTS OF INTEREST The primary goal of health-related research is to generate, in ethically appropriate ways, the knowledge necessary to promote people’s health. However, researchers, research institutions, sponsors, research ethics committees, and policy-makers have other interests (for example, scientific recognition or financial gain) that can conflict with the ethical conduct of research. Such conflicts between the primary goal of health-related research and secondary interests are defined as conflicts of interest. Conflicts of interest can influence the choice of research questions and methods, recruitment and retention of participants, interpretation and publication of data, and the ethical review of research. It is therefore necessary to develop and implement policies and procedures to identify, mitigate, eliminate, or otherwise manage such conflicts of interest. Research institutions, researchers and research ethics committees should take the following steps: o Research institutions should develop and implement policies and procedures to mitigate conflicts of interest and educate their staff about such conflicts; o Researchers should ensure that the materials submitted to a research ethics committee include a disclosure of interests that may affect the research; o Research ethics committees should evaluate each study in light of any disclosed interests and ensure that appropriate means of mitigation are taken in case of a conflict of interest; and o Research ethics committees should require their members to disclose their own interests to the committee and take appropriate means of mitigation in case of a conflict of Interest. Activity 3: Skill-building Activities (with answer key) (18mins + 2mins checking) Page | 20 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________. A. Enumeration: 1-3. Provide 3 considerations in selecting animal models. _________________________ _________________________ _________________________ 4-5. Provide two classifications of animal models. _________________________ _________________________ B.Identification: INSTRUCTIONS: Write the answer beside the number. _______________1. Often defined by comparing the probability and magnitude of anticipated harms with the probability and magnitude of harms ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. _______________2. It refers to an animal species in which a particular disease cannot be produced. _______________3.Violate this requirement if their purpose is to influence clinicians who participate in the study to prescribe a new medication rather than to produce knowledge about the merits of these interventions. _______________4. What does DSMC stand for? _______________5.The IACUC shall be composed of at least________ members: Activity 4: What I Know Chart, Part 2 (4 mins) Instruction: To review what was learned from this session, please go back to Activity 1 and answer the “What I Learned” column. Notice and reflect on any changes in your answers. Activity 5: CHECK FOR UNDERSTANDING (15 mins) A. Instruction: Write True if it`s correct, False if it`s not. 1. Republic Act No. 8485, otherwise known as Animal Welfare Act of 1998 2. Anesthesia is defined as the process of inducing painless death to pets. 3. The IACUC shall be composed of at least three members: 4. The minimal-risk standard often defined by comparing the probability and magnitude of anticipated harms with the probability and magnitude of harms ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 5.) DSMC stand for Data Safety and Monitoring Committee B.What guideline does the statements below belong? Instruction: write the correct letter below. A.Guideline 2 B.Guideline 4 C.Guideline 3 Page | 21 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ D.Guideline 9 E.Guideline 13 __1. This Guideline pertains to settings in which resources are so limited that the population may be vulnerable to exploitation by sponsors and investigators from wealthier countries and communities. __2. The minimal-risk standard is often defined by comparing the probability and magnitude of anticipated harms with the probability and magnitude of harms ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. __3, Proactive and sustained engagement with the communities from which participants will be invited to participate is a way of showing respect for them and the traditions and norms that they share. __4. Researchers have a duty to provide potential research participants with the information and the opportunity to give their free and informed consent to participate in research, or to decline to do so, unless a research ethics committee has approved a waiver or modification of informed consent. __5. Research participants should be reasonably reimbursed for costs directly incurred during the research, such as travel costs, and compensated reasonably for their inconvenience and time spent. C. LESSON WRAP-UP Activity 6: Thinking about Learning (5 mins) A. Work Tracker You are done with this session! Let’s track your progress. Shade the session number you just completed. P1 P2 1 2 3 4 5 6 7 8 9 10 B. Think about your Learning. Tell me about your thoughts! Today we talked about Drug Discovery and Development & Understanding the Biology of the Disease. What surprised you about the lesson today? How can you apply it to your profession? _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ _____________________________________________________________ ________________________________________________________. Page | 22 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ FAQs 1.) When was the first national law to regulate animal experimentation? The first national law to regulate animal experimentation was passed in Britain in 1876—the Cruelty to Animals Act of 1876. This bill created a central governing body that reviewed and approved all animal use in research. Brown, Congressman G.E. (1997). 30 Years of the Animal Welfare Act. Animal Welfare Information Center Bulletin 8: 1-2, 23. 2.) How did Edward Jenner created the first smallpox vaccine? Jenner took samples of matter from inside a dairymaid’s hand lesion and injected it into an unknowing 8-year-old boy, James Phipps. In the following days, Phipps developed a fever, lost his appetite, and felt discomfort in his armpit. However, he soon recovered. Two months later, Jenner injected Phipps with the smallpox virus. While it might have killed the boy, he was unfazed. From this experiment, Jenner created the first smallpox vaccine. © 2005-2022 Healthline Media a Red Ventures Company. ACTIVITY 3 Answer key A. Enumeration (Answers may vary) 1-3.) Provide 3 considerations in selecting animal models. 1. Species availability. 2. Facilities availability. 3. Husbandry and technical expertise availability. 4. Space and caging availability. 5. Special environmental requirements. 6. Genetic characteristics. 7. Nutritional requirements. 8. Microbial ecology of the animal. 9. Reproductive, anatomic, physiological, behavioral considerations. 10. Lifespan 11. Biohazard control. 12. Knowledge of comparative biology. Page | 23 This document is the property of PHINMA EDUCATION  Course Code: PHA 056 Student Activity Sheet #7 Name: _________________________________________________________________ Class number: _______ Section: ____________ Schedule: ________________________________________ Date: ________________ 13. Literature survey. 4-5.) Provide two classifications of animal models. Experimental Model Negative Model Spontaneous Model Orphan Model B. 1. Three 2. The minimal-risk standard 3. NEGATIVE MODEL 4. Seeding trials 5. Data Safety and Monitoring Committee Page | 24 This document is the property of PHINMA EDUCATION