# Consent Form Checklist

**Required elements of consent (from 45CFR46.116(a))**

In this first section, the 8 required elements of consent are first
summarized, with points addressing these elements are listed in the
table.

**(1)** A statement that the study involves research, an explanation of
the purposes of the research and expected duration, a description of the
procedures to be followed, and identification of any procedures which
are experimental:

+-------+--------------------------------------------------------------+
|       | ## Does the form                                             |
|       |  lead off with a statement that the study involves research? |
+-------+--------------------------------------------------------------+
|       | Are the researchers identified?                              |
+-------+--------------------------------------------------------------+
|       | Is the purpose of the research explained so as to be         |
|       | understandable?                                              |
+-------+--------------------------------------------------------------+
|       | Are the procedures to be followed described in simple        |
|       | language, avoiding medical and technical terminology?        |
+-------+--------------------------------------------------------------+
|       | Are procedures or elements of the procedure that are         |
|       | experimental clearly identified as such?                     |
+-------+--------------------------------------------------------------+
|       | Is the length of time for each procedure given, as well as a |
|       | total time commitment for participation?                     |
+-------+--------------------------------------------------------------+
|       | If pregnancy testing and/or birth control requirements are   |
|       | specified in the protocol, is this clearly laid out in the   |
|       | consent form?                                                |
+-------+--------------------------------------------------------------+

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

  -------- --------------------------------------------------------------
           Is the list of physical risks/discomforts complete and
           explained in simple language, avoiding medical and technical
           terminology?

           For commonly encountered risks/discomforts, are the measures
           to treat/correct them explained in the consent form?

           Are confidentiality risks addressed, and measures to minimize
           them explained?
  -------- --------------------------------------------------------------

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

  -------- --------------------------------------------------------------
           Are benefits ascribed to the subject scientifically/medically
           reasonable OR does the form state clearly that there will be
           no direct benefit to the subject from taking part in this
           study?

           Are benefits to society in general accurately summarized?

           Payment to subjects should not be listed as a benefit.
  -------- --------------------------------------------------------------

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

  -------- --------------------------------------------------------------
           If this is a protocol which will provide diagnostic service or
           treatment, are alternative courses of diagnosis or treatment
           listed?

  -------- --------------------------------------------------------------

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

  -------- --------------------------------------------------------------
           If not included under risks, is confidentiality explained in a
           separate section?

  -------- --------------------------------------------------------------

**(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....

+-------+--------------------------------------------------------------+
|       | For protocols involving a physical intervention (i.e., blood |
|       | draw) or which are of greater than minimal risk, is the      |
|       | standard compensation for injury statement included? (The    |
|       | standard language follows.)                                  |
|       |                                                              |
|       | COMPENSATION FOR INJURY If you are injured as a result of    |
|       | taking part in this study, medical care and treatment will   |
|       | be available to you as a participating subject. The costs of |
|       | this care may be covered by the University of California     |
|       | \[add where appropriate: ,or the study sponsor Xxxxxxx,\]    |
|       | depending on a number of factors. If you have any questions  |
|       | regarding this assurance, you may consult or call the        |
|       | Berkeley Lab Human Subjects Committee, MS 26-143, 1          |
|       | Cyclotron Road, Berkeley, CA 94720 (510-486-5399).           |
+-------+--------------------------------------------------------------+

**(7)** An explanation of whom to contact for answers...

+-------+--------------------------------------------------------------+
|       | ## Is contact information for the researcher given?          |
+-------+--------------------------------------------------------------+
|       | Is a contact given for questions about their rights as       |
|       | research subjects?                                           |
+-------+--------------------------------------------------------------+
|       | If the research is biomedical in nature, are the subjects    |
|       | promised a copy of the California state medical subject Bill |
|       | of Rights? Is the Bill of Rights attached?                   |
+-------+--------------------------------------------------------------+

**(8)** A statement that participation is voluntary

  -------- --------------------------------------------------------------
           Does the consent form state clearly in a prominent place that
           participation in research is voluntary?

           If Berkeley Lab employees are to be recruited as subjects, is
           appropriate care taken to assure them of the voluntary nature
           of their participation?
  -------- --------------------------------------------------------------

**Optional elements of consent (from 45CFR46.116(b)):**

+------+------+-------------------------------------------------------+
| Nee  | #    | Optional element:                                     |
| ded? | ## I |                                                       |
|      | nclu |                                                       |
|      | ded? |                                                       |
+------+------+-------------------------------------------------------+
|      |      | 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;          |
+------+------+-------------------------------------------------------+
|      |      | Anticipated circumstances under which the subject's   |
|      |      | participation may be terminated by the investigator   |
|      |      | without regard to the subject's consent;              |
+------+------+-------------------------------------------------------+
|      |      | Any additional costs to the subject which may result  |
|      |      | from participation                                    |
+------+------+-------------------------------------------------------+
|      |      | The consequences of a subject's decision to withdraw  |
|      |      | and procedures for orderly termination of             |
|      |      | participation in the research;                        |
+------+------+-------------------------------------------------------+
|      |      | A statement that significant new findings developed   |
|      |      | during the course of the research which may relate to |
|      |      | the subjects willingness to continue participation    |
|      |      | will be provided to the subject;                      |
+------+------+-------------------------------------------------------+
|      |      | The approximate number of subjects involved in a      |
|      |      | study.                                                |
+------+------+-------------------------------------------------------+

# Additional Standard Elements for Consent Forms

+-------+--------------------------------------------------------------+
|       | ## Financial Con                                             |
|       | siderations: are subjects told how much they will be paid? I |
|       | f participation is of long duration, are payments pro-rated? |
+-------+--------------------------------------------------------------+
|       | Bill of Rights: If the research is biomedical in nature, has |
|       | the subject been promised a copy of the state of California  |
|       | Medical Subjects Bill of Rights?                             |
+-------+--------------------------------------------------------------+
|       | Authorization: Is there a statement authorizing              |
|       | participation?                                               |
+-------+--------------------------------------------------------------+
|       | Signature lines: Are all needed signature lines included?    |
+-------+--------------------------------------------------------------+
|       | LANGUAGE: Is the language appropriate to the intended        |
|       | audience? For most adult subjects, the 8^th^ grade reading   |
|       | level is the desired target. (The reading level can be       |
|       | checked using the Word or WordPerfect grammar function;      |
|       | forms testing with a reading level of 10^th^ grade or higher |
|       | should not be approved without justification.)               |
+-------+--------------------------------------------------------------+

# 

# 

# Administrative Details

+-------+--------------------------------------------------------------+
|       | ## Is the form printed on letterhead?                        |
+-------+--------------------------------------------------------------+
|       | Are the pages numbered 1 of X, 2 of X, etc.?                 |
+-------+--------------------------------------------------------------+
|       | Is the type face large enough to be easily read?             |
+-------+--------------------------------------------------------------+
|       | Is there enough 'white space' on the form to allow easy      |
|       | reading?                                                     |
+-------+--------------------------------------------------------------+
|       | Has room been left for approval stamping of the form?        |
+-------+--------------------------------------------------------------+

These consent form materials were developed by the members of the
Berkeley Lab Human Subjects Committee in 2000 (Henry Stauffer, MD, PhD,
Shirley Ebbe, MD, Robin Rawlings, RN, and Scott Taylor, PhD); Peter
Lichty, MD, MOH; and Program Analyst Chris Byrne, MA, CIP.

Source Materials consulted in the preparation of these forms included:

The Common Rule, 45 CFR 46;

Consent templates of the University of California, San Francisco;
University of California , Los Angeles; Lawrence Livermore National
Laboratory; and the University of California, Berkeley;

Castronovo, Frank P., PhD, "An Attempt to Standardize the
Radiodiagnostic Risk Statement in an Institutional Review Board Consent
Form," *Investigative Radiology* Vol. 28: 6, pp. 533-538.