INFORMED CONSENT TO TAKE PART IN PATIENTSLIKEME
For more information about this pilot study, please read the research participant information form carefully. If you have any questions, please contact us at email@example.com or at (617) 500-1623.
Why is this study being done?
PatientsLikeMe wishes to greatly increase our understanding of human health at the individual level through the capture of additional information about you, over time. In addition to information about your experience, lifestyle, environment, family history, we would like to understand what’s happening inside your body. Today, we have the ability to take hundreds of thousands of measurements from a single vial of blood, when 20 years ago this would have been impossible. This is what it means to “digitize” health -- to have the ability to capture data about you, whether that data be information about what treatments you are taking to which chemicals in your blood increase or decrease over time.
PatientsLikeMe’s goal is to gather data and biospecimens on many individuals so we can ask and hopefully start to answer questions like the ones outlined above. It’s a long journey, and it will take time for our scientists to analyze these data to determine the impact of it. We hope these studies will help researchers develop better ways to prevent, detect, and treat disease.
Who is being studied?
Taking part in this pilot study is entirely voluntary. As a member of PatientsLikeMe, or interested party you may represent a large range of health conditions including participation as a “healthy” volunteer.
Eligibility requirements are as follows:
- You must be a United States citizen or Legal United States resident
- You must be able read and understand English
- You must be 18 years or older; residents of Alabama and Nebraska must be 19 years or older
- If you are an employee of PatientsLikeMe, close affiliates of PatientsLikeMe or members of the iCarbonX Alliance and choose to participate, you will be required to complete Appendix A as part of the consent process. Your decision will have no adverse consequences for your employment and/or relationship with PatientsLikeMe.
You will not be excluded if you are pregnant or nursing, however necessary medical precautions will be taken during specimen collection.
PatientsLikeMe will not exclude medical conditions in which patients may be limited by cognitive impairment. In the specified case PatientsLikeMe will require a legally authorized representative (LAR) to provide his/her consent and signature. Such representatives must be present at time of specimen collection and data capture.
If you are not already an existing member, you may be asked to join PatientsLikeMe to participate in all facets of DigitalMe™ Ignite.
What will happen during this study?
To accelerate our mission, and understand your health better, PatientsLikeMe will ask that you provide the following information to the extent that you are willing:
- Details about you and your health such as your age, medical conditions, symptoms and treatments.
- Updates to your PatientsLikeMe profile and surveys at regular intervals (surveys every 30 days) and at times when you have a health change or health event (e.g. new symptom or treatment; hospitalization). Surveys vary in length, with the longest ones taking up to 30 minutes.
- Study visits, which include specimen collection (blood draw) and a questionnaire, will take approximately 30-40 minutes. Study visits can be scheduled every 4 months, and an additional visit may be requested when you have a significant change in your health status.
PatientsLikeMe asks that you are willing to contribute blood, urine, stool (feces), skin swabs, saliva, hair and other tissues as necessary for use in research. Specimen type and quantity will be communicated through various modes.Blood
- At the time of each blood draw, a phlebotomist (i.e., the person who draws your blood) will insert a needle into a vein in your arm and collect no more than 50 ml of blood. (approximately 3 tablespoons).
- In some instances, we may wish to collect blood through finger or surface prick.
- The samples you provide will be coded for secure identification and will be processed, and transferred securely to the biorepository.
- Other specimens are collected in specific containers that we will provide to you.
- Each specimen container will be coded for secure identification and will be processed, and transferred securely to the biorepository.
PatientsLikeMe will coordinate with you to determine the most appropriate location to collect the desired specimens. We will provide you with the appropriate supplies to acquire the necessary specimens in your home or at a medical facility or office of a health care provider. All specimens will be labeled with the sample type and a unique identifier code to assure privacy and secure identification.
- You may be asked to repeat the blood collections no sooner than one month (dependent upon total blood volume).
- More frequent and/or less latent specimen collections may occur dependent upon the specimen type and study requirement (i.e. healthy volunteers)
- You may be asked by a PatientsLikeMe staff member to participate in media related activities.
- If this occurs, you will be presented with a media release form explaining potential PatientsLikeMe media engagements. If you choose to provide this consent, you have the ability to withdraw your consent to participate with the media at any time. In any event, your biospecimens will remain de-identified throughout the duration of the study. However, if you agree to media participation that uses any personal identifiers (such as your name, photo or video), you could be adding additional risk to your identity being linked to your study data.
- You give PatientsLikeMe permission to conduct research studies on your data and on the specimens you provide for the duration of time that you remain enrolled in DigitalMe™ Ignite.
What biological measurements might be taken from my biosamples?
PatientsLikeMe may elect to do an “omic” profile on your sample. This means we will take many measurements at once. For example, we may look at parts or all of your DNA sequences (a set of genes that are unique to each individual). We may also wish to look at the way the DNA is modified and how it expresses RNA or proteins (e.g. blood sugar), in addition measuring your immune system or the different metabolites that your body produces (e.g., liver enzymes).
How are my samples and health information stored in the biorepository?
- PatientsLikeMe will randomly assign a de-identified code (unique identifier) to your samples and health information.
- Your name, PatientsLikeMe user ID, or other information that easily identifies you will not be stored directly with your samples.
- The key to the code will be stored securely in a separate file, accessible only to key personnel working at or contracted with PatientsLikeMe.
- The coded samples will be held under secure conditions and accessible only to key personnel at or contracted by PatientsLikeMe.
How long will PatientsLikeMe keep my samples and information?
- We may securely store your samples and donated data without a defined end date.
What are the potential risks of being in the study?
- There is the small possibility of minor bruising or bleeding at the site where blood is drawn.
- There is a small risk of light-headedness or feeling faint associated with blood draws.
- It is possible that a participant could be identified using information shared on PatientsLikeMe (and/or combined with your sample or other data sources). Although we endeavor to minimize any risks by only sharing de-identified information with partners and others, there is some risk that your sensitive data could be associated with your identity.
- As with any online related activity, the risk of a data breach is always possible. PatientsLikeMe takes commercially reasonable administrative, procedural, and technical precautions to help keep our members’ data secure.
- There is a possibility that participants may feel uncomfortable sharing information online.
- If you are an employee of PatientsLikeMe, a close affiliate of PatientsLikeMe or member of the iCarbonX Alliance and choose not to take part your decision will have no adverse consequences for your employment and/or relationship with PatientsLikeMe.
Does being in this study provide any benefit and/or individual results?
- During the pilot phase of the DigitalMe™ study, we will not have results to share with you or other participants. Particpating in this phase of the study does not provide any direct benefit to you. Later, if the model for this study proves successful, PatientsLikeMe will share with participants what we have learned.
Other information about the study
- PatientsLikeMe may request participation and/or enrollment into other PatientsLikeMe initiatives including biological give back programs. Lack of acknowledgement or enrollment into additional research opportunities will not automatically withdraw your enrollment in DigitalMe™ Ignite.
- You may receive a newsletter or other information that will tell you about the research discoveries and status updates from this or other projects from DigitalMe™ Ignite.
- When research results are published, they may show that certain groups (for example, racial, ethnic, or men/women) have markers that are associated with increased risk of a disease. If this happens, you or others may learn that you are at increased risk of developing a disease or condition; this does not mean that you absolutely will or will not develop that condition.
As this project continues, you may be asked for other types of participation including:
- Permission to access other medical information including your health records and medical images including standardized video exams.
- Linkage to and/or access to data you are collecting with digital devices such as mobile health apps, sensors or trackers.
Who is paying for this study?
- PatientsLikeMe assumes all costs associated with the study.
Will it cost me anything to be in this study?
- You will not be asked to financially contribute to your participation.
Will I be paid for being in this study?
- You will not receive any payment or compensation for your participation in this study.
- PatientsLikeMe will pay for travel and related costs for participants. This is not payment for participation but potentially allows the inclusion of patients who would otherwise not be able to participate.
- You may receive small items from PatientsLikeMe (for example, gift bags, cards, etc.)
Do I have to be in this study?
- Your participation in this study is completely voluntary and you can withdraw at any time without penalty or loss of benefit.
- The investigator or the New England Independent Review Board (NEIRB) can also stop your participation at any time (for example, if the study is ended early).
Can I stop allowing my specimens and data to be stored and used for research?
- Your participation in this study is completely voluntary and you can withdraw your permission at any time. If you do, your samples stored in the PatientsLikeMe biorepository will be destroyed. However, it will not be possible to destroy samples and information that have already been given to researchers. Once a specimen has been analyzed by a researcher, PatientsLikeMe cannot remove your sample or information from their research process.
- You can choose not to respond to any invitations for biospecimen and/or other forms of data collection at any time.
- The investigator or the IRB can also stop your participation at any time.
- If you, the PatientsLikeMe principal investigator, or the IRB choose to withdraw your participation your PatientsLikeMe membership will not be impacted.
If you decide to withdraw from DigitalMe™ Ignite, please contact us in writing at
or in writing at:
- PatientsLikeMe DigitalMe™ Ignite
- 160 Second Street
- Cambridge, MA 02142
Who will have access to my samples and/or medical information?
- The research team at PatientsLikeMe, and any research partners working with PatientsLikeMe, will have access to your donated data and unique coded samples.
- Your coded samples and health information may also be shared with researchers at other institutions or with for-profit companies that are working with PatientsLikeMe researchers.
- Your samples and information may be used to develop a new product or medical test to be sold. PatientsLikeMe researchers and partners may benefit if this happens. There are no plans to pay you if your samples and information are used for this purpose.
- We will not share information that identifies you with researchers outside PatientsLikeMe without your express permission.
- We may share your de-identified samples and/or DNA sequence (a set of genes that are unique to each individual), your health information, and results from research with other central tissue or data banks, such as those sponsored by the National Institutes of Health, and with researchers from around the world so they can use them to study many conditions.
- If we publish the results of the research, we will only include de-identified information.
- Personally Identifying Information will not be included in any report to partners or in any publications or presentations that come from this research.
- We do not release any individual information to insurance companies. The Genetic Information Nondiscriminatory Act of 2008 (GINA) is a federal law that protects you from discrimination based on your genetic information. It means that you cannot be denied health insurance or employment based on any genetic test results. The law does not apply to life insurance or long-term care insurance.
For what research, might my data and samples be used?
- It is not possible for us to list every research project that may be done. Also, we cannot predict all the research questions that will be important in the future. As we learn more, we may use your samples and information to answer new types of research questions related to human diseases.
PatientsLikeMe plans to do many types of biological and genetic research with your samples, for example, research on neurological disease, cancer, diabetes, mental illness, or respiratory disease to name a few.
- Genetic research potentially done by PatientsLikeMe may include looking at some or all your genes and DNA to see if there are links between specific genes and different types of health conditions.
- PatientsLikeMe may create a "cell line" from your sample that will allow researchers to have an unlimited supply of your cells for research.
- PatientsLikeMe may use your cells to create pluripotent stem cells. This type of cell can be used to create different types of tissue, for example, heart, muscle, or lung cells. Your cells might be used in research that alters genes in the cells to study different diseases and normal healthy processes. Your cells might be mixed with other human cells, animal cells, or grown in lab animals like mice.
- PatientsLikeMe may share your samples and any cell lines that are created, your DNA sequence information, your health information, and results from research with other central tissue or data banks, such as those sponsored by the National Institutes of Health, and with researchers from around the world so they can use them to study many conditions.
- PatientsLikeMe may ask you about your experience and attitudes in participating in this type of research and/or in receiving research results back to you in the form of data derived from collected specimens.
Who do I contact if I have questions about the study?
- For questions, feedback, or more information about this research, contact us at firstname.lastname@example.org or (617) 500-1623.
- If you have questions, complaints or concerns about your rights as a research subject, contact the New England IRB at 800-232-9570 or 617-243-3924 or email@example.com.
We will contact you if there is any new information that might affect your willingness to continue in the study.
I agree that I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction. I may contact Renee Deehan Kenney at firstname.lastname@example.org or (617) 500-1623 if I have any more questions about taking part in this study.
I understand that my participation in this research project is voluntary. I know that I may quit the study at any time without harming my future medical care or losing any benefits to which I might be entitled. The investigator in charge of this study may decide at any time that I should no longer participate in this study.
If I have questions, complaints or concerns about this study or questions about research subjects’ rights, I can contact:
New England Independent Review Board
By signing this form, I have not waived any of my legal rights.
By signing below, I agree that I am at least 18 years old, have read and understood this research subject informed consent form, have had my questions answered, and consent to participate in this research study.
I have read and understand the above information and authorize the use and disclosure of my private health information. I agree to participate in this study and understand that I will be given a copy of this signed and dated form for my own records.
NOTE: If you are an employee of PatientsLikeMe or PatientsLikeMe affiliate (kids; parents; siblings; spouse; or lives in the same household) and choose to participate in DigitalMe Ignite, please contact the PatientsLikeMe Human Protections Administrator at email@example.com before you sign the e-consent.