1. INFORMED CONSENT

2. RESEARCH ETHICS Research Ethics Timeline The Nazi atrocities of World War II: research on Jews in concentration camps led to the creation of Nuremberg Code in 1949: The voluntary consent of the human subject is absolutely essential. This was significant because it was the first international document that advocated voluntary participation and informed consent

3. RESEARCH ETHICS Research Ethics Timeline As part of a research project conducted by the U.S. Public Health Service, 600 low- income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, participants were not told about their disease. Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. In some cases, when participants were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many participants died of syphilis during the study. The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment.

4. RESEARCH ETHICS Respect for persons (be respectful) : Autonomy - Choice, Obtaining informed consent. Ensure that potential participants understand the elements of informed consent Minimize the possibility of coercion and undue influence; The protection of vulnerable populations; obtain assent; honor dissent of cognitively impaired Privacy and Confidentiality – Identify participants without violating privacy and ensure confidentiality of the information/data obtained Beneficence (be nice) : Minimize risk/maximize benefits; ensure that the potential benefits outweigh the risks. Ensure that the rights/welfare of the subject prevail over the need for science Justice (be fair) : Distribute burdens and benefits of research equally Recruit participants fairly without discrimination or bias Belmont Principles (1979)

5. What is an informed consent?  Informed Consent is a voluntary agreement to participate in research.  The ethical basis of the use of informed consent were established with The Belmont Report (http://ohsr.od.nih.gov/guidelines/belmont.html) and the Nuremberg Code (http://www.cirp.org/library/ethics/nuremberg/) both address voluntary informed consent as a requirement for the ethical conduct of human subjects research.  Informed Consent allows researchers to respect individual autonomy, intended as the capability to deliberate and choose. The principle of autonomy implies that responsibility must be given to the individual to make the decision to participate

6. What is an informed consent? The informed consent is not just a document form……. Current guidelines already recognize the informed consent more as a process an ongoing interaction between researcher and participant

7. What is an informed consent? The process usually starts at initial contact (e.g. recruitment) and should: Provide adequate information generally, what a reasonable person would want to know before making a decision Confirm the participants comprehend the information Assure consent is given voluntarily Assure an adequate feedback to the participants

8. How an informed consent should be structured (1)A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. (2) A description of any reasonably or possible risks or discomforts to the subject. (3) A description of any benefits to the subject or to others which may reasonably be expected from the research. (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

9. How an informed consent should be structured (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. (6) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. (7) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

10. How an informed consent should be structured ADDITIONAL ELEMENTS (1) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. (2) A statement that the researchers commit to inform participants of any new finding related to the project and a description of how these information will be communicated (3) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject. (4) A statement explaining the storage procedures and treatment of the biological samples (5) Information regarding the public availability of the data produced in the course of the project and potential risks and benefits of data sharing

11. How an informed consent should be structured On a whole, the informed consent must be able to guarantee  Information  Understanding  Voluntariness  Decision Making Capacity

12. Broad or strictly specified consent? Strictly specified consent is when participant consent the use of their sample and data only for a specific research Broad consent is when participant consent to a broad range of use of their sample and data or opt to be approached on a case-by-case basis

13. Broad or strictly specified consent? Havasupai Indian Tribe vs Arizona State University Members of this tribe had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe’s devastating rate of diabetes. But they learned that their blood samples had been used to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories.

14. Broad or strictly specified consent? Havasupai Indian Tribe vs Arizona State University What were the problems? The informed consent was very simple The purpose of the research described in the consent was limited to diabetes What issues emerge from this case? researchers’ responsibility to communicate the range of personal information that can be gleaned from DNA at a time when it is being collected on an ever-greater scale for research and routine medical care

15. Dynamic consent Dynamic Consent is a new approach for engaging individuals about the use of their personal information. It is also an interactive personalized interface that allows participants to engage as much or as little as they choose and to alter their consent choices in real time. What makes Dynamic Consent “dynamic”? It allows the same samples/information to be (re)used with the knowledge and consent of the individual. It enables individuals to give and revoke consent to the use of their samples and information in response to their changing circumstances. It provides a record of all transactions and interactions in one place. It allows people to be approached for different kinds of consent or to obtain their opinions as new research projects are started and new ethical questions arise. Consent preferences can be modified over time.

16. Dynamic consent Features of Dynamic Consent Participants can: Consent to new projects with ease or alter their consent preferences in real time as their circumstances change. Change contact information and personal preferences and find out how their samples have been used via a secure, password-protected section of the interface. Set preferences about the kind of information they receive, how often they receive it and in what format (eg, text messages, emails, letters). Researchers can: Customise the interface to meet the needs, resources and capabilities of the research enterprise. Integrate the stand-alone online communication interface with other information systems.

17. Dynamic consent Benefits It meets the highest international ethical and legal standards for consent in a world where data protection laws are in flux. It enables participants to keep all of their information in one place, with a record of consent and research involvement, thus enabling more active engagement in research. Collection of one-off consent for research can often occur at a stressful time for the person concerned, such as before treatment or surgery; dynamic consent removes this pressure by allowing participants to return to their decisions and review their consent preferences in their own time. It promotes scientific literacy as participants become more informed about the research carried out on their samples and information, which encourages public trust by making research more transparent and accountable. For researchers, it provides an easy mechanism to identify individuals who have consented to being approached and recruited for new studies, to participate in online surveys or to canvas opinions. It can be tailored for specific situations, as a ‘one-stop’ interface to facilitate better translational research and to coordinate clinical and research activities coordinated around the patient.