Informed Consent in Research

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the primary goal of the Health Insurance Portability and Accountability Act (HIPAA)?

To ensure that all clinical trials are conducted with a minimum of 100 participants.

To establish a national registry for clinical trials.

To provide funding for clinical trials in the field of medicine.

To protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. (correct)

When might you stop a clinical trial due to safety concerns?

If the risk to patients outweighs the benefits. (correct)

If the trial is not funded by a reputable organization.

If the benefits of the treatment outweigh the risks.

If the trial is not conducted in a hospital setting.

What is an essential document to submit when applying for ethics committee approval?

Consent form

Questionnaire

Interview topic guide

All of the above (correct)

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. Signup and view all the answers

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. Signup and view all the answers

When is consent not needed in a research project?

When the ethics committee waives it after a justified request Signup and view all the answers

What is the main reason for waiving consent in qualitative observational studies?

It's not possible to get consent from every person Signup and view all the answers

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. Signup and view all the answers

What is related to the principle of respect in research ethics?

Privacy, confidentiality, and anonymity Signup and view all the answers

What is the researcher's responsibility regarding participant information?

To keep it confidential Signup and view all the answers

What is the participant's right in regards to their information?

The right to control when and with whom their information is shared Signup and view all the answers

Who decides whether consent can be waived in a research project?

The ethics committee Signup and view all the answers

What is the primary purpose of de-identifying data in research?

To ensure participant anonymity Signup and view all the answers

What is the primary principle related to the selection of participants in research?

Justice Signup and view all the answers

What is the primary role of an Institutional Review Board (IRB) in research?

To review research ethics protocols and apply ethical principles Signup and view all the answers

What is the primary purpose of a participant information sheet in research?

To obtain informed consent from participants Signup and view all the answers

What is the primary principle related to minimizing harm in research?

Non-maleficence Signup and view all the answers

What is the primary benefit of conducting a risk-benefit analysis in research?

To maximize benefits to participants and society Signup and view all the answers

What is the primary principle related to obtaining informed consent from participants?

Autonomy Signup and view all the answers

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 Signup and view all the answers

Study Notes

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

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

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.