Informed Consent Form

INFORMED CONSENT FORM

Sponsor / Study Title: Joined Bio “Direct to Patient Minimal Risk Research”
Protocol Number: JB-MR-250225
Principal Investigator (Study Doctor): Christopher Ianelli, MD PHD
Telephone: (978) 219-4496 (24-Hours)
Address: Joined Bio, 450 Bedford St, Lexington, MA    02420

 

INTRODUCTION

You are invited to participate in a research study conducted by Joined Bio. This document explains what the study involves, your rights, and important information to help you decide whether to participate.

An investigator on this study has an ownership interest in and serves on the Board of Directors for Joined Bio, the company sponsoring this research study. Additional steps have been taken to manage the potential conflict of interest that this arrangement may create. Please speak with your study doctor if you have questions about this. 

 

WHAT IS THE PURPOSE OF THIS STUDY?

This study aims to help researchers better understand health conditions and develop improved tests, treatments, and cures for diseases. Joined Bio collects health data, lifestyle information, biological samples, and feedback from people like you and provides this to qualified research partners.

 

WHO ARE YOUR RESEARCH PARTNERS?

Research partners include:

• For-profit organizations (pharmaceutical, biotech, and diagnostic companies)
• Non-profit research organizations
• Universities
• Government agencies
• Other health research organizations

 

WHY AM I INVITED TO PARTICIPATE?

You have been invited to participate in this study because you previously expressed interest in research participation and your health profile matches the needs of a current research project. 

About 100,000 participants participate will in this study.

 

DO I HAVE TO PARTICIPATE?

Your participation is completely voluntary. You may:

• Choose not to participate
• Withdraw from the study at any time
• Decline any specific research activity

There are no penalties for not participating.

If you are an employee of this research center, you are under no obligation to participate in this study.  You may withdraw from the study at any time and for any reason, and neither your decision to participate in the study, nor any decision on your part to withdraw, will have any effect on your performance appraisal or employment at this clinical research center.  You may refuse to participate or you may withdraw from the study at any time without penalty or anyone blaming you.

 

WHAT HAPPENS IF I PARTICIPATE?

If you consent, you may be invited to participate in one or more of these activities:

 

Biological Sample Collection:

Blood samples (by venipuncture, capillary collection device, or finger/heel/ear stick)

Other easy-to-collect samples:

• hair, nail, skin scrapings
• urine, stool, sweat, tears
• uncannulated saliva;
• mucosal and skin cells collected by buccal scraping or mouth washings;
• sputum collected after saline mist nebulization;
• nasal swabs that are inserted no deeper than until resistance is met;
• cheek or throat swabs;
• vaginal swabs when no deeper than 4 inches or until resistance is met;
• external genital swabs.

 

Information Sharing:

• Health and lifestyle questionnaires
• Sharing of your de-identified health information
• Participation in interviews, surveys, or focus groups

 

Other Activities:

• Non-invasive clinical procedures (e.g. electrocardiogram, ultrasound, blood pressure measurement)
• Wearing of a fitness trackers or monitoring devices
• Temporary lifestyle modifications
• Health journaling

 You can decline any activity without affecting your participation in other aspects of the study.

 

HOW LONG DOES IT TAKE TO PARTICIPATE?

Most activities take less than 10 minutes, but time requirements vary by research activity. You will be informed of the expected time commitment before each activity.

 

WILL I GET PAID FOR PARTICIPATING?  ARE THERE COSTS?

There are no costs to you or your insurance for participating in this research and you will receive payment for your time, effort, and contribution to research.

 

Compensation:

Compensation ranges from $10-$250 per activity, based on:

• Time commitment required
• Complexity of the activity
• Type of sample or information provided
• Level of discomfort or inconvenience involved

Compensation Examples:

• $10-$25 for completing a short survey (15 minutes or less)
• $25-$50 for longer questionnaires or interviews (15-60 minutes)
• $50-$100 for providing biological samples like saliva or urine
• $100-$250 for blood draws or more involved procedures

Payment details will be clearly communicated before each activity.

You can decline any activity without losing eligibility for other research opportunities.

Tax Considerations:

• Payments of $600 or more in a calendar year must be reported to the Internal Revenue Service (IRS)
• You will receive a 1099 form for tax purposes if your annual compensation exceeds $600

Commercial Rights:

• You will not receive profits from any commercial products, treatments, or tests developed
• Your biological samples and data may contribute to discoveries with commercial value
• By participating, you waive rights to patents, royalties, or financial benefits from research outcomes

 

ARE THERE BENEFITS TO MY PARTICIPATION?

While direct benefits to you may be limited, potential benefits include:

• The research done may accelerate scientific and medical understanding including new ways to treat, manage or diagnose certain conditions. This may at some point benefit you, your family members, and other people.
• You may feel good about taking part in advancing research and being part of a research community.
• You may receive other benefits we don’t know about.

 

ARE THERE RISKS TO MY PARTICIPATION?

Privacy and Confidentiality Risks:

• Identification Risk: Despite our strong protections, there is a small risk that your personal information could be accidentally released. While we remove identifying information before sharing with researchers, no system is completely foolproof.
• Access to Your Identity: Certain individuals must know your identity to conduct the study properly, including Joined Bio personnel and regulatory authorities such as the US Food and Drug Administration (FDA) who ensure research safety. Though these individuals are trained in confidentiality, there remains a small risk of accidental disclosure.
• Genetic Information Risk: If you provide biological samples, researchers may perform genetic analysis including partial or whole genome sequencing (WGS). This process determines your unique DNA sequence. While we have procedures to prevent linking genetic results to your identity, there is a small possibility that your identifying genetic information could be disclosed. Genetic information is unique to you and could potentially be used to identify you or reveal information about your health predispositions.

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.

This law generally will protect you in the following ways:

• Health insurance companies and group health plans may not request your genetic information that the sponsor will get from this research.
• Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
• Employers with 15 or more employees may not use your genetic information that the sponsor will get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

All health insurance companies and group health plans and all employers with 15 or more people must follow this law.

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.

• Data Security: Though we use bank-level encryption and security protocols, there remains a small risk of unauthorized access to research data systems.

 

Physical Risks:

• Blood Collection Risks: If you provide blood samples, you may experience pain, bruising, redness, or swelling at the needle site. Rarely, some people may experience dizziness, fainting, or infection.
• Other Sample Collection Discomfort: Procedures like nasal swabs may cause temporary discomfort, sneezing, or watery eyes. Cheek swabs might cause minor irritation.
• Monitoring Device Risks: Wearable devices may cause skin irritation or discomfort for some participants.

 

Psychological and Other Risks:

• Survey/Interview Discomfort: Some questions about your health, behaviors, or experiences may cause emotional discomfort or distress.
• Discovering Sensitive Information: Through participation, you might learn unexpected information about your health that could cause anxiety or concern.
• Lifestyle Modification Effects: If you participate in activities involving lifestyle changes, these may cause physical discomfort, disruption to your routine, or psychological stress.
• Time Burden: Participation requires time commitment that may be inconvenient or burdensome.
• Unknown Risks: As with any research, there may be additional risks that are currently unknown or unforeseeable.

Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.

 

ARE THERE ALTERNATIVES TO MY PARTICIPATION?

This research study is for research purposes only. The only alternative is to not participate in this study.

 

HOW DO YOU MAINTAIN MY CONFIDENTIALITY?

Records of your participation in this study will be held confidential except when sharing the information is required by law or as described in this informed consent. The Investigator, the sponsor or persons working on behalf of the sponsor, and under certain circumstances, the FDA and the Institutional Review Board (IRB) will be able to inspect and copy confidential study-related records which identify you by name. This means that absolute confidentiality cannot be guaranteed. If the results of this study are published or presented at meetings, you will not be identified.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

 

HOW DO YOU PROTECT MY PRIVACY?

Protecting your privacy is our highest priority. We implement multiple layers of protection:

Data De-identification Process:

• All direct identifiers (name, address, phone number, email, medical record numbers) are removed before storage.
• You are assigned a unique research identification code that cannot be traced back to you without a special secure key.
• Your identifying information is stored separately from your health data and biological sample information.
• We use sophisticated coding systems to replace personal details with non-identifying codes.

Technical Security Measures:

• All data transfers use 256-bit encryption (the same level used by financial institutions).
• Data storage systems employ multiple security layers including firewalls and intrusion detection.
• Regular security audits and testing are conducted to identify and address vulnerabilities.
• All systems meet or exceed Health Insurance Portability and Accountability Act (HIPAA) security requirements for protected health information.
• We maintain detailed access logs to monitor who accesses data and when.

Access Controls:

• Only authorized research personnel with specific training can access your information.
• Access is granted on a "need-to-know" basis and with minimum necessary privileges.
• All staff undergo privacy and security training annually.
• Background checks are conducted for all personnel with data access.
• We maintain confidentiality agreements with all research partners.

Data Sharing Protections:

• Research partners receive only de-identified information relevant to their specific project.
• Legal agreements require partners to maintain strict confidentiality and security.
• Partners are prohibited from attempting to re-identify any research participants.
• Any data shared with partners is tracked through secure transfer mechanisms.
• We conduct audits to ensure partners comply with all privacy requirements.

Biological Sample Protections:

• Samples are labeled with your unique code only, never with identifying information.
• Sample storage facilities have restricted access and security monitoring.
• Transfer of samples follows chain-of-custody documentation procedures.

 

HOW LONG DO YOU STORE MY DATA?

Any data that has been shared with a research partner as part of a project will be kept for a minimum of six years.  You can request that any other data that has not been shared as part of a project be deleted at any time. 

 

HOW LONG DOES MY PARTICIPATION IN THIS STUDY LAST?

Your consent is valid for one year from the date you sign this consent form. You may be asked to renew your consent annually for ongoing research.

The Investigator or the sponsor can stop your participation at any time without your consent for the following reasons:

• If it appears to be medically harmful to you;
• If you fail to follow directions for participating in the study;
• If it is discovered that you do not meet the study requirements;
• If the study is canceled; or
• For administrative reasons.
   

WHOM TO CONTACT ABOUT THIS STUDY

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:

• Whom to contact in the case of a research-related injury or illness;
• Payment or compensation for being in the study, if any;
• Your responsibilities as a research participant;
• Eligibility to participate in the study;
• The Investigator’s or study site’s decision to withdraw you from participation;
• Results of tests and/or procedures;
   

Please contact the Investigator at the telephone number listed on the first page of this consent document.

If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.

An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:

By mail:

Please reference the following number when contacting the Study Subject Adviser: Pro00085949.

 

COPY OF CONSENT

You will receive a signed, electronic copy of this consent form for your records.

 

PARTICIPANT CONSENT

By signing below, I confirm that:

• I have read and understood the study information
• I have had the opportunity to ask questions
• I voluntarily agree to participate in this study
• I understand my rights as a research participant
• I may be contacted for future research projects
• I will not lose any of my legal rights or release anyone involved in the research from responsibility for mistakes