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					  ADMINISTRATIVE GUIDANCE: Types of Approvals
  AG # 3-9                              TITLE: Advertisements                                               Page: 1 of 6
  Revision #:12
  Effective Date: 5-1-08



OBJECTIVE:
To describe the procedures to follow to create, review and approve an advertisement for a research study.


PROCEDURE FOR SUBJECT RECRUITEMENT MATERIALS:

        CREATING ADVERTISEMENTS FOR SUBJECT RECRUITMENT

                 Instructions for creating subject recruitment materials and standardized templates are available to
                 help in creation of ad at the following website:

                 www.virginia.edu.vprgs.irb


                 The study team may wish to contact the Marketing Communications Department for assistance in
                 design and purchasing of ad space. When creating advertisements for a particular area of service,
                 Center of Excellence etc., the advice of these professionals is highly recommended.
Department: Types of Approvals
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Revision #: 12




     SUBMITTING ADVERTISEMENTS FOR SUBJECT RECRUITMENT TO IRB-HSR


     IRB-HSR’S RECEIPT OF SUBJECT RECRUITMENT MATERIALS

             All subject recruitment materials submitted to IRB-HSR are stamped with the date received.

             An event of RECEIPT OF ADVERTISEMENT will be entered into the database with a comment
             describing the advertisement materials received. For example, the comment entered might read
             TV ad, website ad., etc.

     IRB-HSR’S REVIEW OF SUBJECT RECRUITMENT MATERIALS

             Every effort is made to see that all materials submitted will be reviewed by the IRB-HSR within 3
             days of receipt

             Recruitment materials will be reviewed for the following required elements:

                Name of Facility: “UVa Health System” or “University of Virginia are the preferred locations
                 of reference. Note for display advertising and internal publications ads such as Link and C-
                 Ville this information is included in a pre-approved page banner or logo, so does not have to
                 be repeated in the text of the ad. Department and /or Division must also be included whenever
                 possible. For non-display ads where space is an issue, “UVa” is an acceptable abbreviation.
                Name of Condition/Disease under study: In lay language.
                Purpose of the research: Use lay language and aim for a 6 th grade reading level. Write in
                 short, complete sentences. Make sure you are clear that you are recruiting for research as
                 opposed to providing treatment. It should be very clear that subjects are being recruited for
                 research. ALL drugs and devices listed should be referred to as “experimental” or
                 “investigational” if not approved by the FDA for the indication/dose/route/dose/study
                 population.
                Major inclusion/exclusion criteria such as age/gender requirements: Do not copy this list
                 from the protocol because this is too much information and too soon in the process.
                BRIEF list of procedures required: For example “blood tests, x-rays, etc that will be
                 performed as part of the study.” Note the ad may disclose important features of the study
                 design that may influence enrollment: e.g. the use of placebos or the requirement for prior
                 medication withdrawal.
                Time commitment for participation: For example, number of visits, length of each visit and
                 total length of study participation.
                Compensation: Compensation should be mentioned but not emphasized. Make clear if the
                 amount mentioned is per visit or at study completion.
                Contact Information: Primary contact name and contact info should be present and these
                 people should be listed in the IRB-HSR database for this study. (If not currently listed for this
                 protocol, obtain permission from PI or study coordinator to add them as a sub investigator and
                 verify they have completed training.)
                Name of Principal Investigator (PI): This is only necessary if it is not the primary contact.
                IRB-HSR number: This information is required for every study-specific ad. IRB-HSR number
                 is not required for ads about a particular center.

             Note that the some ads such a Link and Cville must be submitted using the approved template.

             Recruitment materials should not include the following:

                No promises of treatment, cure, or promise of benefits should be noted in recruitment
                 material.
Department: Types of Approvals
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Revision #: 12



                No “catchy” words like “free” and “exciting”. No appearance of coerciveness should be
                 present.
                No words that could be insulting to a potential subject should be present. For example
                 “overweight” should be used instead of the word “fat,” and “lean” instead of the word
                 “skinny”, etc.
                No words that evoke the “YUK response”,(such as pus, snot, etc) should be used.
                No offers of free care or free treatment should be listed. The statement that “Study-related
                 medications, exams, tests, etc. are provided free of charge” is acceptable.
                There should be no information present that could contribute to confusion of the participant
                 between research participation and standard clinical care.
                There should be nothing in the background (photos, clip art, music etc) that would alter the
                 interpretation of the ad.


             Any issues noted during the review of the recruitment material will be communicated back and
             forth with the study team via e-mail, until all issues are resolved. The study team should keep
             these communications with their study files. IRB-HSR will file these communications with the
             Advertising Approval in the IRB-HSR files for that study.


     IRB-HSR APPROVAL OF RECRUITMENT MATERIALS

             As issues are being resolved, IRB-HSR staff will complete an Advertising Approval Checklist.
             This checklist is printed at the bottom on the Clinical Trials Ad Submission Form if ads are
             submitted through the website. A hard copy of the Advertising Approval Checklist is available in
             Appendix A of this document. If hardcopies of the ad were submitted, 2 copies are requested. If
             not available, a copy will need to be made by the IRB-HSR reviewer such that 2 copies of each ad
             are available for stamping purposes. If electronic copies were submitted, 2 copies of each ad
             should be printed. One of the following Approvals will be issued depending on the ad:

                If the ad is in it’s final copy (text is final) except for the possible addition of a UVA logo or
                 formatting as approved by the UVA Marketing and Communications Department, the ad will
                 be issued an Approval. Both copies of each ad will be stamped with the IRB-HSR approval
                 stamp, and the approval date and expiration date completed. An Event of Advertisement
                 Approval will be entered into the database as an Expedited Event. This Approval will be
                 assigned to the next IRB-HSR meeting and assigned to the Agenda. In the comment field, the
                 ad types approved will be listed (website, newspaper, etc). The comment field will also note
                 the category under which the advertisement was approved. For example the comment might
                 read “TV, Website, and Newspaper Advertisement approved via Category #9 – Minimal Risk.
                 An Approval Form is printed and placed with the Advertisement Approval Checklist and the
                 approval approved stamped ads. The Chair or Vice Chair will review the ads and sign the
                 Approval Form. A copy of the approval form, all communication, and a copy of each
                 stamped ad will be filed with the IRB-HSR files. The original signed Approval Form, and a
                 copy of each stamped ad will be sent to the study team. Advertisement Approvals will be
                 reviewed at the upcoming IRB-HSR meeting and that review will be reflected in the minutes
                 for that meeting.

                If the ad is not in its final copy (for example scripts for TV or Radio ads where pictures and/or
                 music are to be added) IRB-HSR will issue Pending Approval. Each ad will be stamped with
                 the IRB-HSR approval stamp and PENDING APPROVAL will be written near the stamp.
                 The Pending Approval date and expiration date will be completed. An Event of
                 Advertisement Approval will be entered into the database as an Expedited Event. This
                 Approval will be assigned to the next IRB-HSR meeting and assigned to the Agenda. In the
                 comment field, PENDING APPROVAL will be entered, and the ad types will be listed
Department: Types of Approvals
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Revision #: 12


                 (Radio, TV etc). An Approval Form will be printed and placed with the approved stamped
                 ads. The Chair or Vice Chair will review the ads and sign the Approval Form. A copy of the
                 approval form, all communication, and a copy of each stamped ad(s) will be filed with the
                 IRB-HSR files. The original signed Approval Form, and stamped ad(s) will be sent to the
                 study team. Advertisement Approvals will be reviewed at the upcoming IRB-HSR meeting
                 and that review will be reflected in the minutes for that meeting.

                SPECIAL NOTE REGARDING RECORDED ADS FOR RADIO AND TV

                 Recorded ads are sent to IRB-HSR by e-mail, tape, VHS tape, CD or DVD.

                      o   Please note if these are received by e-mail, the e-mail itself is printed and stamped.
                          The e-mail with the recorded advertisement should be forwarded to the chair or vice
                          chair to review. The e-mails are deleted following approval.

                      o   If actual recordings are received, the jackets or covers of the recording will be
                          copied, and the copy of the jacket covers will be stamped. Actual recordings will be
                          returned after approval is final.

                 All study-specific ads are given a five-year approval. Ads will expire five years from the
                 original protocol approval date. The ad will automatically be taken off the website on the
                 expiration date or when the IRB-HSR office has been notified that the study is closed to
                 enrollment.

                     All ads that are not specific to a study, but mention research as part of the services
                      provided, will be given an expiration date of 5 years after the approval date. These ads
                      will be stamped with the IRB-HSR approval stamp and the approval and expiration dates
                      documented. No Approval Form will be issued for these ads. A stamped approved copy
                      of the ad will be returned to the study team, and a copy of this approval will be placed in
                      the IRB-HSR File: Center Ads.


     HOW IRB-HSR POSTS A WEBSITE ADVERTISEMENT

             Once the website ad is approved, the text is copied from the final ad. IRB-HSR staff should then:
                 Log into IRB Online
                 Enter the IRB-HSR number to which the ad belongs.
                 When the Main Page for the specific IRB-HSR profile is displayed, ADVERT should be
                     selected.
                 The approved ad text is then pasted into the section of the screen called
                     ADVERTISEMENT.
                 From the Clinical Trial Advertisement Request, the information from the box that asks
                     “Please provide a lay person headline for your trial” is copied and pasted into the section
                     of the screen entitled “Ad Title (plain words)” in IRB On Line.
                 From the Clinical Trial Advertisement Request the category or categories selected by the
                     submitter are entered into IRB Online using the drop down list.
                 From the Clinical Trial Advertisement Request the keywords selected by the submitter
                     are entered into IRB Online using the drop down list.
                 From the Clinical Trial Advertisement Request the contact information for the ad is
                     entered from the drop down list.

     IRB-HSR MANAGEMENT OF CATEGORIES AND KEYWORDS
             When a website ad is listed on the Health System Clinical Trials Website (HSCTW), they appear
             under Categories which are like large umbrella-like areas indicating the area of medical specialty
Department: Types of Approvals
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Revision #: 12


             responsible for this research. Categories are selected by the person submitting the HSCTW
             website ad and their purpose is to help potential subjects find information regarding clinical trials
             of interest. The ad submitter may select at least 1 category but not more than 2. These
             Categories correspond with categories in CenterWatch, which is a nationally recognized
             clearinghouse website for advertising Clinical Trials. All website ads appearing on HSCTW, are
             automatically picked up and displayed on CenterWatch. The School of Medicine Clinical Trials
             Office funds this service. The categories are not subject to change due to this arrangement. The
             list of categories is as follows:

                     Cancer (Oncology)
                     Cardiology/Vascular
                     Dental/Maxillofacial
                     Dermatology/Plastic Surgery
                     Endocrinology
                     Gastroenterology/Hepatitis
                     Healthy Subject Studies
                     Health Subjects - Inpatient
                     Healthy Subject – Outpatient
                     Hematology
                     Immunology/Infectious Disease
                     Musculoskeletal/Sports Medicine
                     Nephrology/Urology
                     Neurology
                     Obstetrics/Gynecology
                     Otolaryngology
                     Pediatrics/Neonatology
                     Pharmacology/Toxicology
                     Psychiatry/Psychology
                     Pulmonary/Respiratory
                     Rheumatology
                     Surgery
                     Trauma/Emergency Medicine
                     Women’s Health

             A set of keywords is associated with each Category. The purpose is to help people refine their
             search for a clinical trial by making available more specific medical terms. An example of a
             keyword would be “Stroke” – and this keyword is under the Category of Neurology.

             The submitter may alter the list of keywords associated with a category, unless otherwise directed
             by someone in the department responsible for recruitment. For instance, the Cancer Center
             submitters are not free to change the keywords associated with Cancer (Oncology) unless Assoc
             Director for Research Administration or designee grants permission.

             To add a new keyword and connect it to a given category:
                  Log into IRB Online
                  Enter the IRB-HSR number to which the ad belongs.
                  When the Main Page for the specific IRB-HSR profile is displayed, ADVERT should be
                     selected
                  Click on Create a New Keyword
                  Type the new Keyword into the space called Add New Keyword
                  Return to ADVERT screen and press update twice.
                  The keyword must be then linked to each Category for this ad, in order to display
                     properly. To do this, the category or categories shown on the ADVERTS page are
  Department: Types of Approvals
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  Revision #: 12


                          selected. From the drop down list under Connect to New Keyword the new keyword is
                          selected and update is clicked. Return to the ADVERT screen and press update twice.
                         Then the new keyword will appear in the keyword drop down list and can be successfully
                          selected for this study.


                 Keywords for individual ads may be added or removed as directed by the study team.

                 There are times when keywords for given category need to be revised per an agreed upon strategy
                 between the department and marketing. Keywords can only be added per instructions above.
                 Keywords can be deleted entirely or from a specific category by:
                      Logging into IRB Online
                      Selecting Utilities
                      Under Reports – select Ad Keywords
                      The Keyword to delete will be selected and it will need to be specified whether this is an
                          entire deletion or whether this deletion affects only one category.
                 
DOCUMENTATION:
Documentation of the approval of an ad will be done with the Advertising Approval Checklist, the IRB-HSR
Approval Form and the stamp on the ad itself. This documentation will be placed in the study file in the IRB-HSR
office. All recorded copies of advertisements will be returned to the PI.


REFERENCES:
FDA Information Sheets: Page 4 “Recruiting Study Subjects”
Miller FG, Shorr AF. Advertising for Clinical Research; IRB. Volume 21, Number 5, September, October 1999.

APPENDIX A: Advertising Approval Checklist

				
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