32. ETHICAL REQUIREMENTS FOR MEDICAL RESEARCH Flashcards
1
Q
- What are the 5 Key Ethical issue that is associated with Medical Research?
A
- Scientific Merit
- Consent
- Confidentiality
- Vulnerable Groups
- Assessment of Risks vs Benefits
2
Q
- What is Scientific Merit?
A
- this is the scientific grounding
- it justifies the Research Study
3
Q
- What questions should we ask ourselves to determine if a Research Study has Scientific Merit?
A
- Is the research question important?
- Is the research based on a thorough knowledge of the
literature? - Is the methodology appropriate?
- Will the results be of benefit to the participants?
- Will the results be of benefit to others in the future?
4
Q
- On what grounds should Medical Research that involves Human Subjects be justifiable on?
A
- scientific grounds
- we always need to be able to justify why the study is
happening
5
Q
- What factors go against Scientific Integrity and Justification?
A
- HUMAN INVOLVEMENT
- a lack of respect for human dignity and autonomy
- THE SUBJECT’S EXPOSURE TO RISK
- for no good reason - THE EXPENDITURE OF RESOURCES
- MISLEADING RESULTS FROM THE RESEARCH
- DOUBTFUL SOCIAL VALUES
6
Q
- What is extremely necessary to obtain before Medical Research is conducted?
A
- informed consent
7
Q
- What are the 3 Key Ethical Issues regarding Consent?
A
- Valid Consent
- Process of Obtaining Consent
- Researchers must ensure that the information is
provided in a way that participants can understand
8
Q
- What is meant by: “Valid Consent”?
A
THE PATIENT:
- has the capacity to make these decisions
- is given sufficient information
- is involved in the research voluntarily
- is continuously giving consent throughout the research
study
9
Q
- What is meant by the: “Process of Obtaining Consent”?
A
- THE PATIENT
- signs a consent form - AN ORAL EXPLANATION IS GIVEN
- about the project
- this explains what the participation will involve - THE PATIENT NEEDS TO BE INFORMED
- that they are free to withdraw their consent to
participate at any time
- this happens without any consequences or
compromise for their health care
10
Q
- What are the main aspects that researchers need to abide by when it comes to Confidentiality?
A
- Research subjects are entitled to Confidentiality
- Using data from patient records in Research
- Communicating the Research Results
11
Q
- What is meant by: “Research subjects are entitled to Confidentiality”?
A
RESEARCH SUBJECTS:
- have the right to privacy
- this is with regards to their personal health
information
- they have the right to choose who they want to have
access to their confidential information
12
Q
- What is meant by: “Using data from patient records in Research” ?
A
- some data may be medically important
- there can be absolutely no identifying of the
participant - EG: facial photos, names, etc.
- clinical case histories are unique
- even if the demographics are removed
13
Q
- What is meant by: “Communicating the Research Results”?
A
- the data is made to be anonymised
- there has to be consent maintained for research uses
- such as conferences, publications, books, etc.
- this consent must be obtained from the participant in
advance - this consent should be explicit
14
Q
- What are Vulnerable Groups?
A
- these are patients that may have terminal illnesses
- they are patients that can lack capacity
- they are disadvantaged
15
Q
- What can often go wrong with these Vulnerable Groups?
A
- They can confuse research for therapy
- They believe that the research is the only gateway to
some type of medical care - They feel that these have a sense of duty or
expression of gratefulness to the doctor
- this can add bias to the results
- this is especially true in Paternalistic cases - They feel fearful to leave the research study
- they fear that the care they are receiving will be
withdrawn by the doctor
- they fear that the care they are receiving will be
