### Appendix D

### Informed Consent Checklists 

**Review Date:\_\_\_\_\_\_\_\_\_**

**Informed Consent Checklist for Protocol \# \_\_\_\_\_\_\_\_\_\_**

CDC holds a Multiple Project Assurance with the Office for Protection
from Research Risks (OPRR), NIH, whereby CDC agrees to abide by the
requirements of Title 45 Code of Federal Regulations for the Protection
of Human Subjects (45 CFR 46).

Section 116 (§46.116) of the federal regulations gives the general
requirements for informed consent. The section reads, in part, "\...no
investigator may involve a human being as a subject in research covered
by this policy unless the investigator has obtained the legally
effective informed consent of the subject\..."

The purpose of this checklist is to aid you in your evaluation of the
informed consent documents accompanying each protocol to assure that
those required elements are included. Please use the blocks to make
notes or simply check that the basic requirement has been satisfactorily
addressed.

*All consent document must address the following three principles:*

+-----------+-----------------------------------------+---------------+
| **Requ    | **45 CFR 46.116**                       | **Consent     |
| irement** |                                         | form**        |
+-----------+-----------------------------------------+---------------+
| *Volun    | A. "An investigator shall               |               |
| tariness* | seek\...consent only under              |               |
|           | circumstances that provide the          |               |
|           | prospective subject\...sufficient       |               |
|           | opportunity to consider whether or not  |               |
|           | to participate\..."                     |               |
+-----------+-----------------------------------------+---------------+
|           | B. "\...and minimize the possibility of |               |
|           | coercion or undue influence."           |               |
+-----------+-----------------------------------------+---------------+
| *Compr    | "The information\...given to the        | Grade level:  |
| ehension* | subject\...shall be in language         |               |
|           | understandable to the subject\..." The  | SMOG:         |
|           | reading grade level and method (SMOG,   |               |
|           | Fry, Flesch-Kincaid) used to determine  | Fry:          |
|           | the reading grade level must be         |               |
|           | specified.                              | Fl            |
|           |                                         | esch-Kincaid: |
+-----------+-----------------------------------------+---------------+
| *         | No informed consent\... may include any |               |
| Coercion* | exculpatory language through which the  |               |
|           | subject\...is made to waive\...any of   |               |
|           | the subject's legal rights, or releases |               |
|           | the investigator, the sponsor or the    |               |
|           | institution \...from liability for      |               |
|           | negligence.                             |               |
+-----------+-----------------------------------------+---------------+

# **Minimal Risk**

The Federal Regulations divide research into that which is minimal or
not greater than minimal risk to the participant and that which is
greater than minimal risk. The definition of minimal risk given in
§46.102(I) reads as follows:

"Minimal risk means that the ***probability*** and ***magnitude*** of
harm or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests."

**Level of Risk for this protocol (please insert "minimal" or "greater
than minimal"):**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Required Elements of Informed Consent**

The Federal Regulations at §46.116 describes eight elements required in
each consent document. Element number six is only required if the
research is determined to be greater than minimal risk. This section
also lists an additional six elements that "When appropriate\...shall
also be provided to each subject."

Please use the following determination key when evaluating each element:

**Y** = appropriately included in the consent form

**N/A** = element not required for this study (IRB must waive and
document)

**M** = element missing (the consent form must be revised to include
this element or the requirement must be waived by the IRB)

**I** = incomplete or problematic

  ------------- ----------------------------------------------- ----------------
  **Element**   **45 CFR 46.116(a)**                            **Consent form**

  **1**         A. a statement that the study involves research 

                B. an explanation of the purposes of the        
                research                                        

                C. the expected duration of the subject's       
                participation                                   

                D. a description of the procedures to be        
                followed                                        

                E. 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**         A. an explanation as to whether any             
                compensation is available if injury occurs      

                B. an explanation as to whether any medical     
                treatments are available if injury occurs, and, 
                if so                                           

                C. what they consist of or where further        
                information may be obtained                     

  **7**         A. an explanation of whom to contact for        
                answers to pertinent questions about the        
                research                                        

                B. an explanation of whom to contact for        
                answers to pertinent questions about the        
                research subjects' rights                       

                C. whom to contact in the event of a            
                research-related injury to the subject          
  ------------- ----------------------------------------------- ----------------

+------+----------------------------------------------+---------------+
| **E  | **45 CFR 46.116(a)**                         | ##            |
| leme |                                              |  Consent Form |
| nt** |                                              |               |
+------+----------------------------------------------+---------------+
| *    | A. a statement that participation is         |               |
| *8** | voluntary                                    |               |
+------+----------------------------------------------+---------------+
|      | B. refusal to participate will involve no    |               |
|      | penalty or loss of benefits to which the     |               |
|      | subject is otherwise entitled                |               |
+------+----------------------------------------------+---------------+
|      | C. the subject may discontinue participation |               |
|      | at any time                                  |               |
|      |                                              |               |
|      | without penalty or loss of benefits to which |               |
|      | the subject is otherwise entitled            |               |
+------+----------------------------------------------+---------------+
| **Ad |                                              |               |
| diti |                                              |               |
| onal |                                              |               |
| elem |                                              |               |
| ents |                                              |               |
| (45  |                                              |               |
| CFR  |                                              |               |
| 4    |                                              |               |
| 6.11 |                                              |               |
| 6(b) |                                              |               |
| of   |                                              |               |
| info |                                              |               |
| rmed |                                              |               |
| con  |                                              |               |
| sent |                                              |               |
| (    |                                              |               |
| when |                                              |               |
| appr |                                              |               |
| opri |                                              |               |
| ate, |                                              |               |
| one  |                                              |               |
| or   |                                              |               |
| more |                                              |               |
| of   |                                              |               |
| the  |                                              |               |
| f    |                                              |               |
| ollo |                                              |               |
| wing |                                              |               |
| elem |                                              |               |
| ents |                                              |               |
| of   |                                              |               |
| inf  |                                              |               |
| orma |                                              |               |
| tion |                                              |               |
| s    |                                              |               |
| hall |                                              |               |
| also |                                              |               |
| be   |                                              |               |
| prov |                                              |               |
| ided |                                              |               |
| to   |                                              |               |
| each |                                              |               |
| sub  |                                              |               |
| ject |                                              |               |
| ):** |                                              |               |
+------+----------------------------------------------+---------------+
| *    | a statement that the particular treatment or |               |
| *1** | 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    |               |
| *2** | subject's participation                      |               |
|      |                                              |               |
|      | may be terminated by the investigator        |               |
|      | without regard to the subject's consent      |               |
+------+----------------------------------------------+---------------+
| *    | any additional costs to the subject that may |               |
| *3** | result from participation in the research    |               |
+------+----------------------------------------------+---------------+
| *    | A. the consequences of a subject's decision  |               |
| *4** | to withdraw from the research                |               |
+------+----------------------------------------------+---------------+
|      | B. procedures for orderly termination of     |               |
|      | participation by the subject                 |               |
+------+----------------------------------------------+---------------+
| *    | a statement that significant new findings    |               |
| *5** | developed during the course of the research  |               |
|      | which may relate to the subject's            |               |
|      | willingness to continue participation will   |               |
|      | be provided to the subject                   |               |
+------+----------------------------------------------+---------------+
| *    | the approximated number of subjects involved |               |
| *6** | in the study                                 |               |
+------+----------------------------------------------+---------------+