Ethical Considerations By BEATRICE K.M. AMUGUNE MENTAL HEALTH TRAINING MAANZONI 2014 University of Nairobi ISO 9001: Certified

 By the end of the session, LEARNERS should be able to:  Define the 4 major ethical principles imperative for protections of human research participants to their own research studies.  Apply the 4 major ethical principles to their own research studies. Presentation objectives

 The interests of research participants have all too often been sacrificed to scientific ends.  Health research has a lengthy history of abuses  Well known scandals and tragedies of research with human subjects are documented  Example: Tuskegee syphilis study ( ) Introduction

 Debates, trials and commissions set up yielded Codes, Declarations and guidelines  The debate mostly dealt on moral virtues and obligations in use of humans in research  Physicians, legal minds, theologians, philosophers etc for decades been involved in debate 4 Ethical principles Reaction to scandals University of Nairobi ISO 9001: Certified

1.Respect for persons-Respect for human dignity, human rights and fundamental freedoms 2.Justice- Maximization of benefit and minimization of harm to research participants 3.Beneficence-Interest and welfare of the individual should have priority over the sole interest of science or society. promotion of well being; maximize benefit 4.non-maleficence - do no harm ( by commission or omission) The four ethical principles

 "Individual autonomy“  privacy, confidentiality autonomy - make own decisions  individual informed consent emphasized; ENSURING  competence, full information/ disclosure  full comprehension; Voluntary or by legal representative  without coercion or inducement  Protect individuals with reduced capacity to exercise autonomy  Vulnerable populations(cognitive or communicative impairment, institutionalized, medical, social etc) [Assess & ensure sufficient knowledge, capacity, free power] Respect for Persons

 Risks should be no more and not greater than risks attached to routine medical or psychological tests  If risk is greater then, the ERC has to establish that:  Research is responsive to the special needs of diseases affecting that population  Risk minimally raised above routine medical & psychological tests risks.  Research important enough to justify the risks  Interventions are reasonably similar with current interventions in that group Individuals not capable of giving informed consent

 "Treat individuals fairly“  In bioethics, distributive justice discussed i.e equitable distribution of burdens and benefits of participation in research  Ethical obligation to treat each person in accordance with what is morally right and proper.  Give each person what is due to them  Special provision must be made for the protection of the rights and welfare of vulnerable persons Justice

CRUCIAL: SELECTION OF SUBJECTS / PARTICIPANTS  Equitable distribution of research harms & benefits  Equitable selection of subjects / participants within a population  Equitable selection of study population ……

Investigator must ensure that:  The research might not equally be carried out with adults  The research obtains knowledge relevant to health needs of children  Parent or legal guardian has given consent  Assent has been obtained from child  Child’s refusal to participate will be respected. Children in Research

 Do not exclude women of reproductive age  BUT thorough discussion of risks to pregnant woman and fetus is required  Pregnant women to participate only if relevant  Access to pregnancy test and contraception assured  No case of spouse consenting instead of woman  Pregnant women must be given adequate information on risks and benefits to self and fetus including subsequent pregnancies and future fertility Women as research subjects

 "Do benefit"  Involves Assessment of risks [harms] and benefits  Minimize harms i.e maximize benefit -to-risk ratio  Use least harmful methods to achieve the results  If there is prospects of benefit to individual, intervention should be at least as good as what is currently available.  If no benefit then consider reasonable risk in relation to importance of knowledge gained.  maximize benefits to participants and even society Beneficence

 = DO NO HARM  Deliberate infliction of harm on participants is proscribed  minimize risk of harm  physical  Psychological e.g emotional trauma  Social including stigma, loss of relationships, job etc  Always consider harm to both individual and community  Protecting future generations, the environment, the biosphere and biodiversity Non-Maleficence

 “Harm, disability or death suffered by a subject at risk of biomedical and behavioral research…where such injury is (1) proximately caused by such research, and (2) on balance exceeds that reasonably associated with such illness from which the subject may be suffering, as well as with treatment usually associated with such illness at the time the subject began participation in the research.” (HEW Task Force, 1977)  Compensation mechanisms to be put in place Research-related injury

 Ethical considerations  subsection methodology-  Discuss ethical considerations in study  briefly explain the ethical issues that may arise and strategies to address them.  APPENDIX A. Attach Consent/assent process explanation B. Attach consent form KNH-UON ERC GUIDELINES

 Provide Information on :  use of human participants in the study  key researchers and telephone numbers in case to be contacted  necessity for approval by ERC (role &contact)rightsprotection  A. Ethical considerations

 Methodology (selection, consenting)  Benefits / Risks  Compensation mechanism if any  Alternative treatments  Voluntarism  Results dissemination plan …..

 Expected time engagement in the study  Follow up schedules, if applicable  Type of specimens and amount to be obtained  Possible storage of specimen for further analysis with the permission fromthe ERC ……..

Informed Consent Process explanation  Involves informing  Sharing knowledge  Admitting ignorance if necessary  Answering questions  Appreciating doubts  Respecting fears  Creating partnership  Giving rights for self-determination  Facilitating open and searching dialogue

……  The language used should be appropriate to the age and comprehension and reading of the study population.  The use of abstract and legal language should be avoided.  Scientific terms, measurements etc should be simplified.

Information Content  Clear invitation: (not a request or demand to become a research participant)  Statement of overall purpose: i.e. a statement that the study involves research  explanation of purposes of the research.  Basis for selection: prospective participants should be told why they have been selected

…….  must contain understandable information about:  Aims, methods  Benefits, risks and discomfort for participant  Sources of funding, conflicts of interests  Right to withdraw without dire consequences ( volunteerism)

Comprehension of information  Informed consent is not valid unless the consenter comprehends the information upon which consent is based.  The language used therefore must be easy and understandable by the consentor.  Grammar and punctuation must be used appropriately to enhance comprehension

NOTE:  The consent document must be revised until the ERC is fully satisfied before approval …… University of Nairobi ISO 9001: Certified

SAMPLE CONSENT INFORMATION FORM  Introduction- Name and contact of investigator  The study you are about to participate in is (briefly describe the study).  Should you agree to participate in the study, you will be asked to (describe the study procedures, potential risk and benefits).

……..  All data collected from you will be coded in order to protect your identity.  Only the research study staff will have access to the information.  Storage, export or any future studies on specimen will only be after ERC approval  At the end of the study, there will be no way to link your name with your data or any left over specimens

……..  Any additional information about the study will be provided to you including the final study results.  You are free to withdraw or refuse to answer any questions at any time without any consequences.  You are free to raise any concerns about your rights as a participant in this study to the ERC that approved this study-Chair, Tel……

………….  Should you agree to participate in the study, please sign your name below, indicating that you have read and understood the nature of the study,  your responsibilities as a study participant, the inconveniences associated with voluntary participation in the study and that all your questions and concerns relating to the study have been answered satisfactorily.

CONSENT FORM You will receive a copy of this signed consent document to take away with you and keep. __________________________________________ Signature/Thumbprint of Study Participant Date __________________________________________ Signature of Person Obtaining Consent Date __________________________________________ Signature of Witness Date

 All types of research, both experimental and non-experimental, both medical and behavioral, have caused (and can cause) major harms / abuses  Researchers MUST understand and agree with the purpose of regulations in research and protect all participants especially the vulnerable.  All PARTICIPATION IN RESEARCH MUSTONLY BE BY INFORMED CONSENT CONCLUSION

THANK YOU FOR ATTENTION End