Date Checklist Completed:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline} PI:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

Date Checklist Updated:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}
Reviewer's Signature:
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

  ------------------------------------ ------------ ---- ----- ---------------------------
  Elements                             Is Element              Comments
                                       Addressed?              

                                       Yes          No   N/A   

  A. Research Description.                                     

  1\. Title and location of study                              
  consistent with protocol. (AR 70-25,                         
  App E-1; OTSG 15-2, App B-1a.)                               

  2\. A statement that the study                               
  involves research and an explanation                         
  of the purpose and objectives of the                         
  research. (32 CFR § 219.116(a)(1);                           
  AR 70-25, App E-3; OTSG 15-2, App                            
  B-1c.)                                                       

  3\. The expected duration of the                             
  subject\'s participation. (OTSG                              
  15-2, App B-1d.)                                             

  4\. The approximate number of                                
  subjects in the study. (32 CFR §                             
  219.116(b)(6); AR 70-25, App E-11f.;                         
  OTSG 15-2, App B-2f.)                                        

  5\. A description of the procedures                          
  followed, and identification of any                          
  procedure that is experimental.                              
  (OTSG 15-2, App B-1e.)                                       

  6\. Inclusion and exclusion                                  
  criteria. (OTSG 15-2, App B-1c.(5))                          

  7\. The precautions to be observed                           
  by the subject before or after the                           
  study (AR 70-25, App E-11g.; OTSG                            
  15-2, App B-2g.; HSRRB Clause 9.01,                          
  Pregnancy Prevention)                                        

  8\. Information about prior,                                 
  similar, or related studies. (AR                             
  70-25, App E-3)                                              

  B. Risks.                                                    

  1\. Description of reasonably                                
  foreseeable risks and discomforts                            
  and methods for minimizing them. (32                         
  CFR § 219.116(a)(2); AR-70-25, App                           
  E-4; OTSG 15-2, App B-1f.)                                   

  2\. A statement that the treatment                           
  or procedure may cause risks to the                          
  subject (or embryo or fetus) which                           
  are currently unforeseeable.                                 
  (Subpart B, 45 CFR § 46.205; 32 CFR                          
  § 219.116(b)(1); AR 70-25, App                               
  E-11a.; OTSG 15-2, App B-2a.)                                

  3\. Description of possible genetic                          
  effects to the offspring of males                            
  (AR 70-25, App E-11a.)                                       

  4\. HSRRB Clause on Investigational                          
  New Drugs. (OTSG 15-2, App B-1e.(3))                         

  C. Benefits.                                                 

  1\. Description of benefits to the                           
  subject or others. (32 CFR §                                 
  219.116(a)(3); AR-70-25, App E-5;                            
  OTSG 15-2, App B-1g.)                                        

  2\. Explanation of whether the                               
  results of the research will be made                         
  available to the subject (AR 70-25,                          
  App E-11i.)                                                  
  ------------------------------------ ------------ ---- ----- ---------------------------

+------------------------------------+---+---+---+--------------------------+
| Elements                           | I |   |   | Comments                 |
|                                    | s |   |   |                          |
|                                    | E |   |   |                          |
|                                    | l |   |   |                          |
|                                    | e |   |   |                          |
|                                    | m |   |   |                          |
|                                    | e |   |   |                          |
|                                    | n |   |   |                          |
|                                    | t |   |   |                          |
|                                    | A |   |   |                          |
|                                    | d |   |   |                          |
|                                    | d |   |   |                          |
|                                    | r |   |   |                          |
|                                    | e |   |   |                          |
|                                    | s |   |   |                          |
|                                    | s |   |   |                          |
|                                    | e |   |   |                          |
|                                    | d |   |   |                          |
|                                    | ? |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
|                                    | Y | N | N |                          |
|                                    | e | o | / |                          |
|                                    | s |   | A |                          |
+------------------------------------+---+---+---+--------------------------+
| D. Alternatives to Participation.  |   |   |   |                          |
| Disclosure of appropriate          |   |   |   |                          |
| alternative procedures or courses  |   |   |   |                          |
| of treatment, if any, which may be |   |   |   |                          |
| advantageous to the subject. (32   |   |   |   |                          |
| CFR § 219.116(a)(4); AR 70-25, App |   |   |   |                          |
| E-6; OTSG 15-2, App B-1h.)         |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| E. Payment/Costs.                  |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Where private citizens are     |   |   |   |                          |
| enrolled, "Other than medical care |   |   |   |                          |
| that may be provided and any other |   |   |   |                          |
| payment specifically stated in the |   |   |   |                          |
| consent form, there is no other    |   |   |   |                          |
| compensation available for your    |   |   |   |                          |
| participation in this research."   |   |   |   |                          |
| (OTSG 15-2, App B-1j.)             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Additional costs to the        |   |   |   |                          |
| subject that may result from       |   |   |   |                          |
| participation in the research. (32 |   |   |   |                          |
| CFR § 219.116(b)(3); AR 70-25, App |   |   |   |                          |
| E-11c.; OTSG 15-2, App B-2c.)      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| F. Possible Sample                 |   |   |   |                          |
| Donation/Commercial Products. See  |   |   |   |                          |
| Clause on Sample Donation (AR      |   |   |   |                          |
| 70-25, 3-1c., 3-1d.)               |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| ## G. Medica                       |   |   |   |                          |
| l Care for Research Related Injury |   |   |   |                          |
| . For research involving more than |   |   |   |                          |
|  minimal risk, a statement that me |   |   |   |                          |
| dical treatment will be provided f |   |   |   |                          |
| or injury proximate to enrollment  |   |   |   |                          |
| in the study. See HSRRB Clause, Me |   |   |   |                          |
| dical Care for Research Related In |   |   |   |                          |
| jury (32 CFR § 219.116(a)(6); AR 7 |   |   |   |                          |
| 0-25, 3-1k.; OTSG 15-2, App B-1j.) |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| H. Confidentiality.                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. A statement describing the     |   |   |   |                          |
| extent to which confidentiality of |   |   |   |                          |
| records identifying the subject    |   |   |   |                          |
| will be maintained. See HSRRB      |   |   |   |                          |
| Clause on Review of Research       |   |   |   |                          |
| Records. (32 CFR § 219.116(a)(5);  |   |   |   |                          |
| AR 70-25, App E-7; OTSG 15-2, App  |   |   |   |                          |
| B-1i.)                             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. For investigational drug or    |   |   |   |                          |
| device studies, a statement that   |   |   |   |                          |
| FDA and MRMC representatives may   |   |   |   |                          |
| review the records. For contractor |   |   |   |                          |
| studies, a statement that DOD may  |   |   |   |                          |
| inspect the records. See HSRRB     |   |   |   |                          |
| Clause on Review of Research       |   |   |   |                          |
| Records. (AR 70-25, App E-7)       |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. Alternative statement about    |   |   |   |                          |
| confidentiality of information for |   |   |   |                          |
| studies using military personnel   |   |   |   |                          |
| as subjects. (OTSG 15-2, App       |   |   |   |                          |
| B-1i.)                             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. If photographs are taken, the  |   |   |   |                          |
| degree to which actions will be    |   |   |   |                          |
| taken to protect the identity of   |   |   |   |                          |
| the subject is described. (AR      |   |   |   |                          |
| 70-25, App E-11h.)                 |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| I. Participation and Withdrawal.   |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. A statement that participation |   |   |   |                          |
| is voluntary, refusal to           |   |   |   |                          |
| participate will involve no        |   |   |   |                          |
| penalty or loss of benefits, the   |   |   |   |                          |
| subject may withdraw at any time   |   |   |   |                          |
| without penalty or loss of         |   |   |   |                          |
| benefits. See HSRRB Clause on      |   |   |   |                          |
| Participation. (32 CFR §           |   |   |   |                          |
| 219.116(a)(8); AR 70-25, App E-9;  |   |   |   |                          |
| OTSG 15-2, App B-1l.)              |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Assent is obtained from        |   |   |   |                          |
| minors, if applicable (consider    |   |   |   |                          |
| age, maturity, psychological       |   |   |   |                          |
| state) or conditions for waiver of |   |   |   |                          |
| assent are met. Assent form should |   |   |   |                          |
| be provided when applicable. (AR   |   |   |   |                          |
| 70-25, 3-1o.)                      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| Elements                           | I |   |   | Comments                 |
|                                    | s |   |   |                          |
|                                    | E |   |   |                          |
|                                    | l |   |   |                          |
|                                    | e |   |   |                          |
|                                    | m |   |   |                          |
|                                    | e |   |   |                          |
|                                    | n |   |   |                          |
|                                    | t |   |   |                          |
|                                    | A |   |   |                          |
|                                    | d |   |   |                          |
|                                    | d |   |   |                          |
|                                    | r |   |   |                          |
|                                    | e |   |   |                          |
|                                    | s |   |   |                          |
|                                    | s |   |   |                          |
|                                    | e |   |   |                          |
|                                    | d |   |   |                          |
|                                    | ? |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
|                                    | Y | N | N |                          |
|                                    | e | o | / |                          |
|                                    | s |   | A |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. The consequences of a          |   |   |   |                          |
| subject\'s decision to withdraw    |   |   |   |                          |
| and procedures for orderly end of  |   |   |   |                          |
| subject\'s participation. (32 CFR  |   |   |   |                          |
| § 219.116(b)(4); AR-70-25, App     |   |   |   |                          |
| E-11d.; OTSG 15-2, App B-2d.)      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. Anticipated circumstances      |   |   |   |                          |
| under which the subject\'s         |   |   |   |                          |
| participation may be terminated by |   |   |   |                          |
| the investigator. (32 CFR §        |   |   |   |                          |
|                                    |   |   |   |                          |
| 219.116(b)(2); AR 70-25, App       |   |   |   |                          |
| E-11b.; OTSG 15-2, App B-2b.)      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 5\. A statement that significant   |   |   |   |                          |
| new findings developed during the  |   |   |   |                          |
| course of research which may       |   |   |   |                          |
| relate to the subject's            |   |   |   |                          |
| willingness to continue            |   |   |   |                          |
| participation will be provided.    |   |   |   |                          |
| (32 CFR § 219.116(b)(5); AR 70-25, |   |   |   |                          |
| App E-11e.; OTSG 15-2, App B-2e.)  |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| J. Contact Information Provided.   |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Whom to contact with questions |   |   |   |                          |
| about the research, including name |   |   |   |                          |
| or office and telephone numbers.   |   |   |   |                          |
| (32 CFR § 219.116(a)(7); AR 70-25, |   |   |   |                          |
| App E-8)                           |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Whom to contact with questions |   |   |   |                          |
| about subjects rights including    |   |   |   |                          |
| name or office and telephone       |   |   |   |                          |
| numbers. (32 CFR § 219.116(a)(7);  |   |   |   |                          |
| AR 70-25, App E-8; OTSG 15-2, App  |   |   |   |                          |
| B-1k.)                             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. Whom to contact in the event   |   |   |   |                          |
| of a research-related injury       |   |   |   |                          |
| including name or office and       |   |   |   |                          |
| telephone numbers. (32 CFR §       |   |   |   |                          |
| 219.116(a)(7); AR 70-25, App E-8;  |   |   |   |                          |
| OTSG 15-2, App B-1k.)              |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. Name and contact information   |   |   |   |                          |
| for the principal investigator.    |   |   |   |                          |
| (AR 70-25, App E-2; OTSG 15-2, App |   |   |   |                          |
| B-1b.)                             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| K. Volunteer Registry. For GTMR    |   |   |   |                          |
| intramural studies, see HSRRB      |   |   |   |                          |
| Clause on Volunteer Registry Data  |   |   |   |                          |
| Base Requirements. (AR-70-25, App  |   |   |   |                          |
| H)                                 |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| L. Documentation.                  |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Printed or typed name and      |   |   |   |                          |
| signature of the subject or        |   |   |   |                          |
| legally authorized representative  |   |   |   |                          |
| (21 CFR § 50.27; AR 70-25, DA      |   |   |   |                          |
| 5303-R; OTSG 15-2, App B-1m.)      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Permanent address of subject.  |   |   |   |                          |
| (AR 70-25, DA 5303-R; OTSG 15-2,   |   |   |   |                          |
| App B-1m.)                         |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. Printed or typed name and      |   |   |   |                          |
| signature of witness. (32 CFR §    |   |   |   |                          |
| 219.117(b)(2); AR 70-25, DA        |   |   |   |                          |
| 5303-R, OTSG 15-2, App B-1m.,      |   |   |   |                          |
| HSRRB Policy Memo, "Witness        |   |   |   |                          |
| Requirement for Informed Consent   |   |   |   |                          |
| Process and Form")                 |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. Copy to be provided to subject |   |   |   |                          |
| and legal representative. (OTSG    |   |   |   |                          |
| 15-2, App B-1c.(6))                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 5\. Consent for photos or          |   |   |   |                          |
| audiotapes. (AR 70-25, App E-11h.) |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 6\. Separate documentation of the  |   |   |   |                          |
| consent if donated samples may be  |   |   |   |                          |
| used in future research studies    |   |   |   |                          |
| and/or have some commercial        |   |   |   |                          |
| applicability. See HSRRB Clause on |   |   |   |                          |
| Sample Donation. (AR 70-25, 3-1c., |   |   |   |                          |
| 3-1d.)                             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+

  ------------------------------------ ------------ ---- ----- ---------------------------
  Elements                             Is Element              Comments
                                       Addressed?              

                                       Yes          No   N/A   

  7\. Documentation of consent for HIV                         
  antibody testing, if scheduled, may                          
  be addressed in the body of the                              
  consent form or as separate HIV test                         
  consent form.                                                

  M. Presentation and Language.                                

  1\. The document is free from any                            
  exculpatory language through which                           
  the subject or representative is                             
  made to waive or appear to waive any                         
  of the subject's legal rights, or                            
  releases or appears to release the                           
  investigator, the sponsor, the                               
  institution or its agents from                               
  liability for negligence. (32 CFR §                          
  219.116)                                                     

  2\. The document avoids used of the                          
  term "I understand" and does not                             
  require subjects to certify                                  
  completeness of disclosure, make                             
  claims of effectiveness that may                             
  unduly influence subjects, or                                
  include explicit statements that an                          
  IRB has approved solicitation of                             
  subjects to participate in research.                         
  (FDA Guide to Informed Consent)                              

  3\. The document presented meets the                         
  following requirements: (32 CFR §                            
  219.116, AR 70-25, 3-2d.; OTSG 15-2,                         
  App B-1c.)                                                   

  a\. Legible                                                  

  b\. Adequate font size                                       

  c\. At a reading level appropriate                           
  for the subjects (8^th^ grade                                
  education level recommended for                              
  adults).                                                     

  d\. Written in the second person.                            
  (FDA Guide to Informed Consent)                              

  e\. Appropriate translation provided                         
  when necessary. (HSRRB Clause 5.0,                           
  Certification of Consent Form                                
  Translation)                                                 

  N. Supportive Materials -- Any                               
  additional information used in the                           
  consent process has been reviewed                            
  (e.g., information sheets, videos,                           
  visit schematic).                                            
  ------------------------------------ ------------ ---- ----- ---------------------------

Additional Comments