Primary Reviewer:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ HSC #:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**WORKSHEET -- 45 CFR 46.116(a) & (b)**

**INFORMED CONSENT CHECKLIST**

**Except as described in IC 702 -- Waivers of Informed Consent, no
investigator may involve a human being as subject in research unless
s/he has obtained the legally effective informed consent of the subject
or the subject's legally authorized representative. The information
presented in the consent document must bein in language likely to be
understood by the subject population. Informed consent documents may not
contain any exculpatory language through which the subject is made to
waive or appear to waive legal rights, or release or appear to release
the Investigator, the Sponsor, or Lawrence Berkeley Lab from liability
for negligence.**

Note: Elements of informed consent under 45 CFR 46.116(a) and 46.116(b)
of the federal regulations are indicated with an asterisk (\*). The
other elements are LBNL recommendations/preferences.

+---------------------------------------------------+---+---+---+-----+
| **BASIC ELEMENTS OF INFORMED CONSENT**            | * | * | * | *   |
|                                                   | * | * | * | *WA |
| *Unless a waiver is approved by HSC, the          | Y | N | N | IVE |
| following information must be included*           | E | O | / | D** |
|                                                   | S | * | A |     |
|                                                   | * | * | * |     |
|                                                   | * |   | * |     |
+---------------------------------------------------+---+---+---+-----+
| **1.Letterhead:**                                 |   |   |   |     |
|                                                   |   |   |   |     |
| Is the consent form presented on letterhead?      |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| **2. Heading & Title:**                           |   |   |   |     |
|                                                   |   |   |   |     |
| Does the consent form include a heading (e.g.     |   |   |   |     |
| "Consent Form for Controls) and                   |   |   |   |     |
|                                                   |   |   |   |     |
| the title of the study?                           |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| **3. Introduction & Identification of             |   |   |   |     |
| Researchers:**                                    |   |   |   |     |
|                                                   |   |   |   |     |
| Are the researchers and divisional/departmental   |   |   |   |     |
| affiliation identified?                           |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| **4. Invitation & Purpose:**                      |   |   |   |     |
|                                                   |   |   |   |     |
| Is there an explanation of why the person is      |   |   |   |     |
| being asked to take part in the study,            |   |   |   |     |
|                                                   |   |   |   |     |
| Using language that avoids connotation of         |   |   |   |     |
| requirement or demand?                            |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| \*Is the purpose of the research clearly          |   |   |   |     |
| explained, including the fact that the study      |   |   |   |     |
|                                                   |   |   |   |     |
| Involves "research"?                              |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| **5. Procedures**                                 |   |   |   |     |
|                                                   |   |   |   |     |
| \*Is there a full and clear description of study  |   |   |   |     |
| procedures using non-technical                    |   |   |   |     |
|                                                   |   |   |   |     |
| language? (If appropriate, screening procedures   |   |   |   |     |
| should be included)                               |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| \*Are the duration of each procedure and total    |   |   |   |     |
| expected time of the subject's                    |   |   |   |     |
|                                                   |   |   |   |     |
| Participation stated?                             |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| \*Are procedures or elements of the procedure     |   |   |   |     |
| that are experimental clearly                     |   |   |   |     |
|                                                   |   |   |   |     |
| identified as such?                               |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| **6. Risks/Discomforts:**                         |   |   |   |     |
|                                                   |   |   |   |     |
| \* Is there a clear description of any reasonably |   |   |   |     |
| foreseeable risks or discomforts?                 |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| Is there a description of measures that will be   |   |   |   |     |
| taken to minimize these risks or                  |   |   |   |     |
|                                                   |   |   |   |     |
| discomforts?                                      |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+
| **7. Benefits:**                                  |   |   |   |     |
|                                                   |   |   |   |     |
| \*Is there a description of benefits to the       |   |   |   |     |
| subjects, to others, and to scientific            |   |   |   |     |
|                                                   |   |   |   |     |
| knowledge that may reasonably be expected from    |   |   |   |     |
| the research?                                     |   |   |   |     |
+---------------------------------------------------+---+---+---+-----+