identify the human participant will be maintained. (If signed informed consent forms are used, regulations require they must be kept for 3 years.) •
An explanation of whom to contact for answers to pertinent questions about the research and research human participants’ rights, and whom to contact in the event of a research-related problem or injury to the human participant.
•
For research involving more than minimal risk, an explanation as to whether any medical or psychological treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
•
A statement that participation is voluntary, that deciding not to participate will involve no penalty or loss of benefits to which the human participant is otherwise entitled, and that the human participant may discontinue involvement at any time without penalty or loss of benefits to which the human participant is otherwise entitled.
•
A statement concerning costs or compensation to the human participant, if any.
•
A statement disclosing alternative treatment courses that may be available to the human participant.
•
A statement similar to this in the consent document: If you have questions or concerns about the research you may contact [name and contact information of investigator and/or the Chair of the Committee for the Protection of Human Participants in Research] at 617-264-7616. Students should also include name of and contact information for their research advisor or course instructor.
The CPHPR may require additional information to be included in the consent process and/or included in the informed consent form. 4.
CPHPR Waiver of Informed Consent Requirements
Waiver of the Informed Consent Process Requirement The CPHPR may waive the requirement that the investigator undergo the informed consent process, in accordance with the DHHS regulations (45 C.F.R. § 46.116), if it finds that: (a)
The research involves no more than minimal risk to the participants;
(b)
The waiver (or alteration of certain of the informed consent requirements) will not adversely affect the rights and welfare of the human participants;
(c)
The research could not practicably be carried out without the waiver or alteration; AND
(d)
Whenever appropriate, the participants will be provided with additional pertinent information after participation.
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