Harm-Benefit analysis

Transcription

1 Harm-Benefit analysis Harm Benefit analysis is a systematic way to analyze harms, benefits and how they are balanced. Aurora Brønstad University of Bergen Tittel og navn på foreleser Navn på institusjon Public Underst Sci May;23(4): doi: / Epub 2012 Aug 3. Painful dilemmas: A study of the way the public's assessment of animal research balances costs to animals against human benefits. Lund TB1, Mørkbak MR, Lassen J, Sandøe P. S u p p o r t Care-In 16 1

2 The project evaluation shall consist in particular of the following: (d) a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations, and may ultimately benefit human beings, animals or the environment; Care-In Emphasize of harm-benefit assessment in written guidelines EU directive 2010/63 the IACUC is obliged to weigh the objectives of the study against potential animal welfare concerns. AAALAC International expects that IACUC's (or comparable oversight body), as part of the protocol review process, will weigh the potential adverse effects of the study against the potential benefits that are likely to accrue as a result of the research. This analysis should be performed prior to the final approval of the protocol, and should be a primary consideration in the review process. Decisions regarding the welfare, care and use of animals should be guided by scientific knowledge and professional judgement, reflect ethical and societal values, and consider the potential benefits and the impact on the well-being of the animals involved. P.X: The oversight framework should promote a harm-benefit analysis for animal use, balancing the benefits derived from the research or educational activity with the potential for pain and/or distress experienced by the animal. Ethical review: means consideration of the validity and justification for using animals including: an assessment and weighing of the potential harms for animals and likely benefits of the use and how these balance; Harm-benefit analysis: means the process of weighing the likely adverse effects (harms) to the animals against the benefits likely to accrue as a result of the proposed project. Project Proposal Review: (i) ethical considerations such as the application of the Three Rs and a harm/benefit analysis; the benefits should be maximised and the harms, in terms of pain and distress, should be minimized; 17 The art of comparing apples and oranges Care-In 18 2

3 Harm-Benefit Analysis the AALAS-FELASA Working Group proposal Aurora Brønstad University of Bergen Tittel og navn på foreleser Navn på institusjon AALAS-FELASA Harm-Benefit WG 1. Review existing literature on harm-benefit analysis. 2. Define and describe the current concepts and elements of the harm-benefit analysis. 3. Recommend how it can be addressed by persons responsible of the protocol/project applications. 4. Define how the harm-benefit analysis can be implemented by committee members as part of the ethical evaluation. 5. Present practical cases that may exemplify common situations in the research environment. Care-In 20 3

4 Care-In 21 Models for Harm-Benefit Analysis Tables, spreadsheet E = mc 2 S = e HBA Strengths Categories are useful to simplify a complex picture. Stimulate actions to avoid severe categories. Algorithms are helpful in guiding a decision Weaknesses The categories do not fit all cases Moral dilemmas cannot/shall not be solved by arithmetic s Graphic representations have pedagogic value in visualizing the concept and relationship between harm and benefit Process oriented models structure the HBA process, how to balance different opinions and question quality of the analysis. Generic Depend on defined categories (eg. low-middle-high) Not operational (too simple?) Too generic (?) - Does not provide an answer on what model (as previous) to use or provide solutions for conclusions Care-In 22 4

5 The AALAS-FELASA WG Proposal The working group defines HBA as a systematic, transparent way to assess and compare harms, benefits of a particular animal study. The WG has structured a simple, systematic, and flexible approach and developed a tool to perform a thorough HBA. Consideration of harms is based upon the domains of the 5 Freedoms and a set of modulating factors that can have mitigating or aggravating effect. Consideration of benefits is based upon a specific set of domains (what, who, how, when) and modulating factors. Care-In 23 Key what, who, how, when? Benefit = Domains Social benefits Human health Animal health Environmental health Socioeconomic benefits Scientific benefits Educational benefits Safety and efficacy Harm = Impact on Five Freedoms Freedom from Pain/Injury Freedom from Fear/Distress Freedom from Hunger/Thirst Ability to express normal behavior Freedom from Discomfort/appropriate husbandry Table 1. KEY: Benefit Domains and Harm Factors Care-In 24 5

6 Minimal Harm High Benefit White - Light Much Harm Less Benefit Dark red Table 3. Summary of color gradient and score scheme for harm/benefit factors. Care-In 25 Detail the harms and benefits at the top of tables. Engage in a systematic review of how different animal, experimental, and environmental variables affect, or modulate harms what, why, how and when the bene- fit will what, be realized. why, how and when the bene- fit will be realized. Table 2b. Benefit table. Table 2a. Harm table. 6

7 Outcome Harm - Benefit Analysis Minimal Harm High Benefit White - Light Acceptance Harm Benefit Rejection Harm Benefit Much Harm Less Benefit Dark red Evaluate Improvements Harm Benefit Care-In 27 Tittel og navn på foreleser Navn på institusjon 7

8 5 Freedoms* 5 Domains** 5 Domains/ Freedoms HarmAnimal Welfare harms Animal Right harms Pain Duration Discomfort Ability to suffer Injury or Disease Hunger and Thirst Quality of animals Number of animals Severity of procedures Fear, anxiety and distress Frequency of procedures Species, choice of animals Duration related to lifespan Sentience and consciousness Staff competence and quality Origin, acquisition or transport Deaths (caused by the experiment) Risk of harm = probability x severity Possibility to express Normal Behaviour Care, housing factors, handling, health care Impact on: 1. Hunger and Thirst 2. Discomfort 3. Pain, Injury or Disease 4. Normal Behavior 5. Fear and Distress Respect for nature Genetic modulation of animals Intrinsic value and animal rights Quality harms Scientific Quality Aim, Realistic potential Non-publishing of negative results Care-In 29 Animal Welfare harms Harm Impact on: 1. Hunger and Thirst 2. Discomfort 3. Pain, Injury or Disease 4. Normal Behavior 5. Fear and Distress *Brambell, Five Freedoms (1965) Farm Animal Welfare Council **Mellor&Reid, Concepts of animal well-being and predicting the impact of procedures on experimental animals (1994) ** There ** There is a danger is a danger that with that focus with largely focus largely on suffering on suffering we could we overlook a broader could view of overlook welfare a which broader may view be more of welfare informative which may and safeguard be more more effectively informative the interests and safeguard of the experimental more effectively animals the interests of the experimental animals Care-In 30 8

9 Refinement Refinement To be refined To be refined NHP 32 F3 generation Limited control Statistically justified Well Trained for purpose Sentient species social animals individually housed for a period of time provided with a very good enrichment program, with access to open areas and human contact Individual housing Care-In 31 Sentience, cognitive ability, phylogenetic scale, adaption to the laboratory conditions, rarity and societal concern. NHP 32 F3 generation Limited control Statistically justified Well Trained for purpose Sentient species Total number of animals (by species) to be used in the project Origin (source) of animals and acclimatization period Clinical/subclinical condition, which could cause harm to animals. Experimental and spontaneous genetic mutants that have adverse phenotypes should be considered Individual housing EMBO Practical Course on Mouse Genome Engineering

10 Tittel og navn på foreleser Navn på institusjon Benefit Promised Benefits Actual Benefits Quality Benefits Secondary benefits Benefits for humans Benefits for animals Benefits for environment Health interests Economic interests Primary/direct Safety interests Educational interest Knowledge interests Scientific Quality Aim, Realistic potential Non-publishing of negative results Care-In 34 10

11 Key questions to assess benefits? Care-In 35 x x X WHY is the study important? Although this cannot be defined with certainty an estimation of the importance of the outcome of the study should be made. This can be framed in terms of immediate and short-term benefits as well as the anticipated impact of the outcome for subsequent studies and long-term benefits. Why: Unmet medical need How/what: New drug Zebrafish model HOW will the objectives be met? and WHAT will the objectives be? The degree to which a sound hypothesis and clear objectives are elucidated can support the driving purpose of the study and ensure that the study outcome has value/benefit. WHO will the study benefit? and WHEN will the benefit be realized? An assessment of how feasible the study is and how quickly the results can be expected to be applied to the benefit domain. EMBO Practical Course on Mouse Genome Engineering

12 Harm-Benefit Analysis in a nutshell What are you going to do? What is the impact on the animals? (harm) Why are you going to do it? What do you want to achieve? (benefits) Care-In 37 Summary HBA as a transparent systematic method to gather information about harm to animals and expected benefit of experiments so that qualified decision of approval or rejection of projects can be made HBA identifies harm and stimulate researchers to seek alternative approaches HBA question and clarifies if harm is necessary for achieving certain benefits HBA is a way to assure that animals are only used when it is justified because of potential benefit HBA is important for transparency and public relations HBA is important to limit uncritical use of animals even for the cause of the good HBA provides an ethical framework and is an essential part of the ethical review HBA is based on utilitarian consequence ethics the proper course of an action is the one that maximizes utility HBA stimulates ethical reflection and discussion HBA is dependent on and limited to the current context (external factors) i.e. it has an expire date HBA is influenced by subjective opinions ( affective heuristics ) Care-In 38 12