Ethical Considerations in Protocol Development Flashcards
The ethical discomfort in the use of human participants
in a research is alleviated by the assurance that the
researcher is qualified.
The goal of much research is societal benefit; however, in the
interest of securing societal benefits, no individual shall be
intentionally injured.
- Application: Maximize risk:benefit ratio
Monitoring
Beneficence
“An autonomous person is an individual capable of deliberations
about personal goals and of acting under such deliberation. To
respect autonomy is to give weight to the autonomous person’s
considered opinions and choices while refraining from
obstructing his or her actions….” (Belmont Report)
- Application: Voluntary participation
Informed consent
Maintaining confidentiality
Autonomy
Respect for Persons
Obligation to treat people fairly and equitably, without bias
* Application:
* Participant selection
* Equal access to benefits/ equal share of burdens
* Adequate representation of women, children, minorities
* Vulnerable populations
* Fair compensation, avoiding undue inducement
* Managing conflicts of interest
Justice
- Social and clinical value
- Scientific validity
- Fair subject selection
- Favorable risk-benefit ratio
- Independent review
- Informed consent
- Respect for potential and enrolled subjects
Principles to guide research
Researches not automatically exempted
* Investigator is liable - not the
ERB
- Research needs to be justified
Significance of the Study
forms, database and spreadsheets
Deidentify
for everything (be in a database, have pictures
taken, procedures, etc.)
Consent
Protocol
* Sound scientific question based on updated knowledge
* Describe the following IN DETAIL:
* Extent of human involvement (observational,
experimental)
* Duration of human involvement
* Process of obtaining consent, with emphasis on protecting
the vulnerable population
* Expected discomfort and risks for participants
* Ways to protect participants’ identity and confidentiality
Responsibilities of the Investigators
What the IRB/ERB will look for?
- Technical soundness (objectives, inclusion/exclusion/withdrawal,
sampling, methodology and design, data analysis) - Ethical
permission granted in the knowledge of the possible consequences,
typically that which is given by a participant to be included in a study
with full knowledge of the possible risks and (including the lack of
direct) benefits.
Informed Consent
document detailing the rights and responsibilities of
_______ in a procedure/study
participants
- Process: begins before consent is given and continues until the end of
involvement
Parts of the Informed Consent
- Introduction of investigator, funder
- Statement that the invitation is for research
- Statement of objectives
- Details of the study
- No. of participants
- Methodology
- Responsibilities of participants
- Duration of participation
- Benefits (direct, indirect, community)
- Risks and protection
- Withdrawal criteria
- Contact information
All research conducted in academic institutions by
students/trainees, including postdoctoral fellows,
should be under the ______ and _____ of a
senior researcher or faculty adviser.
supervision and guidance
Other Considerations
Written informed consent
* Maintain confidentiality
Budget and timeline: Patient remuneration and allowances
* Good research/clinical practice training
* Ethics review and approval by IRB
* Registration in trial registry
Coding data, storage of data collection forms in locked cabinet or
password-protected devices, data encryption, limiting access to
study files, data destruction
Maintain confidentiality
In Summary
- First, do no harm
- Second, don’t waste your and participants’ time
- Make sure participants decide AFTER being informed
