Annette Taylor commented
However, by federal guidelines there MUST BE TWO contact people listed on any
consent/instructions and a copy of that information must be made available to
each participant in writing! I didn't make up that rule, it's a federal rule, so
if the school needs and FWA for grant receiving purposes they should not violate
it.
Annette,
As an IRB chair (since 1981), I am not familiar with the TWO
contact people rule. I could not find the "Two contacts"
provision in the guidelines.
Where did you find it?
George
My understanding of the regulations found at:
http://ohrp.osophs.dhhs.gov/irb/irb_chapter3.htm#e2
are the following:
"The Regulations. The federal regulations require that
certain information must be provided to each subject [Federal Policy
�___.116(a)]:
(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;
(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.
The regulations further provide that the following additional information be provided to subjects, where appropriate [Federal Policy �___.116(b)]:
(1) 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) which
are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) Any additional costs to the subject that may result from participation in the research;
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will
be provided to the subject; and
(6) the approximate number of subjects involved in the study.
(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.
The regulations further provide that the following additional information be provided to subjects, where appropriate [Federal Policy �___.116(b)]:
(1) 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) which
are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) Any additional costs to the subject that may result from participation in the research;
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will
be provided to the subject; and
(6) the approximate number of subjects involved in the study.
--
George D. Goedel
Professor & Chairperson
Department of Psychology
Northern Kentucky University
Highland Hts., KY 41099-2000
(859) 572-5574
fax (859) 572-6085
[EMAIL PROTECTED]
---George D. Goedel
Professor & Chairperson
Department of Psychology
Northern Kentucky University
Highland Hts., KY 41099-2000
(859) 572-5574
fax (859) 572-6085
[EMAIL PROTECTED]
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