Abstract:
The present invention (referred to herein as EthAssist) is a computer software application that delivers healthcare, life sciences, and academic industries professionals and educators an integration of academic and applied bioethics for daily use in their facilities. EthAssist provides a standardized methodology and process for gathering information supported by a comprehensive searchable body of current, relevant, academic research on clinical ethics topics specific to four knowledge bases: Knowledge-ICB, EthicsConsult, Curriculum Builder, and Internal Review Board Quality Assurance (IRBQA).

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a Non-provisional application that claims the benefit of U.S. Provisional Application Ser. No. 61/709,443, titled HEALTHCARE ORGANIZATIONAL TOOLKIT FOR ETHICS, filed Oct. 4, 2012, which is incorporated by reference herein. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to the field of ethics training, more particularly, this invention relates to a real-time system that provides a database with current materials on ethics topics in the sciences, medical, research, and other professions capable of being searched and compiled into a customizable format for dissemination to professionals, students, and administrators. 
       BACKGROUND OF THE INVENTION 
       [0003]    Many organizations lack bioethics manpower and expertise, and tackle ethics-related issues by engaging a variety of staff or others who may possess limited knowledge about bioethics best practices. By doing so, they often experience decision-making difficulty and run the risk of significant exposure when serious issues arise. There are no similar tools on the market currently that can be used by any healthcare facility or life science business that has a requirement for an ethics function. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention (referred to as herein as EthAssist) is a computer software application that delivers healthcare, life sciences, and academic industries professionals and educators an integration of academic and applied bioethics for daily use in their facilities. EthAssist provides a standardized methodology and process for gathering information supported by a comprehensive searchable body of current, relevant, academic research on clinical ethics topics specific to four knowledge bases: 
         [0005]    Clinical Ethics—serving healthcare facilities and universities focusing on medical ethics; 
         [0006]    Clinical Research Ethics—serving the life science industries and universities; 
         [0007]    Public Health Ethics—serving government organizations supporting preparedness planning and community initiatives; and 
         [0008]    Healthcare Organizational Ethics—serving all life science and healthcare organizations with compliance and culture initiatives. 
         [0009]    EthAssist can be used by any healthcare facility or life science business that has a requirement for an ethics function. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The present invention is illustratively shown and described in reference to the accompanying drawings, in which: 
           [0011]      FIG. 1  is a system diagram of the present invention; 
           [0012]      FIGS. 2A and 2B  are system diagrams that depict the interrelationship of EthAssist modules and human and machine interfaces; 
           [0013]      FIGS. 3A-3C  is an example of a report generated by the present invention; 
           [0014]      FIGS. 4A-4E  is an illustration of an exemplary database schema of the present invention; 
           [0015]      FIG. 5  is an exemplary database structure of the present invention; 
           [0016]      FIGS. 6A-6G  are web page screen shots examples of the present invention; 
           [0017]      FIGS. 7A-7F  are exemplary questions that can be asked during an interview and match the prototype functionally; 
           [0018]      FIGS. 8A-8P  is a conceptual diagram of Curriculum Builder module; 
           [0019]      FIGS. 8A-8K  are screen shots of the Educator Template process; 
           [0020]      FIGS. 8L-8Q  are screen shots of the Student My Lessons process; and 
           [0021]    FIGS.  9 A 1 - 9 M 2  are the flow charts that document decision points and warning or critical responses to questions and “Calls” to send and receive information to Knowledge-ICB. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    Now turning to  FIG. 1  that illustrates an overview of an exemplary computer system of the present invention  10 . The present invention (referred to herein as EthAssist) is a Saas (Software as a service) technical software model  12 , which is software that resides on a remote computer server  14  and data storage  16  managed by an outside service that guarantees capacity, network speed, and security back up. This strategy also provides system access by users  18  from anywhere (for example, location A—first personal computer, location B—laptop, location C—mobile device, location D—second personal computer, etc.) in the world via the internet cloud  20 . Though the exemplary system  10  illustrates ethics topics, system  10  is not limited to ethics topics. System  10  can be setup for educating any subject matter using the same RLO concept. 
         [0023]    Core Idea 
         [0024]    Now turning to  FIGS. 2A and 2B  for illustrations of EthAssist  10  that can comprise four software modules: Knowledge-ICB  22 , EthicsConsult  26 , Curriculum Builder  28 , and Internal Review Board Quality Assurance (IRBQA)  30 . Knowledge-ICB  22  and in a category of Tools-ICB  24  (previously referred to as Reliance-ICB), are the other three software modules: EthicsConsult  26 , Curriculum Builder  28 , and Internal Review Board Quality Assurance (IRBQA)  30 . The core idea of the product is the bridge and integration of Knowledge-ICB  22  (the academic modules), and Tools-ICB  24  (the applied ethics module). The intelligence built into components of Tools-ICB  24  extracts information from Knowledge-ICB  22  integrating it into the other modules  26 ,  28 ,  30  as required and directed by the users  18 . This integration provides users  18  with relevant ethics learning or process guidance, in a 24/7 environment, pertinent to the situation at-hand. 
         [0025]    EthicsConsult  26  and IRBQA  30  are self-documenting tools. Both use embedded logic trees with decision points as indicated in  FIGS. 7A-7F . A report  34  is generated at the conclusion of each tool processing documents, questions posed, and corresponding responses. IRBQA  30  reports critical and warning messages based on the importance of the question and response. See  FIG. 3  for an example of a report  34 . 
         [0026]    In  FIGS. 2A and 2B , the block labeled “Ethical Considerations”  36  are thought processes humans inject as indicated on  FIG. 7C  steps  34  and  40 , into decisions based on conditions presented by the software. In both EthicsConsult  26  and IRBQA  30 , the interviewer or IRB member has the option to extract an RLO from Knowledge-ICB regarding the particular ethics situation. This on the spot education would be available to be viewed by anyone involved in the EthicsConsult or IRBQA process. 
         [0027]      FIGS. 2A and 2B  depict the interrelationship of EthAssist modules and human and machine interfaces. Interfaces between Knowledge-ICB  22  and EthicsConsult  26 ,  FIG. 1A , and interfaces between Knowledge-ICB  22  and IRBQA  30 ,  FIG. 2A , are similar in nature. In both cases intelligent logic, is built into each of the tools. The logic is driven by the human interface responses to questions the software presents to either an interviewer, or internal review board committee member depicted on the flow charts as “Input/Facts of Industry Segments”  32 . 
         [0028]    The Curriculum Builder module  28 , depicted on  FIG. 2A , relies heavily on the human interface (Input/Fact of Industry Segments  38 ) and data interface  40  to Knowledge-ICB  22 . The Curriculum Builder module  28  allows educators to extract predetermined lessons and classes  42 , use them as is, modify existing or build customized education by the Course Developer  44  to build a course  46  that suites the needs of a medical facility, clinical research organization or university. 
         [0029]    Knowledge-ICB  22   
         [0030]    Bioethicists research, synthesize, and incorporate the latest knowledge and best-of-breed practices and theories into the searchable database  50  of Knowledge-ICB  22 . Database  50  updates occur on an as-need basis, which can be continuously updated when new material is available or batch updated at a predetermined period, such as hourly, daily, monthly, quarterly, bi-annually, or annually, to best meet the needs of the clients. This model also contains Reusable Learning Objects (RLO)  52  class outlines and content suitable for teaching the associated topic  48 . The users  18  of the system can extract information on hundreds of ethical topics  48  directly from Knowledge-ICB  22 . Users  18  of the system  10  can use drop down menus of word search technology to find topics  48  that they need information about. Once the particular topic  48  is found, Knowledge-ICB  22  presents the user  18  with a set of related topics  49  for more in-depth information. Information is presented in three forms: on-screen text, video  54 , and or voiceover narrations of PowerPoint slides. 
         [0031]    Knowledge-ICB  22  is built on a relational database  50  with a keyword search and topic selection capability. Users  18  navigate to the relational database  50  directly from a selection on a home page menu selection. Once there, and option is presented to search Knowledge-ICB relational database  50  by the entry of a word or subject matter query. An alternate method is to select a grouping of topics  48  by ethical subject area and the system presents the user with an number of topics  48  within that group, and another selection is then made from that list to extract the requested information  49 . In both query methods, a narrative is presented to the user  18  that contains information of the topic  48 . Within the narrative are hyperlinks to related topics  49  pertaining to the subject area. 
         [0032]    Knowledge-ICB  22  is also built to send and receive queries from Tools-ICB. In these instances information on a topic  48  is sent to any of the three modules in Tools-ICB. EthicsConsult  26  and IRBQA  30  receive topical narratives to be used for reference or as assistance in a required activity. Queries for information are also sent to Knowledge-ICB  22  received from Curriculum Builder  28  where subject matter training material is available from predefined curriculums or sent to the user  18  to construct customized courses. Requests for video extracts or voice over narrations are sent to a multimedia database noted in  FIG. 8M  and used in classroom or individual training sessions when they occur. 
         [0033]    The key data elements of Knowledge-ICB  22  are as follow: 
         [0034]    1. Topic Number 
         [0035]    2. Topic Grouping 
         [0036]    3. Topic Title and Description 
         [0037]    4. Topic Narrative 
         [0038]    5. Narrative Citations 
         [0039]    6. RLO Number 
         [0040]    7. RLO Name 
         [0041]    8. RLO Duration 
         [0042]    9. RLO Out-Line and Scripts 
         [0043]    10. RLO Video Number 
         [0044]    11. RLO Voice Over Narration Number 
         [0045]    12. RLO Assessment Questions 
         [0046]    See  FIGS. 4A-4E  for an exemplary database schema and  FIG. 5  for an exemplary database structure of present invention  10 . Further,  FIGS. 6A-6G  are examples of screen shots including navigation and date flow with the notation “Call” for input and output movement of information to Knowledge-ICB&#39;s database  50 . 
         [0047]    Now turning to  FIGS. 6A-6G . This is a description of the users interaction of Knowledge-ICB  22 . Depicted in  FIG. 6A , a user  18  is first presented with a secure login screen  102  where a user id  104  and password  106  is required for entry into the system  10 . The user  18  information is setup prior to the user  18  attempting to login by a system administrator. There is a reset password process a user  18  can follow should they forget their password. Once into Knowledge-ICB  22 , a menu  68  of navigation options is presented. The menu  68  allows the user  18  to select a database  50  by Industry Segment  32  or select an applied tool from Tools-ICB  24 . For this example, the user  18 , selects the Clinical Ethics  56  in database  50 . 
         [0048]    On  FIG. 6B , the user  18  is presented with a screen  110  that provides instructions about the structure  111  of the database  50  and a drop down box  58  of Categories  60  to choose from. Once a Category  60  is selected, a call  112  is initiated to the database  50  to retrieve the desired information  116 . At this point the system  10  presents another dropdown box  114  to the user  18  with a list of sub-categories  62  to choose from as depicted of  FIG. 6C . Once a sub-category  63  is selected (e.g., Informed Consent), another call  118  is initiated to the database  50  to retrieve the information  120  requested as depicted in drop down box  122  in  FIG. 6D , where the user  18  is presented with topics  64  (e.g., topics for Informed Consent). The user  18  next selects to desired topic  64  and yet another call  124  is initiated to the database  50  to retrieve the information  126 . At this point, the topic  64  information is presented in the form of an RLO  52  that has the topic  64  content (e.g., Informed Consent) as shown in  FIG. 6E . The topic  64  content describes the clinical ethics  56  subject, addressing ethics issues, religious and cultural considerations and any legal concerns. Additionally as shown on  FIG. 6E , the user  18  has the option to view a video  54  that has more information about the topic  64 . If the user  18  selects the video  54 , a video call  128  is initiated to the database  50  to retrieve  130  the video  54 . 
         [0049]    A listing  222  of Related Topics  224  (e.g., Do Not Resuscitate Orders) of the selected sub-category  63  (e.g., Informed Consent) can be displayed as shown in  FIG. 6F  if user  18  desires more information. User  18  selects related topic  224  ( FIG. 6D ,  6 E) to send a call  134  to database  50  to return content  138  ( FIG. 6F ) of related topic  224 . 
         [0050]    Also as depicted on  FIG. 6F , a dropdown box  132  is presented with a list of related topics  48  that the user  18  can request from the system  10  if further information is required on the selected topic content  138 . 
         [0051]    Now turning to  FIG. 6G , users  18  of Knowledge-ICB  22  also have the ability to go directly to a topic  64  by using the systems  10  keyword search  66  capability. A keyword search call  140  is sent to database  50  to search stored topics  64  containing the search criteria (e.g., human) that are retrieved  142  from the system  10  and displayed  144  to the user  18 . So they can review and select the desired topic  64 . 
         [0052]    Tools-ICB  24  (Formally Reliance-ICB) 
         [0053]    Tool-ICB module  24  is the applied ethics component of EthAssist  10 . As mentioned above, Tools-ICB  24  has three separate and distinct software modules that work independently from one another which send and retrieved information from Knowledge-ICB  22 . 
         [0054]    The EthicsConsult module  26  is an automated methodology to guide patient interviews to ensure all information pertaining to demographic, family relationships, patient condition, and ethical situation is collected and reported consistently. It is built upon a foundation of best-of-breed healthcare ethics procedures and practices. It includes sequenced, connected steps supplied by information from Knowledge-ICB  22  with well-defined inputs and outputs that can interface to any hospital administration system. 
         [0055]    The following are examples of the instructions for medical staff conducting clinical interview using EthicsConsult module  26 . These examples of questions are not intended to limit the invention. There are information points during the interview that will require information to be retrieved from Knowledge-ICB  22  via calls for data link  40  ( FIG. 2A ). A case, in most instances, will require interviews of several people, family members, decision makers, medical staff and so on. No actual names are recorded but are codified so as to avoid meaningful use issues. The interview data for each case must be maintained until the interviewer feels that all necessary people are interviewed. Once the interview is complete, the interviewer can either print a summary report; send an electronic version to the hospital admiration system, or both. Once that occurs, all interview data regarding the case is removed from the system  10 . 
         [0056]      FIGS. 7A-7F  are exemplary questions (also listed below) that can be asked during an interview and match the prototype functionally: 
         [0057]    1. Case ID number—Computer generated 
         [0058]    2. CLINICIAN: Who is being interviewed: Patient, family, decision maker Pull down menu for those three choices. 
         [0059]    CLINICIAN: At this point the interview begins. You can introduce the start of the interview as you feel is best. Some suggestions include, “I am going to a few questions now to get a little background information.” Then proceed to gather, in your own language, medical and social history as well as where the patient resides. Also, 
         [0060]    3. Patient&#39;s medical history: CLINICIAN This includes the following information: Current problem, brief past history, any relevant information pertaining to current admit to hospital text box to enter 
         [0061]    4. Patient&#39;s social History: text box to enter 
         [0062]    5. Where is patient/you from (city)? text box to enter 
         [0063]    6. Is anyone here with you? 
         [0064]    7. With whom does/do patient/you live? (pull down menu: alone, family, nursing home, other) 
         [0065]    a—Family—How are they related to patient/you? text box to enter 
         [0066]    b—If nursing home—In which facility does patient/you reside? text box to enter 
         [0067]    c—Alone 
         [0068]    8. Is the patient is a relationship? If so, with whom? Text box to enter 
         [0069]    9. Are you/Is the patient working, retired? text box to enter 
         [0070]    10. Any additional information pertaining to social history? 
         [0071]    11. CLINICIAN, now you will gather information on patient medical history. You may prompt with a question such as, “Now I am going to ask a few questions about your medical history.” 
         [0072]    12. Current Medical Problems. 
         [0073]    13. Brief past medical history: 
         [0074]    a. clinical probes; 
         [0075]    b. diagnosis(es); 
         [0076]    c. chronic illness; 
         [0077]    d. medications; 
         [0078]    e. surgeries; and 
         [0079]    f. other data. 
         [0080]    14. Any relevant information pertaining to current admittance to hospital. 
         [0081]    15. CLINICIAN, now you will gather information on family medical history. You may prompt with a question such as, “Now I am going to ask a few questions about your family&#39;s medical history.” Patients who have non-biologically related siblings or parents may state this at this point, however there is no need to specifically ask if this person is a blood relative. You may state this in the notes. 
         [0082]    16. Patient Family History 
         [0083]    17. Is the patient&#39;s parent&#39;s living? Yes, age and significant medical issues. No, age and cause of death. 
         [0084]    18. How many brothers/sisters do you/does the patient have? Pull down for number of siblings&#39; numbers: 0-10. If 0 siblings, SKIP 18 
         [0085]    a. Are any siblings deceased?
       If Yes, (any are deceased): What did your/the patient&#39;s sibling die from?   No, age and any significant medical issues.       
 
         [0088]    Additional notes: (text box) 
         [0089]    19. Does the patient have any children? Pull down for number of children numbers: 0-10. If 0 children, SKIP 19 
         [0090]    a. Are any children adults?
       If Yes, how many are adults?       
 
         [0092]    20. Any additional family medical history that is important? (text box) 
         [0093]    21. Additional Information 
         [0094]    22. Main menu 
         [0095]    To begin select the main topic which the consultation may utilize: (pull down) 
         [0096]    1. Informed consent 
         [0097]    2. Decision making capacity 
         [0098]    3. Surrogate Decision-making 
         [0099]    4. Treatment and goal planning 
         [0100]    23. Main menu 1. Informed Consent 
         [0101]    Information regarding topic is extracted from Knowledge-ICB  22 . 
         [0102]    24. See  FIG. 7B  for recital of step. 
         [0103]    25. Has the patient been given all of the information regarding his or her medical procedures and firmly understands all of the associated risks and benefits to the procedure? 
         [0104]    The questions below should be specific to how patient answered question 25. If 25 is a NO, go to 26. If 25 is a YES, got to 29. 
         [0105]    26. What is the barrier to understanding the consent process? 
         [0106]    CLINICIAN PROBES (pull down) 
         [0107]    Is it patient centered?
       Was enough information given to the patient?   What aspect is not clearly understood?   If there family conflict?   Is the patient expressing fear or anxiety?   Is there a language barrier?   Is there cultural barrier?   Is patient able to read?   Is the patient overwhelmed, cannot decide and needs more time than given to decide?       
 
         [0116]    28. Is it medical staff centered?
       Was information provided in technical terminology or not easily understood language to the patient?   Was the information provided too quickly by physician?   Have all of the patient&#39;s questions have been answered?       
 
         [0120]    (text field to enter reason why, include this note: Clinician: please ever why you feel that patient understanding is compromised. If needed, use probes for guidance.) 
         [0121]    29. Is the patient decisionally capable of making these decisions? Question 25 must be considered along with Questions 29. Rules: Both questions get asked. If yes to 29 and 25, STOP SECTION 1. To indicate section ends insert a prompt stating: This patient is capable of making his or her own medical decisions. 
         [0122]    If no to either or both question 29 or question 25, continue with subsequent follow-up questions. One no to either question, 29 or 25 warrants continuing as one NO to 29 or 29 is a sub-threshold criteria. 
         [0123]    30. If No to 25. Why is the patient not decisionally capable of giving informed consent? 
         [0124]    31. CLINICIAN: If at this time, the barrier to informed consent in relation to understanding is able to be resolved and the patient has decision making capacity. This patient can now give informed consent. 
         [0125]    32. Can this be resolved? 
         [0126]    a. Yes: 
         [0127]    i. YES to 25 and NO to 20, continue to box 33; 
         [0128]    ii. NO to 25 and YES to 29, resolve issue; 
         [0129]    iii. NO to 25 and NO to 29, continue to box 33. 
         [0130]    b. NO, continue to box 33. 
         [0131]    33. CLINICIAN: Addressing each barrier to understanding requires clinical judgment and to determine interviewer should engage the patient in conversation to gather this information. This would be a good breaking point to do so. Clinicians should look for signs of confusion or incoherence from the patient, as well as opinion of the patient&#39;s family to determine if the patient is not himself or herself when trying to determine signs that capacity may be lacking. 
         [0132]    Main menu 2 Decision capacity: 
         [0133]    35. To have mental capacity is the possess the ability to hear and comprehend information, appreciate all of the consequences of a medical procedure, communicate a choice, and deliberate ones&#39; values in decisions between the patient and the doctor. Capacity may be compromised by a number of factors. Capacity must be present in order to give informed consent to any medical procedures. Jonsen, 65. 
         [0134]    36. Is there a specific indication that patient may not have decisional capacity? CLINICIAN PROBES(pull down) 
         [0135]    Is the patient experiencing a great deal of anxiety? 
         [0136]    Is the patient in a great deal of pain? 
         [0137]    Is the patient very afraid? 
         [0138]    Is the patient&#39;s illness rendering him/her obviously unable to communicate? (for example, unconscious, comatose, delirium) 
         [0139]    Has there been a change in mental status*? 
         [0140]    Are the medications being used in treatment affecting capacity? 
         [0141]    Has the patient always lacked capacity? (for example, profound mental retardation) 
         [0142]    Is the patient unwilling or refusing treatments, if so, why? 
         [0143]    37. *Note to clinicians for psychiatric patients: If patient has a psychiatric diagnosis this does not mean the patient is unable to make his or her own medical decisions, however is does make determining capacity more difficult. Having a mental illness does not make on decisionally incapable, however, the illness may at the time inhibit the patient from understanding in a particular situation. Altering medications or psychiatric interventions can help one regain capacity but delusions, for example, may not be able to be remedied. Consult with psychiatry for patients with MH diagnosis. i  (text field to enter reason why, include this note: Clinician: please ever why you feel that patient decision making capacity is compromised. If needed, use probes for guidance) 
         [0144]    38. Capacity assessments should be conducted by your specific hospital department (psychiatry, neuropysch, etc.). However due to your recommendation this may help to determine if such an assessment should be conducted. If you recommend there be an official capacity assessment, please contact the appropriate contact within your facility. 
         [0145]    39. CLINICIAN: Is the barrier or hindrance to decision making capacity able to be overcome? 
         [0146]    Yes (if yes AND no to question A, stop here. Include note: CLINICIAN: how will this be overcome?) 
         [0147]    No, (if no patient needs a surrogate decision maker to make decisions on his or her behalf) Proceed to surrogate decision maker 40. 
         [0148]    40. Main Issue 3. Surrogate decision maker 
         [0149]    41. When patients are no longer able to make medical decisions, often times the duty falls upon another who is the patient&#39;s surrogate decision maker. A surrogate is an individual who is authorized to make medical decisions on behalf of another. While they are still healthy many will appoint a surrogate decision maker in their advance directive. A surrogate may be appointed under a health care power of attorney and often is in combination with a living will. Surrogates can also be appointed without a health care power of attorney as many states have family consent statutes. A surrogate may be a patient&#39;s next of kin such as a husband or wife, child, sibling, or parent as a family member most often serves in the surrogate role. 
         [0150]    42. See  FIG. 7C  for Pennsylvania Act 169 summary. 
         [0151]    Information regarding topic is extracted from Knowledge-ICB  22 . 
         [0152]    43. Does this patient have a surrogate decision maker? 
         [0153]    a. If YES, proceed with these questions: 
         [0154]    44. Who is the patient&#39;s surrogate decision maker? (text field) 
         [0155]    45. Is the patient&#39;s surrogate decision maker aware of the patient&#39;s wishes, please explain? (text field) 
         [0156]    a. If YES, then continue to box 46. 
         [0157]    b. If NO, then continue to box 46. 
         [0158]    46. Does the patient have an advance directive? YES NO pull down 
         [0159]    Information regarding topic is extracted from Knowledge-ICB
       Is the surrogate familiar with the patient&#39;s values enough to gauge what the patient would want? Please explain. (text field (NOTE TO CLINICIAN: probing for additional details and other patient information is acceptable)       
 
         [0161]    47. CLINICIAN: Do you think the surrogate is acting to uphold this patient&#39;s autonomy and wishes in a sincere fashion? (text field). If YES, then STOP, you have identified surrogate decision maker. If NO, then proceed to box 48. 
         [0162]    48. Is there any next of kin or contact listed in patient&#39;s chart or any record from any facility? (pull down. YES NO pull down. If yes (there is a contact found), then go to box 49. CLINICIAN: Contact this person. If no, go to box 53. 
         [0163]    Consensus needed for conflict among siblings, see Pennsylvania Act 169 to determine proper order for surrogacy in PA. 
         [0164]    Information regarding topic is extracted from Knowledge-ICB 
         [0165]    49. Who is this person? (text box) 
         [0166]    Upon contact: 
         [0167]    50. Are they willing to take on this role and are they reasonably available to do so? (text box) 
         [0168]    51. Is the surrogate familiar with the patient&#39;s values enough to gauge what the patient would want? (text box) 
         [0169]    52. CLINICIAN: Do you think the surrogate is acting to uphold this patient&#39;s autonomy and wishes in a sincere fashion? (text box) 
         [0170]    53. No next of kin or contacts can be found: INCLUDE THIS TEXT If all avenues are exhausted to locate a potential surrogate decision maker. Options include: 1. If applicable, a private investigator to locate a potential surrogate. 2. A legal guardian can be appointed by a court for this patient. 3. For cases that are critical, the ethics committee can be involved and uphold beneficence and nonmaleficence as long as any conflict of interests are not a factor, for cases which are outside consultants should be contacted. ii  (text box for notes here) 
         [0171]    Main Issue 4: Treatment and Goal Planning 
         [0172]    55. Text: Often consultations are for treatment and goal planning for patients and families. These may help guide a patient in determining their wishes in regard to a variety of treatments for many different conditions. However, many times this is something utilized for end of life care. For either case, it is a good time to introduce an advance directive to a patient and/or his or her family. 
         [0173]    Information regarding topic is extracted from Knowledge-ICB 
         [0174]    56. See  FIG. 7D  for a definition of an Advance Directive. 
         [0175]    57. Does the patient have an advance directive? 
         [0176]    If yes, CLINICIAN: obtain a copy for review and continue with next question. 
         [0177]    If no, CLINICIAN: encourage patient to complete one in the future. Help them in the process by explaining what the selections mean and have them go over the form with their family. Obtain a copy the version (or provide the various kinds) that your hospital uses to the patient and explain terminology and answer all questions. Continue with next question. 
         [0178]    Who do you want to make your decisions for you should you be unable to make them for yourself? (Do you have a durable power of attorney for health care? A health care power of attorney is a person, called and health care agent, who will legally make all of your medical decisions if you are not able to do so for yourself due to your illness. You can place limitations of this. If you do not appoint a person to do so, in Pennsylvania health care providers will ask your next of kin or another person who knows you well for these medical preferences. You will have to complete a legal document to appoint a health care agent. This is why it is very important to have an advance directive to help guide your agent in your treatment preferences. See boxes 58-61 of  FIG. 7E  for a discussion on Health Care Power of Attorney and Living Will and treatment preferences. 
         [0179]    62. Is this a consultation for end of life care planning? 
         [0180]    If yes, (text) TO CLINICIAN: This is a good time to begin a conversation with patients and families about treatment goals. These are very similar to an advance directive. Values and beliefs may guide the patient in making their choices. Questions should be open ended and include: 
         [0181]    63. Treatment preferences include: 
         [0182]    i. What medical treatments are acceptable and which would you never want should you become very sick and may not recover? 
         [0183]    ii. If your heart stops beating and/or you stop breathing, do you want to be resuscitated? 
         [0184]    iii. Would you want to have a machine breathe for you if you were not able to breathe for yourself (placed on a ventilator) if you were not going to get better? 
         [0185]    iv. How do you feel about feeding tubes if you are very sick? 
         [0186]    v. If you become seriously or terminally ill, where would you rather be at the hospital, someplace your family can get help taking care of you, or at home? 
         [0187]    Boxes 64-68 are further boxes that address religious and spiritual issues. 
         [0188]    As mentioned above,  FIGS. 7   a - 7 E illustrate information flow chart with interface data calls for information from Knowledge-ICB  22  for decision in the EthicsConsult Tool  26 . Also  FIGS. 3A-3C  is a sample EthicsConsult output report which can be created as a data file for input into patients records of a hospital control system. 
         [0189]    Now returning to  FIG. 2A , the Curriculum Builder module  28  is a tool that uses RLO&#39;s  52  enabling educators to customize healthcare ethics training in any number of topics in any order and duration of time. Knowledge-ICB  22  is the source for the information. After constructing a training course  46 , the system  10  generates course outlines, teaching guides and scripts. The system  10  is designed to integrate brief video snippets  54  and voiceover narrations into the training on the related topics  49 . Curriculum Builder  28  also performs assessment testing providing a variable number of questions, one to five, determined by the educator. These questions are randomized using a total group of seven for each RLO  52 . There are also embedded comprehension questions that are interactive using drag and drop and grouping technology. Additionally, Curriculum Builder  28  has a function that allows the trainer to develop and deliver out of system assignments for students to complete. 
         [0190]    Curriculum Builder  28  is a tool that allows an individual responsible for education and training to build a customized curriculum or modify an existing one by selecting from hundreds of reusable learning objects (RLO&#39;s)  52  for any type of healthcare ethics that are stored in Knowledge-ICB  22 . RLO&#39;s contain multimedia content, either a video  54  or a voice over narration. 
         [0191]    Curriculum Builder  28 , Educator function is the process begins with an educator logging into the building a lesson portion of the system. The organizational administrator grants an educator access to the process. It begins with a selection menu display similar to one used in Knowledge-ICB  22 . Once a training topic  48  is identified, a selection is made and information extracted from Knowledge-ICB  22  regarding the course outline and multimedia duration. This information is placed in a course-building table and displayed to the educator. A running total of the training duration is accumulated and displayed to the user  18  so that they can determine if the total time required to complete the course meets the requirements or restrictions. The system  10  will allow the user  18  to edit their RLO  52  selection as needed. Once the educator is satisfied with the RLO&#39;s, which constitute the class, a complete button is selected, and all the information that is contained in Knowledge-ICB  22  for the selected RLO&#39;s is extracted and stored by the educators deification number and a lesson number assigned by the educator. 
         [0192]    Curriculum Builder  28 , Student function allows students who are assigned to complete an EthAssist course  46  to will be given security access and will log into the student section of Curriculum Builder  28 . Once logged in, they will be presented with the courses they are required to complete. When the student chooses to take the class, they select the RLO&#39;s in the sequence displayed. Once a topic  48  is selected the multimedia is streamed from the multimedia library. ROL&#39;s may have engagement activities assigned with a topic  48  or they may have embedded drag and drop comprehension questions. The student can review the class material up too three occurrences before an assessment test is given. These assessment questions can number from one to five and are presented randomized from a pool of seven questions for each topic in the test. A numerical percentage is displayed and stored for the educators review. The student has an opportunity to improve their score by retaking the assessment test as many as three times. All student activity is logged and date stamped to review by the educator. 
         [0193]    See  FIGS. 8A-8P  for a conceptual diagram of Curriculum Builder  28 :  FIGS. 8A-8K  are screen shots of the Educator Template process;  FIGS. 8L-8P  are screen shots of the Student My Lessons process. Notations on the flow charts, “Calls,” indicate information input to (requests) and outputs from (responses) Knowledge-ICB  22 . 
         [0194]    Now turning to  FIG. 8A-8P . This is a description of the user&#39;s  18  interaction with Curriculum Builder  28 . As depicted in  FIG. 8A , a user  18  is first presented with a secure login screen  102  where a user id  104  and password  106  is required for entry into the system  10 . The user  18  information is setup prior to the user  18  attempting to login by a system administrator. There is a reset password process a user  18  can follow should they forget their password. The user  18  is now at the EthAssist  68  menu page where navigation options are presented. The menu  68  allows the user  18  to select Curriculum Builder  28  from the Tool-ICB  24  section of the menu page. 
         [0195]      FIG. 8B  is another menu  108  illustration and selection of Curriculum Builder  28  is next executed to take the user  18  into the Educator Template Creation  70  process shown on  FIG. 8C , where a secondary menu selection  146  is presented to the user  18 . The user  18  selects Course Templates  72  from the Browse Course Template screen  82  to begin the process of creating a new course. The user  18  in this process is called Admin  74 . The Admin  74  selects a template design  148  as depicted on  FIG. 8D . In this example, a new blank template  76  is called from the database  50  in the Lesson Template Screen  75 . Next the Admin  74  will customize a lesson  76  by assigning a name  150 , lesson number  78  and Engagement Activity  80  to the lesson  76  as illustrated on  FIG. 8E . Once the Admin  74  completes entry of the required data, they will mark status  152  of the lesson  76  as Draft or Active and submit  154  the lesson  76  to the database  50  for storage. After the Admin  74  submits the lesson  76 , the system  10  takes the Admin  74  to the Browse Course Template  82  screen where the Admin  74  can see the lesson  76  they just completed. 
         [0196]    On  FIG. 8F , the Admin  74  clicks on the lesson  76  just created and activate it. At this point, the Admin  74  can select the New Template Topic button  86  and the system  10  will allow the Admin  74  to browse the database  50  in Knowledge-ICB  22  selecting RLO&#39;s  52  ( FIG. 2A ) that they want to include in the lesson  76 . Upon finding the desired RLO  52 , the Admin  74  by selecting it initiates a call  158  to the system  10  by clicking on the Insert New Template Topic  86  button to launch an Insert new Template Topic screen  160  ( FIG. 8G ). As depicted on  FIG. 8G , the Admin  74  can also search the Knowledge-ICB  22  database  50  using a search capability and a dropdown box  162  containing topics  64  that can be included in the lesson  76 . After selection of a topic (e.g., Assent), a request or call  164  for the related media type  88  is sent to database  50 , either video  54  or narration  90  (e.g., Narration  94 ), for selection, which is required. The Admin  74  then selects the submit button  166  and the lesson  76  is stored in the Knowledge-ICB  22  database  50  ( FIG. 8H ). The Admin  74  can repeat this process as shown on  FIG. 8H  as many times as required, by returning (via return key  168 ) to the Lesson Template Screen  75 . 
         [0197]    The next step in Educator Template Creation  68  is assigning students to the lesson  76 . Students are loaded into the systems Validation Table  226  by the admin  74  for security validation as shown in  FIG. 8Q . The Educator  98  does a search of the Validation Table  226  by typing the student&#39;s name into user name box  228  to assign students enrolled in lesson  76  they are teaching. Call  230  is sent to Validation Table  226  for retrieval of all the students in the Validation Table  226  that meet the search criteria. The Admin  74  must navigate from the Browse Course Templates screen  82  via a dropdown menu  170  when module key  172  is selected that launches a menu page  174  where a call  176  is sent to database  50  to select a lesson  76  to which students will be assigned as illustrated on  FIG. 8I . 
         [0198]    The last step in creating a lesson  76  is to assign quiz questions. The Questions module  178  in  FIG. 8C  is selected to launch Insert new Lesson screen  176 , as shown on  FIG. 8J , where the Admin  74  activates the quiz questions  92  that are associated to the lesson  76 . User  18  enters template name  150 , status  152 , whether or not to Use Comprehension questions  180 , and the number of questions  182 . Submit button  154  will send a call  184  to the database  50  to activate the quiz questions  92 . Questions are randomly generated for each quiz based on known techniques. User  18  will be directed back to (or a call to return to) the Browse Course Template screen  82  to view lesson  76  being created (or updated) and saved. 
         [0199]    After selection of lesson  76  on  FIG. 8J , out of class homework can be given for lesson  76  by selecting Insert New Course Assignment  94  to launch Insert New Course Assignment screen  188 . Lesson assigner can search for users  18  by typing a user&#39;s name into User Name box  190 . A user name call  194  is sent to database  50  for each letter typed into User Name box  190 . A dropdown menu  192  is displayed showing likely known users based on the letters typed into user name box  190 . Lesson assigner has the option to select one of the names listed in the dropdown menu  192  or type the full name of the user  18 . All calls to the database  50  are depicted on the figures in proper location. 
         [0200]    The Student “My Lesson”  96  process starts on  FIG. 8L  with the secure login and EthAssist  68  menu screen. A student assigned to a class after login will select Student “My Lesson” button  96  from Tool-ICB  24 . Upon selection of the “My Lesson” button  96 , system  10  launches the My Lessons screen  196  that will present the student with a list of lessons  76  assigned to the student as shown in  FIG. 8M . The student can select a lesson  76  (e.g., Four Principles Approach) and the system  10  will send a call  200  to the database  50  to display the topics  64  contained in the lesson  76  in Lesson screen  202 . When the student is ready to take lesson  76 , the student selects the topic  64  in the order displayed. System  10  indicates (e.g., check mark) that a topic  64  has been completed as shown in  FIG. 8N . Once the student takes the lesson  76 , the system  10  indicates (e.g., check mark) that the lesson  76  was completed. At the same time, a historical record of the student&#39;s activity is maintained on database  50  such that the educator  98  can view the progress of the student. Once the student has completed a lesson  76 , the student is required to take a quiz  100 . The student selects Take Quiz button  204  that launches the first question  206  of quiz  100 . The system  10  will randomly call  208  questions for database  50 . For example, quiz  100  can consist of one to four questions randomized from a list of seven questions for each topic. The number of correct and incorrect answers are stored on database  50 , as well as the questions taken and not taken, for course analytics and student individualized evaluation. One embodiment of system  100  provides options to repeat lesson  76  prior to taking quiz  100 . 
         [0201]    After completing the quiz  100 , system  10  calls  209  the stored quiz results (e.g., correct and incorrect answers) from database  50  and calculates a numerical score based on the stored quiz results (e.g., correct and incorrect answers) and displays the score  210  in Quiz Score screen  212  to the student, as shown in  FIG. 8O . The system  10  has the ability to give the student the option to taken a quiz, up to a predetermined value set by the curriculum builder, for example, three times, after review of the lesson  76  again. 
         [0202]    The system  10  stores the results of the quiz  100  and the number of attempts  214  the student completed and can be called  215  from database  50  and displayed on the My Lessons screen  196 , along with length of time  216  to complete lesson  76  and status  218  (e.g., not taken, in-progress, completed) of lesson  76  each time the My Lessons screen  196  is launched. As mentioned above, the system  10  also stores incorrect answers such that educators  98  can do analysis on the effectiveness of the course material. All transactions that are stored on database  50  are time and date stamped. 
         [0203]      FIG. 8P  illustrates a screen  218  that an educator can use to view the status of a student&#39;s progress through an educator login screen (similar to user login screen  102 ) that provides access to students who are assigned to either the educator or a particular course or both. The student&#39;s summary is called  220  from database  50 . 
         [0204]    IRBQA Module  30   
         [0205]    Now turning to  FIG. 2B , the last module is Internal Review Board Quality Assurance (IRBQA)  30 . IRBQA module  30  is an automated guide to walk Internal Review Boards (IRB) members through the IRB process out lined in the IRB Hand Book. IRBQA module  30  requires users  18  to respond to each question specific to the particular trial under review. It is self-documenting proving a report of outstanding responses and note which board member responded to the questions with a time and date stamp. This provides a complete record of IRB&#39;s actions to improve quality of clinical trials and can be stored in defenses of their decisions. 
         [0206]    The IRBQA module  30  functions as an automated check-list and chronological documentation of Internal Review Boards (IRB) answers to questions to ensure that clinical trials conducted on humane subjects are following best practices to safeguard patients. IRBQA module  30  starts by requiring that the board membership document whom they are and that they have the required education and experience to make decisions regarding the particular clinical trial in which they are participating. If the membership does not have the correct membership the chairman has the responsibility to stop the trial review until the membership is corrected. IRBQA records all answers to the qualification questions and will not allow it use unless the chairman overrides the stop condition, which the override is documented as such. This jeopardizes the fundamental existence of the IRB and any decisions made by them. 
         [0207]    The next steps are taken depending upon the type of clinical trial and the groups of subjects that are in the trial. Decisions are made within the process the direct the IRB to follow automated process that record actions and decisions made during the trial. A report is generated that indicates warning messages and critical messages as the trial proceeds. All response to questions are time and date stamped to maintain an audit trial of the IRD decisions. 
         [0208]    The following are the sub-set clinical trial review subject topics and sequential questions and decision points within the subject topics automated by IRBQA. FIGS.  9 A 1 - 9 M 2  are the flow charts that document decision points and warning or critical responses to questions and “Calls” to send and receive information to Knowledge-ICB  22 . 
         [0209]    §46.107 IRB Membership. 
         [0210]    See FIG.  9 A 1  for the decision flow chart for the following questions: 
         [0211]    1) Does the IRB have at least 5 members of varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution? 
         [0212]    a) If “yes” proceed.” 
         [0213]    b) If “no” please insure IRB is properly staffed. 
         [0214]    2) Will the IRB review a protocol that involves a vulnerable population such as children, prisoners, and pregnant women, handicapped or mentally disable persons. 
         [0215]    a) If “yes” please answer following: Does the IRB have a member who specializes in the specific vulnerable population? 
         [0216]    i) If “yes” proceed. 
         [0217]    b) If “no” proceed. 
         [0218]    3) Does the IRB consist of members from multiple occupations? 
         [0219]    a) If “no”, IRB must have a more diversified makeup. 
         [0220]    b) If “yes” proceed. 
         [0221]    4) Does the IRB have at least one member with a scientific background? 
         [0222]    a) If “yes” proceed. 
         [0223]    b) If “no”, IRB must admit a member with a scientific background. 
         [0224]    5) Does the IRB have at least one member with a non-scientific background? 
         [0225]    a) If “yes” proceed. 
         [0226]    b) If “no” IRB must have at least one member with a non-scientific background. 
         [0227]    6) Does the IRB include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution? 
         [0228]    a) If “yes” proceed. 
         [0229]    b) If “no” IRB must review membership qualifications. 
         [0230]    7) Does the IRB have a member in the IRB&#39;s initial or continuing review of any project in which the member has a conflicting interest? 
         [0231]    a) If “yes” please review for conflict of interest (Note: Example, can insert a link for conflict of interest from education module) 
         [0232]    b) If “no” proceed. 
         [0233]    See FIG.  9 A 2  for the decision flow chart for the following questions: 
         [0234]    8) Does the IRB need a non-member individual with competence in special areas to assist in the review of issues for the research protocol, which require expertise beyond or in addition to that available on the IRB? 
         [0235]    a) If “yes,” please seek and appoint expert. 
         [0236]    b) If “no”, proceed. 
         [0237]    9) Is the user the Administrator? 
         [0238]    a) If “yes,” enter all IRB members names and background information. 
         [0239]    b) If “no”, proceed. 
         [0240]    10) Is Informed Consent Document completed for this trial? 
         [0241]    a) If “yes,” go to Informed Consent section. 
         [0242]    b) If “no”, set warning flag and STOP. 
         [0243]    11) Does this research involve children as defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted? 
         [0244]    a) If “yes,” go to Children section. 
         [0245]    b) If “no”, proceed. 
         [0246]    FIG.  9 B 3  are gateways to policies related to other possible subjects (e.g., women, neonates, prisoners) and other topics (e.g., placenta, advertising, compensation). This list is not intended to limit the invention but to provide examples of the broad and flexible capabilities of system  10 . 
         [0247]    Reviewer Assessment Questions 
         [0248]    See FIGS.  9 C 1 - 9 C 3  for the decision flow chart for the following questions: 
         [0249]    General Questions of Preparation 
         [0250]    a) Has the reviewer read the consent document(s)? 
         [0251]    b) Has the reviewer read the protocol summary? 
         [0252]    c) Has the reviewer read the full protocol and supporting or supplemental materials? 
         [0253]    d) Does the reviewer have a conflict of interest with this protocol? 
         [0254]    Background 
         [0255]    1) Are the specific aims of the research clearly specified? 
         [0256]    2) Is there adequate preliminary data to justify the research? 
         [0257]    3) Id their appropriate justification for this protocol? 
         [0258]    Design 
         [0259]    4) Is the scientific design adequate for the protocol? 
         [0260]    5) Are the objectives likely to be achievable in the stated timeframe of the research? 
         [0261]    6) Is the scientific design, such as placebo controls, Phase I, II, or III, randomization etc., described and adequately justified? 
         [0262]    Criteria 
         [0263]    7) Are inclusion and exclusion criteria for subjects clearly specified and appropriate? 
         [0264]    8) If women, children or minorities are excluded, is this justifiable? 
         [0265]    9) Is the choice of subjects appropriate for the questions being asked? 
         [0266]    10) Is the principle of distributive justice adequately incorporated into the inclusion and exclusion criteria for the protocol? 
         [0267]    11) Is the subject selection equitable? 
         [0268]    Recruitment 
         [0269]    12) Are the methods for recruitment of subjects well defined? 
         [0270]    See FIGS.  9 D 1 - 9 D 3  for the decision flow chart for the following questions: 
         [0271]    13) Are the location and timing of the recruitment process appropriate for the process? 
         [0272]    14) Are there acceptable methods for screening subjects before recruitment? 
         [0273]    Procedures 
         [0274]    15) Is the rationale and details of the research procedures accurately described and acceptable? 
         [0275]    16) Is there a clear differential between research procedures and standard care? 
         [0276]    17) Are the personnel performing the procedures appropriately trained and educated? 
         [0277]    18) Is the location of where the procedures will be performed acceptable? 
         [0278]    19) Is there adequate plans to inform subject about specific clinical results? 
         [0279]    Drugs and Devices 
         [0280]    20) Is the status of the drug, biological or device described? (E.g. Investigational new drug biological or device, FDA-approved drug, biological or device etc.) 
         [0281]    21) Are the drugs dosage and route of administration appropriate? 
         [0282]    22) Is the drug, biological or device safety and efficacy data sufficient to warrant the proposed phase of testing? 
         [0283]    23) Is the significant risk or nonsignificant risk status of the drug, biological or device described and appropriate? 
         [0284]    Analysis 
         [0285]    24) Is the rationale for the proposed amount of subject reasonable? 
         [0286]    25) Are the plans for data and statistical analysis defined and justified, including the use of stopping rules and end points? 
         [0287]    26) Are there adequate provisions for monitoring data? 
         [0288]    Risks, Discomforts and Benefits 
         [0289]    27) Are the risks and benefits adequately identified, evaluated and described? 
         [0290]    28) Are the potentials risks minimized and the likelihood of benefits maximized? 
         [0291]    See FIGS.  9 E 1 - 9 E 3  for the decision flow chart for the following questions: 
         [0292]    29) Is the risk to benefit ratio acceptable for proceeding with the research? 
         [0293]    30) If children are involved, which regulatory category of risk/benefit does the protocol fall within? 
         [0294]    Compensation and Costs 
         [0295]    31) Is the amount and type of compensation or reimbursement reasonable? 
         [0296]    32) Are there adequate provisions for the subject to avoid out of pocket expenses or sufficient justification for the subjects to incur costs? 
         [0297]    Privacy and Confidentiality 
         [0298]    33) Are there adequate provisions to protect the privacy and ensure the confidentiality of the research&#39;s subjects? 
         [0299]    34) Are there adequate plans to store and code the data? 
         [0300]    35) Is the use of identifiers or links to identifiers necessary? 
         [0301]    36) Is the identifier or link to identifier protected? 
         [0302]    Informed Consent 
         [0303]    37) Are the elements of informed consent contained in the consent document? 
         [0304]    38) Is the process of obtaining consent or assent adequately described? 
         [0305]    39) Is assent required? 
         [0306]    40) Is a waiver of consent or assent possible and justifiable? 
         [0307]    Conflict 
         [0308]    41) Does any investigator have a conflict of interest with this protocol? 
         [0309]    42) Have conflict of interest statements of forms been filed and reviewed? 
         [0310]    See FIGS.  9 F 1 - 9 F 3  for the decision flow chart for the following questions: 
         [0311]    Informed Consent Document 
         [0312]    1) Has a consent document been prepared for this trial? —CORE 
         [0313]    A. If “yes” proceed. 
         [0314]    B. If “no” prepare document 
         [0315]    2) Does the document discuss the research purpose and procedures, including but not limited to, duration of the study and identification of experimental procedures to be followed? 
         [0316]    A. If “yes” proceed. 
         [0317]    B. If “no” review document 
         [0318]    3) Does the document adequately discuss the risks, discomfort and side effects to the trial participant? 
         [0319]    A. If “yes” proceed. 
         [0320]    B. If “no” review document. 
         [0321]    4) Does the document describe possible benefits to the subject that may be reasonably be expected from the research? 
         [0322]    A. If “yes” proceed. 
         [0323]    B. If “no” review document. 
         [0324]    5) Does the document discuss alternative procedures or treatments that may be advantageous and beneficial to the subject? 
         [0325]    A. If “yes” proceed. 
         [0326]    B. If “no” review document. 
         [0327]    6) Does the document describe the confidentiality and privacy of the data to the subject? 
         [0328]    A. If “yes” proceed. 
         [0329]    B. If “no” review document. 
         [0330]    7) Does the document discuss the subjects recourse for research related illness or injury? 
         [0331]    A. If “yes” proceed. 
         [0332]    B. If “no” review document. 
         [0333]    8) Does the document list research contacts for the subject to inquire or comment during the course of the trials? 
         [0334]    A. If “yes” proceed. 
         [0335]    B. If “no” review document. 
         [0336]    9) Does the document have a statement regarding the voluntary nature of enrolling in the research, including the right to cease participation at any time without consequences? 
         [0337]    A. If “yes” proceed. 
         [0338]    B. If “no” review document 
         [0339]    10) Does the research involve unforeseeable risks? 
         [0340]    A. If “yes” answer following: 
         [0341]    I. Does the document contain a statement about the risks to the subject of any unforeseen risks as a result of the research? 
         [0342]    a) If “yes” proceed to next question. 
         [0343]    b) If “no” review document. 
         [0344]    B. If “no” proceed. 
         [0345]    11) Does the document have a statement noting that the researcher without regard to subjects consent can terminate the research? 
         [0346]    A. If “yes” proceed. 
         [0347]    B. If “no” review document. 
         [0348]    12) Does the form disclose if any additional costs may be expected from the subject? 
         [0349]    A. If “yes” proceed. 
         [0350]    B. If “no” review document. 
         [0351]    13) Does the form have procedure listed for the subject to terminate from the research and the subsequent consequences from voluntary termination? 
         [0352]    A. If “yes” proceed. 
         [0353]    B. If “no” review document 
         [0354]    14) Does the form disclose how any significant new findings from the research may be communicated to the subjects? 
         [0355]    A. If “yes” proceed. 
         [0356]    B. If “no” review document. 
         [0357]    15) Does the form disclose the number of participants in the research. 
         [0358]    A. If “yes” proceed. 
         [0359]    B. If “no” review form. 
         [0360]    See FIGS.  9 G 1 - 9 G 2  for the decision flow chart for the following questions: 
         [0361]    Research Involving Pregnant Women or Fetuses. 
         [0362]    1) Does the research involve pregnant women or fetuses.? 
         [0363]    a) If “yes” proceed. 
         [0364]    b) If “no” Skip below questions 
         [0365]    2) Has scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, been conducted and provided data for assessing potential risks to pregnant women and fetuses? 
         [0366]    a) If “yes” proceed. 
         [0367]    b) If “no” Stop 
         [0368]    3) Is the risk to the fetus caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus? 
         [0369]    a) If “yes” proceed. 
         [0370]    b) If “no” see further questions: 
         [0371]    i) Is the risk to the fetus not greater than minimal and the purpose of the research is the development of important biomedical knowledge, which cannot be obtained by any other means? 
         [0372]    a) If “yes” proceed. 
         [0373]    b) If “no” Stop 
         [0374]    4) Is the risk the least possible to achieve the results of the research? 
         [0375]    a) If “yes” proceed. 
         [0376]    b) If “no” Stop 
         [0377]    5) Does the research hold out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means? 
         [0378]    a) If “yes”, Has the woman&#39;s consent been obtained in accordance with informed consent revisions of all applicable regulations? 
         [0379]    i) If “yes” proceed. 
         [0380]    b) If “no” Stop 
         [0381]    6) Does the research hold out direct benefit for the fetus solely? 
         [0382]    a) If “yes”, Has the father&#39;s consent been given, except in the cases if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest? 
         [0383]    i) If “yes” proceed. 
         [0384]    ii) If “no” “Obtain fathers consent.” 
         [0385]    7) Has each individual necessary to give consent on the fetus behalf been fully informed of consent and regarding the reasonably foreseeable impact of the research on the fetus? 
         [0386]    a) if “yes”, proceed. 
         [0387]    b) If “no” secure proper informed consent from all parties. 
         [0388]    8) Is the pregnant women or father of the fetus considered children who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted? 
         [0389]    a) If “yes” go to 
         [0390]    b) If “no” proceed. 
         [0391]    9) Is there a monetary or other inducement to the subject to terminate the pregnancy? 
         [0392]    a) if “yes” Stop, go to regulation 45 CFR 46.204 
         [0393]    b) If “no” proceed. 
         [0394]    10) Is any individual engaged in the research involved in any decisions as to the timing, method, or procedures used to terminate a pregnancy? 
         [0395]    a) If “yes” Stop. 
         [0396]    b) If “no” proceed. 
         [0397]    See FIGS.  9 H 1 - 9 H 5  for the decision flow chart for the following questions: 
         [0398]    Research involving neonates. 
         [0399]    Research Involving Non-Viable Neonates. 
         [0400]    1) Have scientifically appropriate, preclinical and clinical studies been conducted and provide data for assessing potential risks to the neonates? 
         [0401]    a) If “yes” continue. 
         [0402]    b) If “no” Stop 
         [0403]    2) Do individuals engaged in the research have a part in determining the viability of a neonate? 
         [0404]    a) If “yes” Stop. 
         [0405]    b) If “No” continue. 
         [0406]    3) Has the legally effective informed consent of both parents of the neonate been obtained in accord with proper informed consent procedures? 
         [0407]    a) If “yes” proceed. 
         [0408]    b) If “No” answer following: 
         [0409]    i Was the pregnancy a result of rape or incest? 
         [0410]    a. If “yes,” then father&#39;s signature not needed. 
         [0411]    B. If “no,” then: 
         [0412]    i) Is either parent unable to consent because of unavailability, incompetence, or temporary incapacity? 
         [0413]    a) If “no” stop. 
         [0414]    b) If “yes” answer following: 
         [0415]    Is informed consent obtained from at least one competent and available parent? 
         [0416]    A) “If “yes” continue to Question 4 
         [0417]    B) If “no” Stop. 
         [0418]    4) After delivery of the nonviable neonate will all of the following conditions apply: 
         [0419]    A) Vital functions of the neonate will not be artificially maintained; 
         [0420]    B) The research will not terminate the heartbeat or respiration of the neonate; 
         [0421]    C) There will be no added risk to the neonate resulting from the research; 
         [0422]    D) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means. 
         [0423]    a) If “yes” continue, 
         [0424]    b) If “No” stop. 
         [0425]    Research Involving Neonates of Uncertain Viability 
         [0426]    1) Has the IRB determined that he research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective? 
         [0427]    a) If “yes” continue. 
         [0428]    b) If “no” stop. 
         [0429]    2) Has the IRB determined the purpose of the research is the development of important biomedical knowledge, which cannot be obtained by other means, and there will be no added risk to the neonate resulting from the research? 
         [0430]    a) If “yes” continue. 
         [0431]    b) If “no” stop. 
         [0432]    3) Has the legally effective informed consent of both parents of the neonate been obtained in accord with proper informed consent procedures? 
         [0433]    a) If “yes” proceed. 
         [0434]    b) If “No” answer following: 
         [0435]    i) Is either parent unable to consent because of unavailability, incompetence, or temporary incapacity? 
         [0436]    a) If “no” stop. 
         [0437]    b) If “yes” answer following: 
         [0438]    Is informed consent obtained from at least one competent and available parent? 
         [0439]    A) “If “yes” continue to Question ii 
         [0440]    B) If “no” Stop. 
         [0441]    ii) Was the pregnancy a result of rape or incest? 
         [0442]    a) If “yes” the father&#39;s signature not needed. 
         [0443]    b) If “No” continue. 
         [0444]    Research Involving Viable Neonates. 
         [0445]    1) Have scientifically appropriate, preclinical and clinical studies been conducted and provide data for assessing potential risks to the neonates? 
         [0446]    a) If “yes” continue. 
         [0447]    b) If “no” Stop 
         [0448]    2) Do individuals engaged in the research have a part in determining the viability of a neonate? 
         [0449]    a) If “yes” Stop. 
         [0450]    b) If “No” continue. 
         [0451]    3) Has the legally effective informed consent of both parents of the neonate been obtained in accord with proper informed consent procedures? 
         [0452]    a) If “yes” proceed. 
         [0453]    b) If “No” answer following: 
         [0454]    i) Is either parent unable to consent because of unavailability, incompetence, or temporary incapacity? 
         [0455]    a) If “no” stop. 
         [0456]    b) If “yes” answer following: 
         [0457]    Is informed consent obtained from at least one competent and available parent? 
         [0458]    A) “If “yes” continue to Question ii 
         [0459]    B) If “no” Stop. 
         [0460]    ii) Was the pregnancy a result of rape or incest? 
         [0461]    a) If “yes” the father&#39;s signature not needed. 
         [0462]    b) If “No” continue. 
         [0463]    §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material. 
         [0464]    1) Does the research involve, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus? 
         [0465]    a) If “yes” continue. 
         [0466]    b) If “no” stop. 
         [0467]    2) Is information associated with material described in question #1 recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals? 
         [0468]    a) If “yes” those individuals are research subjects and proper methods of consent must be obtained. 
         [0469]    b) If “no” stop. 
         [0470]    §46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates. 
         [0471]    1) Is the research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates? 
         [0472]    a) If “yes”. Notification by the Secretary of HEW must be sought to approve this protocol. 
         [0473]    b) If “no” stop. 
         [0474]    See FIGS.  9 I 1 - 9 I 3  for the decision flow chart for the following questions: 
         [0475]    Research on children 45 CFR 46, Subpart C. 
         [0476]    1) Does this research involve children as defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted? 
         [0477]    a) If yes, proceed #2. 
         [0478]    b) If no, stop. 
         [0479]    2) Does this research involve minimal risk? 
         [0480]    a) If yes, proceed to question #9. 
         [0481]    b) If no, go to #3 
         [0482]    3) Does this research involve greater than minimal risk and no prospect of direct benefits to the subjects but will yield generalized knowledge about the subject&#39;s disorder or condition? 
         [0483]    a) If yes, proceed to question #4. 
         [0484]    b) If no go to #5. 
         [0485]    4) Does this research satisfy the following conditions? 
         [0486]    i) The risk is justified by the anticipated benefits to the subjects. 
         [0487]    ii) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches 
         [0488]    iii) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians. 
         [0489]    a) If yes, proceed #13. 
         [0490]    b) If no, stop. 
         [0491]    5) Does this research involve greater than minimal risk and no prospect of direct benefits to the subjects but will yield generalized knowledge about the subject&#39;s disorder or condition? 
         [0492]    a) If yes, go to #6. 
         [0493]    b) If no, go to #8. 
         [0494]    6) Does this research risk represent a minor increase over minimal risk? 
         [0495]    a) If yes, proceed #7. 
         [0496]    b) If no, Stop. 
         [0497]    7) Does the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations? 
         [0498]    a) If yes, proceed #8 
         [0499]    b) If no, stop. 
         [0500]    8) Does the intervention or procedure likely to yield generalizable knowledge about the subjects&#39; disorder or condition, which is of vital importance for the understanding or amelioration of the subjects&#39; disorder, or condition? 
         [0501]    a) If yes, go to #9. 
         [0502]    b) If no, stop. 
         [0503]    9) Have adequate provisions made for soliciting assent of the children and permission of their parents or guardians? 
         [0504]    a) If yes, go to #14. 
         [0505]    b) If no, seek permission. 
         [0506]    10) Is this research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children? 
         [0507]    a) If yes, go to #11. 
         [0508]    b) If no, stop. 
         [0509]    11) Does the IRB the IRB find that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children? 
         [0510]    a) If yes, go to #12 
         [0511]    b) If no, stop. 
         [0512]    12) Has the IRB received approval from the Secretary of DHHS, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment that the research is warranted? 
         [0513]    a) If yes, go to #16. 
         [0514]    b) If no 
         [0515]    13) If the research involves greater than minimal risk, but presenting the prospect of direct benefit to the child, has permission of at least one parent or guardian been given? 
         [0516]    a) If yes, go to #18. 
         [0517]    b) If no, stop. 
         [0518]    14) If the research involves greater than minimal risk and no prospect of direct benefits to the subjects but will yield generalized knowledge about the subjects disorder or condition has the IRB obtained both parents&#39; permission? 
         [0519]    a) If yes, go to #18 
         [0520]    b) If no, go to #15. 
         [0521]    15) If the IRB has not received both parents&#39; permission for research on the child is one of these conditions applicable: 
         [0522]    i) One parent is deceased. 
         [0523]    ii) One parent is incompetent. 
         [0524]    iii) One parent is unknown. 
         [0525]    iv) One parent is not reasonably available. 
         [0526]    v) Only one parent has legal responsibility for the child&#39;s care and custody. 
         [0527]    a) If yes, go to #18. 
         [0528]    b) If no, stop. 
         [0529]    16) If this research is not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children and has been approved by the Secretary of DHHS, has permission of one parent been given? 
         [0530]    a) If yes, go to #18. 
         [0531]    b) If no, go to #17 
         [0532]    17) If the IRB has not received both parents&#39; permission for research on the child is one of these conditions applicable: 
         [0533]    i) One parent is deceased. 
         [0534]    ii) One parent is incompetent. 
         [0535]    iii) One parent is unknown. 
         [0536]    iv) One parent is not reasonably available. 
         [0537]    v) Only one parent has legal responsibility for the child&#39;s care and custody. 
         [0538]    a) If yes, go to #18. 
         [0539]    b) If no, stop. 
         [0540]    18) Has a written permission or consent form, which details the appropriate requirements for informed consent been signed by the parents? 
         [0541]    a) If yes, go to #19. 
         [0542]    b) If no, stop. 
         [0543]    19) Has the IRB sought and received the assent of the child for research? 
         [0544]    a) If yes, go to CORE 
         [0545]    b) If no, go to #20 
         [0546]    20) Is the capability of the child so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefits that is important to the health of the child and is available only in the context of the research? 
         [0547]    a) If yes, go to CORE 
         [0548]    b) If no, seek assent 
         [0549]    See FIGS.  9 J 1 - 9 J 3  for the decision flow chart for the following questions: 
         [0550]    Prisoners 45 CFR 46 Subpart C: 
         [0551]    1) Does this research involve prisoners? Core Question 
         [0552]    a. If yes, proceed to subset. 
         [0553]    b. If no,—Return to core 
         [0554]    Subset Questions 
         [0555]    1) Does this research involve at least one of the following categories? 
         [0556]    (i) Study of the possible causes, effects, and processes of incarceration, and of criminal behavior. 
         [0557]    (ii) Study of prisons as institutional structures or of prisoners as incarcerated persons, 
         [0558]    (iii) Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) 
         [0559]    (iv) Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. 
         [0560]    a) If yes, #2 
         [0561]    b) If no, return to core 
         [0562]    2) Does this research involve minimal risk which is defined as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons? 
         [0563]    a. If yes, #3 
         [0564]    b. If no, core 
         [0565]    3) Are the risks involved in the research commensurate with risks that would be accepted by non-prisoner volunteers? 
         [0566]    a. If yes, #4 
         [0567]    b. If no, core. 
         [0568]    4) Is at least one member of the Board a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity? 
         [0569]    a. If yes, #5. 
         [0570]    b. If no, core. 
         [0571]    5) Does the majority of the Board (exclusive of prisoner members) have no association with the prison(s) facilities involved in the research? 
         [0572]    a. If yes, #6. 
         [0573]    b. If no, core. 
         [0574]    6) Does any possible advantages accrue to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison and are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired? 
         [0575]    a. If yes, #7. 
         [0576]    b. If no, core. 
         [0577]    7) Are the procedures for the selection of subjects within the prison fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners? 
         [0578]    a. If yes, #8. 
         [0579]    b. If no, core. 
         [0580]    8) Is the research information presented to the prisoner consistent with his language skills and educational levels to make an informed decision? 
         [0581]    a. If yes, #9. 
         [0582]    b. If no, core. 
         [0583]    9) Is their adequate assurance that parole boards will not take into account a prisoner&#39;s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole? 
         [0584]    a. If yes, #10. 
         [0585]    b. If no, core. 
         [0586]    10) Have adequate provisions been made if there may be a need for follow-up examinations or care of participants after the end of their participation in the research and taking into account the varying lengths of individual prisoners&#39; sentences, and for informing participants of this fact? 
         [0587]    a. If yes, finished, return to core. 
         [0588]    b. If no, stop. 
         [0589]    See FIGS.  9 L 1 - 9 L 2  for the decision flow chart for the following questions: 
         [0590]    Advertising 
         [0591]    1) Will the research involve advertisements, through various posters, brochures, scripts or other advertising for recruitment of subjects? CORE 
         [0592]    a) If yes, go to #2. 
         [0593]    b) If no, stop return to core. 
         [0594]    Subset questions: 
         [0595]    2) Is the name, address of the investigator and/or research facility or institution listed on advertising materials? 
         [0596]    a) If yes, go to #3 
         [0597]    b) If no, stop. Warn and continue through subset 
         [0598]    3) Is the medical condition or affliction or the purpose of the research listed on the advertising materials? 
         [0599]    a) If yes, go to #4 
         [0600]    b) If no, stop. Warn and continue through subset 
         [0601]    4) Is the inclusion criteria or exclusion criteria noted on the advertising materials? 
         [0602]    a) If yes, go to #5. 
         [0603]    b) If no, stop. Warn and continue through subset 
         [0604]    5) If a list of procedures are involved in the research, is a brief summary of those procedures on advertising materials? 
         [0605]    a) If yes, go to #6. 
         [0606]    b) If no, stop. Warn and continue through subset 
         [0607]    6) Are potential benefits to the subject listed and explained on the advertising materials? 
         [0608]    a) If yes, go to #7. 
         [0609]    b) If no, stop. Warn and continue through subset 
         [0610]    7) Is time and commitments such as number of visits, duration of research, follow-ups etc., noted on the advertising materials. 
         [0611]    a) If yes, go to #8. 
         [0612]    b) If no, stop. Warn and continue through subset 
         [0613]    8) Are the details of the compensation or reimbursement noted on the advertising materials? 
         [0614]    a) If yes, go to #9. 
         [0615]    b) If no, stop. Warn and continue through subset 
         [0616]    9) Are the details of compensation inconspicuous and non-deceptive? 
         [0617]    a) If yes, go to #10. 
         [0618]    b) If no, Warn and continue through subset 
         [0619]    10) Is the location of the research and contact information for further details noted on the advertising materials? 
         [0620]    a) If yes, go to #11. 
         [0621]    b) If no, stop. Warn and continue through subset 
         [0622]    11) Is the advertising material free from deceptive phrases and words such as, free, exciting, last chance, cutting edge etc.? 
         [0623]    a) If yes, go to #12 
         [0624]    b) If no, stop. Warn and continue through subset 
         [0625]    12) Is the advertising material free from misleading information regarding the purpose and type of research? 
         [0626]    a) If yes, go to CORE. 
         [0627]    b) If no, stop. Warn and continue to CORE. 
         [0628]    See FIGS.  9 M 1 - 9 M 2  for the decision flow chart for the following questions: 
         [0629]    Waiver or Alteration of Consent 
         [0630]    1) Does the research involve minimal risk to the subjects? Core 
         [0631]    a) If yes, go to #2. 
         [0632]    b) If no, go to CORE—INFORMED CONSENT MODULE 
         [0633]    2) Is the informed consent document the only record linking the subject and the research and would the principle risk would be potential harm from a breach of confidentiality? 
         [0634]    a) If yes, Warning—Obtaining informed consent document may be eligible to be waived. Go to CORE. 
         [0635]    b) If no, go to #3. 
         [0636]    3) Does the research present no more than minimal risk to the subject AND involves no procedures for which written consent is normally required outside of the research context? 
         [0637]    a) If yes, Warning—Obtaining informed consent document may be eligible to be waived. Go to CORE. 
         [0638]    b) If no, “Warning-Obtain a written informed consent document,” go to CORE #4 
         [0639]    4) Does the research involve minimal risk AND a waiver or alteration of informed consent will not adversely affect the welfare and rights of the subjects? CORE 
         [0640]    a) If yes, go to #5 
         [0641]    b) If no, go to CORE—INFORMED CONSENT MODULE 
         [0642]    5) Would the research be impaired or could not practicably be carried out without an alteration or waiver of the informed consent process? 
         [0643]    a) If yes, go to #6 
         [0644]    b) If no, go to CORE—INFORMED CONSENT MODULE 
         [0645]    6) In this research, is it possible to provide subjects with additional pertinent information during a debriefing after participation in the research? 
         [0646]    a) If yes, “Warning—An alteration or waiver of informed consent may be appropriate. Go to, CORE—COMPENSATION MODULE (NOTE: SKIP INFORMED CONSENT MODULE) 
         [0647]    b) If no, “Warning-Obtain a written informed consent document” Go to CORE—INFORMED CONSENT MODULE 
         [0648]    See FIGS.  9 B 1 - 9 B 3  for the decision flow chart for the following questions: 
         [0649]    Categories of IRB Reviews. 
         [0650]    1) Does this research protocol involve the use of human test subjects? CORE 
         [0651]    a) If yes, go to #2 
         [0652]    b) If no, WARNING: Research may be exempt and not subject to full IRB 
         [0653]    Review. 
         [0654]    Exempted research. 
         [0655]    2) Is the research being conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods?CORE 
         [0656]    a) If yes, WARNING: Research may be exempt and not subject to full IRB Review. 
         [0657]    b) No, go to #3 
         [0658]    3) Does the research involve the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects&#39; responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects&#39; financial standing, employability, or reputation? CORE 
         [0659]    a) If yes, WARNING: Research may be exempt and not subject to full IRB Review. 
         [0660]    b) No, go to #4 
         [0661]    4) Does the research involve the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter?CORE 
         [0662]    a) If yes, WARNING: Research may be exempt and not subject to full IRB Review. 
         [0663]    b) No, go to #5 
         [0664]    5) Does the research involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects? CORE 
         [0665]    a) If yes, WARNING: Research may be exempt and not subject to full IRB Review. 
         [0666]    b) No, go to #6 
         [0667]    6) Is the research or demonstration projects which are conducted by or subject to the approval of governmental department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs? CORE 
         [0668]    a) If yes, WARNING: Research may be exempt and not subject to full IRB 
         [0669]    Review. 
         [0670]    b) No, go to #7 
         [0671]    7) Does the research involve taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture? CORE 
         [0672]    a) If yes, WARNING: Research may be exempt and not subject to full IRB Review. 
         [0673]    b) No, go to next CORE question. 
         [0674]    Expedited Research 
         [0675]    1) Does the primary research present no more than minimal risk to human subjects, and involve clinical studies of drugs and medical devices, and only when condition (a) or (b) is met? CORE 
         [0676]    i) (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) 
         [0677]    ii) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. 
         [0678]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0679]    b) If no go to #2. 
         [0680]    2) Does the primary research present no more than minimal risk to human subjects, and involve collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: CORE 
         [0681]    i) (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or 
         [0682]    ii) from other adults and children 2 , considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. 
         [0683]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0684]    b) If no go to #3. 
         [0685]    See FIGS.  9 K 1 - 9 K 3  for the decision flow chart for the following questions: 
         [0686]    3) Does the research present no more than minimal risk to human subjects, and involves prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. CORE 
         [0687]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0688]    b) If no, go to #4. 
         [0689]    4) Does the research present no more than minimal risk to human subjects and involve collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. CORE 
         [0690]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0691]    b) If no, go to #5. 
         [0692]    5) Does the primary research present no more than minimal risk to human subjects and involve materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) CORE 
         [0693]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0694]    b) If no, go to #6 
         [0695]    6) Does the primary research present no more than minimal risk to human subjects and involve the collection of data from voice, video, digital, or image recordings made for research purposes? CORE 
         [0696]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0697]    b) If no, go to #7. 
         [0698]    7) Does the primary research present no more than minimal risk to human subjects, and is conducted on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) CORE 
         [0699]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0700]    b) If no, go to #8. 
         [0701]    8) Is this protocol a continuing review of research previously approved by the convened IRB as follows: CORE 
         [0702]    i) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or ii) where no subjects have been enrolled and no additional risks have been identified; or 
         [0703]    iii) where the remaining research activities are limited to data analysis. 
         [0704]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0705]    b) If no, go to #9. 
         [0706]    9) Is this protocol a continuing review of research, not conducted under an investigational new drug application or investigational device exemption where it is not listed in the prior questions for exempt or expedited categories but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. CORE 
         [0707]    a) If yes, Warning An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB 
         [0708]    b) If no, go to next CORE. 
         [0709]    Alternative embodiments of the present invention include computer generated notices to users (e.g., curriculum builders) that the Knowledge-ICB database has been updated and that information previously pulled or downloaded from the Knowledge-ICB database for course building, for example, may be outdated. System  10  will maintain the old version of the lesson  76  until all students complete the lesson  76  when topic  64  is updated in a RLO  52  that are part of a lesson  76 . Further embodiments of the present invention can include identifying the particular course that contains the outdated information and identifying the students whom have taken test questions that relate to the outdated information. 
         [0710]    Another embodiment of system  10  can be used by an organization to load their organization policies and procedures for electronic distribution and training of employees. For example, Carlow University can access the Knowledge ICB  22  through EthAssist web page  68  by selecting the Carlow University button  232  on  FIG. 8A . The subsequent web pages can be customized to meet the educational and training needs of the organization, where the organization can place its policies and procedures on Knowledge ICB  22  for exclusive use by its employees and other authorized personnel. The educational and training modules can be developed based on the techniques described above. 
         [0711]    Yet another embodiment of system  10  can allow patients to directly access Knowledge-ICB  22  to educate themselves regarding healthcare ethics they are facing. A separate login screen, possibly through an insurance company web site, is provided for read-only access to ethics topics and other applicable topics. 
         [0712]    Still yet another embodiment of system  10  can allow the general public to take specific lessons in Curriculum Builder  28  for continuing education units, for example for a subscription fee, pay for play transaction. 
         [0713]    While the disclosure has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the embodiments. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.