REPOSITORY TITLE: War on Melanoma: Enlisting a cohort of melanoma survivors and their families.
PRINCIPAL INVESTIGATOR: Sancy Leachman, MD, PhD 503-494-8533
REPOSITORY GUARDIANS: Tracy Petrie, PhD 503-494-8410
STUDY COORDINATORS: Ravi Samatham na
Elizabeth Stoos 503-418-9356
FUNDED BY: This protocol is currently unfunded
ABOUT RESEARCH REPOSITORIES
Generally, a research repository collects, stores and distributes data for use in future research projects. Storing and gathering numerous data together can help to conduct future research and avoid re-collecting it over and over again. With this stored information and samples, researchers may understand better how the human body works, develop new tests to find diseases, find new ways to treat diseases, or develop new products, such as drugs. When researchers collect and store data together and use them for different kinds of research in the future, or share them with other scientists, this is called a research repository. "You" refers to you or your child in this consent form.
You are invited to take part in this registry because you are interested in melanoma research, have been identified as someone who has a personal history of melanoma or are a relative or friend of someone who had melanoma, or are using the Mole Mapper Study cellphone application. PURPOSE:
The purpose of this repository is to build a cohort, called Melanoma Community Registry, of melanoma patients, family members and friends. This registry will serve as a data repository for future research and thus will collect, store and/or share data for and with melanoma researchers for an indeterminate period of time. Beyond research, it will be a means to communicate with you information about community outreach and educational events. We plan to enroll approximately 100,000 people in this repository. The data would include:
1. Key information about you collected during consent, such as email address, date of birth, zip code of current residence and personal/family history of melanoma.
2. Responses to a variety of questionnaires about your personal and family health history, eye color, hair and skin characteristics, behaviors that might impact skin cancer risk (sun exposure), circumstances that impact your ability to access care and other social data.
3. Photographs of skin lesions you wish to share via cellphone apps, pictures in your medical records or what you may provide at community events.
4. Links to connect your information in this repository to your data in other ethics-approved data sources such as the BioLibrary, medical records, pathology reports, etc.
5. Information about your interests to volunteer unique skills or tap personal networks to raise awareness/educate in communities and bring the "patient voice" to the research process by providing feedback on survey development, looking at educational materials, sharing your story with media (with permission), and other outreach activities.
PROCEDURES:
If you take part in this repository, you are allowing us to:
• Contact you, by email, and request you complete on-line surveys or questionnaires or participate in discussion sessions (i.e. focus groups) on a range of topics such as your history of sun exposure, use of sun protective clothing or sunscreens, personal history of melanoma including stage and depth, relations in your family who have also had melanoma, obstacles faced, feedback on written or oral materials that are intended for the public, etc. • Request you complete medical release forms so we can get and store records of your care and diagnostic results. This will allow us to have this important medical information regardless of where you received care. • Maintain linkages that allow us identify your data, as opposed to being anonymous, so we can study your unique characteristics. This will allow is to, for example, look at survey data that indicates your hair and eye color, amount of lifetime sun exposure, pathology reports, genetic information, and clinical/treatment data to study potentially important relationships. • Query the list of names in the registry to aid other researchers in enrolling in their studies using data already collected. This may or may not include the need to re-contact you. This can potentially speed the progress in other melanoma-related studies. • Connect you to other melanoma-related community organizations and activities. There are many activities that take place outside an academic medical center that may be of interest to you. We will make you aware but will not give your information to any group. This will be informational only and will require you to contact them if interested. WHAT WILL HAPPEN TO THE DATA?
By agreeing to be included in the Melanoma Community Registry, you are providing consent or permission for OHSU researchers to keep information you provide to the Melanoma Community Registry in a confidential, privacy-protected, ethics board-approved database. All the data we collect will be stored on secure, encrypted servers behind an OHSU firewall. We will establish a coded identifier of letters and numbers (not name or social security number) that can link your data from multiple sources (clinical records, survey responses). Only the IRB-approved personnel and other OHSU personnel working on this study will be authorized access to these identifiable data. We will store this data indefinitely, unless you expressly chose to withdraw from this study. Because melanoma is a cancer of the skin, photographs are important data for our research. During this study you may provide or have photos taken. We will use the photographs for research publications and academic educational opportunities. We will conceal your identity by using a black bar over eyes or other identifiable features. We will obtain your permission (media release) to use photos used for public education or study marketing purposes. By being part of this repository, the data you provide can assist other researchers in their studies. We share data with qualified researchers following specific criteria. All requests for data release are reviewed by the Principal Investigator and the Guardian of this repository to ensure data are transferred, used, and stored in a secure and confidential manner. FUTURE STUDIES
As described above, data we collect or generate may be given to other researchers as part of the search for causes and treatments of diseases. This may include, but is not limited to, studies of scientific or biologic relevance to cells involved in melanoma development. Your authorization to use your health information will never expire unless you revoke it. The samples and clinical information will be labeled and stored as described in the PRIVACY & CONFIDENTIALITY section.
WILL YOU RECEIVE RESULTS FROM RESEARCH INVOLVING YOUR DATA?
You will not receive results from data you provide. In most cases, the studies are being conducted by researchers outside of this data repository and therefore, our study personnel would not have knowledge of their findings. In addition, it is possible that researchers conducting future studies will receive only information that is coded and does not include identifiers (your name) so contacting you is not possible.
RISKS AND DISCOMFORTS:
You may answer questions about your or a family member's experience with cancer. Some of these questions may seem very personal or embarrassing. They may upset you. You may refuse to answer any of the questions that you do not wish to answer. If the questions make you very upset, we will help you to find a counselor.
Although we have made every effort to protect your identity, there is a small risk of loss of confidentiality. If the results of any studies of your genetic makeup were to be accidentally released, it might be possible that the information we will gather about you as part of this research repository could become available to an insurer or an employer, or a relative, or someone else outside the repository. Even though there are discrimination and confidentiality protections in both Oregon law and Federal law, there is still a small chance that you could be harmed if a release occurred. A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that this federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease being tested. BENEFITS
You will not personally benefit from participating in this repository. However, by serving as a participant, you may contribute new information which may benefit patients in the future.
ALTERNATIVES
You may choose not to participate in this repository.
PRIVACY & CONFIDENTIALITY PROTECTIONS
We will create and collect health information about you as described in the above sections of this form. Health information is private and is protected under federal law and Oregon law. By agreeing to be in this repository, you are giving permission (also called authorization) for us to use and disclose your health information as described in this form.
We will take steps to keep your personal information confidential, but we cannot guarantee total privacy. We will create a coded identification (letters and numbers) instead of names. This coded ID will be accessed only by study personnel authorized to receive identifiable data as described earlier. The investigators, study staff, and others at OHSU may use the information we collect and create about you in order to maintain and oversee this research repository and to conduct future research projects. We may release this information to others outside of OHSU who are involved in conducting or overseeing research, including: • The funder of this study and the funder's representatives
• The Food and Drug Administration
• The Office for Human Research Protections, a federal agency that oversees research involving humans Those listed above may also be permitted to review and copy your records. We will not release information about you to others not listed above, unless required or permitted by law. LIABILITY
If you believe you have been injured or harmed while participating in thi repository and require immediate treatment, contact your regular doctor or primary care physician.
If you are injured or harmed by the study procedures, you will be treated. OHSU does not offer any financial compensation or payment for the cost of treatment if you are injured or harmed as a result of participating in this research. Therefore, any medical treatment you need may be billed to you or your insurance. However, you are not prevented from seeking to collect compensation for injury related to negligence on the part of those involved in the research. Oregon law (Oregon Tort Claims Act (ORS 30.260 through 30.300)) may limit the dollar amount that you may recover from OHSU or its caregivers and researchers for a claim relating to care or research at OHSU, and the time you have to bring a claim. If you have questions on this subject, please call the OHSU Research Integrity Office at (503) 494-7887. COMMERCIAL DEVELOPMENT
Samples and/or information including any photographs about you or obtained from you in this research may be used for commercial purposes, such as making a discovery that could, in the future, be patented or licensed to a company, which could result in a possible financial benefit to that company, OHSU, and its researchers. There are no plans to pay you if this happens. You will not have any property rights or ownership or financial interest in or arising from products or data that may result from your participation in this study. Further, you will have no responsibility or liability for any use that may be made of your samples or information.
PARTICIPANT RIGHTS:
If in the future you decide you no longer want to participate in this research repository, we will destroy all your information provided. However, if your information or genetic samples are already being used in an on-going research project and if their withdrawal jeopardizes the success of the entire project, we may ask to continue to use them until the project is completed.
This research is being overseen by an Institutional Review Board (IRB). You may talk to them at (503) 494-7887 or irb@ohsu.edu if: • Your questions, concerns, or complaints are not being answered by the research team.
• You want to talk to someone besides the research team.
• You have questions about your rights as a research subject.
• You want to get more information or provide input about this research. You may also submit a report to the OHSU Integrity Hotline online at https://secure.ethicspoint.com/domain/media/en/gui/18915/index.html or by calling toll-free (877) 733- 8313 (anonymous and available 24 hours a day, 7 days a week). PARTICIPATION:
Your participation in this study is voluntary. You do not have to join this or any research repository. You do not have to allow the use and disclosure of your health information for this repository, but if you do not, you cannot join the repository.
If you do join the repository and later change your mind, you have the right to quit at any time. This includes the right to withdraw your authorization to use and disclose your health information. If you choose not to join this repository, or if you withdraw early from the repository, there will be no penalty or loss of benefits to which you are otherwise entitled, including being able to receive health care services or insurance coverage for services. Talk to the investigator if you want to withdraw from the repository. If you no longer want your health information to be used and disclosed as described in this form, you must send a written request or email stating that you are revoking your authorization to: OHSU Department of Dermatology
3303 SW Bond Ave, Portland, OR 97239
Attn: Melanoma Community Registry Coordinator
Or WarOnMelanoma@ohsu.edu Your request will be effective as of the date we receive it. However, health information collected before your request is received may continue to be used and disclosed to the extent that we have already acted based on your authorization. Your health care provider may be one of the investigators of this research repository, and as an investigator is interested in both your clinical welfare and in the conduct of this research. You do not have to be in any research study offered by your physician. Your health care outside the research, the payment for your health care, and your health care benefits will not be affected if you do not sign this form. If you have any questions, concerns, or complaints regarding this research repository now or in the future, contact Sancy Leachman, MD, PhD at (503) 494-8533 or contact a study coordinator at (844) 300-SPOT (7768). 