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Duke University Health System Institutional Review Board

By Randy Green,2014-07-01 16:15
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Duke University Health System Institutional Review Board

     DUKE UNIVERSITY MEDICAL CENTER AND HEALTH SYSTEM

    Community Health Activity Request Form

     Community Health Internal Office Use Only: Community Health Credentialed Faculty: Department of Community and Family Medicine Chair’s Office: Community Health Activity Approved: Community Health Activity Approved: Yes No Yes No

    Additional Information Needed: Additional Information Needed:

    ___________________________________________________ _______________________________________________________ Signature DateSignature Date

Forms must be received at least 30 days prior to any scheduled community health activity. Attach

    additional sheets as necessary to completely answer all questions. For research related activity,

    contact the Duke University Health System (DUHS) Institutional Review Board.

    A. ADMINISTRATIVE INFORMATION

    1. Activity Coordinator (person in charge of the event): E-mail: Phone: Fax: Dept.&Division:

    2. Faculty Sponsor (required for Duke students): E-mail: Phone: Fax: Dept.&Division:

    3. Qualifications of Coordinator and Personnel

    a) Activity Coordinator and Personnel completed and passed the on-line training Yes No module and test, “Basic Community Health Training”.http://chtraining.duhs.duke.edu/

    b) Activity Coordinator and Personnel involved in the community health activity Yes No N/A that includes medical screenings, completed and passed the on-line training module

    and test, “Medical Screening in a Community Setting”. http://chtraining.duhs.duke.edu/

    c) Duke learners completed and passed the on-line training module and test, Yes No “Working Effectively In Communities”.http://chtraining.duhs.duke.edu/

    d) Activity Coordinator is certified in Basic Life Safety (BLS). Yes No

    e) All personnel providing testing and or advice to patients have been Yes No N/A competency-tested. (Documentation must be maintained by the Coordinator)

    f) Staff working directly with patients has received a copy of the procedure Yes No for this community health activity.

    g) Duke employee and learner’s duties and responsibilities at this community health activity are listed below. (Attach a separate sheet if needed). Note: Duke employee and/or learner participation at the activity is not allowed unless the individual is included on this list.

    Name and Degrees Duties/ Responsibilities Position at Duke

Community Health Activity Form, 04/01/09 Page 1 of 4

B. COMMUNITY HEALTH ACTIVITY INFORMATION

    1. Title of Activity:

    2. Name of Unit or Entity Sponsoring Activity:

     3. Date(s) of activity (list all that will apply): 4. Time(s) of activity (inclusive of set up/clean up time):

    5. Location of the activity (address, city and state):

6. Describe the target population to be served by this activity (e.g., geographic, age, sex and ethnicity):

    7. Health condition(s) of interest (list all that apply):

8. Type of Activity: (Check all that apply)

    Education *Note: Sections D-F may not be applicable to Health Education based activities.

    Screening

    Clinical Service (e.g., school physicals)

    Prevention Services (e.g., flu vaccinations)

9. Activity Notification: medium to be used (check all that apply and attach materials)

    Poster/billboard Flyer Brochure Newspaper/Magazine Radio TV/Video Internet website/email Other:

10. Describe how, when and where activity notification will be given. (Attach a separate sheet if needed)

C. PROCEDURES

1. Select and attach a copy of your procedure(s) for the following (check /attach all that apply):

    Registration Screening Patient Education

    Informed Consent Vaccination Anticipated Emergencies

2. Describe the method(s) of the above procedures to be used (list all that apply):

    3. Informed Consent Form (ICF) approved by Duke Risk Management. Yes No N/A (Attach consent form). (If no, submit to Duke Risk Management)

    4. Education Information will be provided at this activity. Yes No

     (If yes, attach the education materials)

    5. Emergencies: Are there potential emergencies? Yes No If yes, list all that apply:

    6. Emergency Management Team (EMT): If there are any potential Yes No emergencies listed above, will local EMT be notified of the activity, date and times?

Community Health Activity Form, 04/01/09 Page 2 of 4

    *Note: Sections D-F may not be applicable to Health Education Activities, if so, proceed to section G.

D. STANDARDS FOR EQUIPMENT

    1. Are there equipments or instrumentation to be used? Yes No N/A If yes, list all that apply:

    a) Has the equipment to be used been calibrated by the department or Yes No company that owns the equipment?

b) Has the equipment had regular maintenance by an authorized person? Yes No (Documentation must be kept by the Coordinator)

2. Who keeps the published schedule or record of maintenance?

    Name: E-mail Phone: Fax:

E. MANAGEMENT OF THOSE WHO REQUIRE FURTHER ATTENTION

    1. Are there medical screenings at this community health activity? Yes No N/A

2. Screening Activities: The US Department of Health and Human Services recommends follow up for those who

    screen positive (Put Prevention into Practice, Clinician’s Handbook of Preventive Services)

    a) Describe the proposed follow up procedure for patients with positive or abnormal results requiring emergent or urgent action.

    b) Describe the proposed follow up procedure for patients with positive or abnormal results NOT requiring emergent or urgent action.

c) Describe how patients with positive or abnormal results will be counseled.

    d) Who will counsel these patients? Name(s): E-mail Phone: Fax:

    e) List the provider(s) who will offer follow up care to those with positive or abnormal results. (Attach a separate sheet if needed)

    Name(s): E-mail Phone: Fax:

    f) Describe the documentation process of any recommendation to those patients with positive or abnormal results.

g) Information/materials will be given to patients (check all that apply):

    Written materials will be given to patients on their results

    Written information will be given to patients on the disease

    Written materials will be given to patients on available providers and providers contact information

Community Health Activity Form, 04/01/09 Page 3 of 4

F. NOTIFICATION TO LOCAL PROVIDERS

    1. Have local primary care providers been notified of this activity? Yes No N/A

If yes, explain the methods used (e.g., face to face, letters, email or other):

    2. Primary care providers will be contacted by phone and in writing Yes No on emergent patients.

    3. Non-urgent or emergent results will be promptly mailed to primary care providers Yes No including information or guidance given to patients.

    4. Patients without a primary care provider are given options Yes No for available follow up care. (Documented in survey records)

    G. DOCUMENTATION

1. Data Storage and Confidentiality: Documentation must be maintained in a safe, secure location for at least 7 years.

    (Attach a copy of the confidential health information to be stored.)

a) Describe how and where data/health information will be stored and secured to ensure confidentiality.

    Note: The information on this community health activity form will be shared with the DUHS Community Relations Office (CRO). The CRO requires that all community health activities are entered via a web based system: Community Benefits Inventory/Social

    Accountability (CBISA) which is hosted on Duke internal site: https://www.cbisaonline.com/dm_1600. Contact your department administrator for further assistance in CBISA training.

    By signing below, I declare that I have reviewed this report which provides a complete and accurate description of this

    community health activity as well as reviewed the Community Health activity policy and procedures. I have completed all

    the required training modules and passed all required tests prior to my participation in this community health activity.

    Also, as the Activity Coordinator I understand that it is my responsibility to check the applicable rules in the state where

    the event is being offered.

Signature of Activity Coordinator Date

    Signature of Faculty Sponsor (required for Duke students) Date

     SUBMIT THE COMPLETED FORMS AND ATTACHMENTS TO:

     Division of Community Health

     Department of Community & Family Medicine

     DUMC Box 104425

     Durham, NC 27710

     Phone: (919) 681-6595

     Fax: (919) 613-6899

     Email: CommunityHealthActivity@notes.duke.edu

Community Health Activity Form, 04/01/09 Page 4 of 4

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