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BRM
MOD 4
COMMUNICATING RESEARCH FINDINGS
INFORMED CONSENT
Informed consent is the process of telling potential research particpants about the key elements of a research study and what their participation will involve. The informed consent process is one of the central components of the ethical conduct of research with human subjects. The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants. In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate)
Why is It Important?
- Ensures the protection of subjects’ rights
- Records information that was discussed with the subject
- Documents the subject’s willingness to participate.
What is Generally Required?
- Information must be presented in lay terms and in a language that is understandable to the subject
- Consent documents should be written no greater than an 8th grade reading level
- Avoid using complicated medical or technical terms
- Should not contain any exculpatory language (verbal or written)
- Avoid language that waives the subject’s legal rights
- Avoid language that frees the investigator, the sponsor, or the institution from liability of negligence
- Information must include the required regulatory elements.
- A copy of the consent form must be provided.
Research Involving Children
- For research involving children aged 7 or above, assent, a child’s affirmative agreement to participate in research, is usually required.
- Parents/guardian permission must be obtained in a written informed consent document or a separate Parental Permission Form. Children aged 7-11:
- Assent should be obtained in the presence of a parent/guardian
interviews, where the participant identities are known to the researcher, therefore, only confidentiality, not anonymity, can be offered). The research design needs to consider the potential of harm to the participants, the researcher, the wider community, and the institution. The harm can range from physical, resource loss (including time), emotional, and reputational. When considering the potential for harm, the approach should be, in descending order, to eliminate, isolate, and minimize the risk, with the participants being fully informed on what the risks are. Conflict of Interest – Existing relationships or prior activities by the researcher can potentially create a conflict of interest that are important to transparently report on within an ethics approval application so the committee can provide guidance on how to manage this conflict of interest. Ethical Expectations – The level of attention on ethical conduct (the actions that are personal, professional, and during research activity) has both increased and broadened in response to society’s expectation of greater
accountability (Haggerty, 2004; Held, 2006; Zegwaard, Campbell, & Pretti, 2017). At many educational institutions, to collect data from human participants for research purposes without ethical approval would place the researcher outside the institutions Staff Code of Conduct (often worded within the requirement of adherence to institutional regulations, which will include the Human Research Ethics regulation). Data Protection – Routine collection and storing of electronic data and use of data mining techniques has raised new concerns about confidentiality of information. The information may be used for different purposes than what it was collected for. Personal data must be processed fairly and lawfully. The data must be obtained only for one or more specified and lawful purposes and not further processed in any manner incompatible with the original purpose. Personal data must be adequate, relevant and not excessive in relation to the purpose or purposes for which they are processed. The data must be accurate and where necessary, be kept up to date and must not be kept longer than necessary. Data must not fall into the wrong
