HUMAN RESEARCH ETHICS: Assessment
CASE STUDY ONE
Trial and evaluation of a comprehensive sun protection program targeting adolescents in school settings.
SUMMARY OF PROJECT:
The goals of this research are:
- to design and trial a targeted program, in school settings, aimed at improving the sun protection behaviours, attitudes and knowledge of adolescents;
- to evaluate the program's effects on the sun related behaviours, attitudes and knowledge of adolescents.
The evaluation is a pre--post study design, using an unmatched population sample, which aims to measure the sun protection attitudes, knowledge and behaviour is of 14 and 15-year-olds before and after participating in the targeted program. In order to measure the impact of the program, the evaluation will compare two program regions with a control region, and the targeted program against a minimal sun protection program (poster).
The principal researcher is Prof Sarah James, BA, MBA (Marketing), PostGradDip HealthProm, MAassessEval, PhD. Prof James is director of the Centre for Public Health at the State University and will be responsible for the overall conduct of the intervention, protocols and communication. She will also be responsible for the recruitment and management of the project staff and will coordinate the reporting and dissemination of the results. Prof James will also co-supervise Mary Wilson.
There are two co-investigators. The first is Doctor Patrick Trent, Associate Professor in the Department of Psychology, Faculty of Health at the State University. Doctor Trent will be responsible for overseeing the statistical analyses. The second co-investigator is Ms Mary Wilson, R.N. MPH who is a PhD student. She will be responsible for leading all aspects of the evaluation, including conducting surveys, data entry and analysis as well as reporting results under the guidance of her supervisors.
Prof James has extensive experience in the conduct of social science research, the design and implementation of surveys and the statistical analysis of outcomes. She has published more than 40 peer-reviewed articles. Doctor Trent has extensive experience in the statistical analysis of population health research and has a publication record exceeding 35 peer-reviewed articles. Ms Wilson has, during her Master of Public Health degree, conducted a number of surveys and, in her professional work as a nurse, conducted numerous interviews with patients. Because her focus in nursing was in child health, many of those communications have been with adolescents.
The funding for the proposal will be provided by an Australian Research Council linkage grant of $235,000 and $300,000 from the industry partner, Sunshield Limited. Sunshield is an Australian subsidiary of Interpharma Ltd, a pharmaceutical manufacturing corporation based in the United States of America. Sunshield has agreed to also provide the sun protection cream samples at no cost.
There are no commercialisation or intellectual property implications in the funding arrangements. The sunscreen product to be provided by Sunshield is listed on the Australian Register of Therapeutic Goods.
None of the investigators have any commercial relationship with Sunshield or Interpharma and none have a commercial interest or a financial interest in the outcome of the project.
Sunshield Ltd has entered into a contract with the State University to provide funding for a range of research and development projects during the next 10 years. The current research project is the first expenditure under that contract.
The study has been funded in part by the Australian Research Council through its Linkage Grants scheme and in the course of achieving this funding was subjected to peer review.
Australia has the highest incidence of skin cancer in the world. Skin cancer is the most common form of cancer in Australia, with incidence rates outnumbering all other forms of cancer by more than 3 to one. The majority of skin cancers could be prevented if the public could be persuaded to adequately protect themselves from the sun. Childhood and adolescence are recognised as the most vulnerable periods for increasing sun cancer risk. However, despite 25 years of mass media and other programs aimed at improving sun protective behaviours in the Australian community, sun protection practices among adolescents have continued to decline. This is of significant concern as sun damage before the age of 20 is the main cause of melanoma, the most dangerous type of skin cancer.
Sun protection programs for this demographic should take a holistic approach. This necessitates multifaceted, multi-setting approaches inclusive of the wider community. Focusing on the deleterious effects of sun exposure on appearance may be an effective way of gaining adolescent interest in a sun protection message and, at the same time, promote benefits which can be realised in the short rather than long term. This implies that sun protection initiatives need to be reframed for adolescents as a means to prevent skin damage and maintain attractiveness, moving away from a focus on skin cancer protection.
This project builds on previous research which involved a comprehensive examination of the literature on adolescent sun protection, the development of evidence-based guidelines related to the development of sun protection social marketing programs and extensive formative research with adolescents regarding sun protection knowledge, attitudes and behaviours. Consequently, this project provides an opportunity to apply best practice methods to reverse the negative trends in behaviours and ultimately reduce the overall risk in adolescence of developing sun-related cancers.
The extensive literature review and formative research previously undertaken by the research team suggests a comprehensive sun protection campaign targeting adolescents would be more effective at improving the sun protection behaviours, attitudes and knowledge of adolescents than current practices. This research project investigates this hypothesis.
In particular the targeted programme aims to improve:
- the use of multiple sun protection strategies by adolescents;
- the effective use of sunscreen by adolescents; and,
- the sun protection knowledge and attitudes of adolescents.
To this end, the evaluation will investigate:
- the pre-post impact of the program with all regions combined, and differences between regions;
- the difference between pre and post attitudes and beliefs in each region;
- the effect of the program on specific sun related behaviours separately (e.g., increase hat use, sunscreen use, shade); and
- the effect of the program on an overall measure of sun related behaviours.
The overall objective of the targeted program is to make sun protection fun, easy and popular/fashionable for adolescents. Consequently, the particular messages and activities have been chosen with this objective in mind. In addition, the program is guided by our previous research which indicates that a focus on the damaging effects of sun exposure on appearance may be an effective way of gaining adolescents' interest in sun protection messages and promoting the benefits of adopting sun protection behaviours.
Beckman K & Conor (2004) Sun protection practices among South Australian adolescents in 2002: results of the 2002 ASSAD survey. The Cancer Council of South Australia.
Coogan PF et al (2001) Sun protection practices in preadolescents and adolescents: a school-based survey of almost 25,000 Connecticut schoolchildren. Journal of the American Academy of Dermatology 44 (3): 512-9
Dixon H et al. (1999) Sun protection and sunburn in primary school children. Preventive Medicine 28 (2): 119-30
Dobbinson S & Hill D (2004) Patterns and causes of sun exposing and sun protecting behaviour, in Prevention of Skin Cancer, D. Hill, J. M. Elwood and D. R. English, editors. Kluwer Academic Publishers: Dordrecht
Livingston PM & White (2003) Sun exposure and sun protection behaviours among Australian adolescents: trends over time. Preventive Medicine 37 : 577-84.
Schofield PE & Freeman JL (2001) Trends in sun protection behaviour among Australian young adults. Australian and New Zealand Journal of Public Health 25 (1): 62-5
Sjoberg L et al. (2004) Tanning and risk perception in adolescents. Health, Risk & Society 6(1): 81-94
BENEFITS AND RISKS
The benefits of the project for the wider community are increased knowledge and understanding of the importance of adopting sound sun protection behaviours among adolescents. By targeting this demographic, the project can promote a lasting understanding of effective cancer protection behaviour that can then be adopted by future generations.
The benefit for participants will be to identify the effectiveness of the measures used in the project to promote improved sun protection behaviour. The benefit to them will, accordingly, be education in the correct application of sunscreen and an individual improvement in reducing the risks of skin cancer. Further, those participants who, through their participation recognise the need for advice and additional medical treatment in relation to some affected skin conditions, will be provided with access to such advice and treatment.
The risks involved in the project are:
The use of the Glitterbug potion. The Glitterbug potion has the consistency of moisturiser and fluoresces (shines brightly) under UV elimination. Students will be asked to volunteer as demonstrators and apply sunscreen on the arms and face. A UV lamp will then reveal the effectiveness of the application and will form part of a broader discussion. There is a risk of some skin or other irritation from the use of this product. Students with identified skin sensitivities and will not be permitted to volunteer for the demonstrator activity of the Glitterbug.
The use of the Polaroid UV detector camera which is an instant photograph generating camera showing sun damaged skin. The UV photographs involve the use of portable UV camera which takes photographs that reveal any acquired sun damage that sits below the skin surface and is invisible to the naked eye. Students who wish to discuss their results will be encouraged as part of a broader discussion regarding the importance of skin protection strategies. Students who do not wish to have a photo taken will not be involved in the discussion. UV camera photography is the same as having a normal photograph taken. On one side of the image all visible light is filtered out only allowing the UV light to penetrate the film plane. There should be no harmful effects of excessive UV light. It would be more harmful to stand outside in unprotected UV light for four minutes. Each student will receive an instant printout of their UV photograph of their face. As the camera does not have the capacity to store images, no copies of photographs will be retained by the investigators. Because these photographs may disclose evidence of skin damage, there is some risk of causing emotional distress in the some participants.
Personal UV warning wristbands are wristbands that are UV sensitive and provide a warning about the need for renewed sunscreen application. When the UV detection wristbands are covered with sunscreen the wristband changes colour to warn the user when to reapply sunscreen or find shade.
It is not anticipated that these will cause any harm.
The surveys, both baseline and follow-up, do not involve, in the researchers' opinion, sensitive questions which could lead to distress in participants.
In order to minimise these risks, the researchers will adopt the following strategies:
- four students will be asked to volunteer, particularly those who say they have sensitive skin, to using the Glitterbug potion and will be provided with cleaning material in the form of wet wipes so that they can remove the potion residue in the event of any sensitivity or irritation occurring.
- with regard to the Polaroid UV detect camera, the Cancer Council helpline flyer will be provided to all students at the same time as the photographs are taken. The flyer provides contact details for help and advice in relation to skin cancer.
- the UV sensitive wristband will be applied under supervision so that when students conduct the first application of sunscreen they will understand how the wristband functions and be reassured of its inert effects.
The investigators will provide all participants with contact details of the human research ethics committee secretariat in the event of questions or concerns.
The conduct of the project, the taking of UV photographs, the application of the Glitterbug potion and the use of UV wristbands will be supervised primarily by Mary Wilson. Her experience as a nurse and with adolescents will enable her to monitor and address any emergent risks of distress or harm.
Participants in this project will be school students in years eight and nine, with an average age of 14 to 15. Students will be recruited from schools in two coastal areas in the state.
In each school, at least 50 students from years eight and nine, one class in each year, will be invited to participate and consent from their parents and guardians will be sought.
A total of ten schools in the coastal areas will be approached to participate, of which five will involve interventions and five will be used as a control. Of the five schools to be involved in the intervention, three will participate in the baseline survey, the educational poster, UV photo and discussion and sunscreen demonstration, wristband reminder and follow-up survey while two will participate in the baseline survey, the poster and the follow-up survey. The five schools to be used as a control will participate only in the baseline and follow-up surveys. A total of approximately 450 students will be involved.
Participation for all students will involve completing the baseline and follow-up surveys. These are designed to measure attitudes and behaviours relating to sun protection. Each student will be asked to fill out a written survey containing questions about their current sun protection attitudes and behaviours.
In the five interventions schools, the Cancer Council poster about good sun protection behaviours will be displayed
In three of the intervention schools, students will be invited to have the UV photographs taken, to use the Glitterbug potion and to use UV wristbands. In the remaining two intervention schools, the surveys and the Cancer Council sun protection advice poster only will be used.
Recruitment from the control schools will, with the principals' consent, be by invitation to year 8 and 9 students to complete the baseline and follow-up surveys. Copies of the surveys with reply paid envelopes will be made available for distribution to year 8 and 9 students who can choose to complete and return the surveys or not. These surveys will identified only by a code for the school.
There is no existing relationship between any of the investigators, any of the schools and any of the potential participants to be recruited.
Principals of the 10 schools will be approached, following Department of Education approval of the project, for their consent to the intervention being applied in their schools.
Following that consent, one class in the years 8 and 9 of each school will be invited to participate. The invitation will be provided in person by one of the investigators in a classroom session.
Consent documentation will be provided to all students in the nominated classes for their parental consent. Only when students' parents have consented to their participation will they be included.
At the end of the project, each school that participates in the intervention activities will receive an adolescent sun protection kit (including curriculum resources, sunscreen pump packs and other tangible resources), provided by Sunshield and valued at approximately $200. This kit will be presented to the schools at a parents and citizens meeting with a brief oral presentation of the research findings.
In addition, those schools involved in the poster and surveys only, will be offered 50 free UV photos as an optional benefit of participating.
In addition, those schools from whom students provide follow-up surveys will be provided with a number of individual sunscreen Sunshield pump packs equal to the number of students who provided surveys.
PRIVACY AND CONFIDENTIALITY
Source and description of information about participants
The only information collected from participants will be their responses to the survey, anonymous contributions to discussions about sun protection behaviours and mechanisms. None of the information collected will be identifiable other than the UV photos. Because these are taken with a Polaroid camera which does not retain any images, participants will receive the only copy of their own photographs.
Use of information about participants
Information collected through discussions and surveys will remain anonymous and will be used in the analysis of the results.
Storage of information
During the course of the project, the survey material and output of discussions as notes will be kept on an encrypted computer not linked to a database or institutional system. Participants will receive their own copies of UV photographs and researchers will have no control over the use of these.
Ownership of the information
It is understood that the State University and Sunshield Limited will retain ownership of the information collected and the results generated.
Reporting of individual results
Because there will be no identifiable information, other than the UV photographs which participants will retain, no individual results will be generated and therefore none will be provided.
Disposal of the information
On completion of the data analysis and the publication of a report on the project and/or peer reviewed articles, decisions about the destruction of the information will be made by the State University and Sunshield Limited.
|APPENDIX A||Information sheet for parents of children in intervention schools|
|APPENDIX B||Indicative questions from survey|