Belmont Research

Belmont Research

1. Ethical Principles & Guidelines for Research Involving Human Subjects

   • Principles Relevant to Research
     • Provides analytical framework, can not always apply to every situation
     • Part A: Boundaries Between Practice and Research
       • Distinction between biomedical and behavioral research is important (in order to know activities to use to protect subjects) Research and Practice are usually seen as the same due to blurred definitions or environment where both are doing together If any research is involved within a setting/therapy, the activity should go under review to protect human subjects
       • Practice
         • Enhance well-being of individual, reasonable expectation for success 
       • Research
         • Activity designed to test hypothesis Contribute to generalized scientific knowledge Set of protocol / rules to follow for set of procedures
     • Part B: Basic Ethical Principles
       • Ethical prescriptions and evaluations of human subjects 
       • 1. Respect for Persons
         • Individuals Treated as Autonomous Agents
           • Capable of deliberation about personal goals acting upon those goals Choices are to be given Lack of respect of person's autonomy infringed upon their judgments , denying their freedom
         • Persons with Diminished Autonomy are Entitled to Protection
           • Not every human is capable of self-determination May lose capacity due to illness, mental disability, or situations restricting liberty Respect for them may require protecting them as they mature Protecting them must be depended upon risk of harm and likelihood of benefit Autonomy must be reviewed periodically
       • 2. Beneficence
         • Securing well being Is an obligation to patient Extend to particular research projects/ entire enterprise of research
         • Do not Harm
           • Do not harm one person regardless of benefits of other persons' However, avoiding harm requires understanding what is harmful Hippocratic Oath: Benefit their patients "according to their best judgement" 
         • Maximize Possible Benefits/ Minimize Harm
           • Could help treat childhood disease Conflict of difficult choices
       • 3. Justice
         • Injustice: When someone is denied without good reason Equals should be treated equally
         • Formula's for Treating People Equally
           • 1. Each person has equal share 2. Individual need 3. According to individual effort 4. Societal contribution 5. To merit
     • Part C: Applications
       • General principles to the conduct of research
       • 1. Informed Consent
         • Opportunity to choose what shall/shall not happen Agreement 
         • Information
           • Disclosure to give subjects sufficient information Research procedure, purposes, risks, benefits, opportunity to withdraw Make decision regarding your care Can impair validity of test, Incomplete disclosure is therefore needed as long as no risks are presented, and there is a plan for debriefing 
         • Comprehension
           • Manner and context of information Involvement should be honored
         • Voluntarism
           • Agreement that constitutes voluntarily given participation Free of coercion (threat to do harm)
       • 2. Assessment of Risks and Benefits
         • Review Committee Are risks justified?
         • Nature and Scope of Risks/Benefits
           • Risk: May cause harm Benefit: Something of positive value to health or welfare -Balanced, shown in a favorable ratio Risk should be clarified
       • 3. Selection of Subjects
         • Justice gives rise to moral requirements that will be fair procedures and outcomes in the selection of research subjects
         • Social Justice
           • Requires distinction between classes of subjects that participate in any kind of research Some persons should bear burdens before others such as older people, and prisoners
         • Individual Justice
           • Should not offer potentially beneficial research to only "undesirable" persons for risky research