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

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

+------------------------------------+---+---+---+--------------------------+
| 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 |                          |
+------------------------------------+---+---+---+--------------------------+
| A. Protocol Title. Protocol title  |   |   |   |                          |
| used consistently on all documents |   |   |   |                          |
| and multi-protocol proposal        |   |   |   |                          |
| referenced appropriately. (AR      |   |   |   |                          |
| 70-25, App B-1)                    |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| B. Scientific Review. PI has       |   |   |   | Date of scientific       |
| responded appropriately to         |   |   |   | review:                  |
| recommendations of the Scientific  |   |   |   |                          |
| Review Committee. (32 CFR §        |   |   |   |                          |
| 219.115(a)(1); AR 70-25, 2-9c.(6), |   |   |   |                          |
| 3-2c.(3), App. B-17; OTSG 15-2,    |   |   |   |                          |
| 6.a.(2))                           |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| C. Institutional Committee(s)      |   |   |   | Date(s) of approval:     |
| Review. As appropriate, review by  |   |   |   |                          |
| Radiation Control Committee,       |   |   |   |                          |
| Biosafety Committee, BioMedical    |   |   |   |                          |
| Engineering Committee, other is    |   |   |   |                          |
| completed. PI has responded        |   |   |   |                          |
| appropriately to recommendations.  |   |   |   |                          |
| (AR 70-25, 3-2c.(4))               |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| D. IRB/HURC Approval.              |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Local IRBs have OHRP FWA or    |   |   |   | Assurance Number(s):     |
| DOD Assurance. (AR 70-25, 3-2k.;   |   |   |   |                          |
| DOD Guidance Memo (10 Jun 93))     |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Appropriate local IRB(s)       |   |   |   | Name of IRB of Record:   |
| reviewed and approved protocol.    |   |   |   |                          |
| (32 CFR § 219.111; 21 CFR §        |   |   |   | Date of initial review   |
| 56.109; 21 CFR § 56.115; AR 70-25, |   |   |   | and approval of local    |
| App B-15, App B-17, App C-2)       |   |   |   | IRB(s):                  |
+------------------------------------+---+---+---+--------------------------+
| 3\. Assigned IRB number and title  |   |   |   |                          |
| in protocol are consistent with    |   |   |   |                          |
| IRB number and title in IRB        |   |   |   |                          |
| approval letter.                   |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. IRB of Record assigned risk    |   |   |   | Risk Level:              |
| level to protocol. (AR 70-25,      |   |   |   |                          |
| 3-1e.)                             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 5\. IRB has specified date by      |   |   |   | Date continuing review   |
| which continuing review report is  |   |   |   | report due:              |
| due. (AR 70-25, 3-2e.(1)(f); OTSG  |   |   |   |                          |
| 15-2, 7.)                          |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| E. Study Locations. A list of all  |   |   |   |                          |
| facilities and study locations are |   |   |   |                          |
| provided. (AR 70-25, App B-3)      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| F. Protocol Timeline. Projected    |   |   |   |                          |
| start and completion times are     |   |   |   |                          |
| provided as appropriate. (AR       |   |   |   |                          |
| 70-25, App B-4)                    |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| G. Description of Protocol Drugs   |   |   |   |                          |
| or Devices. (AR 70-25, App B-5,    |   |   |   |                          |
| Review of IND Protocols SOP,       |   |   |   |                          |
| Review of Medical Device Protocols |   |   |   |                          |
| SOP)                               |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| H. Purpose. Purpose of the study   |   |   |   |                          |
| and/or research objectives,        |   |   |   |                          |
| questions, and/or hypotheses are   |   |   |   |                          |
| provided. (AR 70-25, App B-5)      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 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 |                          |
+------------------------------------+---+---+---+--------------------------+
| I. Research Design.                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Research design is described.  |   |   |   |                          |
| (AR 70-25, App B-5, App B-6).      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Subject identification. Code   |   |   |   |                          |
| system to be used to maintain      |   |   |   |                          |
| subject identification is          |   |   |   |                          |
| described. (AR 70-25, App B-5, App |   |   |   |                          |
| B-6)                               |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. Subject assignment.            |   |   |   |                          |
| Randomization process or other     |   |   |   |                          |
| procedures used for subject group  |   |   |   |                          |
| assignments is described.          |   |   |   |                          |
|                                    |   |   |   |                          |
| (AR 70-25, App B-5, App B-6)       |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| J. Study Population and Sample.    |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Target population is           |   |   |   |                          |
| described. (AR 70-25, App B-5, App |   |   |   |                          |
| B-6)                               |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Sample size justification      |   |   |   |                          |
| demonstrates that the proposed     |   |   |   |                          |
| number of subjects is the minimum  |   |   |   |                          |
| needed to achieve the research     |   |   |   |                          |
| objectives. (AR 70-25, 3-1h.)      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. Sampling Method. Sampling      |   |   |   |                          |
| method is described.               |   |   |   |                          |
|                                    |   |   |   |                          |
| (AR 70-25, App B-6)                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. Inclusion and exclusion        |   |   |   |                          |
| criteria are listed. (AR 70-25,    |   |   |   |                          |
| App B-6)                           |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 5\. Pregnancy exclusion            |   |   |   |                          |
| procedures. If applicable,         |   |   |   |                          |
| addresses pregnancy testing and    |   |   |   |                          |
| contraceptive practices. (AR       |   |   |   |                          |
| 70-25, App B-6; HSRRB Clause,      |   |   |   |                          |
| "Pregnancy Prevention")            |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 6\. Biomedical and behavioral      |   |   |   |                          |
| research involving prisoners as    |   |   |   |                          |
| subjects. If applicable, must      |   |   |   |                          |
| comply with Federal, DOD, State,   |   |   |   |                          |
| and local law. (Subpart C, 45 CFR  |   |   |   |                          |
| § 46.306; 32 CFR § 219.111(b); AR  |   |   |   |                          |
| 70-25, App C-4c.; OTSG 15-2, App   |   |   |   |                          |
| B-3)                               |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| K. Recruitment and Informed        |   |   |   |                          |
| Consent Process.                   |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. The recruitment process is     |   |   |   |                          |
| described and recruitment and/ or  |   |   |   |                          |
| advertisement materials provided.  |   |   |   |                          |
| (21 CFR § 312.7; AR 70-25, 3-1p.;  |   |   |   |                          |
| OTSG 15-2, App B-1; FDA            |   |   |   |                          |
| Information Sheet, "Recruiting     |   |   |   |                          |
| Study Subjects")                   |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. An appropriate informed        |   |   |   |                          |
| consent process that takes place   |   |   |   |                          |
| prior to the subject participating |   |   |   |                          |
| in the research is described.      |   |   |   |                          |
| Individuals are given adequate     |   |   |   |                          |
| time to review and understand all  |   |   |   |                          |
| information before agreeing to     |   |   |   |                          |
| take part in the study. The        |   |   |   |                          |
| possibility of coercion and undue  |   |   |   |                          |
| influence is minimized. (32 CFR §  |   |   |   |                          |
| 219.116; AR 70-25, 3-1a.,f.,j.;    |   |   |   |                          |
| OTSG 15-2, 6.a.(5), (8), (9))      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+

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

                                       Yes          No   N/A   

  3\. Intent to Benefit. If subjects                           
  cannot give their own consent to                             
  participate in the study, there is                           
  an intent to benefit each such                               
  subject enrolled in the study. See                           
  HSRRB Clause on 10 USC 980. (10 USC                          
  980; AR 70-25, 3-1o.; OTSG 15-2,                             
  6.a.(5))                                                     

  4\. Consent of Legally Authorized                            
  Representative. If subjects cannot                           
  give their own consent to                                    
  participate in the study, there is a                         
  plan for consent of the individual's                         
  legally authorized representative to                         
  be obtained prior to the subject's                           
  participation in the study. (AR                              
  70-25, 3-1o.(3); OTSG 15-2, 6.a.(8))                         

  5\. Consent for Medical or Surgical                          
  Procedures. Procedural consents for                          
  standard procedures performed as                             
  part of the research study are                               
  provided. (OTSG 15-2, 6.a.(1))                               

  L. Data Collection.                                          

  1\. Screening procedures.                                    
  Evaluations (lab, history, physical                          
  exam) required to determine                                  
  eligibility/suitability for study                            
  participation are described. (AR                             
  70-25, App B-6, App B-7)                                     

  2\. Laboratory Evaluations. Data                             
  collection procedures are described.                         
  Examples include: lab evaluations,                           
  specimens, special precautions,                              
  labeling and storage procedures. (AR                         
  70-25, App B-6, App B-7)                                     

  3\. Clinical assessments. Clinical                           
  assessments, such as the schedule of                         
  clinical evaluations and follow-up                           
  procedures, are described. (AR                               
  70-25, App B-7, App B-11)                                    

  4\. Research instruments. Research                           
  instruments, such as case report                             
  forms, data collection forms,                                
  questionnaires, rating scales, and                           
  interview guides, are described. (AR                         
  70-25, Apps B-6, B-7, B-9, B-11,                             
  OTSG 15-2, 6.a.(6), 6.a.(7))                                 

  M. Data Management.                                          

  1\. Data analysis. Data analysis                             
  plan is consistent with study                                
  objectives. (AR 70-25, App B-6, App                          
  B-7)                                                         

  2\. Disposition of Data. Where, how                          
  and by whom data will be stored and                          
  the length of time data will be                              
  stored are described. (AR 70-25,                             
  Apps B-6, B-7; OTSG 15-2, 6.a.(6),                           
  6.a.(7))                                                     

  3\. Confidentiality. Where                                   
  appropriate, there are adequate                              
  provisions to protect the privacy of                         
  subjects and maintain the                                    
  confidentiality of data. (AR 70-25,                          
  Apps B-6, B-7, E-7; OTSG 15-2,                               
  6.a.(6), 6.a.(7))                                            

  4\. For extramural studies, there                            
  should be a statement that                                   
  representatives of the DOD may                               
  inspect the records. See HSRRB                               
  Clause on review of records by MRMC                          
  (AR 70-25 App E-7; OTSG 15-2,                                
  6.a.(7))                                                     
  ------------------------------------ ------------ ---- ----- ---------------------------

+------------------------------------+---+---+---+--------------------------+
| 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 |                          |
+------------------------------------+---+---+---+--------------------------+
| N. Risks/Benefits Assessment.      |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Risks. Risks to subjects and   |   |   |   |                          |
| study personnel are adequately     |   |   |   |                          |
| described. (AR 70-25, App B-6;     |   |   |   |                          |
| OTSG 15-2, 6.a.(1), (3))           |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. Precautions. Measures to be    |   |   |   |                          |
| taken to minimize or manage risks  |   |   |   |                          |
| to subjects and study personnel    |   |   |   |                          |
| are described.                     |   |   |   |                          |
|                                    |   |   |   |                          |
| (AR 70-25, App B-6)                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. Special care needs. Special    |   |   |   |                          |
| medical/nursing care and equipment |   |   |   |                          |
| that will be needed for subjects   |   |   |   |                          |
| are described.                     |   |   |   |                          |
|                                    |   |   |   |                          |
| (AR 70-25, App B-6)                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. Benefits. Benefits of research |   |   |   |                          |
| to subjects are appropriately      |   |   |   |                          |
| described. Note that if there are  |   |   |   |                          |
| no benefits, this should be        |   |   |   |                          |
| stated. Also, payment for research |   |   |   |                          |
| participation is not a benefit.    |   |   |   |                          |
| (AR 70-25, App B-6)                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| O. Study Personnel.                |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 1\. Biosketch of Principal &       |   |   |   |                          |
| Associate Investigators indicate   |   |   |   |                          |
| qualified for position. (AR 70-25, |   |   |   |                          |
| App B-17d.)                        |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 2\. A description of roles and     |   |   |   |                          |
| responsibilities of study          |   |   |   |                          |
| personnel is provided. Personnel   |   |   |   |                          |
| conducting the research are        |   |   |   |                          |
| appropriate for their assigned     |   |   |   |                          |
| roles and responsibilities. (AR    |   |   |   |                          |
| 70-25, 3-1p., 3-1q.)               |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 3\. If GTMR, PI has no conflict of |   |   |   |                          |
| interest. If appropriate, Conflict |   |   |   |                          |
| of Interests declared in written   |   |   |   |                          |
| statement by investigator(s);      |   |   |   |                          |
| includes description of measures   |   |   |   |                          |
| to eliminate, manage or reduce     |   |   |   |                          |
| COIs. (HSRRB Policy Memo)          |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 4\. If GTMR, Medical Monitor is    |   |   |   |                          |
| assigned to protocol, role and     |   |   |   |                          |
| responsibilities are described, &  |   |   |   |                          |
| biosketch indicates qualified for  |   |   |   |                          |
| position. (AR 70-25, 2-9e., 3-1r., |   |   |   |                          |
| 3-2e.(2)(c), App B-14)             |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| 5\. Medical Monitor's role is      |   |   |   |                          |
| appropriately described, and the   |   |   |   |                          |
| Medical Monitor has no apparent    |   |   |   |                          |
| conflict of interest. Medical      |   |   |   |                          |
| Monitor not under supervision of   |   |   |   |                          |
| PI or other investigators or       |   |   |   |                          |
| research staff. Exceptions may be  |   |   |   |                          |
| made. (AR 70-25, 2-9e., 3-1q., App |   |   |   |                          |
| B-14; HSRRB Policy Memo)           |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| P. Protocol Modification. The      |   |   |   |                          |
| procedure to be followed if the    |   |   |   |                          |
| protocol is modified, terminated,  |   |   |   |                          |
| or extended is described. (AR      |   |   |   |                          |
| 70-25, 2-9c.(6), App B-10)         |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+
| Q. Protocol Departure. The         |   |   |   |                          |
| procedure to be followed if        |   |   |   |                          |
| departure from the protocol should |   |   |   |                          |
| occur (including who will be       |   |   |   |                          |
| notified) is described. (AR 70-25, |   |   |   |                          |
| App B-8)                           |   |   |   |                          |
+------------------------------------+---+---+---+--------------------------+

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

                                       Yes          No   N/A   

  R. Withdrawal from Protocol.                                 

  1\. The consequences of a subject\'s                         
  decision to withdraw and procedures                          
  for orderly end of subject\'s                                
  participation are described, if                              
  appropriate. (32 CFR §                                       
  219.116(b)(4); AR-70-25, App E-9,                            
  App E-11)                                                    

  2\. Anticipated circumstances under                          
  which the subject\'s participation                           
  may be terminated by the                                     
  investigator are described, if                               
  appropriate. (32 CFR §                                       
  219.116(b)(2); AR 70-25 App E-11)                            

  S. Adverse Event Reporting. Plan for                         
  reporting unanticipated problems to                          
  subject or others included in                                
  protocol. See HSRRB Clause on                                
  Reporting of Serious and Unexpected                          
  Adverse Events. (AR 70-25, 2-9c.(4),                         
  App B-9; OTSG 15-2, 4.e.(2); HSRRB                           
  Policy Memo)                                                 

  T. Medical Care for Research Related                         
  Injury. Medical care for research                            
  related injuries must be provided to                         
  subjects at no cost to them. Ensure                          
  that there is no language in the                             
  protocol stating that this medical                           
  care will not be provided. (AR                               
  70-25, 3-1k.)                                                

  U. Volunteer Registry Database. If a                         
  GTMR intramural study, a plan for                            
  collection of Volunteer Registry                             
  Data Sheets is included in protocol.                         
  See HSRRB Clause on Volunteer                                
  Registry Data Base Requirements. (AR                         
  70-25, App H)                                                
  ------------------------------------ ------------ ---- ----- ---------------------------

Additional Comments