CONSENT TO PARTICIPATE IN RESEARCH
This consent form is meant to give you enough information about our research study, so that you make an informed choice about whether to participate. Participation in any study is completely voluntary.If you have any questions about this information, please contact us before signing.
If you agree to participate in our research,you do not give up any of your legal rights. We - the researchers or sponsors - are not relieved of any liability we may have.
Who are we?
3TandAi is a company that provides custom-tailored food recipes and life style coaching based on the results of a person’s genetic tests, tests for organisms in the gut, body measurements,and other blood markers. These are available through our website.
What will you be asked to do?
The 3TandAi program of nutritious recipes and online life style coaching customized for you based on information about your body measurements, blood markers, DNA, the organisms in your body separate from your own cells, and your answers to various surveys about activity levels, food preferences, family history, etc.You will gain access to the program for the full 16weeks of the research study. If at the end of the study you are interested in retaining access to the online program, you will be able to pay for a subscription. If, at any point you choose to withdraw from the study (or at the end of the study), you will have 30 days to download your Wellness Report and any recipes before you would have to pay for the program to retain access.To withdraw, you may email firstname.lastname@example.org with the subject "WITHDRAW."
Participation in research consists of:-
- weighing yourself and taking your waist and hip measurements every 4 weeks for 16 weeks (5 times total), so that we can track if you are losing weight during this time; and
- submitting results from a fresh blood test (less than 30 days old), and getting your blood drawn at 16 weeks and 12 months (3 blood draws altogether), and submitting the results so that we can track how your blood markers for cholesterol and diabetes change (or don’t change); and.
- spitting in a vial and submitting that for DNA analysis; and
- swabbing your poop and submitting it for microbiome analysis once every 2 weeks for a total of 16 weeks (9 times total), so that we can track how the organisms in your gut change (or don’t change) over that time frame; and
- allowing 3TandAi investigators to use your genetic, microbiomic, and blood marker information for research; and
- filling out questionnaires and surveys about yourself into 3TandAi Research features on the 3TandAi website, including questions about:
- activity levels
- medical history
- diet information
- whether youʼre using the recommended online recipes or the online life style coaching.
How is data handled?
It is important to us to maintain your privacy and confidentially as best we can. 3TandAi uses a range of procedures to protect the privacy of your personal information. A key protection is that personally identifying Registration Information (e.g.,your name, address, email address, user ID, password) is only available to a small group of people that needs access to this information for particular purposes where access to that data is necessary.These data are digitally encrypted and stored separate from data that we would use for research. Your research data will be stripped of identifying information and pooled with that of other research subjects.
3TandAi may collaborate on research with external members of our research consortium or with the public. External parties will only have access to pooled data stripped of identifying information, with the following exceptions:
- 3TandAi may release your individual-level data to a third party if we ask for, and receive, your explicit authorization to do so.
- 3TandAi’s partners or service providers (e.g. uBiome or our contracted laboratory) may process and/or store your information in order to provide you with 3TandAiʼs services.
- Researchers invited by 3TandAi to conduct research may access your information (but not your name or contact information) for the purpose of scientific research.
- 3TandAi may release individual-level information in response to requests from law-enforcement agencies, courts of law, regulatory and government agencies, and if otherwise required to do so by law.
- The Institutional Review Board (IRB) and government officials responsible for monitoring our study may inspect the study records.
What are the Benefits of Participating?
There may to be no health benefit to you. However, other benefits include free access to an online life style coach, free access to large recipe database, and free access to our online software tools. Possible benefits may include weight loss and/or improvement in blood sugars and lipids.
Discoveries made as a result of this research could be used to understand the basic causes of disease.
Are there Risks of Participating?
There are some potential risks to participating in the 3TandAi research study:
- The risks of drawing blood from a vein include discomfort at the site of puncture; possible bruising and swelling around the puncture site; rarely an infection; and, uncommonly, fainting from the procedure.
- Obesity and diabetes are conditions with serious health repercussions. Participation in research is NOT a substitute for professional medical care. 3TandAi recommends that you retain the services of a personal physician to oversee your care, and advises that you notify your physician of your participation in 3TandAiʼs research.
- 3TandAiʼs recipe recommendations depend on you accurately representing your food sensitivities or allergies. It is important that you carefully check recipes to ensure that you do not ingest foods that you know you are sensitive to.
- While 3TandAiʼs diet and exercise recommendations are based on scientific evidenceand chosen in consultation with physicians, you may experience adverse effects such as hunger, dizziness or light headedness, or food sensitivities.
- You may be uncomfortable or embarrassed about answering questions regarding your diet or exercise habits.
- You may feel uncomfortable or squeamish submitting your DNA (saliva from spitting) or gut microbiome (swabbing your poop) samples.
- In the event of a security breach, if your data are associated with your identity, they may be made public and it may have social and psychological consequences for you or your loved ones. Further more, if a physical sample is stolen or mishandled by an employee or contractor, they may obtain additional information from the sample, such as sequencing data from your DNA.
- When 3TandAi investigators publish results from this study, your information may be included within pooled summaries that are made public. Identification of your individual-level data from those summaries would be extremely difficult, but it is possible that a third party that has obtained partial data from you could compare their partial data to the published results and indirectly determine some of your survey responses.
- While the information we keep will not include names, human genetic information is unique and can be used to identify people by linking or tracing DNA in public databases. It may also identify your family since your DNA is shared with your family.
- As with any online service, if you disclose your account password to others, they may be able to access your account and your information.
- Data that you choose to share with others for any reason could be used against your interests.
- 3TandAi is a private company and the Chief Scientific Officer of the company is also the Primary Investigator (head of research) of this study. There may be a conflict of interest between these two roles; however, the Primary Investigator is obligated to hold the interests of research above those of the company for purposes of the research study.
- Information you choose to share with your physician or other health care provider may become part of your medical record and through that route be accessible to other health care providers and/or insurance companies in the future.
- There may be additional risks to participation that are currently unforeseeable.
Costs: If you visit a physician to discuss your participation in 3TandAi Research or to obtain orders for bloodwork, any such consultations are subject to the billing agreement between you and your medical provider, and you will be required to pay accordingly. You may be responsible for paying for your blood draws out-of-pocket or as arranged with your insurance carrier. Your insurance carrier may not pay. Your medical provider may not be willing to order labs viewed as medically unnecessary.
Payment: You will not be paid to participate in 3TandAi research. If you gained free access to the 3TandAi program by participating in research button or decide to withdraw from the study, you will have 30 days free access to your program before you would have to pay to retain access. After 30 days, any data collected before you withdraw consent will be archived with other research data.
Injury: Although 3TandAi does not expect any injuries, they are always possible. We have made no arrangements to treat or compensate for injury.
If 3TandAi develops intellectual property and/or commercializes products or services, directly or indirectly, based on the results of this study, you will not receive any compensation.
What are my alternatives?
You can choose to use the 3TandAI products and website without participating in this study.
Can I withdraw from the study?
Participation in 3TandAi Research is completely voluntary. You can choose to not take part or to withdraw from the study without penalty or loss of benefits to which youare otherwise entitled. If you do decide to stop, we are still allowed to use the information we gathered up to that date but not after. To withdraw, please emailus at email@example.com with the subject "WITHDRAW."
3TandAi can also stop the study at any time for any reason. If we do, we will notify you.
Study questions: If you have any questions or concerns about the study, if you feel you may have suffered a research-related injury, if you have a question your rights as a research subject, or if you would like to offer input, please contact the following:
3TandAi Human Protections Administrator
3TandAi service or website questions.
3TandAi Customer Service by email at privacy@3TandAi.com
Rights and Concerns:If you have any questions, concerns or complaints about research that you do not wish to discuss with 3TandAi, you may contact the following independent, impartial research review board:
Ethical and Independent (E&I)Review ServicesIRB
Reference study #: 18053
Please print and store a copy of this form for your records.
What is the purpose of this study?1
This study will evaluate a select group of 3TandAi users to see whether following 3TandAi recommended recipes and meeting with an online health coach over a 16-week period has an impact on weight and blood sugar levels.
1This study is not accepting anyone who cannot give consent for themselves:
- People with legal guardians for any reason
- Anyone who is incapacitated
We are also not accepting people whose diets should be handled with their doctor:
- Pregnant or breast-feeding
- Are taking insulin or sulfonylurea related drugs to treat diabetes.
Participation is voluntary. It should be informed. Before agreeing you should have read this form and contacted us at firstname.lastname@example.org with any questions. If any information arises that could potentially alter your decision to participate, we will send that information to you.