CONFIDENTIALITY. INFORMED CONSENT IN BIOETHICS Yulia Peeva, PhD, Chief Assistant Professor

1. CONFIDENTIALITY. INFORMED CONSENT IN BIOETHICS Yulia Peeva, PhD, Chief Assistant Professor Department of Public Health Faculty of Public Health Medical University - Plovdiv

2. CONFIDENTIALITY  Definition  Levels  Exceptions INFORMED CONSENT  Concept and Importance  Historical Background  Elements of Informed Consent  Informed Consent Form PRESENTATION GOALS

3. WHAT DOES THE DUTY OF CONFIDENTIALITY REQUIRE? Confidentiality is one of the core and fundamental tenets at medical practice. It requires health care providers to maintain a patient’s personal health information privateunless consent to release the information is provided by the patient. It was established in Hippocratic Oath (5th BC). Confidentiality provides a foundation for trust in the physician-patient relationship. Physicians are obliged to keep all of the information about their patients confidential.

4. THE CORE OF THE CONFIDENTIALITY IS BASED ON: • Respect the patient privacy – the patient expect doctors to maintain confidentiality • Confidentiality promotes trust in physician-patient relationship • Confidentiality heartens patients to seek medical attention • Confidentiality encourages patients to share information that can be important for the decision on the treatment • Prevention of harmful consequences to patients – discrimination based on ill health

5. WHAT INFORMATION IS CONFIDENTIAL? All identifiable patient information, whether written, computerised, visually or audio recorded is subject to the duty of confidentiality. It covers:  any clinical information about an individual’s diagnosis or treatment  a picture, photograph, video, audiotape or other images  who the patient’s doctor is and what clinics patients attend and when shared medical information at conferences  all facts that have been found out during the consultation and investigations  all the information about the patient that the physician has learned while practicing his profession

6. WHAT DOES THE DUTY OF CONFIDENTIALITY REQUIRE? THE COMPUTER IN OUR DAILY WORK. Electronic medical records can pose new and unique challenges to confidentiality. In accordance with the Health Information Portability and Accountability Act of 1997 (HIPAA),institutions are required to have policies to protect the privacy of patients’ electronic information, including procedures for computer access and security.

7. VIOLATION OF CONFIDENTIALITY. LEVELS Unauthorised release of confidential information, disclosure of confidential information Levels of breaching confidentiality: 0 – no breach of confidentiality: between the members of the medical team or required by law 1 – trivial breach of confidentiality: the information is shared to third person without names 2 – significant breach of confidentiality: medical information is discussed with non-medical person and identifies the patient; damages to the patients could follow 3 – severe breach of confidentiality: shared with non-medical; patient is identified and too much compromised in the society

8. WHEN CAN CONFIDENTIALITY BE BREACHED? Overriding concerns can lead to the need to breach confidentiality in certain circumstances. Exception 1: Concern for the safety of other specific persons Examples:  homicidal ideation, when the patient shares a specific plan with a physician;  psychotherapist to harm a particular individual;  the man, just tested positive for HIV…

9. WHEN CAN CONFIDENTIALITY BE BREACHED? • In many countries State Law requires the report of certain communicable/infectious diseases to the public health authorities. That’s why, the duty to protect public health outweighs the duty to maintain a patient's confidence.  • Exception 2: Legal requirements to report certain conditions or circumstances • Examples: • measles, rabies, anthrax, botulism; • sexually transmitted diseases, and tuberculosis; • suspected cases of child, dependent adult, and elder abuse are reportable; • gunshot wounds.

10. WHAT IF A FAMILY MEMBER ASKS HOW THE PATIENT IS DOING? If there is not explicit permission from the patient to share information with family member, it is generally not ethically justifiable to do so. Except in cases where the spouse is at specific risk of harm directly related to the diagnosis, it remains the patient's rather than the physician's, obligation to inform the spouse.

11. CONCEPT OF INFORMED CONSENT  Medical advances should not require some people to sacrifice their health and rights for the good of all. Informed consent is a process which is designed to empower the individual to make a voluntary informed decision regarding participation in the research.  Voluntary consent means that the participants were able to consent, were not being coerced to do the study and understood the risks and benefit involved.

12. INFORMED CONSENT Definition: A patient’s willing acceptance of a medical intervention after adequate disclosure from their MD of the nature of the intervention, risks, benefits and alternative treatment options What constitutes informed consent? Disclosure: information to allow reasonable person to make a decision Understanding: comprehension of the information given Voluntary: no coercion or incentive to accept or deny a treatment Agreement: verbal or written (preferred) to discussed intervention

13. INFORMED CONSENT ˚Informed consent is a key instrument in protecting the right. ˚ Procurement of consent ensures human dignity of the participants and also shows respect for them. ˚ Informed consent is one of the primary ethical principles governing human subject research. ˚ Informed consent assures that prospective research subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.

14. INFORMED CONSENT The fundamental ethical duty of respect for persons requires that we do not act against a person’s wishes, and thus genuine consent to participate in research must be obtained.

15. Informed Consent ˚ Why get informed consent? • Respect for person • Autonomy • Justice

16. INFORMED CONSENT Importance of Informed Consent • Informed Consent is the first and longest of the 10 principles in the Nuremberg code. • Informed Consent is included in every guidelines on Research Ethics. • Informed Consent is one of the 8 requirements for clinical research.

17. INFORMED CONSENT Informed Consent allows individuals:  To determine whether participating in research fits with their values and interests.  To decide whether to contribute to this specific research project.  To protect themselves from risks.  To decide whether they can fulfill the requirements necessary for the research.

18. HISTORICAL BACKGROUND OF INFORMED CONSENT Early References 1891 Prussian Minister of Interior, tuberculin for the treatment of tuberculosis must not be used a person’s will. 1898 Dr. Albert Neisser was fined by the Royal disciplinary court of Prussia for not seeking patient’s consent for his experimental studies of vaccination for Syphilis. 1907 Sir Willium Osler endorsed the necessity of informed consent in medical research. 1931 Health Department regulations of German Reich stated that both human experimentation and the use of novel treatment required consent in a clear and undebatable manner.

19. In 1947, a panel of judges at the Nuremberg Medical Tribunal found 16 individuals guilty of abuses that occurred during the Holocaust under the guise of medical research. The trial included testimony addressing “ethical and legal conventions…for human experimentation.” The discovery of unethical research and the resulting public outcry contributed to the institution of informed consent policies in research. HISTORICAL BACKGROUND OF INFORMED CONSENT

20. HISTORICAL BACKGROUND OF INFORMED CONSENT During the Syphilis Study conducted in Tuskegee, Alabama and sponsored by the U.S. Public Health Service from 1932 until 1972, participants were left untreated for syphilis infections despite the availability of penicillin, so that researchers could observe the natural progression of the disease. One result of the trials was the establishment of the Nuremberg Code (1947), which stresses the necessity of informed consent to research. World war II and unethical clinical trials done by US Health Services gave birth of Bio-ethics. Creation of (Institutional Review Board) IRB and notion of Informed Consent.

21. President F. Roosevelt - Office of Scientific research to combat Dysentery, Influenza, Malaria Use orphan, mentally retarded, psychotic patients Penicillin to prisoners to settle the dose. Thalidomide - Birth defects Amendment to FD and cosmetic acts. 1966 Henry Beecher, NEJM, describes 22 examples done on vulnerable group. 1997:President Clinton apologized HISTORICAL BACKGROUND OF INFORMED CONSENT

22.  The nature of the decision/procedure  Reasonable alternatives to the proposed intervention  The relevant risks, benefits, and uncertainties related to each alternative  Assessment of patient understanding  The acceptance of the intervention by the patient WHAT ARE THE ELEMENT OF INFORMED CONSENT?

23. Competence: A legal term for the capacity to make a rational choice. A physician can make a judgment about an individual's competence. Factors include the following:- ability to comprehend medical information and consequences of decisions ability to one's age- competence is presumed in healthcare decisions at age 18 years. WHAT ARE THE ELEMENT OF INFORMED CONSENT?

24. Amount and accuracy of information:inheritance of condition and patient-specific riskspotential benefits, risks, and limitation of all management optionsavailable alternatives WHAT ARE THE ELEMENT OF INFORMED CONSENT?

25. Patient understanding: this is perhaps the most challenging aspect of informed consent; it is the responsibility of the healthcare provider to identify and attempt to overcome such barriers as the following:fear or denialillnessunder education or reduced cognitive abilitycultural considerationsunscientific beliefs, family mythslanguage barriers WHAT ARE THE ELEMENT OF INFORMED CONSENT?

26. Voluntariness: the patient has to make a personal decision without coercion. He or she cannot simply yield to the suggestion of a family member, healthcare provider, or any other individual.Authorization: the patient should actively agree to a course of action and that decision should be documented. WHAT ARE THE ELEMENT OF INFORMED CONSENT?

27. WHAT IF A FAMILY MEMBER ASKS HOW THE PATIENT IS DOING? If there is not explicit permission from the patient to share information with family member, it is generally not ethically justifiable to do so. Except in cases where the spouse is at specific risk of harm directly related to the diagnosis, it remains the patient's 

28. ELEMENTS OF INFORMED CONSENT FORM  Name of the patient  Name of organization to make the disclosure  Kind and amount of information to be given  Purpose of the disclosure  Statement that consent may be revoked at any time, except as already relied upon and/or criminal justice system consent  Date or condition when consent will terminate  Patient’s signature and date  Or signature of minor’s parent or other authorized to sign in lieu of client when necessary  Signature of staff assisting client with release

29. FORM OF INFORMED CONSENT Tacit consent – expressed by no objection to an intervention • Implied consent – patient indicates by his behavior willingness to undergo a certain procedure or a treatment • Explicit consent – expressed by direct words, orally or in written • Most often the informed consent is in a written form that has to be signed by the patient • Informed consent is valid for usually of 30 days. In case of treatment planned in advance, consent may be valid for 6 monhts.

30. REFERENCES: • Prof. Stoykova, PhD. Lecture course in bioethics, 2013-14 • Prof. Velkova, PhD. Lecture course in bioethics, 2014-15 • 3. Khatun S., MPH, Mphil. Informed consent in bio-medical research. Involving human participants • 4. Wang C. Is this patient competent. 2005. • 5. WMA. Medical ethics Manual. Physicians and patients. • 6. https://depts.washington.edu/bioethx/topics/

31. Thank you for your attention! For more info you can ask me on julipeeva@abv.bg