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Informed Consent

Informed Consent is a Requirement of all IRB Reviews


Informed consent involves providing a potential subject with adequate information about the research to allow for an informed decision about the subject’s voluntary participation in the research.  Informed consent must include a process to facilitate a subject’s comprehension of the information, in a language understandable to the subject, and allow adequate opportunity for the subject to ask questions and consider whether or not to participate.


Basic Elements of Informed Consent

The purpose of informed consent is to assure that the fundamental rights and welfare of subjects are protected.  


A signed informed consent document is evidence that:

1) the document has been provided to a prospective subject;

2) risks and benefits have been explained to the subject, and;

3) the subject has agreed to participate in the research.

 

IRB review of informed consent documents is to ensure that research protocols comply with these three elements and with applicable regulations as noted in:


US DHHS Code of Federal Regulations Title 45, Part 46, Protection of Human Subjects


1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;


2) A description of any reasonably foreseeable risks or discomforts to the subject;


3) A description of any benefits to the subject or to others which may reasonably be expected from the research;


4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;


5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;


6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;


7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and


8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.



NB: Health Media Lab’s IRB does not provide pre-written informed consent statements.  This is the responsibility of the investigators for each study population and sub-population.  


Also, for more information on non-English speaking and illiterate subjects, please go here:

FDA Guide to Informed Consent