Human Subjects Research Flashcards
OHRP
Office for human research protections
Under HHS umbrella
Establishes and registers IRBs
Issues the FWA - required to participate in clinical trials
3 parts to the Belmont Report
Respect for person
- acknowledge autonomy (a choice)
- protect those w diminished autonomy (e.g. vulnerable pops)
Beneficence
- do no harm
- maximize benefits, minimize harms
Justice
8 IRB exceptions
- Education settings
- Tests, surveys, interviews or observation
- Demonstration projects
- Taste and food quality
- Benign behavioral interventions
- Secondary research on data or specimens
- Secondary research use of data or specimens
- Storage/maintenance of data/specimens
Full Board IRB Review
Research involves greater than minimal risk
Involves vulnerable pops
Must be reviewed by IRB w quantum, and vote needs majority
Can approve, contingently approve w modifications, table, table w modifications or disapprove
Informed Consent Form (ICF) 8 req components
- explanation of procedures
- Description of risks
- Description of expected benefits
- Alternatives to participation (other studies)
- Explanation of confidentiality
- Who to contact w ???s
- Explanation that participation is voluntary and participant can withdrawal
8 criteria for IRB approval
- risk to subjects minimal
- Risk reasonable relative to benefits
- Selection of subjects is equitable
- Informed consent obtained
- Informed consent documented
- Adequate steps in place for monitoring collected data for safety of subjects
- adequate steps for protecting subject privacy and confidentiality of data
- if vulnerable pops, additional protections in place
9 expedited IRB review categories
- drug and device study
- blood samples
- noninvasive biological specimens
- noninvasive procedures
- data, docs, records, specimens
- voice, video, image, digital recordings
- behavioral/social science research
- long term followup. No subjects enrolled. Data analysis
- determined minimal risk by convenes IRB
IRB definition of research
Systematic investigation designed to develop/contribute to generalizable knowledge
Expedited IRB Review key characteristics
- does NOT mean “review faster”
- must be reviewed by a Board member
- must be minimal risk to subject
- must not involve vulnerable pops
- must fit within one of nine expedited categories
Federal-wide Assurance (FWA)
- submitted to OHRP by all NFEs that do federally funded HS research
- must be renewed every 5 years
- states that NFE will comply w all regs set forth in common rule
- ensures protection of HS
- reviews, disapproves, or requires modifications to submitted protocols
- ensures researcher compliance w OHRP and submit FWA
Institutional Review Board
IRB def of human subject
- living individual about whom an investigator conducting research obtains data from
- intervention/interaction w individual, identifiable private info, or identifiable bio specimens
- response to Nazi WWII prisoner experiments
- 3 major components
1) obtain consent / voluntary participation (can stop at anytime)
2) researchers are qualified and responsible to stop if injury, disability or death
3) research is bit not random, it’s necessary
Nuremberg Code (1947)
Declaration of Helsinki (1964)
- covers biomedical research, medical research, clinical research (treatment) but NOT social/behavioral
- builds on Nuremberg Code
Informed Consent
- Direct result of Belmont Report
- Disclose procedures, purpose(s), risks, benefits, alt. methods, compensation
- Allow participant to ask questions and withdraw at any time
- 8th grade reading level
- Assessment of risks and benefits
- Selection of subjects
National Research Act (1974)
- created national commission for the protection of human subs of biomedical and behavioral research
- requires establishment of a board “institutional review board” to review biomedical and behavioral research involving human subs
Institutional Review Board (IRB)
- ensures protection of human subs rights on the govt and the entity
- reviews and approves/disapproves/requires modification of protocols
- ensures researcher compliance w regulations and follows through on the federal wide assurance
IRB Membership
Each IRB should have at least 5 voting members
- at least one scientist
- at least one non-scientist
- at least one health care professional
- at least one community member who has no employment or contractual relationships w the entity
Nuremberg Code (1947)
1st international standard for protection of human subjects, in response to Nazi war experiments on human beings, specifically Dr. Josef Mengele.
10 Ethical Principles
Introduces concept of informed consent
Provides framework for performing experiments (participant can leave study, doctor must stop experiment if can harm patient, risks must not outweigh benefits.)
Neuremberg Code - 10 Ethical Principles
- voluntary consent
- good of society
- prior animal testing
- avoid unnecessary suffering
- no research should move forward where serious injury and/or death are potential outcomes
- degree of risk cannot exceed benefits
- proper environment and protection for participants is necessary
- conducted by scientifically qualified persons
- human subs must be allowed to discontinue
- scientists must be prepared to terminate if there is cause to believe continuing might be harmful
Guided by Belmont Report —> Common Rule
Authorized by fed regulations, overseen by OHRP
Main purpose is to ensure following are true relating to studies w human subs:
1) risks are minimized and reasonable related to benefit
2) informed consent or waiver of consent occurs
3) rights and welfare of subjects are maintained
IRB
Widely regarded as the gold standard for evaluating health care technologies because it allows us to be confident that a difference j. Outcome can be directly attributed to a difference in the treatments and not due to some other factor
randomized controlled trial
Nuremberg Code 3 focal points
1) subjects: voluntary consent, right to stop at any time
2) researchers: qualified, responsible to stop if suspect danger
3) research: must be necessary, avoid all unnecessary suffering, risks shouldn’t outweigh importance
International Conference Harmonization - Good Clinical Practice (ICH-GCP)
3 goals
3 goals -
1) protect rights, safety and welfare of humans participating in research
2) assure quality, reliability, integrity of data collected
3) provide standards and guidelines for conduct of clinical trials
National Research Act (NRA) 1974
- informed by Stanford Prison Experiment and Tuskegee Syphilis Study
- created the Natl Commission for the Protection of Human Subs of Biomedical and Behavioral Reseach
- requires each entity to establish an Institutional Review Board (IRB)
