Informed and Voluntary Consent (2.1)

2.1.1. Participation of a human subject in any research project or teaching session must be voluntary and based on understanding of adequate or appropriate information about what such participation will involve.  Information provided should be in simple, clear language appropriate to the potential participants.

2.1.2. All prospective participants must know:

  • the names of the people responsible for the project
  • the procedures they will be asked to agree to participate in,  for example, interviews,  testing, participation in a focus group, for example
  • why the project is being undertaken and how the information will be used, for example, thesis,  publications
  • that they can withdraw from the process without penalty before data collection process is completed
  • what will happen to the information when it is obtained, for example, aggregated with other information or used as a case study
  • whether information obtained will be transcribed by another person.  It is good practice to inform potential participants that the transcriber will be required to sign a confidentiality form
  • how confidentiality and anonymity will be protected.  If either of these cannot be guaranteed, participants should be advised of this fact and the reasons why
  • what will happen to the data on completion of the process
  • whether they are able to see the final report and, if so, how this process will be conducted

2.1.3. In general, this information will be provided in written form through the Information Sheet (Refer to Appendix D1 for the exemplar) and the Consent Form which will need to be signed by each participant (Refer to Appendix E for the exemplar). These forms should be adapted appropriately to the particular research.

2.1.4. Points for applicants to consider:

  • the level of literacy and understanding of potential participants
  • the need to allow adequate time for potential participants to consider, clarify and ask questions, after reading the Information Sheet and before signing the Consent Form
  • if group meetings or focus groups are to be used, a sentence should be included in the Consent Form stating that participants undertake to keep all discussion confidential to group members
  • where oral consent is culturally appropriate it should be verified or recorded in some way
  • coercion or pressure to participate is always unacceptable as is inducement through payment or gifts (refer to Appendix A - Glossary on Payment and Koha)
  • the possibility that if there is a dependent relationship between potential participants and researcher(s), this may be implicitly coercive and may require special consideration
  • transcripts or data analyses should be submitted to participants for verification
  • the special position of vulnerable participants such as children and disabled persons. (Refer to Sections 2.8 and 12, as well as to Appendix N ). The consent of another appropriate person will be needed if a child or disabled person is unable to give consent or assent.

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