Research Ethics Dr Nichola Seare Aston Health Research & Innovation Cluster

Overview  Ethics – what is it ?  Research Ethics  Ethics associated with using human subjects in research  Workshop: Reviewing Applications

Ethics – what is it ?  Ethics is a system of values  In research, it is the principles of the way the data is collected and used  Concerns itself with the power relationship between researcher and researched

Ethics – what is it ?  The importance of research ethics developed during the 20 th Century  The discovery that some Nazi’s conducted experiments on people led to international developments:  Nuremberg Code (1948)  Declaration of Helsinki (1964)  Although developed around medicine, increasingly different disciplines have developed their own codes

Ethics – what is it ?  Does not = charges of wrong doing  A process of critical reflection on ethical questions faced by researchers  Explores the moral, social, legal and political implications of research  Different people give different answers

Principles guiding ethical research Principles rather than rules guide ethical research The three main principles are:  Beneficence  Respect  Justice

Beneficence Beneficence is action that is done for the benefit of others Beneficent actions can be taken to help prevent or remove harm or to simply improve the situation of others Maximising good outcomes for all research participants Balancing the benefit to the researcher and the research subject(s)

Respect Protecting individual’s autonomy  Acknowledging the individual’s right not to participate, or not to respond to a particular question  Maintaining confidentiality and preserving anonymity Key issues:  What is informed consent?  Can confidentiality always be maintained?  Can you preserve anonymity?

Justice Ensuring those who bear the risks of research benefit the most from it  Fairness as equity  Fair and equitable distribution of benefits and burden  Fairness in the selection of research subjects

Approaches to Decision Making The “Six E’s” Ego (Emotion) – how would I decide if I were there? Empathy – how would I decide if I were the participant? Experience – what have I/we decided before? Ethics – what would ethics suggest is fair or right? Experts – what judgements have experts made? Evidence – what published evidence is there? And the researchers want: Expediency

Research Ethics  Research ethics need to be considered  During the research design  During the research process  During the writing/publishing  Ethical conduct legitimates the entire process

What needs to be considered? Scientific Merit Competency Risks and benefits Harm: likelihood of occurrence and severity Informed Consent Confidentiality Conflict of interest Reporting of results

Ethical Issues – Human Subjects Research Risks associated with being a research participant:  Adverse effects  Loss of rights and dignity  Not understanding the consequences of participation +

Ethical Issues – Human Subjects Research  Safety of the research participant Researchers must carefully consider the risk/benefit ratio, and continually monitor this as the research proceeds  Informed consent Should ideally be obtained in writing (although not always possible) after the participant has had the opportunity to consider the risks and benefits and to ask any questions  Privacy and confidentiality Participants should understand who will have access to their personal information and associated research data

Ethical Issues – Human Subjects Research Consider how adverse events will be handled Who will provide insurance for negligent harm

INFORMED CONSENT Consent & Confidentiality

Why is Consent Needed?  Legitimises research  Good Practice – reflects right of participants  Authorises procedures  Acts as defence in common law tort of trespass to the person (battery) and in criminal law under CJA 1988

Valid Consent For consent to be valid it must:  Be given voluntarily  By an appropriately informed person  Who has the capacity to give consent

Information  The nature and purpose of the research  The procedures/methods to be used  The expected benefits to the participant and/or society  The potential of reasonably foreseeable risks, stresses, and discomforts  Procedures in place to ensure the confidentiality or anonymity of the participant  Compensation arrangements for research-related injury  Contact details for questions about the research study The informed consent document must be written in lay language, avoiding any technical jargon.

Key Requirements  Understanding The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the investigators  Voluntariness The participant's consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation  Competence  Documentation Participants must authorise their participation in the research study, preferably in writing

Confidentiality  Duty also under Art 8 ECHR  Caldicott Committee Report 1997 identified 86 flows of identifiable patient information and led to appointments of Caldicott Guardians  Data Protection Act

Research Considerations  Identification of participants  Invitation to participate in a research study  Coding of data  Data storage  Data transfer  Publication

Review Bodies Aston Business School Ethics Committee Aston University Ethics Committee and for research with NHS patients, their samples/tissues or data or adult participants without capacity to consent NHS or Social Care Research Ethics Committee

NHS & Social Care Research Ethics Committees Integrated Research Application System (IRAS) application-system National Research Ethics Service -

Research Ethics Committee Decisions  Accept outright  Accept subject to changes  Reject

QUESTIONS ANY QUESTIONS