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Self-assessment (2)

2. Multi-choice

Question

When preparing a PIS and consent form, which of the following sentences is NOT appropriate? (Choose one answer only)

Answers

‘You do not have to take part in this study if you do not want to. Saying “no” will not affect any current or future care that you receive from our team.’

‘We will ask you and others in the (focus) group not to share what was discussed within the group with people outside the group. However, we cannot guarantee that others in your group will keep anything that you said confidential.’

‘You can stop participating in this study at any point, without any penalty. However, we hope that you can inform us and tell us why if you decide to do so.’

e-CFR (Revised Common Rule) [Internet]. United States Electronic Code of Federal Regulations. Sect. Part 46—Protection of Human Subjects Jul 19, 2018. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html Office for Protection from Research Risks. Exculpatory Language in Informed Consent [Internet]. HHS.gov. 1996 [cited 2019 Jan 16]. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/exculpatory-language-in-informed-consent-documents/index.html

‘By agreeing to take part in this study, you agree not to hold us liable for any loss or injury that you suffer because of this study, including those caused by our negligence.’

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