MCN’s customizable template, Elements Required for Informed Consent for Research Studies, is taken from our Home Infusion Therapy Policy and Procedure Manual. MCN Healthcare’s proven policy and procedure templates, competencies and compliance tools have assisted more than 20,000 health care organizations worldwide meet their regulatory compliance goals.

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Here is some sample content from Elements Required for Informed Consent for Research Studies:

	POLICY: Informed consent for research studies should include the following: A statement that the study relates to research An explanation of the research's purpose and the expected duration of the subject's participation A procedure description and identification of any experimental procedures A description of any risks reasonably foreseeable or discomforts which the subject might expect A description of any benefits to the subject or others who may reasonably benefit from the research A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be...
Second excerpt:
	...the subject may discontinue participation at any time without penalty or loss of benefits One or more of the following elements of information will also be provided to each subject, when appropriate: A statement that the particular treatment or procedure may involve risks to the subject or to the embryo or fetus, if the subject is or may become pregnant Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's...