5. Collaborating Site(s) - Milken Institute School of ...



NIH Human Subjects SAMPLE TEMPLATE for behavioral trials1. RISKS TO THE SUBJECTS Human Subjects Involvement and Characteristics: The {A B C LOCATION} population is approximately 95% white; 47% male, 53% female. Relevant to Human Subjects, youth smokers could be ages 13-18 who smoke >1 cigarettes in past 30 days. All adult participants, smokers and non smokers, will be >18. Although the sample will likely contain < 10% minority participants, it will be comprised of another under-served population–poor, Appalachians. The sample will be drawn from {A B C LOCATION}, a predominantly rural, white state, and the only state fully encompassed by Appalachia. It has a markedly low per capita income (< $16,000), with 18% living below the poverty level. Are the communities located near the investigators? The longest possible driving distance is about 5 hours from XTOWN (location of {X Y Z UNIVERSITY}), to the most remote southern part of {A B C LOCATION}. Researchers have conducted many studies in {A B C LOCATION}; traveling to set up studies and collect data, researchers are familiar and comfortable with the {A B C LOCATION} terrain and plan accordingly. Sources of Materials: As discussed in the narrative, our data collection involved Tier 1, Tier 2, and Tier 3. Tier 1 involved secondary data analyses, for which we will obtain exemption. Tier 2 involves IRB-approved consent/assent with teens and parents, and Tier 3 involves the collection of data from parents and potentially public sources. This human subject section is specifically related to Tier 2 data collection. As relevant for Tier 2 data collection, sources will be youths and adults. All data will be collected by NIH Ethics/HIPPA certified, trained research staff in the selected sites within the experimental counties, following an IRB-approved protocol. At least two researchers will be present at each data collection occasion. Per Aim 2.0, Tier 2, data will be collected on three occasions: baseline, 3 months post baseline, and 6 months post baseline. The total battery for each participant is expected to last less than 1 hour as it is currently proposed. Data will be collected by group at each site. Data will be collected within a 3-week period for each baseline and follow up occasions. Note: For Aim 2, we will obtain IRB exemption for Tier 1, secondary data. We will also obtain exemption for the Field Intercept Survey for Aim 1.Table 7: Sample Data collection ScheduleYear 2Year 3Year 4quarter123412341234County 1 (E)BEBEIEIEIEIEFEFEFEFEFEFECounty 2 (C)BCBCBCBCBCBCBCBCBCBCBCBCCounty 3 (E)------BEBEIEIEIEIEFEFEFECounty 4 (C)------BCBCBCBCBCBCBCBCBCCounty 5 (E)------------BEBEIEIEIEIECounty 6 (C)------------BCBCBCBCBCBC(E) = Experimental County; (C) = Control County; B = Baseline assessment; I = Intervention; F = Follow-up assessmenta. Instruments and tools for the Aim 1.0 Field Intercept Survey. The field intercept survey will use items from the Global Adult Tobacco Survey. ADDIN EN.CITE <EndNote><Cite><Author>Prevention</Author><Year>2009</Year><RecNum>306</RecNum><DisplayText><style face="superscript">110</style></DisplayText><record><rec-number>306</rec-number><foreign-keys><key app="EN" db-id="tsw9str95ztp9peeewu50dseee9wwtwfx959">306</key></foreign-keys><ref-type name="Electronic Article">43</ref-type><contributors><authors><author>Centers for Disease Control and Prevention</author></authors></contributors><titles><title>Global Adult Tobacco Survey</title></titles><dates><year>2009</year><pub-dates><date>May 20, 2009</date></pub-dates></dates><urls><related-urls><url> These items will be administered in an interview format, and data entered directly into a PDA computer. All data collected will be anonymous. We selected this survey because it supplies excellent reference/comparison data and includes items related to secondhand smoke exposure (Section E of GATS), exposure and knowledge of tobacco-related media (Section G of GATS), and knowledge, attitudes and perceptions relating to tobacco use and tobacco products (Section H 0f GATS). All of the items are pertinent to our Aims.b. Instruments and tools for Aim 2.0. Tier 2 instruments involve the collection of confidential information for research purposes. However, only instruments that involve the collection of potentially sensitive or protected information are detailed for the requirements of the NIH human subjects section. A discussion of potential risks and a data safety and monitoring plan follow. Note: All study instruments are detailed in Table 8 and will be generated using Redcap software. Table 8: Data Sources and Information Collected by TierInstrumentYouth SmokersAdult SmokersParent ParticipantsTier 1 data Tier 2 dataTier 1Tier 2Tier 2Individual Information Form/Demo-graphics (IIF)Assesses demographics (i.e., race, gender, age). Time to complete < 1 minute.Add: place of residence, employment status. SameSameSameFour Factor Index of Social Status (FFI) /SES ADDIN EN.CITE <EndNote><Cite><Author>Hollingshead</Author><Year>1975</Year><RecNum>120</RecNum><DisplayText><style face="superscript">98</style></DisplayText><record><rec-number>120</rec-number><foreign-keys><key app="EN" db-id="tsw9str95ztp9peeewu50dseee9wwtwfx959">120</key></foreign-keys><ref-type name="Unpublished Work">34</ref-type><contributors><authors><author>Hollingshead, AB</author></authors></contributors><titles><title>Four factor index for social status.</title></titles><dates><year>1975</year></dates><publisher>Yale University</publisher><urls></urls></record></Cite></EndNote>98 NANANAMethod of assessing SES used extensively in research. It yields aggregate scores (range: 8-66) indicate 5 possible classes from lower class to upper class. Time =5 minutesSameSmoking History Questionnaire (SH) ADDIN EN.CITE <EndNote><Cite><Author>IOX Assessment Associates</Author><Year>1988</Year><RecNum>616</RecNum><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>616</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">616</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>IOX Assessment Associates,</author></authors></contributors><titles><title>Program Evaluation Handbook: Smoking Cessation</title></titles><dates><year>1988</year></dates><pub-location>Los Angeles</pub-location><publisher>IOX Assessment Associates</publisher><urls></urls></record></Cite></EndNote>11 Assesses smoking onset, number of cigarettes smoked a day during the first year of smoking, reasons for smoking, smoking locations. Time to complete=3-5 minutes. SameSameSameSameSmoking Survey (SS) ADDIN EN.CITE <EndNote><Cite><Author>IOX Assessment Associates</Author><Year>1988</Year><RecNum>616</RecNum><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>616</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">616</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>IOX Assessment Associates,</author></authors></contributors><titles><title>Program Evaluation Handbook: Smoking Cessation</title></titles><dates><year>1988</year></dates><pub-location>Los Angeles</pub-location><publisher>IOX Assessment Associates</publisher><urls></urls></record></Cite></EndNote>11Assesses current and frequent smoking, number of cigarettes smoked on weekdays/weekends, prior quit attempts, confidence in quitting, motivation to quit, use of smokeless tobacco/cigars in the past month, and current use of nicotine replacement therapy. and reasons for quitting. Time=3-5 minutes.ADD: smoking status of parents/guardians, siblings, and friends; social support to reduce smoking.SameADD: smoking status of other household members; social support to quit.Same (among parents who smoke)Fagerstrom Tolerance Questionnaire (FTQ) ADDIN EN.CITE <EndNote><Cite><Author>Heatherton</Author><Year>1991</Year><RecNum>842</RecNum><DisplayText><style face="superscript">99</style></DisplayText><record><rec-number>842</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">842</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="Times New Roman" size="100%">Heatherton, T. F.</style></author><author><style face="normal" font="Times New Roman" size="100%">Kozlowski, L. T.</style></author><author><style face="normal" font="Times New Roman" size="100%">Frecker, R. C.</style></author><author><style face="normal" font="Times New Roman" size="100%">Fagerstrom, K. O. </style></author></authors></contributors><titles><title><style face="normal" font="Times New Roman" size="100%">The Fagerstrom Test for Nicotine Dependence: A revision of the Fagerstrom Tolerance Questionnaire. </style></title><secondary-title><style face="normal" font="Times New Roman" size="100%">British Journal of Addictions</style></secondary-title></titles><pages>1119-1127</pages><volume>86</volume><dates><year>1991</year></dates><urls></urls></record></Cite></EndNote>99NAThe Modified ADDIN EN.CITE <EndNote><Cite><Author>Heatherton</Author><Year>1991</Year><RecNum>842</RecNum><DisplayText><style face="superscript">99</style></DisplayText><record><rec-number>842</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">842</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="Times New Roman" size="100%">Heatherton, T. F.</style></author><author><style face="normal" font="Times New Roman" size="100%">Kozlowski, L. T.</style></author><author><style face="normal" font="Times New Roman" size="100%">Frecker, R. C.</style></author><author><style face="normal" font="Times New Roman" size="100%">Fagerstrom, K. O. </style></author></authors></contributors><titles><title><style face="normal" font="Times New Roman" size="100%">The Fagerstrom Test for Nicotine Dependence: A revision of the Fagerstrom Tolerance Questionnaire. </style></title><secondary-title><style face="normal" font="Times New Roman" size="100%">British Journal of Addictions</style></secondary-title></titles><pages>1119-1127</pages><volume>86</volume><dates><year>1991</year></dates><urls></urls></record></Cite></EndNote>99FTQ for youth assesses participants’ level of nicotine dependence. ADDIN EN.CITE <EndNote><Cite><Author>Heatherton</Author><Year>1991</Year><RecNum>842</RecNum><DisplayText><style face="superscript">99</style></DisplayText><record><rec-number>842</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">842</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="Times New Roman" size="100%">Heatherton, T. F.</style></author><author><style face="normal" font="Times New Roman" size="100%">Kozlowski, L. T.</style></author><author><style face="normal" font="Times New Roman" size="100%">Frecker, R. C.</style></author><author><style face="normal" font="Times New Roman" size="100%">Fagerstrom, K. O. </style></author></authors></contributors><titles><title><style face="normal" font="Times New Roman" size="100%">The Fagerstrom Test for Nicotine Dependence: A revision of the Fagerstrom Tolerance Questionnaire. </style></title><secondary-title><style face="normal" font="Times New Roman" size="100%">British Journal of Addictions</style></secondary-title></titles><pages>1119-1127</pages><volume>86</volume><dates><year>1991</year></dates><urls></urls></record></Cite></EndNote>99 FTQ is a widely-used and reliable 8-item scale. It yields an aggregate score between 0 and 2 = very low dependence, 3 or 4 = low dependence, 5 = medium dependence, 6 or 7 = high dependence, and 8 to 11 = very high dependence. Time to complete=2 minutes.NAThe Adult FTQ is a widely-used and reliable 8-item scale. It yields an aggregate score between 0 and 2 = very low dependence, 3 or 4 = low dependence, 5 = medium dependence, 6 or 7 = high dependence, and 8 to 11 = very high dependence. Time to complete=2 minutes.Same Adult FTQ among parents who smoke.c. Other Important Measurement Considerations: Least Invasive Biochemical ValidationA number of methodological issues surround the determination of smoking status recorded on the SS (which will be used to assess quit rates) and COR. The issue most relevant to human subjects involves biochemical validation. The three commonly used methods are Carbon Monoxide (CO), saliva cotinine, and saliva thiocyanate. The use of biochemical validation to corroborate self-reported tobacco use or non-use can enhance confidence in the accuracy of the self-report measures. Yet, it has been found that under most circumstances false reporting is low. ADDIN EN.CITE <EndNote><Cite><Author>Sussman</Author><Year>1995</Year><RecNum>606</RecNum><DisplayText><style face="superscript">111</style></DisplayText><record><rec-number>606</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">606</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Sussman, S.</author><author>Dent, C. W.</author><author>Burton, D.</author><author>Stacy, A. W.</author><author>Flay, B. R.</author></authors></contributors><titles><title>Developing school-based tobacco use prevention and cessation programs.</title></titles><dates><year>1995</year></dates><pub-location>Thousand Oaks, CA</pub-location><publisher>Sage</publisher><urls></urls></record></Cite></EndNote>111 ADDIN EN.CITE <EndNote><Cite><Author>Velicer</Author><Year>1992</Year><RecNum>574</RecNum><DisplayText><style face="superscript">112</style></DisplayText><record><rec-number>574</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">574</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Velicer, W. F.</author><author>Prochaska, J. O.</author><author>Rossi, J. S.</author><author>Snow, M. G.</author></authors></contributors><auth-address>Department of Psychology, University of Rhode Island, Kingston 02881.</auth-address><titles><title>Assessing outcome in smoking cessation studies</title><secondary-title>Psychol Bull</secondary-title></titles><pages>23-41</pages><volume>111</volume><number>1</number><keywords><keyword>Follow-Up Studies</keyword><keyword>Human</keyword><keyword>Outcome and Process Assessment (Health Care)/statistics &amp; numerical data</keyword><keyword>Patient Compliance/psychology</keyword><keyword>Smoking Cessation/*psychology/*statistics &amp; numerical data</keyword><keyword>Support, U.S. Gov&apos;t, P.H.S.</keyword></keywords><dates><year>1992</year><pub-dates><date>Jan</date></pub-dates></dates><accession-num>1539088</accession-num><urls><related-urls><url> In reviewing the literature, Sussman et al. ADDIN EN.CITE <EndNote><Cite><Author>Sussman</Author><Year>1995</Year><RecNum>606</RecNum><DisplayText><style face="superscript">111</style></DisplayText><record><rec-number>606</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">606</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Sussman, S.</author><author>Dent, C. W.</author><author>Burton, D.</author><author>Stacy, A. W.</author><author>Flay, B. R.</author></authors></contributors><titles><title>Developing school-based tobacco use prevention and cessation programs.</title></titles><dates><year>1995</year></dates><pub-location>Thousand Oaks, CA</pub-location><publisher>Sage</publisher><urls></urls></record></Cite></EndNote>111 maintain that the use of biochemical validation with youth may actually enhance the false positive rate (i.e., reports of use with negative results on the validation measure). In contrast, Velicer et al. ADDIN EN.CITE <EndNote><Cite><Author>Velicer</Author><Year>1992</Year><RecNum>574</RecNum><DisplayText><style face="superscript">112</style></DisplayText><record><rec-number>574</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">574</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Velicer, W. F.</author><author>Prochaska, J. O.</author><author>Rossi, J. S.</author><author>Snow, M. G.</author></authors></contributors><auth-address>Department of Psychology, University of Rhode Island, Kingston 02881.</auth-address><titles><title>Assessing outcome in smoking cessation studies</title><secondary-title>Psychol Bull</secondary-title></titles><pages>23-41</pages><volume>111</volume><number>1</number><keywords><keyword>Follow-Up Studies</keyword><keyword>Human</keyword><keyword>Outcome and Process Assessment (Health Care)/statistics &amp; numerical data</keyword><keyword>Patient Compliance/psychology</keyword><keyword>Smoking Cessation/*psychology/*statistics &amp; numerical data</keyword><keyword>Support, U.S. Gov&apos;t, P.H.S.</keyword></keywords><dates><year>1992</year><pub-dates><date>Jan</date></pub-dates></dates><accession-num>1539088</accession-num><urls><related-urls><url> stated that biochemical validation should be considered in situations where there are high demand characteristics (e.g., studies with youth and studies involving intensive interventions). We have chosen to use CO as our validation measure because it is lower in cost, easier to obtain, ADDIN EN.CITE <EndNote><Cite><Author>Velicer</Author><Year>1992</Year><RecNum>574</RecNum><DisplayText><style face="superscript">112</style></DisplayText><record><rec-number>574</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">574</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Velicer, W. F.</author><author>Prochaska, J. O.</author><author>Rossi, J. S.</author><author>Snow, M. G.</author></authors></contributors><auth-address>Department of Psychology, University of Rhode Island, Kingston 02881.</auth-address><titles><title>Assessing outcome in smoking cessation studies</title><secondary-title>Psychol Bull</secondary-title></titles><pages>23-41</pages><volume>111</volume><number>1</number><keywords><keyword>Follow-Up Studies</keyword><keyword>Human</keyword><keyword>Outcome and Process Assessment (Health Care)/statistics &amp; numerical data</keyword><keyword>Patient Compliance/psychology</keyword><keyword>Smoking Cessation/*psychology/*statistics &amp; numerical data</keyword><keyword>Support, U.S. Gov&apos;t, P.H.S.</keyword></keywords><dates><year>1992</year><pub-dates><date>Jan</date></pub-dates></dates><accession-num>1539088</accession-num><urls><related-urls><url> may be less threatening to participants and school/community personnel concerned about drug testing, ADDIN EN.CITE <EndNote><Cite><Author>Lichtenstein</Author><Year>1992</Year><RecNum>575</RecNum><DisplayText><style face="superscript">113</style></DisplayText><record><rec-number>575</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">575</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lichtenstein, E.</author><author>Glasgow, R. E.</author></authors></contributors><auth-address>Oregon Research Institute, Eugene 97401.</auth-address><titles><title>Smoking cessation: what have we learned over the past decade?</title><secondary-title>J Consult Clin Psychol</secondary-title></titles><pages>518-27</pages><volume>60</volume><number>4</number><keywords><keyword>Administration, Cutaneous</keyword><keyword>Behavior Therapy/*methods</keyword><keyword>Combined Modality Therapy</keyword><keyword>Human</keyword><keyword>Motivation</keyword><keyword>Nicotine/administration &amp; dosage</keyword><keyword>Patient Care Team</keyword><keyword>Smoking/adverse effects/psychology</keyword><keyword>Smoking Cessation/*methods/psychology</keyword><keyword>Support, U.S. Gov&apos;t, P.H.S.</keyword></keywords><dates><year>1992</year><pub-dates><date>Aug</date></pub-dates></dates><accession-num>1506500</accession-num><urls><related-urls><url> and it is of greater practicality in school settings (i.e., schools are often reluctant to consider methods involving bodily fluids). Moreover, recent studies with both youth and adults suggest that there is little advantage of using more costly cotinine data over CO data. ADDIN EN.CITE <EndNote><Cite><Author>Sussman</Author><Year>1995</Year><RecNum>606</RecNum><DisplayText><style face="superscript">111</style></DisplayText><record><rec-number>606</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">606</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Sussman, S.</author><author>Dent, C. W.</author><author>Burton, D.</author><author>Stacy, A. W.</author><author>Flay, B. R.</author></authors></contributors><titles><title>Developing school-based tobacco use prevention and cessation programs.</title></titles><dates><year>1995</year></dates><pub-location>Thousand Oaks, CA</pub-location><publisher>Sage</publisher><urls></urls></record></Cite></EndNote>111 ADDIN EN.CITE <EndNote><Cite><Author>Velicer</Author><Year>1992</Year><RecNum>574</RecNum><DisplayText><style face="superscript">112</style></DisplayText><record><rec-number>574</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">574</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Velicer, W. F.</author><author>Prochaska, J. O.</author><author>Rossi, J. S.</author><author>Snow, M. G.</author></authors></contributors><auth-address>Department of Psychology, University of Rhode Island, Kingston 02881.</auth-address><titles><title>Assessing outcome in smoking cessation studies</title><secondary-title>Psychol Bull</secondary-title></titles><pages>23-41</pages><volume>111</volume><number>1</number><keywords><keyword>Follow-Up Studies</keyword><keyword>Human</keyword><keyword>Outcome and Process Assessment (Health Care)/statistics &amp; numerical data</keyword><keyword>Patient Compliance/psychology</keyword><keyword>Smoking Cessation/*psychology/*statistics &amp; numerical data</keyword><keyword>Support, U.S. Gov&apos;t, P.H.S.</keyword></keywords><dates><year>1992</year><pub-dates><date>Jan</date></pub-dates></dates><accession-num>1539088</accession-num><urls><related-urls><url> {X Y Z UNIVERSITY} researchers have used CO in all cessation trials with only minor issues. Research has shown high levels of agreement between self report and CO validation rates (ex: 3_month:Kappa=1, p=.0001, 6_month:Kappa=1, p=.0001). ADDIN EN.CITE <EndNote><Cite><Author>Horn</Author><Year>2003</Year><RecNum>782</RecNum><DisplayText><style face="superscript">114</style></DisplayText><record><rec-number>782</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">782</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Horn, K.</author><author>Fernandes, A.</author><author>Dino, G.</author><author>Massey, C</author><author>Kalsekar, I.</author></authors></contributors><titles><title>Adolescent Nicotine Dependence and Smoking Cessation Outcomes</title><secondary-title>Addictive Behaviors</secondary-title></titles><pages>769-776</pages><volume>28</volume><dates><year>2003</year></dates><urls></urls></record></Cite></EndNote>114 We will report rates with biochemical validation and use only self report when CO is not available. Potential Risks: Most notably, if youth and adult participants try to completely quit smoking or reduce cigarette use, they may experience some nicotine withdrawal symptoms. Although these symptoms are temporary, they could last for up to 2 weeks. These symptoms could include irritability, frustration, anger, sleep disturbance, appetite changes and weight gain. These symptoms result from a physiological reaction to nicotine, the addictive substance in cigarettes. Another potential discomfort for youths, in particular, is the admission of smoking to parents. Participants in the PROGRAM Z groups also may experience some discomfort around the discussion of feelings and emotional discomfort related to stress and coping. All of our selected intervention programs are intended to address and ease potential discomforts. For blood draws, the risk is possible pain or bruising at the location of the stick. A certified phlebotomist will draw blood samples. ADEQUACY OF PROTECTION AGAINST RISKS Recruitment and Informed Consent: a. Eligibility and enrollment. Both recruitment and retention have been described as issues that plague smoking cessation efforts, especially among youth. ADDIN EN.CITE <EndNote><Cite><Author>Sussman</Author><Year>1995</Year><RecNum>606</RecNum><DisplayText><style face="superscript">111</style></DisplayText><record><rec-number>606</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">606</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Sussman, S.</author><author>Dent, C. W.</author><author>Burton, D.</author><author>Stacy, A. W.</author><author>Flay, B. R.</author></authors></contributors><titles><title>Developing school-based tobacco use prevention and cessation programs.</title></titles><dates><year>1995</year></dates><pub-location>Thousand Oaks, CA</pub-location><publisher>Sage</publisher><urls></urls></record></Cite></EndNote>111 ADDIN EN.CITE <EndNote><Cite><Author>Massey</Author><Year>2003</Year><RecNum>573</RecNum><DisplayText><style face="superscript">115</style></DisplayText><record><rec-number>573</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">573</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Massey, C. J.</author><author>Dino, G. A.</author><author>Horn, K. A.</author><author>Lacey-McCracken, A.</author><author>Goldcamp, J.</author><author>Kalsekar, I.</author></authors></contributors><auth-address>Dept. of Psychology, 226 Vincent Science Hall, Slippery Rock University, Slippery Rock, PA 16057, USA. catherine.massey@sru.edu</auth-address><titles><title>Recruitment barriers and successes of the American Lung Association&apos;s Not-On-Tobacco Program</title><secondary-title>J Sch Health</secondary-title></titles><pages>58-63</pages><volume>73</volume><number>2</number><dates><year>2003</year><pub-dates><date>Feb</date></pub-dates></dates><accession-num>12643020</accession-num><urls><related-urls><url> Consequently, procedures to adequately recruit and then maintain ongoing participation in our intervention programs will be given top priority. Over several years of study, we have determined a variety of techniques that are effective for cessation program recruitment. ADDIN EN.CITE <EndNote><Cite><Author>Prochaska</Author><Year>1992</Year><RecNum>568</RecNum><DisplayText><style face="superscript">116</style></DisplayText><record><rec-number>568</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">568</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Prochaska, J. O.</author><author>DiClemente, C. C.</author><author>Norcross, J. C.</author></authors></contributors><auth-address>Cancer Prevention Research Consortium, University of Rhode Island, Kingston 02881.</auth-address><titles><title>In search of how people change. Applications to addictive behaviors</title><secondary-title>Am Psychol</secondary-title></titles><pages>1102-14</pages><volume>47</volume><number>9</number><keywords><keyword>Aftercare/psychology</keyword><keyword>Behavior, Addictive/psychology/*rehabilitation</keyword><keyword>Health Maintenance Organizations</keyword><keyword>Human</keyword><keyword>*Motivation</keyword><keyword>Outcome and Process Assessment (Health Care)</keyword><keyword>*Psychotherapy</keyword><keyword>Smoking Cessation/psychology</keyword><keyword>Social Support</keyword><keyword>Support, U.S. Gov&apos;t, P.H.S.</keyword></keywords><dates><year>1992</year><pub-dates><date>Sep</date></pub-dates></dates><accession-num>1329589</accession-num><urls><related-urls><url> b. Retention/follow up. Though additional recruitment and retention methods will be with our community partners, we expect to use a few basic approaches. Material incentives (e.g., food, beverage, t-shirts) valued at $25 per participant will be provided to youths and during data collection events. Many of our proposed fiscal rewards are linked to baseline and follow up events. To enhance dyad participation, whenever possible, we will link incentives to joint participation of youths and their parents. These strategies were effective in previous studies conducted by Branstetter. Many researchers report that these types of fiscal incentives are particularly motivating for rural families for research participation. Data will be collected on three occasions: baseline, 3 months post baseline, and 6 months post baseline. For follow up at 3 and 6 months, a Contact Form will record participant name, address, gender, age, birth date, day/evening phone #, and e-mail (when applicable). Some items will be used for cross validation of information on other forms. Information on the Contact Form will used when we are unable to track a students or parents in the school setting (i.e., secondary addresses will be used when issues of transience or attrition occur). c. Informed consent/assent: Youths. Parental consent issues must be addressed for minors who are a part of Tier 2 data collection. Because some reviewers may be concerned that consent issues will negatively impact recruitment and enrollment, several related questions are addressed next. Will all study participants have parental consent? Consistent with our IRB, all 14- to17-year-old participants must have signed parental consent to participate. Youth who are > age 18 will not be required to have parental consent, unless they choose to obtain it. What if youths do not want their parents to know they smoke so they refuse participation? This is an issue that must be addressed in any youth tobacco study. We always will lose potential participants because they do not want their parents to know that they smoke. Interestingly, a recent study of {A B C LOCATION} 9th graders found that 50% of the smokers reported that their parents know they smoke. ADDIN EN.CITE <EndNote><Cite><Author>Horn</Author><Year>1999</Year><RecNum>467</RecNum><DisplayText><style face="superscript">117</style></DisplayText><record><rec-number>467</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">467</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Horn, K.</author><author>Dino, Geri A.</author><author>Gao, X.</author><author>Momani, A.</author></authors></contributors><titles><title>Feasibility evaluation of Not On Tobacco: the American Lung Association&apos;s new stop smoking programme for adolescents</title><secondary-title>Health Education Journal</secondary-title></titles><pages>192-206</pages><volume>5</volume><keywords><keyword>Smoking</keyword><keyword>Young people</keyword><keyword>Feasibility</keyword><keyword>USA</keyword></keywords><dates><year>1999</year></dates><urls><related-urls><url> This percentage is likely to be higher as youth get older (e.g., 17 or 18 years old). Youths will be briefed on the study and will be informed up front (before they answer questions) that their parent/s or guardian/s must consent to dyad participation. Simply, they will be told that their assent for participation is an admission of smoking. Youths always will be given a choice and we will discourage forced participation by a parent or guardian. Youths must sign an assent form. Because we are recruiting small groups, limited to a maximum of 15 per group, we do not anticipate that consent will be an obstacle for obtaining adequate recruitment or participation. Past years of PROGRAM Z study have shown sufficient participation. d. Informed consent: Adults. All adult participants (> age 18) will provide written IRB-approved consent prior to participation in any phase of research involving Tier 2 data collection.Protection Against Risk: One of the important purposes of the intervention is to assist youth and adult smokers in dealing with the quitting process, including withdrawal symptoms, in positive and healthy ways. All youths (as well as adults) will have access to {X Y Z UNIVERSITY}’s statewide free Health Line if they have questions or concerns about their general health. Additionally, participation is voluntary, and youth and adults will have a choice about whether or not to participate or to disclose information about their smoking to parents, research staff, or facilitators. They may elect not to participate or to withdraw at any point in the study. Participants who experience emotional discomfort around mental health issues may also benefit from the programs. Notably, individuals who opt out of Tier 2 study participation will not be denied participation in the intervention programs. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE PARTICIPANTS AND OTHERS The risks of participation are minimal compared to the benefits. Participation in cessation interventions may help and adults quit or reduce smoking, thereby improving their health. Participation also may improve social and coping skills, attitudes and awareness about tobacco use, and knowledge about the negative effects of tobacco. Knowledge gained from this project will be used to design other effective interventions. Parents who participate in the parent component may increase their parental competence. In addition, parents who smoke will be offered referrals to the Quitline (a toll free quit line for all {A B C LOCATION} people).IMPORTANCE OF THE KNOWLEDGE TO BE GAINED An innovative approach to smoking cessation is one that considers all of the concepts or methods already discussed. An effective intervention will be developmentally appropriate for across ages; based in developmental science and theory; tailored to the needs of high risk smoking populations; process and implementation as well as content oriented; sensitive to motivation to alter smoking behavior; focused on smoking rather than all tobacco types; and collaboratively developed. How does this type of approach advance scientific knowledge? This type of approach is important for integrating what we know about the current state-of-the-art in smoking cessation. Building on the existing research base for program development, and eventually efficacy testing, will advance the field’s understanding of smoking outcomes as well as translate and make positive use of a decade of research the risks that potentially lead to tobacco-induced morbidity and mortality.Data Sharing. Data sharing is an important part of our overall research philosophy, including dissemination and translation of research. It increases the likelihood that findings will impact policy and practice for the Appalachian community. As such, a data-sharing plan not only provides assurances to a granting agency (e.g., NIH), it also provides assurances and essential resources to the target communities, partners, and stakeholders served by our Project. Consistent with NIH guidelines for data sharing, we have detailed a plan that will serve our Project and its research projects., our plan shows that our research team makes a commitment to collecting, analyzing, and sharing the data: in a timely manner; completely and accurately; and in a way that fosters growth and empowerment in {A B C LOCATION}.5. Collaborating Site(s)NA6. Women and Minority Inclusion in Clinical ResearchInclusion of Women and Minorities. Youth participants will be ages 13-18. Adults will be > age 18. Equal numbers of males and females will be recruited among youths. However, it is expected that among adults and parents, we will have higher participation among women or female guardians. Consistent with the {A B C LOCATION} Appalachian region, approximately 95% of {A B C LOCATION} people are white; 47% male, 53% female. Although the study sample will contain few minority (<10%), it will be comprised of another type of underserved population—low SES, rural white participants from Appalachia. Previous PROGRAM Z offerings in {A B C LOCATION}, for example, have shown minority enrollment up to 8%, depending on the location of implementation. It is not possible to over recruit minorities in some counties because the diverse population base is so limited. Study procedures will adhere to the nondiscriminatory policies of {X Y Z UNIVERSITY}; no one will be excluded on the basis of gender, race, ethnicity, socioeconomic status, religion, or sexual orientation. We will follow the revision of Statistical Policy Directive No. 15, Race and Ethnic Standards for Federal Statistics and Administrative Reporting. ADDIN EN.CITE <EndNote><Cite ExcludeYear="1"><Author>Office of Management and Budget</Author><Year>2003</Year><RecNum>910</RecNum><DisplayText><style face="superscript">118</style></DisplayText><record><rec-number>910</rec-number><foreign-keys><key app="EN" db-id="r5xeadfx522tdje9207v5f9pet5revf9tzxw">910</key></foreign-keys><ref-type name="Government Document">46</ref-type><contributors><authors><author><style face="normal" font="Times New Roman" size="100%">Office of Management and Budget, 2003</style></author></authors></contributors><titles><title>Statistical Policy Directive No. 15, race and Ethnic Standards for Statistics and Administrative Reporting.</title></titles><dates><year>2003</year></dates><urls><related-urls><url>omb/inforeg/statpol.html</url></related-urls></urls></record></Cite></EndNote>118 See the required enrollment form. A question on race/ethnicity will have five categories for data on race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. There will also be two categories for data on ethnicity: "Hispanic or Latino" and "Not Hispanic or Latino." Age and rural-urban residence will be also added to the pool of socio-demographic characteristics as they might be associated with quitting. Participants may check more than one race/ethnicity. 7. Inclusion/Exclusion of Children The PROGRAM Z program is developmentally designed 14-18 year old youths who are daily smokers. Youth < age 14 will not be included in PROGRAM Z. RAZE is designed for youth > age12. Inclusion criteria for Tier 2 are described below. As described in the data safety and monitoring plan, the investigative team has expertise in dealing with and studying children at the ages included. All data will be collected in appropriate facilities of schools and community centers that serve the target population. Recruitment and consent procedures are discussed above in 2, a-c. A full data safety and monitoring plan follows as it relates to the target population of youth ages 14-18 and details our plan for working with children as research participants.Inclusion and exclusion criteria for youth. Relevant to the Tier 2 data, youth will be eligible if they (1) self report smoking on 1 or more cigarettes in the past 30 days, (2) volunteer to participate, ADDIN EN.CITE <EndNote><Cite ExcludeYear="1"><Author>3</Author><RecNum>122</RecNum><DisplayText><style face="superscript">118</style></DisplayText><record><rec-number>122</rec-number><foreign-keys><key app="EN" db-id="tsw9str95ztp9peeewu50dseee9wwtwfx959">122</key></foreign-keys><ref-type name="Government Document">46</ref-type><contributors><authors><author><style face="normal" font="Times New Roman" size="100%">Office of Management and Budget, 2003</style></author></authors></contributors><titles><title>Statistical Policy Directive No. 15, race and Ethnic Standards for Statistics and Administrative Reporting.</title></titles><dates><year>2003</year></dates><urls><related-urls><url>omb/inforeg/statpol.html</url></related-urls></urls></record></Cite></EndNote>118 speak English, and (4) are between ages 14 and 18. What circumstances might prohibit involvement? Youth will be ineligible if they (1) have severe communication deficits such as an inability to speak English, or are severely hearing, vision, or speech impaired; (2) are deemed mentally incompetent by the school staff; or (3) are unable to obtain parental consent. What about NRT? Previous or current use of NRT will be queried at baseline and follow up. In addition, in the assent/consent form, youths and parents will be informed that youths cannot use any type of NRT during the study period. Youth will be reminded again by researchers face-to-face during baseline data collection. What if youth are enrolled in another tobacco cessation intervention or another PROGRAM Z study? Youth may only participate if they have not been enrolled in a study or other any type of cessation intervention > 12-month time period. Previous or current participation in another intervention will be queried at baseline and follow up. In addition, in the assent/consent form, youths and parents will be informed that youths cannot participate in another cessation intervention during the study period. Adult parent participants must be age 18 or older. They must volunteer to participate and speak English. They will be excluded if they have an inability to speak English; are severely hearing, vision, or speech impaired; or are deemed mentally incompetent.8. Data and Safety Monitoring Plan1. Potential adverse events resulting from participationAdverse events include potential violation of confidentiality; possible discomfort or embarrassment in disclosing sensitive information; possible dissatisfaction with the intervention programs or study activities; possible discomfort from withdrawal symptoms from quit attempts; possible embarrassment or consequences for admitting smoking to family, friends, and teachers; and possible discomfort from official or legal procedures required for reporting abuse, neglect, harm claims should any be reported by participant.2. Procedures to safeguard against adverse eventsInformed consent. Youth are required to sign an assent form and adults are required to sign a consent form prior to participation. The adults and youth are informed about the voluntary nature of the study and their rights to refuse or withdraw without consequence. Trained research staff are available throughout the study to address participant or parent concerns about study procedures. If research staff determine that youth, in particular, exhibit comprehension difficulties, extra guidance will be provided to make sure they feel fully informed about the study. Parents will be encouraged to call the PI, school facilitators, and/or school principals for questions or clarification. Confidentiality safeguards. All participant information will be coded so that data cannot be associated with any participant. Each participant will have an assigned code and his/her respective data will remain in a unique bound folder in a locked cabinet throughout the course of the study. Files for each participant will be maintained based on three initials and identification number--no identifying information will be maintained in the participant file. Individual data and names will never be in the same location or attached in any way. Data will be collected by trained, NIH/HIPPA certified project personnel. Data will be entered into a computerized data base with assigned codes/id numbers only. Computers are maintained in a locked area. Only research team members will have access to the computerized or stored data.Mandatory reporting safeguards. Professional ethics and concern for the welfare of participants demand that the project have procedures in place to address instances where participants present with psychological issues or circumstances that warrant professional attention (e.g., “duty to warn” for suicidal thought, drug abuse, pathological depression and anxiety, any type of abuse or neglect to youth, or intent to harm others). First, facilitators will receive training by ALA {A B C LOCATION} and the research team on when and how to refer youth to local services, when to contact a parent, and when to contact the project PI, or all of these. Second, youth and parents will be told in advance (in the consent/assent forms and again in person at baseline) that such disclosures must be reported to the appropriate officials for action, per law, or to parents (i.e., Duty to Warn). In our county, it is mandated that abuse or neglect of a child or youth be reported to the Department of Children’s Services. Thus, any interventionist or research staff member who has reason to suspect abuse or neglect is obligated to file a report to Children’s Services within 24 hours. In addition the PI must be notified in that same time frame, before contact with Children’s Services. Instances of suicidal thought or other psychological concerns reported to staff by a youth must be discussed with the parent within 24 hours. The reasons and consequences of these procedures will be discussed with parents and youths in person at baseline. Third, the project team will provide or make sure that each facilitator has a list of local mental health referral resources at the onset of the study. Also parents and youths will be provided this list at baseline. Fourth, project investigators will keep an updated list of recommended books and other reference material that address adolescent mental health issues to share with parents or team members. Fifth, {X Y Z UNIVERSITY} has a Psychiatric Hospital on the Health Sciences campus, with clinical faculty with expertise in adolescent mental health; these faculty are available as additional resources. Finally, as elaborated below, research team members and facilitators will be trained on strict protocol about when, how, and to what extent they contact the project PI (e.g., Emergency Response Matrix). Documentation will be kept; follow up will occur with each reported or identified incident. Will research staff ever be in harm’s way? No research team member or data collector has ever been harmed or threatened during or as result of their duties with the program. As a safeguard, staff are well trained, always collect data in teams, and work within a protected public environment where police officers or other public safety officials are available if needed.Staff training safeguards. All project staff will receive a structured training module. See Table 9. All training will be provided by the PI, , during a 2-week period in the end of year 1, and before participant contact begins. The Facilitators also will receive a simplified version of this training as part of their core face-to-face training with the PI, prior to intervention onset. The PI’s office previously developed a Data Management Policies and Procedures Manual. The purpose of these policies and procedure is to enable us to consistently produce exemplary, high-quality research. To ensure these high standards, policies on research confidentiality, ethics, and data management are enforced for all research staff. The manual is divided into three sections. The first section discusses our position on Recruitment and Informed Consent and how we interact with our research participants, how to recruit, acquire consent, how to respond to crisis, and how to administer the research. The second section discusses Data Management Plan. It was developed to organize and streamline project data procedures, assure data integrity and protection, and to maximize our efficiency. This section also describes our communication procedures, handling and entering data, as well as study close-out procedures. We recognize the need to provide complete project documentation and a formal method of tracking documentation and communication related to individual participants. A third section provides detailed information on research ethics, including a review of mandatory codes from American Psychological Association, National Association of Social Workers, and American Public Health Association. Prior to study start up, a team meeting will be held to train all staff on the policies and procedures manual. This includes training on how to deal with mandatory reporting. In addition, all research team members must remain up-to-date on HIPPA certification and the standard NIH Ethics training offered on line. Last, in compliance with our DSMB, we will develop an Emergency Response Matrix with our school/community partners that outline the precise response required for indicators of depression, anxiety, suicidality, harm to others, and harm from others. Indicators will be derived from the research instruments, participant verbal reports, and staff/facilitator observations. All research staff and partners are required to meet with the PI to review the protocol and methods for administering each of the standardized measures. Training topics are outlined in Table 9.Table 9: Project Staff and Facilitator Training Module ContentPart 1: NIH Ethics and HIPPA Certification Training (on-line course required)Part 9: Emergency Response MatrixMandatory reporting incidents/events(suicide, abuse/neglect, danger/harm, family crisis)Required chain of response per incidentFollow up procedures per incidentMental health referral listings/resources{A B C LOCATION} public school protocol for mandatory reportingReporting safeguardsPart 2: Assent/Consent ProceduresPart 3: Confidentiality of Participant Data and Disclosures/Participant RightsPart 4: Potential Adverse Events and DiscomfortsPart 5: Data Management Policy and Procedures Part 6: Effective Reporting and DocumentationPart 7: Effective Communication and Interviewing SkillsPart 8: Data CollectionData management safeguards. All records supplied by or associated with participants will be kept strictly confidential as required by {A B C LOCATION} State law and the Federal Privacy Act. Any data collection is subject to the oversight of {X Y Z UNIVERSITY}’s Institutional Review Board. All identifying information will be removed from data records prior to storing. All records will be kept in a secured location for a period of not less than 3 years after the completion of the study. Data collection and management will require the coordination of procedures at {X Y Z UNIVERSITY} with those of participating schools. As a result of previous studies, most of the data collection forms already have been developed. Research project staff have experience and procedures for working with school-based data collection and organization. Again, each participant will have an assigned code and his/her respective data will remain in a unique bound folder throughout the course of the study. Files for each participant will be maintained based on three initials and identification number--no identifying information will be maintained in the folder. Data will be collected by trained NIH/HIPPA-certified project personnel. To ensure proper data collection and accuracy of files, several mechanisms will be established: (1) regular communication among project staff, including a daily log book, daily meetings and/or telephone conversations between the school-level facilitators/contacts and the research program manager and research assistants; (2) regular review of forms/files by the program manager, including feedback to the PI on corrected information or errors; ADDIN EN.CITE <EndNote><Cite ExcludeYear="1"><Author>3</Author><RecNum>122</RecNum><DisplayText><style face="superscript">118</style></DisplayText><record><rec-number>122</rec-number><foreign-keys><key app="EN" db-id="tsw9str95ztp9peeewu50dseee9wwtwfx959">122</key></foreign-keys><ref-type name="Government Document">46</ref-type><contributors><authors><author><style face="normal" font="Times New Roman" size="100%">Office of Management and Budget, 2003</style></author></authors></contributors><titles><title>Statistical Policy Directive No. 15, race and Ethnic Standards for Statistics and Administrative Reporting.</title></titles><dates><year>2003</year></dates><urls><related-urls><url>omb/inforeg/statpol.html</url></related-urls></urls></record></Cite></EndNote>118 completion of Missing Data Revision Form; (4) documentation of day-to-day operations in the log book; (5) maintenance of a Data Concerns book; and (6) storage and organization of participant packets in locked file cabinets. The Program Manager will meet with the PI weekly to review the Data Concerns book and address pertinent issues. Importantly, our office has an existing data management policy which outlines precise procedure for handling, entering, and analyzing research data. All data is kept is a secured, locked location. Access is permitted by staff members only. Our offices are separated from public access by locked doors. The university computing system is protected from outside access by a firewall system and access is monitored by a Network Administrator. Discomfort and disclosure safeguards. If a participant has questions about any study procedure, the PI or a trained staff member will be available to answer questions. PI and IRB contact information is provided in the assent and consent forms. Participants will have contact numbers and email addresses of research staff. Should a participant feel embarrassed or uncomfortable asking questions of a staff member, we will refer the participant to the {X Y Z UNIVERSITY} free HEALTH LINE, 1-800-982-8242, for health-related concerns. In addition, we will keep an up-to-date referral list of professionals in the community who can act as an advocate for youth or their families should they need a “voice.” The professionals will not be hired by the project but will be available to handle problems encountered as a result of this project. Contacting these individuals is the choice of the study participants. To prevent or ease the event of discomfort or embarrassment, staff will undergo training in building rapport, and trust skillful interviewing and data collection. All study participants will be informed that that they may choose to skip any question or procedure they find uncomfortable. If any individual becomes overly distressed or distraught during any part of the study, the activity or assessment will be stopped immediately and staff will talk privately with the affected participant(s). Referrals will be made, as needed. Dissatisfaction safeguards. Staff will encourage participants to discuss with the PI, staff, or facilitators any possible dissatisfaction with the intervention or assessment activities. Referrals to alternative community services will be made if it appears to be appropriate and alternative services are available. This safeguard will be written into the consent/assent forms.3. Response proceduresDisclosure. As a part of our initial study training, staff will be instructed by {C}{Z} and {Y} to respond to embarrassment or other uncomfortable feelings in an appropriate and compassionate manner. If staff observe or note other participant experiences or adverse reactions during the study, appropriate community mental or physical health referrals will be considered. An up-to-date community service resource list will be available to all participants to take home with them and use in the event of a delayed adverse reaction for which they wish to seek help. Participants will also be encouraged to contact the PI and other research staff in the event of a later adverse reaction. Again, all of this will be detailed in an Emergency Response Matrix. Figure 5 shows the chain of communication for emergency responses.Mandatory reporting. As noted above, research staff must report to appropriate authorities per site protocol and to the PI the instances of physical abuse, neglect or threat of physical harm among participants to themselves or others. The Emergency Response Matrix will have procedures and guidelines to respond to risk disclosures. As discussed next, the Matrix will be tailored to indicators that are likely to result from the study instruments. The team will also respond to self reports of suicidality, harm to others, and harm from others. Staff training will include instruction on how to recognize risks or crises that require immediate reporting response. See Figure 5. Tailored plans will be made by the research team contingent upon the type of incident.a. Suicidal ideation or attempt. We will address ideation or interest in suicide and action towards suicide (including both thoughts of suicide or a plan and means to accomplish suicide). As the participant completes the instruments or any focus group or interview, staff will be required to review notes or instruments and items for response values that indicate concern. Training will address this matter in detail. Should concerns arise, staff will be required to review information with the PI and, if necessary, follow-up with participants to determine level of risk. If the participant is determined to present immediate risk of suicidal action, {C}{Z} and team will develop a “safety plan” for the participant and a response will occur within 24 hours. If any disclosure occurs during a verbal interview or focus group, the staff member will follow through with private interview to clarify the presence of suicidal risk or develop a plan of action. In either case, {C}{Z} will be consulted to determine follow-up responsibility. b. Abuse or neglect. According to NIH guidelines, child abuse or neglect may be defined as “(a) the parent or child verbally indicates that abuse has occurred or is occurring, (b) the parent or child answers one or more assessment questionnaire items suggesting the possibility of abuse, (c) the child is observed being treated abusively during an assessment or intervention session, (d) the child is observed with bodily injury (e.g. bruises, burns, black-eyes) whose origin appears to differ from the explanation given of the injury” . If at any time our staff observes or suspects abuse or neglect of participants, action will be taken as outlined in the Emergency Response Matrix. Whenever possible, plans will be tailored to each individual case (e.g., ways to communicate to the family, further inquiry needs, follow-up, and reporting methods). If this abuse complaint does not involve the parents, the project psychologist will help to develop a “safety plan” with the parents that may include a participatory report of abuse to child protective services.c. Threat of danger to others. Disclosure of potential physical includes harm by a participant to others, including family members or other individuals in the school or community. If staff suspects potential or active harm to others, steps will be outlined for staff to obtain additional information and contact the PI {Z}. Although the Emergency Response Matrix will provide general guidance for safety issues, a tailored “safety plan” will be developed on a case-by-case basis. d. Family crisis. Family crisis might include domestic violence or marital crisis, mental health symptoms of family members, and family environmental changes such as loss of employment or housing. Staff will be trained to recognize signs of family crisis and to consult with PIs to the extent that these issues impact participant involvement in the study or may suggest abuse or neglect. Following steps outlined in the Emergency Response Matrix, together, staff and the PIs will determine the best response to the family's needs, including a recommendation for referral, if indicated. Any reported incident is kept in written form in a participant's confidential file for future reference.4. Reporting proceduresThe results of our analyses, including the occurrence of adverse events or disclosures noted above, will be reported both to our IRB and to NIDA through required progress reports. {C}{C} and the PI must be verbally contacted with 24 hours of any disclosure as outlined in the Emergency Response Matrix. The PI must be notified in writing by project staff of any event within 24 hours of disclosure. Any serious life threatening or unexpected adverse events will be reported by the PI to the IRB and NIDA within 48 hours. AE forms will be filed with the IRB within 72 hours, per protocol. See Figure 5 below.Figure 5: Chain of Response for Mandatory ReportingFacili-tatorRes. Project StaffParent/GuardianPI{C}{Z}IRBNIHDHHSFacili-tatorRes. Project StaffParent/GuardianPI{C}{Z}IRBNIHDHHS115633510160000318135-127024 hours0024 hours5. OversightThe PI and project manager will review of participant data and files quarterly. In addition, this project will be subject to a yearly review of its DSMP by the university IRB. In addition, the DSMP 5-member committee will be formed specifically for this project to review risks and benefits to study participants; participant recruitment, accrual, and retention methods; data quality and data management; confidentiality issues; external scientific developments with impact on the safety of participants or the ethics of the study; any adverse events or disclosures. The committee will include the staff psychologist, an IRB representative, two research faculty members not involved in the project, one staff member (not on the project staff), and the project director. We also will have ongoing access to university legal counsel as needed. The committee will meet 2 times per year and more if necessary to review our procedures. Committee recommendations will be reviewed with the PI, and the university IRB. 6. Additional Communications Plan. Communication is an essential part of assuring the protection of human subjects. Based on past research experiences, we can communication across study members and partners by (a) creating very specific roles and responsibilities for research team members, partners, and facilitators (i.e., written contracts and memorandum of understanding); (b) using well-planned and team-generated time lines and deadlines documents; (c) agreeing to be flexible and sensitive to time and schedule constraints; (d) acknowledging the challenges; (e) agreeing to be accountable to each other via record keeping and information sharing; and (f) reimbursing partners and participants for their time (e.g., gift cards). Given our current working partnership with the {A B C LOCATION} community, we believe that a solid communication plan will eliminate or reduce potential communication problems. {X Y Z UNIVERSITY} researchers also have internal communication tools: (a) phone calls will be summarized in writing and a log will be maintained in our office; (c) a communication log will be maintained at {X Y Z UNIVERSITY} (using ACCESS software); (d) bi-weekly face-to-face research team meetings will occur and meeting minutes will be dispersed to all partners (external partners will participate via phone as appropriate); and (e) master study files will be maintained by the {X Y Z UNIVERSITY} program manager. A research study LISTSERV will be maintained for all partners and team members throughout the study. Finally, our current Community Partnership Board or CPB maintains an active LISTSERV that facilitates communication and direct contact between the researchers and community members across the state of {A B C LOCATION}.How does the scientific environment contribute to the probability of rigorous oversight and human subject assurances? {X Y Z UNIVERSITY} is a land-grant academic/research institution, located in XTOWN, {A B C LOCATION}. The lead {X Y Z UNIVERSITY} researchers, Drs. {Z} and {Y} are nationally known and well published in the field of youth tobacco cessation and evaluation. They are affiliated with a CDC-funded Prevention Research Center (Director, {C}{Y}) and the Cancer Center (Associate Director, {C}{Z}) in the School of Medicine. State-of-art technical equipment and facilities are available and all members have well-equipped offices with phones, internet and network connections, and sufficient administrative support. Most of the team researchers are housed within the same corridor of {X Y Z UNIVERSITY}’s Health Sciences Center, allowing ease of communication and teamwork. Is there evidence of institutional support and availability of resources necessary to perform the project? This project is consistent with the research missions of {X Y Z UNIVERSITY}’s Health Sciences Center and the School of Medicine to serve the priority health needs of {A B C LOCATION}. Reducing smoking among youth is a priority in {A B C LOCATION}’s Healthy People 2010. See letters of support from institutional leaders in Part H of the overall P01 application. Of Importance: The Cancer Center () has a fully constituted Protocol Review and Monitoring System (PRMS) comprised of the following two key elements: 1) a Protocol Review and Monitoring Committee (PRMC) that reviews all cancer related research projects that involve human subjects for scientific merit and prioritization; and 2) a Data Safety and Toxicity Committee that reviews all investigator-initiated research projects for adverse events and safety of human subjects. All cancer-related human subject protocols are reviewed and approved by the {X Y Z UNIVERSITY} Institutional Review Board (IRB) after review and approval for scientific merit by the CANCER CENTER Protocol Review and Monitoring Committee. The policies and procedures that govern human subject investigation at the Cancer Center are provided in The Clinical Trials Operation Manual (Version 1.0, April 2008), also commonly referred to as “The Blue Book”. The project-specific Data Safety Monitoring Plan (DSMP) required for this P50 CPHHD proposal will be fully integrated into the Cancer Center institutional Protocol Review and Monitoring System.VertebraTe AnimalsNAConsortium/Contractual ArrangementsINSERT NAME (See Scope of Work)INSERT NAME State University (See Scope of Work, X, PI)INSERT NAME University (See Scope of Work)ALA {A B C LOCATION}BeBetter, Inc.ConsultantsAppendiCESAPPENDIX A: Letters of Support ................
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