This document was last updated May 30, 2020.
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 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?
Digbi Health is a company that provides custom-tailored food recipes and lifestyle 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 is the purpose of this study?
This study will evaluate a select group of Digbi Health users to see whether following DigbiHealth recommended recipes and meeting with an online health coach over a 24-week period, followed by up to a year of access to the Digbi Health app, to see if this has an impact on weight and health.
Who is eligible for this study?
This 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.
What will you be asked to do?
You already have access to Digbi Health’s program of recipes and online lifestyle coaching. This program was made for you based on your body measurements, things you’ve told us about yourself, and your saliva and poop samples that you’ve provided.
In addition to using the Digbi Health wellness program that you have paid for (either out-of-pocket or via your health insurance company), participation in research consists of:
- allowing Digbi Health investigators to use your genetic, microbiomic, and blood marker information for research; and
- weighing yourself regularly and logging your weight in the Digbi Health mobile app (or weighing yourself on the Digbi Health integrated Fitbit Aria scale); and
- filling out occasional questionnaires and surveys about yourself into Digbi Health Research features on the Digbi Health website or via email, including questions about activity levels, medical history, diet information, whether you’re using the recommended online recipes or the online lifestyle coaching.
To withdraw at any time, you may email firstname.lastname@example.org with the subject “WITHDRAW.” You will continue to be able to access all Digbi Health features and support for as long as you are a subscriber, regardless of whether you are participating in research.
How is data handled?
It is important to us to maintain your privacy and confidentially as best we can. Digbi Health 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.
Digbi Health 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:
- Digbi Health may release your individual-level data to a third party if we ask for, and receive, your explicit authorization to do so.
- Digbi Healthʼs partners or service providers (e.g. AKESOgen, our contracted laboratory) may process and/or store your information in order to provide you with Digbi Health’s services.
- Researchers invited by Digbi Health to conduct research may access your information (but not your name or contact information) for the purpose of scientific research.
- Digbi Health 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 is likely to be no benefit to you; although we may occasionally provide incentives (such as discounted extra reports or Amazon gift cards) for participating in small surveys.
Discoveries made as a result of this research could be used to understand the how to treat obesity and diabetes.
Are there risks of participating?
There are some potential risks to participating in the Digbi Health research study:
- Obesity and diabetes are conditions with serious health repercussions. Participation in research is NOT a substitute for professional medical care. Digbi Health 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 Digbi Health’s research.
- Digbi Health’s 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 Digbi Health’s diet and exercise recommendations are based on scientific evidence and chosen in consultation with physicians, you may experience adverse effects such as hunger, dizziness or lightheadedness, 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. Furthermore, 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 Digbi Health 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.
- Digbi Health is a private company and the Chief Executive Officer of the company is also the Primary Investigator (head of research) of this study, and all data analysis in the research study is performed internally by employees of Digbi Health. There may be a conflict of interest between these two roles (of provision of care and administration of research); however, the Primary Investigator and other investigators are 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 Digbi Health Research or to obtain orders for blood work, any such consultations are subject to the billing agreement between you and your medical provider, and you will be required to pay accordingly.
Payment: You will not be paid to participate in Digbi Health research. If you have already paid for the Digbi Health program, you will retain access to your program whether you choose to participate in research or not. Even if you are not paying an out-of-pocket cost for Digbi Health because it is covered by your health insurance, Digbi Health is still compensated by your health insurance, so you are indirectly paying for the program.
Injury: Although Digbi Health does not expect any injuries, they are always possible. We have made no arrangements to treat or compensate for injury.
If Digbi Health 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 Digbi Health website and app without participating in this study.
Can I withdraw from the study?
Participation in Digbi Health (formerly 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 you are 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 email us at email@example.com with the subject “WITHDRAW.”
Digbi Health 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:
Digbi Health (formerly 3TandAi) human protections administrator email: firstname.lastname@example.org
Digbi Health service or website questions:
Digbi Health customer service by email at:
Rights and Concerns: If you have any questions, concerns or complaints about research that you do not wish to discuss with Digbi Health, you may contact the following independent, impartial research review board:
Ethical and Independent (E&I) Review Services IRB
Reference study #: 18053
Please print and store a copy of this form for your records.
Participation is voluntary. It should be informed. Before agreeing you should have read this form and contact us at email@example.com with any questions. If any information arises that could potentially alter your decision to participate, we will send that information to you.