Informed consent: Ethical considerations

1. Informed consent:Ethical considerations Research seminar 2nd Regional African AAC conference, August 1st, 2011, Center for Augmentative and Alternative Communication University of Pretoria, South Africa & INTERFACE Professor Eva Björck-Åkesson School of Education and Communication Jönköping University Sweden

3. Ethical vetting in research in Sweden • 6 regional boards - independent authorities - independent decisions • medical science section • other research section • each section is headed by a chairman who is a judge • ten members with high scientific qualifications and five to represent the general public - appointed by the government. • important that every application should be processed by members who have sufficient expert knowledge. • a scientific secretary is appointed from the scientific members

4. Definition of research Ethical review act - SFS 2008:192 • “research” is understood to mean not only scientific, experimental or theoretical work to obtain new knowledge, but also developmental work carried out on a scientific basis, with the exception of that which is carried out as part of a programme of study at an institute of higher education at a basic or advanced level.

5. Applicability of vetting rules • Research that involves: • a physical intervention affecting a person who is participating in the research • is conducted in accordance with a method intended to physically or mentally influence a person who is participating in the research

6. Vetting based on UN Convention’s understanding of human rights • Respect for the inherent dignity, individual autonomy — including the freedom to make one’s own choices — and independence of persons. • Equality • Full and effective participation and inclusion in society • Respect for difference • Accessibility

7. Definition of consent • The Social Research Association (UK, 2003) defines informed consent as: • ‘.. a procedure for ensuring that research participants understand what is being done to them, the limits to their participationand awareness of any potential risks they incur’ (p28). • Royal College of Nursing (RCN) Research Society (UK, 2011) • “The process of agreeing to take part in a study based on access to all relevant and easily digestible information about what participation means, in particular, in terms of harms and benefits. • Parahoo K (2006) Nursing research: principles, process and issues (2nd edition), Basingstoke: Palgrave Macmillan.

8. Information and consent - vulnerable people • Informing in an appropriate way • Provide information in a way that is adapted to the age, maturity and cognitive ability of the person • Ensuring that AAC participants in the research are provided with communication aids that embodies the principle of accessibility • Exhaustive documentation is particularly important, when children or people with a diminished ability to make decisions participate in the study • Respects people with disabilities as active participants and not as passive objects of research

9. Information and consent – Swedish rules • Research may only be approved if it can be assumed that the appropriate provisions concerning information and consent will be observed. • If a person who is a subject of the research is in a situation of: • dependency with respect to the responsible research body • or a person conducting the research • or if the person who is a subject of the research can be presumed to have difficulties in asserting their rights • issues concerning information and consent should be given particular attention during the course of an ethical vetting.

10. Consent – Swedish rules • The research may only be carried out if the subject of the research has consented to the research that concerns him or her • Consent is only valid if the subject of the research has previously been given information concerning the research • The consent is to be voluntary, explicit and specific to particular research • The consent is to be documented

11. Information – Swedish rules • The subject of the research is to be informed about: • the overall plan for the research • the purpose of the research the methods that will be used • the consequences and risks that the research might entail • the identity of the responsible research body • the fact that participation in the research is voluntary • and the right of the research subject to cease participating at any time • If the subject of the research is less than 18 years old special rules apply • The capacity to make voluntary informed decisions, i.e. to assent, evolves with age, maturity and previous experiences of life.

12. How to inform research participants • Information form should contain all the information that a person could reasonably need to know in order to decide whether or not to participate in a research project, but no more than that. • The written information is a complement to the information that is to be given orally. • There should always be an opportunity to ask questions. • The consent form may be separate, but a copy of it, as well as a copy of the information form and any annexes, is to be kept by the person participating in the research. • It is important that the information for a person participating in the research is given in a simple and clear language and does not include words that could be interpreted as coercive or exaggerating the possible worth of the study.

13. How to inform research participants The information should be adapted to the age of the person and other general circumstances or any other grounds that would constitute a diminished ability to make a decision.When the research involves children, the information is to be addressed both to the child (if he/she can read) and to the custodian of the child.The information should not be too long and should only exceed 3-4 A4-sized pages in exceptional circumstances.If necessary, detailed instructions can be supplied in an annex.

14. Research subjects less than 18 years of age • If the subject of the research is over 15 years of age, but has not attained the age of 18 and realizes what the research entails for his or her part, he or she shall personally be given information about the research and shall consent to the research • In other cases when the subject of the research has not attained the age of 18, the subject’s guardians are to be informed and their consent • As far as possible, however, the research persons themselves are to be informed about the research • Even if the consent of guardians has been obtained, research may not be carried out if a person who is the subject of the research is younger than 15 years of age, understands what it entails for his or her part and objects to it being carried out

15. Good practice in research involving people with disabilities - issues of informed consent • “there are no simple solutions that can be applied universally to resolve all ethical dilemmas. Rather, researchers need at all stages of the research process to be mindful of the various issues that can arise in the context of their individual research projects. Issues can relate to: • the needs of participants • ensuring ongoing assent or consent • handling relationships that develop during the research process • unanticipated, distressing emotions • unexpected revelations” • Rose Wiles, Vikki Charles, Graham Crow and Sue Heath (2004), University of Southampton. Informed Consent and the Research Process. Paper presented at the ESRC Research Methods Festival at the University of Oxford, 2nd July 2004 .http://www.sociologyandsocialpolicy.soton.ac.uk/proj/informedconsent/index.htm (accessed 20 7/2011).

16. Ways to make people express that they understand what they agree to, or do not agree to • Find methods to agree or say no no without going via somebody else – gatekeeper, proxy • Use a sign, symbol or a card for yes and no or a stop card, after practicing with the researcher before the data collection starts • Provide information to potential participants and then ask them to repeat it back to check their understanding • Repeat the information and the consent process during the research • Carry out the consent procedure after the data have been collected - only then that the participant will know what they agree to or if they do not want to agree

17. Informed consent in social research • Adequate information – people should know what they are consenting to • Voluntariness - people should be aware they are under no obligation to participate and have a right to withdraw at any stage • Competence - that potential participants should be capable of understanding what consent will entail and of deciding whether or not they wish to participate • Wiles, R., Charles, V., Crow, G. and Heath, S. (2004), ‘Informed consent and the research process’. Paper presented at the ESRC Research Methods Festival, University of Oxford, 2 July. Available at http://www.sociology.soton.ac.uk/Proj/Informed_Consent/methsfest%20.rtf (accessed 10 6/2009)

18. Culturalissues – in relation to information, voluntariness, competence • Responsibility for a child, a vulnerable person – ”who shallspeak for the child/vulnerable person” • Parent • Family • Child/person • Other persons with authority, facilitators – church, school ….. • View of the (cognitive and social) maturity of the child/young person • Whencan a childdecideabout different issues, make ownchoises? • When and aboutwhatshould the child/young person take full responsibility? • Interpretation of concepts in society • Disability, handicap, impairment, difficulty, problems

19. Scenario 1 – Adequate information • A researcher conducts research on experiences of participation in societal everyday life for adults who use AAC. • The researcher plans to conducted 7 focus groups, and video-observations of the participants in everyday situations. The participants use AAC to express themselves. • The researcher explains in spoken and written words that he will use their input in the focus groups and information from their everyday life to answer his research questions to receive a full picture of participation in everyday life situations. • How can the researcher assure that the participants have understood what he will do?

20. Scenario 2 – Adequate information • A researcher is conducting research with school children using AAC looking at their experience of possibilities to do independent choices at school. • The researcher wants to inform each child about the study and needs to do it with the help of the children´s personal assistants. Most assistants are very active in explaining the child´s questions and what the children means. • The researcher becomes vary of her possibilities to catch the child´s genuine questions and understanding. • How can the researcher be sure of catching each child´s own view?

21. Scenario 3 - Voluntariness • A researcher is conducting some research with preschool children using AAC looking at the language environment for the child. • She provides each child and assistant with a camera and asks them to take photos of things that are important to the child. • In the photos other children and people in stores, playgrounds etc are present. Can she use these as data if she doesn’t have the permission of the people in the photos to do so? • How far should the researcher go in seeking consent?

22. Scenario 4 - Voluntariness • A researcher conducts research on experiences of participation in school for children who use AAC. • The researcher has conducted 5 focus groups with children in the ages of ten to fourteen. As part of the consent process he sends all families and children a copy of the transcript of the group in which the children participated. • If any participant wants to change or remove something they had said from the transcript they could let him know. • The researcher is writing up his research for publication, after completion of the data collection six months previously, when a focus group participant says that she wants to withdraw her data from the focus group. • How can the researcher assure withdrawal at an earlier point of time? Is there a time limit to withdrawal?

23. Scenario 5 – competence - do participants understand what consent will entail? • A researcher conducts research with families and children who use AAC. • As part of the consent process the study participants are promised anonymity and are told that participants will be given pseudonyms in the write up of the study. • A number of the study participants express a strong preference to use their own name and the name of their child and other identifying details. They feel this is an important part of having their experience validated. Other participants require anonymity. • What are good ways to handle understanding of consequences of giving consent?

24. Code of conduct social science research UNESCO Paul de Guchteneire • 11. Freely given informed consent should be obtained from all human subjects. Potential participants should be informed, in a manner and in language they can understand, of the context, purpose, nature, methods, procedures, and sponsors of the research. Research teams should be identified and contactable during and after the research activity. • 12. There should be no coercion. Participants should be fully informed of their right to refuse, and to withdraw at any time during the research. • 13. Potential participants should be protected against any and all potentially harmful effects and should be informed of any potential consequences of their participation. • 14. Full confidentiality of all information and the anonymity of participants should be maintained. Participants should be informed of any potential limitations to the confidentiality of any information supplied. Procedures should be put in place to protect the confidentiality of information and the anonymity of the participants in all research materials. • 15. Participants should be offered access to research results, presented in a manner and language they can understand. • 16. All research should be reported widely, with objectivity and integrity.