8 - ethics

1. Modern medical practice is evidence-based (based on research)

2. Research provides intellectual stimulation and access to new evidence, leading to better practice of medical practice

3. It provides the knowledge of terminology and techniques needed to understand textbooks and research papers.

Why is it important for a medical practitioner to study and engage in research?

true

Modern research ethics developed in response to serious violations during World War II, including non-consensual experiments on prisoners by the Germans and the Japanese

✅❌

true

Following the trials of Nazi doctors in Nuremberg, a set of principles for human research was established, known as the Nuremberg Code. ✅❌

true

One of the most important principles of the Nuremberg Code is the requirement of informed and voluntary consent. ✅❌

Summarize the 10 Principles of the Nuremberg Code ?

The Helsinki Declaration (and its subsequent amendments).

In which declaration were the principles of Nuremberg updated in 1964?

Good Clinical Practice (GCP) guidelines.

What did the International Conference on Harmonization publish in 1996?

Clinical researchers worldwide.

Who follows the Good Clinical Practice (GCP) guidelines?

• Basis: Based on the Helsinki declaration.

• Objectives:

  • 1. Protect the subject/patient.

  • 2. Ensure credible and accurate data.

What is the basis of the GCP guidelines and what are its two main objectives?

1. Informed consent.

2. Independent review and approval of the research protocol

What are the methods used to ensure patient/subject protection in research?

1. Full disclosure of study details for an informed decision.

2. Participation must be voluntary and free.

3. provided Information must be written and approved by review governance.

4. Participants must be given time to ask questions.

5. The form must be signed, dated, and witnessed.

6. The participant must receive a copy of the form

What are the requirements for Informed Consent in research?

1. Purpose, research nature of procedures/treatments, and duration.

2. Expected benefits, risks/inconveniences, and alternative treatments.

3. Freedom to withdraw without reason, confidentiality, and compensation for injury.

4. number of subjects, and contact person for questions/injury.

5. Permission for direct access to his/her records.

What information must be included in a research Informed Consent form?

• In the emergency room

when the patient is incapable of giving consent

and the research is necessary for improving service delivery.

What is one situation where consent can be waived in research?

may bias the respondent.

Why might seeking consent be problematic in some psychological research?

It examines the situation very carefully before approving research

What does review governance do before approving research without consent?

What is a clinical trial?

1. Benefit vs. risk

2. patient safety

3. confidentiality.

What are the ethical considerations in clinical trials?

True

Approval of a study should be based on a careful consideration of the benefits and risks. ✅❌

True

Participants in a study may benefit from a new treatment, especially if traditional treatments have failed. ✅❌

False, Some participants (the control group) may receive no direct benefit, in these cases, the study’s benefit to the community must be considered.

All participants, including those in the control group, are expected to receive equal direct benefits from the study. ✅❌

The benefits of the study, whether individual or public, have to be considered against the risk that the study subject faces.

يجب موازنة فوائد الدراسة، سواء كانت فردية أو عامة، مع المخاطر التي يتعرض لها المشارك.

How should study benefits be evaluated against risks?

False, Studies aim to minimize risks, but not all risks can be predicted in advance, so safety monitoring systems are required.

All potential risks in research can be fully predicted beforehand, eliminating the need for ongoing safety monitoring.✅❌

1. Monitoring

2. reporting adverse events.

What is required to ensure patient safety during a study?

1. Must be defined in the protocol

2. Reported

How are potential adverse events handled in a study?

True

Serious adverse events have to be reported to the review governance body and the study sponsor.✅❌

• Death and life-threatening conditions are reported within 7 days

• others are reported within 15 days

What is the reporting timeline for death and life-threatening conditions?

True

Investigations may lead to suspending or stopping the study. ✅❌

False, Study data should not be disclosed to any third parties. (اطراف ثالثة)

Study data may be shared with third parties if they are indirectly involved in the research process.✅❌

False, Data should be disclosed only on a need-to-know basis.

Study data can be freely accessed by all research team members regardless of their role.✅❌

True

Study documents should be locked or stored on password-protected computers. ✅❌

True

The sponsor has no right to access patient notes; only anonymized data can be submitted. ✅❌

Who is involved in research?

1. Comply (الالتزام) with study procedures

2. report any adverse events promptly.

What are the main responsibilities of the subject?

What are the main responsibilities of the investigator?

What are the main responsibilities of review governance?

◦ Provide the investigational product.

◦ Funding of the study.

◦Follow-up and monitoring.

What are the main responsibilities of the sponsor?

1. Research protocol: The main document in research and a comprehensive and detailed guide to conducting the research.

2. case report form (CRF).

What are the research documents?

What must the research protocol contain?

constructed in such a way that captures data correctly.

What is required in constructing the Case Report Form (CRF)?

True

Special precautions are needed to ensure the security of electronic CRFs. ✅❌

Research is a secondary role and should never be allowed to interfere with care and/or safety because The primary role of HCP is to treat patients.

What is the role of research for HCP?

When the sponsor of the study

influences reported outcomes

to make them favorable to the new investigational product through

1. financial rewards

2. promotions

3. publications.

What is conflict of interest in clinical research?

1. By following conflict of interest guidelines

2. providing full disclosure

How can conflict of interest be avoided?

1. Submitting positive findings for publication and suppressing negative ones

2. authorship & plagiarism.

What are unethical actions in research publication?

1. Medicine is inherently experimental.

2. Monitor and evaluate current treatments to determine whether they are effective for specific patients.

3. Seek a better understanding of human physiology, and disease pathophysiology.

What is the importance of medical research?

True

Before a new drug can be approved by regulatory authorities, it must undergo extensive testing for safety and efficacy. ✅❌

What is the process of introducing a new drug?

What are the phases of clinical research to introduce a new drug ?