Informed Consent
If your study/project will involve human participants, you will need to secure their informed consent to participate. Often there is confusion as to when an informed consent form is needed.
DNP candidates: unless required by your site, you often do not need an informed consent form. For example, if you are focused on a quality improvement project and assessing nurses' understanding of an established EBP protocol for the use of a clinical screening form, and then collecting data via a chart review to determine how the quality improvement initiative impacted screening, the IRB would not require an informed consent form from the nurses. However, you will need to provide a permission form from the site, granting you permission to implement the project. If in doubt, please email the IRB: IRB@apsen.edu (always cc your chair on any communication with the IRB).
The informed consent form represents a contract of confidentiality and ethical principles between you and the participants. Your consent materials must be clear and understandable, which means you should use non-technical, straightforward language. Specific regulations require that you present key information to facilitate understanding and ensure consent includes sufficient detail to assist an individual with making a decision regarding participation. Unless specifically waived by the IRB, informed consent must be documented by a written consent form approved by the IRB and signed by the participant or by the participant’s legally authorized representative.
If your study/project requires a consent form, use the template available in the lounge and tailor the content accordingly (see Appendix D for examples).
The informed consent form is the "documentation" of consent. Although the "documentation" of informed consent is important, the "process" of informed consent is where participants are protected and why the IRB application requires you to include details related to the process of consent in your application.