20 Questions
What is the primary goal of the Health Insurance Portability and Accountability Act (HIPAA)?
To protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.
When might you stop a clinical trial due to safety concerns?
If the risk to patients outweighs the benefits.
What is an essential document to submit when applying for ethics committee approval?
All of the above
Why is it important to submit an application to an ethics committee in advance?
Because ethics committees often have set dates to meet and decisions can take at least 4 weeks.
What might be a reason to stop a clinical trial due to benefit?
If the benefit is proven early for those in the inferior group.
When is consent not needed in a research project?
When the ethics committee waives it after a justified request
What is the main reason for waiving consent in qualitative observational studies?
It's not possible to get consent from every person
What is an example of a scenario where a clinical trial might be stopped due to futility?
If the trial realizes early that it is unable to prove the hypothesis.
What is related to the principle of respect in research ethics?
Privacy, confidentiality, and anonymity
What is the researcher's responsibility regarding participant information?
To keep it confidential
What is the participant's right in regards to their information?
The right to control when and with whom their information is shared
Who decides whether consent can be waived in a research project?
The ethics committee
What is the primary purpose of de-identifying data in research?
To ensure participant anonymity
What is the primary principle related to the selection of participants in research?
Justice
What is the primary role of an Institutional Review Board (IRB) in research?
To review research ethics protocols and apply ethical principles
What is the primary purpose of a participant information sheet in research?
To obtain informed consent from participants
What is the primary principle related to minimizing harm in research?
Non-maleficence
What is the primary benefit of conducting a risk-benefit analysis in research?
To maximize benefits to participants and society
What is the primary principle related to obtaining informed consent from participants?
Autonomy
What is the primary consequence of not obtaining ethical approval from an IRB before starting a research study?
The researcher may be liable for any harm caused
Study Notes
Informed Consent
- Most participants provide verbal or written consent
- Consent may be waived by the ethics committee, but only with a good reason
- Good reasons for waiving consent include qualitative observational studies where it's not possible to get consent from every person, or minimal risk studies such as reviewing records
- Even if consent is waived, participants should still be provided with information about the study
Privacy, Confidentiality, and Anonymity
- Related to the principle of respect
- Privacy is the ability to control one's own information and decide when and with whom it is shared
- Participant must agree to share information, which is related to consent
- Confidentiality is protecting personal information
- Institutional ethics and hospital ethics committees determine who has access to collected data
Submitting an Application for Ethical Approval
- Read the information carefully
- Use an application form if provided
- Provide supporting documents such as questionnaires, interview topic guides, and consent forms
- Ensure submission is done in advance, as ethics committees often have set dates to meet and decisions can take at least 4 weeks
- Be prepared to provide further information
HIPAA
- Health Insurance Portability and Accountability Act
- Federal law in the US
- Protects sensitive patient health information from being disclosed without patient's consent or knowledge
Ethical Issues in Clinical Trials
- A clinical trial may be stopped if:
- Safety: risk to patients outweighs benefits
- Benefit: benefit proven early, and it's ethical to continue for those in the inferior group
- Futility: realizing early that you are unable to prove the hypothesis
Scenarios in Health Research Ethics
- Data security measures should be implemented
- Anonymity is achieved by not collecting identifying information, de-identifying data, or using codes or pseudonyms for participants
Risks and Benefits of Research
- Related to beneficence and non-maleficence (do no harm)
- Weigh the risks against the benefits
- Benefits apply to all participants and the wider society
- Risks include physical, mental/emotional, social, financial, and reputational harm
- Minimize risk as much as possible
Selection of Participants
- Related to justice
- Be fair in choosing participants
- Don't cherry pick or discriminate based on gender, race, ethnicity, or socio-economic status
Role of IRB
- Institutional Review Board (IRB) or Ethics Review Committee or Research Ethics Committee
- Reviews research ethics protocols and applies ethical principles for research
- Research protocol must be submitted to a research ethics committee for approval before starting any study
- Some studies can be exempt from formal ethical approval, but this decision is made by the ethics committee, not the researcher
- Ethical approval cannot be obtained retrospectively
Participant Information Sheet and Obtaining Ethical Approval
- Ethics committees may have information on their website or require a phone call
- May need to obtain ethical approval from multiple ethics committees
This quiz covers the basics of informed consent in research, including when it's necessary, when it can be waived, and the role of the ethics committee.
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