NIH Human Subjects SAMPLE TEMPLATE for Behavioral Trials

NIH Human Subjects SAMPLE TEMPLATE for behavioral trials

1. 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 Schedule

(E) = Experimental County; (C) = Control County; B = Baseline assessment; I = Intervention; F = Follow-up assessment

a. Instruments and tools for the Aim 1.0 Field Intercept Survey. The field intercept survey will use items from the Global Adult Tobacco Survey.110 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.

c. Other Important Measurement Considerations: Least Invasive Biochemical Validation

A 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.111 112 In reviewing the literature, Sussman et al.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.112 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,112 may be less threatening to participants and school/community personnel concerned about drug testing,113 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.111 112 {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).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.

1. 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.111 115 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.116

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.117 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.

1. 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).

1. 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)

NA

6. Women and Minority Inclusion in Clinical Research

Inclusion 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.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, 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.