Investigators must obtain informed consent and research authorization, prior to enrolling a research participant into a study and/or conducting any procedures required by the protocol, unless waived by the IRB. Individuals obtaining consent MUST be identified on the application form. Although the PI may delegate the responsibility for obtaining consent from research participants to members of his/her research team, the PI retains ultimate responsible for insuring that each prospective participant is adequately informed about all aspects of the research and understands the information provided. The consent process does not end with the formal signing of the consent document. Rather, it is an ongoing process that continues throughout the participation in the study. The investigators remain responsible for continued assessment of the research participant’s understanding of what is happening to him/her, his/her willingness to participate and for providing the research participant with any new information that may affect their willingness to participate. It is the PI's responsibility to train and supervise the study personnel who are obtaining consent. An adult research participant has the capacity to consent to his or her own participation in a research activity if (s)he demonstrates an appreciation: that the activity is research, not standard treatment for his/her disease or condition; of the risks and benefits of a study; of the alternatives that are available; and that, if (s)he chooses not to participate, this decision will be accepted without penalty, i.e., without jeopardizing clinical care. In reaching a decision about participation, it is essential for the potential research participant to demonstrate an ability to use this information in a rational manner as determined by the PI or in consultation with a Psychiatrist if necessary. Thus, in considering risks, benefits, and available alternatives, research participants should demonstrate they understand the aspects of these factors that are unique to them as individuals. To highlight this distinction, a person who is suffering with severe depression may be able to demonstrate an appreciation of the above, but may not care, or may want to accept the risks. Such individuals should not be considered for the research.
Investigators must obtain informed consent and research authorization, prior to enrolling a research participant into a study and/or conducting any procedures required by the protocol, unless waived by the IRB. Individuals obtaining consent MUST be identified on the application form. Although the PI may delegate the responsibility for obtaining consent from research participants to members of his/her research team, the PI retains ultimate responsible for insuring that each prospective participant is adequately informed about all aspects of the research and understands the information provided. The consent process does not end with the formal signing of the consent document. Rather, it is an ongoing process that continues throughout the participation in the study. The investigators remain responsible for continued assessment of the research participant’s understanding of what is happening to him/her, his/her willingness to participate and for providing the research participant with any new information that may affect their willingness to participate. It is the PI's responsibility to train and supervise the study personnel who are obtaining consent. An adult research participant has the capacity to consent to his or her own participation in a research activity if (s)he demonstrates an appreciation: that the activity is research, not standard treatment for his/her disease or condition; of the risks and benefits of a study; of the alternatives that are available; and that, if (s)he chooses not to participate, this decision will be accepted without penalty, i.e., without jeopardizing clinical care. In reaching a decision about participation, it is essential for the potential research participant to demonstrate an ability to use this information in a rational manner as determined by the PI or in consultation with a Psychiatrist if necessary. Thus, in considering risks, benefits, and available alternatives, research participants should demonstrate they understand the aspects of these factors that are unique to them as individuals. To highlight this distinction, a person who is suffering with severe depression may be able to demonstrate an appreciation of the above, but may not care, or may want to accept the risks. Such individuals should not be considered for the research.
IRBGuidance-LegallyEffectiveInformedConsentandHIPAAResearchAuthorization12.02.2016.docx