Research Integrity, Big Data and the Ethics of AI

Presidential Apology 1 (1997)

A public apology by Bill Clinton to the victims of the Tuskegee study.

Tuskegee (Syphilis) Study

A clinical study conducted from 1932 to 1972 where black peasants in Alabama were infected with syphilis without their knowledge or consent.

Tuskegee (Syphilis) Study

Scientists withheld penicillin and information about it from the patients, leading to numerous deaths and congenital syphilis cases.

The Tuskegee Bioethics Center

Established in 1999 with a large financial aid to compensate the people of Tuskegee and Macon County.

Apology (2) for Guatemalan Syphilis Experiment

US officials apologized for a 1940s medical experiment in which Guatemalan prisoners were deliberately infected with syphilis.

The syphilis inoculation experiment

Inoculation of prostitutes, prisoners, soldiers, and mental patients without their knowledge or permission.

Evaluating research involving human beings

The challenging task of balancing scientific development and ethical concerns.

Nuremberg war crime trials (WWII) – Nuremberg Code

Nazi biomedical researchers were prosecuted, leading to the development of the Nuremberg Code.

Nuremberg Principles

Emphasize respect for voluntary research participation, informed consent, and the responsibility of investigators for human welfare.

NUREMBERG CODE

The first international guidelines in ethics, highlighting the essential requirement of voluntary consent from human subjects.

The Declaration of Geneva (WMA - 1948)

Pledge by medical professionals to respect human life and not violate human rights and civil liberties.

WMA International Code of Medical Ethics (1949)

Specifies the duties of physicians and their obligation to adhere to local and national codes of ethics.

WMA Declaration of Helsinki (1964)

Fundamental guide for biomedical research involving human subjects, revised multiple times.

What is the purpose of biomedical researches? Research aims to contribute to science, social utility, and the improvement of health and diagnostic procedures.

Biomedical research on humans should conform to generally accepted scientific principles and be conducted by qualified personnel.

What are the responsibilities of the doctor towards patients in biomedical research? Physicians must protect the life, health, dignity, integrity, and confidentiality of research subjects.

Dignity-Integrity-Confidentiality

Ethical principles that physicians should uphold when participating in medical research.

Why do we do biomedical researches? Research is necessary for scientific progress, testing new treatments, and ensuring the safety and efficacy of medical interventions.

Helsinki Declaration

The first code to differentiate between therapeutic and non-therapeutic biomedical research and promote reduced risk to research participants.

Therapeutic research

Involves patients suffering from a specific condition, with the potential for direct medical benefit.

Non-therapeutic research

Conducted solely for the purpose of generating new knowledge, with no expected medical benefit for participants.

The Belmont Report

Provides ethical principles and guidelines for the protection of human subjects in research, prompted by the Tuskegee Syphilis Study.

Respect for persons

Treating individuals with courtesy and respect, obtaining informed consent, and avoiding deception.

Beneficence

Maximizing benefits for research while minimizing risks to participants, following the principle of "Do no harm."

Justice

Ensuring fair selection of research participants and the fair distribution of costs and benefits in research.

Scientific concerns

The distribution of benefits and burdens of research, the selection of research participants, and the prevention of systematic biases.

Informed consent

Obtaining voluntary, informed, and comprehensible consent from research participants after providing them with all relevant information.

Vulnerable populations

Individuals who may be at higher risk of harm or exploitation in research, such as children, prisoners, pregnant women, and mentally impaired individuals.

Institutional Review Board (IRB)

An independent committee responsible for reviewing and approving research involving human subjects to ensure ethical compliance.

Data confidentiality

Protecting the privacy and confidentiality of research participants' data and ensuring it is securely stored and accessed only by authorized individuals.

Data sharing and transparency

The ethical obligation to share research findings and data to promote scientific progress and transparency in the research community.

Conflict of interest

Situations where researchers or institutions have competing interests that may influence the design, conduct, or reporting of research.

Animal research

Ethical considerations and regulations surrounding the use of animals in biomedical research, ensuring their welfare and minimizing harm.

Placebo control

The use of a placebo (inactive substance) in a control group to evaluate the effectiveness of a new treatment or intervention.

Randomized controlled trial (RCT)

A research design that randomly assigns participants to different treatment groups to compare the effects of different interventions.

Data falsification and fabrication

Unethical practices of manipulating or inventing research data, compromising the integrity and validity of research findings.

Data integrity and reproducibility

Ensuring research data is accurate, reliable, and can be reproduced by other researchers for verification.

Ethical review process

The systematic evaluation of research proposals to assess their ethical implications and compliance with ethical guidelines.

Post-trial access

The provision of continued access to the investigational treatment or intervention for participants after the trial has ended.

Research misconduct

Serious violations of ethical standards in research, including plagiarism, data manipulation, and unethical authorship practices.

Cultural considerations

Recognizing and respecting cultural differences when conducting research involving diverse populations, including language, beliefs, and customs.

International research collaborations

Ethical considerations in cross-border research collaborations, including equitable distribution of benefits and capacity-building in low-resource settings.

Data ownership and intellectual property

Addressing issues related to the ownership, control, and use of research data and intellectual property rights.

Ethical implications of emerging technologies

Considering the ethical challenges posed by new technologies such as gene editing, artificial intelligence, and nanotechnology.

Community engagement

Involving and consulting with the affected community in research planning, implementation, and dissemination of findings.

Research with minors

Additional ethical safeguards and considerations when involving children and adolescents as research participants.

Human genome research

Ethical considerations in the study of the human genome, including privacy, informed consent, and potential discrimination.

Long-term safety monitoring

Ethical obligations to monitor and report long-term safety outcomes of interventions even after the research study has ended.

Research on prisoners

Unique ethical considerations and safeguards when conducting research involving incarcerated individuals.

Ethical implications of genetic research

Addressing the ethical challenges related to genetic testing, personalized medicine, and genetic discrimination.