Guidelines
Belmont Report
Boundaries Between Prctices & Research
Practice: intervention used to enhance the well-being of individuals.
Basic Ethical Priciples
- Respect for Persons
- autonomy assurance
- autonomy protection
- Beneficence
- do not harm
- maximize benefits and minimize harms
- Justice
- equal share
- need-based
- effort-based
- contribution-based
- meried-based
Application
- Informed Consent
- Information
- procedure
- purpose
- risk
- anticipated benefits
- alternatives
- statement of asking and withdrawing at any time
- Comprehension
- Voluntariness
- Assessment of Risks and Benefits
- nature and scope
- systematic assessment
- selection of subjects
Definition
What is Research
Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
What is Human Subject
a living individual about whom a researcher (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
What is private information
Federal Regulations
What research must be reviewed
- research
- human subject
Not Research:
Scholarly and journalistic activities
Public health surveillance activities
Collection and analysis by or for a criminal justice agency for activities authorized by law or court order or criminal investigative purposes
Authorized national activities
Expedited Review or Convened IRB Review
initial approval - no more than minimal risk to subjects - eligible research activities
Who must review
- individuals screen research
- 1+ IRB members
- members of a convened IRB
What quetsions should be address
exempt research
expedited Review
- cannot reject
- no need continuing review
- IRB Review
Additional Review for approved research
criteria
- continuing review
- changes need review and approval
- report unanticipated problem
expedited or IRB
expedited:
- no more than minimal risk and no additional risks
- not subjects enrolled and no additional risks
IRB
An IRB is a review committee established to ensure that the rights and welfare of human research subjects are protected.
Membership
- sensitivity
- knowledge and experience
- conversant
Identifying Risk
categories of risks
- invasion of privacy
- breach of confidentiality
- study procedures
assessing risks
- probability and magnitude of harm
- situation and time
- subject population
both researchers and potential subjects should be involved into the assessing risks.
balancing risks
subjects need to be given sufficient information to make a decision about whether they are willing to accept risks and participate in the research.
minimizing and managing risk
- data protection
- certificates of confidentiality
- consent document