August 18, 2022
North Star Review Board
This is a text copy of the informed consent. All participants complete an official informed consent upon registration.
RARE Registry eConsent Form
Please note that for the purpose of this consent “I” and “you” and “your” refer to the individual affected by acral, mucosal, or non-acral cutaneous melanoma who has registered and consented to participate. Caregivers can register to provide information on behalf of a family member who had acral, mucosal, or non-acral cutaneous melanoma that is deceased.
WHAT IS THE RARE REGISTRY?
A registry collects family history, medical, and other related information from patients with specific types of diseases and uses the data, after removing any information that can identify a patient, for medical research purposes. The Melanoma Research Alliance (MRA), a non-profit funder of melanoma research based in Washington, DC, USA, is sponsoring RARE, an innovative patient registry that intends to accelerate acral and mucosal melanoma research. RARE will collect data about medical and non-medical topics from patients with acral and mucosal melanoma and create a database of information for research purposes. Patients with non-acral cutaneous melanoma, the more common type of melanoma caused by sun exposure, will also be included in the registry so that features of a patient’s journey with acral and mucosal melanoma can be compared with non-acral cutaneous melanoma.
For individuals 18 years or older that have been diagnosed with acral, mucosal, or non-acral cutaneous melanoma, we are asking for your permission, also called consent, for the collection, storage, maintenance, and use of your information. Family members and friends (caregivers) who are 18 years or older and have provided care for deceased patients who had acral, mucosal, or non-acral cutaneous melanoma can also register and provide appropriate information on behalf of the deceased patient. Via a web-based platform, you will be asked to respond to surveys to collect information including your demographics, disease history, genetic/tumor biomarker status, how your disease was monitored, your overall health & lifestyle, and information about your quality of life. In addition, you will be asked to complete surveys collecting information about surgeries, radiation, and medical treatments that you have received. You may also be asked to upload medical reports such as genomic, surgical, and pathology so that additional clinical information can be obtained. All information that you enter, or upload will be stored in a secure and private database. The information that you provide will be de-identified, (meaning all personal health information that could be used to identify you, including but not limited to your name, birthdate, address, etc., will be removed) before it is shared with third parties for research purposes only.
RARE has four main objectives: 1) to create a database of participant-reported information from people with acral, mucosal, and non-acral cutaneous melanoma; 2) to create an open-access Research Portal for the study of de-identified participant data; 3) to provide participants with aggregated, de-identified data emerging from the registry so they can learn more about their disease; and 4) to inform participants of potentially relevant clinical trials – and other research advances – that they could discuss with their clinicians.
After carefully reading the following sections and having any questions answered by MRA staff by emailing them at firstname.lastname@example.org, you consent:
- to answer surveys and treatment history information;
- to answer future surveys designed by researchers or other organizations who are seeking additional information;
- to upload medical reports should you choose to do so;
- to be notified about emerging data from the registry, webinars to attend, other educational information that may be pertinent to your disease and if you potentially match clinical trials being conducted (referred to as Insights); and
- to give MRA continued use of your de-identified data if you pass away.
You can change your mind about storing, maintaining, using, and sharing your data at any time. You may change your mind at any time about being contacted by MRA to receive additional surveys, Insights, and/or clinical trial notifications. If you change your mind, please email email@example.com and indicate that you do not want to receive further communications.
WHY COLLECT INFORMATION IN THE RARE REGISTRY?
Mucosal and acral melanomas, two rare subtypes of melanoma, are currently treatable but not curable and each affect approximately 2,000-3000 people each year in the US. Many challenges exist that prevent seamless research into various questions about living with these rare melanoma subtypes. No national database for the experience and outcomes of patients with acral and mucosal melanoma exists anywhere in the world and existing datasets do not adequately represent the total patient population. Prior research in these rare subtypes has been performed at individual clinical centers and the data has not always been widely shared. Survival times and responses to different treatments are not collected in a consistent manner across different centers or are not widely available. The RARE registry can help overcome some of these obstacles by collecting not only data about your medical treatments and disease characteristics regarding acral and mucosal melanoma but also information about your quality of life, lifestyle, and other related topics. This information will be extremely important in advancing acral and mucosal research to find better and more efficient treatment options and managing these diseases.
WHO IS PAYING FOR THIS STUDY?
The MRA, the sponsor of the study, is paying for this study.
HOW WILL INFORMATION BE COLLECTED FROM PARTICIPANTS?
You must first complete a registration and consent process which will require you to enter your name and date at the end of this consent form which will serve as your signature on this document in order to participate. You will then be given access to your RARE Registry account and dashboard that includes different surveys and a treatment timeline that you can complete. This website is compatible with a smartphone so you can use your smartphone, tablet and/or computer to complete all of these steps and input any information.
WHAT TYPES OF INFORMATION COMMONLY REFERRED TO AS DATA WILL BE COLLECTED?
Data from Surveys and Treatment Profile:
Study information (commonly referred to as data) will include your responses during registration, answers to surveys, and treatment details. The initial surveys are entitled: 1. Demographics, 2. Disease History, 3. Genetics and Biomarker Testing, 4. Monitoring, 5. Overall Health & Lifestyle, 6. Treatment Overview, and 7) Quality of Life (QoL) survey. An additional survey called Treatment Timeline, will ask you to provide information about your past and current treatments for your melanoma (if applicable). The treatment timeline is a record of the treatments you have received or are receiving, organized in a timeline. A single line of treatment may consist of medications, surgery, radiation, or other interventions. A completed line of treatment has a start date and an end date. If you are currently receiving a line of treatment, this is indicated by entering a start date and then selecting that the treatment is still in progress. For a surgical procedure, you will enter the date of the surgery. If you participated in one or more clinical trials, you will also be asked to provide the details about each trial in the treatment timeline survey.
You will likely need at least 30-60 minutes to complete all of the surveys and your treatment timeline. The number of total questions you answer will vary depending on your response to each question, as you will sometimes be prompted to answer follow-up questions based on your response. In addition, some questions are optional. Each survey is between 9 and no more than 58 questions long divided into different forms. Each survey can be answered in as many sessions as you need, taking as much time as you need. You may answer all surveys at once or you may answer them one at a time at your own pace. Subsequent surveys – after those available upon registration – will likely require far less time to complete. However, once you submit a completed survey you will not be able to change your responses. If you need to make an edit to your responses, you can contact MRA staff at firstname.lastname@example.org, and we can make an edit, or un-submit a survey on your behalf.
Having your medical records handy will be especially helpful for completing the treatment timeline. Because you may have to look up that information in your notes or ask your doctor or caregiver, completing treatment information may take more time.
You will be asked to complete the Quality of Life survey and update your Treatment timeline every four months to monitor any changes over time.
Data from Medical Reports:
To get a more complete clinical picture and history of your disease, you will be asked, but not required, to upload medical reports including, but not limited to, surgical, pathology, and genomic/tumor biomarker reports into your personal dashboard on the RARE registry website. The data in the reports will only be viewed by MRA RARE registry staff or contractors that have been appropriately trained and certified in protecting your privacy and personal health information. No identifiable information from the reports will be shared with other participants, researchers, or additional interested parties. The actual reports and any information extracted from the reports will be stored in a HIPAA compliant cloud-based database.
WHO WILL BE ABLE TO VIEW AND USE RARE REGISTRY DATA?
Federal Privacy Regulations provide safeguards for privacy, security, and authorized access of participant data. In the circumstances listed below, MRA may be legally required to share your protected health information (which means information that can individually identify you) with federal and state agencies or shared with other people in the following situations:
- The sponsor, Melanoma Research Alliance, and people who work with or for the sponsor will use your records to review the study and to check the results of the study.
- If there is a federal audit of the study, some government workers, such as employees of the U.S. Food and Drug Administration (FDA), will be able to see your information.
- You release your information to other people not involved in the study.
- You agree in writing to the release of your information to other people.
Your protected health information will be stored in a different database from your medical, non-identifiable information. Only authorized employees or consultants of MRA and Ordinal Data (Ordinal Data is the RARE registry technology partner engaged by MRA) who have received special training and are certified in protecting human participant data, and you and your caregiver will have access to your protected health information. Accounts of all types are protected by strong, participant-selected passwords.
In all other cases, MRA will remove “identifying” information from the medical and clinical data that will be accessed and used by external parties. We will share this de-identified information provided by you with researchers who sign up to use the Research Portal. All personally identifying information will be removed from surveys and the treatment timeline before it is shared through the Research Portal. Giving researchers access to a large body of medical and treatment information offers the possibility of discovering patterns of treatment that may result in optimal management of acral and mucosal melanoma or new insight into future avenues of research.
Some surveys include free-text answer fields that allow you to type in a response using your own words. These free-text field responses will not be shared with researchers but may be used by MRA to provide summary information based on an analysis of free-text field responses entered by many participants.
WILL BEING IN THIS STUDY HELP ME?
Being in this study may not directly benefit you. Information from this study might help researchers understand acral, mucosal, and non-acral cutaneous melanomas better and potentially benefit future patients who are diagnosed with melanoma.
You may consider that allowing the MRA to store, maintain, use, or share your data have indirect benefits, which may include, depending on preferences:
- Notification of clinical trials that may be pertinent to your melanoma
- Increased understanding of your disease in relation to others with acral, mucosal, and non-acral cutaneous melanoma through use of “Insights” provided by RARE
- Satisfaction from providing research data that may help you or others with acral and mucosal melanoma in the future
- Increased level of engagement with the research community
- Notification about acral and mucosal melanoma events such as conferences and webinars, as well as news about acral and mucosal melanoma
- Invitation to join Melanoma>Exchange, an online community of online discussion community of several thousand melanoma patients and caregivers.
WILL IT COST ANYTHING TO BE IN RARE REGISTRY STUDY?
The MRA is paying for this study. As this is not a treatment study expenses related to your condition and its therapies, doctor charges, other office visits, or other tests are not paid by the registry. You or your medical insurance provider will be responsible for all costs associated with your regular medical treatment.
While there are no fees associated with participating in the RARE registry, standard internet or data fees from your internet service provider may apply.
HOW LONG WILL I BE IN THE REGISTRY?
If you decide and consent to be in this study, and are eligible, your participation will last as long as the registry is active or until you decide to withdraw from the study.
Participation in RARE is entirely up to you. You can withdraw from the study at any point for any reason and may do so by notifying MRA at email@example.com. If you withdraw from the study, no new data about you will be collected for study purposes other than data needed to keep track of your withdrawal. Upon withdrawal, data that had been previously entered will be deleted from our database and will not be used for future analysis. However, any data that have already been downloaded from the Research Portal for study purposes will outlast your withdrawal. Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits to which you are entitled, and will not affect your access to health care.
WHAT ARE THE RISKS IN BEING IN THE STUDY?
There are no physical risks associated with this study. There is, however, the minimal potential risk of loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed. There is a small risk that someone outside of the MRA could link your data to you. If that happened, it is possible that someone could deny you a job or health insurance. You could also experience stress, anxiety, or embarrassment.
Some of the questions we will ask you as part of this study may make you feel uncomfortable. You may take a break at any time during the study. You may stop your participation in RARE at any time. MRA does not anticipate any discomfort, hazards, or physical, social, legal, or economic risks with participation. There are no provisions for research-related injury compensation from MRA.
WILL MRA CONTACT PARTICIPANTS IN THE FUTURE?
Some researchers or organizations may want to perform additional studies and may request answers to additional questions beyond those included in the initial surveys and/or treatment timeline You may be contacted in the future to answer these additional surveys. Any data obtained through subsequent surveys will also be de-identified and made available to researchers on the Research Portal. You can also change your mind at any time and opt out of these additional surveys by contacting the MRA at firstname.lastname@example.org.
You may be notified via RARE about Insights learned from the data reported in RARE, webinars and other pertinent educational information or about a potential clinical trial of interest (with the name of the trial, trial contact information, and a link to publicly available information about the trial). You may change your mind about participating in receiving insights or the clinical trial information feature by opting out of this feature by contacting email@example.com or by indicating this via your RARE Registry account profile.
IF YOU HAVE QUESTIONS, WHO CAN YOU TALK TO ABOUT THE STUDY?
You can ask questions about the study or this consent process at any time by emailing MRA RARE registry staff at firstname.lastname@example.org. A study staff member will respond to your inquiry. The study staff member can only answer questions about the RARE registry study and cannot answer questions about the reasons or validity of your medical treatment. This type of question should be referred to your treating doctor(s).
North Star Review Board has reviewed the different aspects of the RARE Registry study. North Star Review Board is composed of people carefully trained to review research studies to protect the rights and welfare of research participants. For inquiries about your rights as a participant in RARE, you may call North Star Review Board (toll free) at: 800-820-8210 or email: info@northstarreviewboard.
WHAT ARE SOME OF THE FUTURE DIRECTIONS FOR THE RARE REGISTRY?
In the future, MRA plans to expand the outreach and capabilities of the RARE Registry. As RARE will initially launch in the U.S., the registry will eventually expand to include participants from all over the world. In addition, RARE participants will have the option in the future to consent to provide additional clinical data from their medical records and access to their tissue specimens for genomic and other analyses. We anticipate these plans will strengthen our understanding of acral and mucosal melanoma, the journeys that patients with these subtypes face, and potentially identify new treatment options and better management of these diseases.
Please select one of the following statements: *
- I am registering myself as an adult (>18 years old) affected by acral, mucosal, or non-acral cutaneous melanoma
- I am completing registration for an affected individual to whom I have provided care and is deceased
By entering my name below, I confirm that I have read this consent form and understand the purpose of the registry and information that I will need to fill in and what information can be shared with the MRA and others.
To consent please enter your name here: *_______________________________________.
If applicable enter the name of the deceased affected person you are representing here: ____________________________.
To consent please enter the date here: * (Calendar pop up will appear to enter the date)
A copy of this form will be accessible via your RARE registry account. If you have any questions or problems during the study, please contact the Melanoma Research Alliance at email@example.com.
MRA RARE Registry eConsent_Appendix 12 v1.0