ethics and integrity Flashcards
history ethics: Nürnberg code
- Nürnberg code 1947
- reaction on medical experiments during WW2
- 10 ethical principles:
1. participation is voluntary
2. leads to information that is of value for society
3. no unnecessary damage (physical/mental)
4. informed consent
5. always allowed to stop
history ethics: declaration of Helsinki
- declaration of Helsinki 1964 (current 2013 version)
- by World Medical Association (medical research)
- most important issues:
1. patient interest is primary concern
2. participation is voluntary & informed consent is necessary
3. design of study needs to be adequate
4. results need to be published (at least knowledge you gain should be available to other people in the world)
laws
- different laws in different countries based on Helsinki declaration
- about medical experiments on humans
- in the Netherlands: WMO
- one governmental body oversees this: CCMO
- CCMO has delegated part of its responsibilities to local Medical Ethical Committees (METc)
- experiments have to be reviewed by Medical/ Ethical commitees
- in more complicated cases: reviewed by the central body itself
When is something a medical experiment?
according to Dutch law:
- which is medical-scientific in nature AND
- in which participants are subjected to tests that threaten their integrity and/or are imposed to behave in a certain way
= all RCTs with patients aimed at improving health
What does this mean for your study?
- principal investigator: BROK (certification on laws and ethics)
- RCT proposal needs to be approved before the first patients (by Medical Ethical review board)
- might take a long time (6 months) to be approved
- it might mean that certain designs are not possible:
1. to withhold patients from treatment
2. not to create waitlist for treatment
3. to include suicidal patients
4. informed consent needs to be written on paper (not online)
what does the METc require?
- numerous documents:
1. research protocol (SPIRIT based)
2. patient information (informed consent, information folder, advertisement)
3. medical device forms
4. risk classification (and insurance)
5. data safety monitoring board
6. contract with grant body
7. CV independent doctor
8. CV of the principal investigator - ABR form (general review and registration form)
medical device
- instrument used for health including internet programs/ apps
- 3 different laws
- CE marking = fulfills requirements of safety (EU)
- for both: investigational medical device dossier (IMDD)
IMDD
- includes items about the manufacturer:
- providing permission to use and information on safety
- manufacturer reports study to inspectorate
risk classification
- small/ moderate/ large chance to cause slight/ moderate/ severe damage
- -> negligible/ moderate/ high risk
- insurance needed unless negligible risk (patient insurance and you have to provide information to the patient about that)
- high risk: data and safety monitoring board required: meeting on a regular basis and see how you handle patients and data, otherwise optional
METc
- do not start before approval
- report (within expected limits)
- serious adverse events
- suspected unexpected serious adverse reaction
- serious adverse device effect
(also when not related to your study, cause if it happens in multiple patients, it might actually be related)
- if anything changes in protocol
- general report to METC: every year –> &at the end
integrity
- your own behavior as a researcher
- umbrella organization of universities in the Netherlands: code: principles that researchers need to follow
code: honesty and scrupulousness
- honest and fortright
- perform scrupulously
- unaffected by the pressure to achieve
code: reliability
- support and strenghten the fundamental reliability of science
code: verifiability
- information is verifiable
2. it is made clear what the data and conclusions are based on
code: impartiality
- practitioners are led by no other interest than academic interest
code: independence
- academic freedom and independence (not organization who developed a treatment…)
code: responsibility
- responsibility for the societal implications of their work
what can go wrong?
rare: 1. fraud 2. plagiarism more normal: 1. authorship 2. p-hacking/ selective outcome reporting 3. making mistakes, being sloppy
what can go wrong? authorships
rules for being a co-author
confirmation bias
looking for data that confirms hypothesis, e.g., scale of graph in a specific way
bias in RCT
RCT is done to prevent bias
- but design carefully
- still many opportunities for bias:
1. confirmation bias
2. researcher allegiance
researcher allegiance
researchers in favor for a treatment/ developed it themselves find higher effects than in replication studies that don’t have a tie to the treatment
what does that mean for your research?
- work according to integrity principles
- use SPIRIT/CONSORT
- take BROK exam
- publish protocol
- discuss authorship early
- when you suspect integrity issues: VU integrity officers
