What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
Summary Information to Help you Decide Whether to Join this Study
Study Title | Evaluating CJC-1295’s Impact on Heart Rate |
---|---|
Study Author | Matthew Amsden, Ivan Fedkiv |
Sponsor | This study is made possible by your payment to join. |
Cost of Products, Services & Information to Participant | $0 |
Included Products & Services | Apple Watch, Oura Ring |
Outcome Measures | Oura Sleep |
Contact | help@efforia.com |
Introduction & Summary
Welcome! We invite you to join this research study on the "Efforia" platform. This study is made possible by your support through participation. The purpose of this document is to help you understand the study, its goals, and whether it aligns with your interests. Your participation is entirely voluntary, and you may leave the study at any time without penalty. Please seek answers to any questions you have before proceeding.
Purpose of the Study
This study aims to evaluate the impact of CJC-1295 supplementation on resting heart rate and heart rate variability. By using state-of-the-art tools like the Apple Watch and Oura Ring, we hope to gain insights that could benefit our understanding of cardiovascular health. CJC-1295 is a peptide that may influence growth hormone release, potentially affecting heart health. This study contributes to scientific knowledge and may offer societal benefits by advancing our understanding of CJC-1295's effects.
What You Will Do as Part of this Study
While participating in this research study, you will need to:
- Be willing and able to follow the study directions and procedures
- Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
- Ask questions as you think of them, via help@efforia.com or online chat.
- Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.
Participant Responsibilities and Tasks
As a participant in the study "Evaluating CJC-1295's Impact on Heart Rate," you will be responsible for several key activities aimed at assessing the effects of CJC-1295 supplementation on resting heart rate and heart rate variability over a six-month period. Your commitment to adhering to the schedule is crucial for the integrity and success of the study.
Overall Schedule and Timeline
The study spans six months, during which you will engage in regular data collection and monitoring activities. It is essential to link your Google Calendar and Todoist for an organized approach and to ensure timely completion of tasks. Communication will be facilitated through prioritized emails from Efforia.
Treatment Activities
- Capture Resting Heart Rate: Utilize the Apple Watch and Oura Ring to measure and record your resting heart rate regularly.
- Assess Heart Rate Variability (HRV): Monitor and document HRV using the provided tools.
- Evaluate Sleep Quality: Capture data on sleep patterns to assess overall sleep quality.
- Determine Recovery Index: Evaluate your recovery status as part of the holistic health assessment.
- CJC-1295 Administration: Ensure proper administration of the CJC-1295 supplement as per the protocol.
Frequency and Measurement
These activities will be conducted at regular intervals, and consistent data collection is vital. The frequency of these measurements will be detailed in your personalized protocol schedule. Adhering to the timeline and maintaining consistency in data input are critical to obtaining accurate and reliable study outcomes.
Your participation is instrumental in advancing our understanding of CJC-1295's impact, and we thank you for your dedication and precision in following the study requirements.
The Risks, Discomforts & Benefits of Being in this Study
There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.
Consider your Own Risk-Benefit Comfort Level
It is important to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.
Personal and Overall Findings
Efforia will provide you with both personal outcomes and overall findings. These findings will be made available at various data collection points during your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved. Remember, participation is voluntary, and you may exit at any time by emailing help@efforia.com.
Possible Benefits of Participation
Your participation may contribute to a better understanding of CJC-1295's effects on heart health. Additionally, you may gain personal health insights based on your data. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.
Possible Serious Adverse Events & Side Effects
In the Case of an Adverse Event
If you experience any adverse events or reactions while participating in the study involving the use of CJC-1295, Apple Watch, or Oura Ring, please seek immediate medical attention by calling 911 or visiting the nearest emergency room. After addressing any urgent health concerns, please contact Efforia to report the incident. This step is crucial for the safety and integrity of the study, and to ensure that all potential risks are documented and analyzed.
Introduction and Summary of Common Known Risks
The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.
When using CJC-1295, a growth hormone releasing hormone (GHRH) analog, there are several risks and side effects that have been documented. These include but are not limited to fluid retention, irritation at the injection site, and increased risk of diabetes and cancer. The use of wearable technology like the Apple Watch and Oura Ring generally presents fewer risks, primarily related to skin irritation or allergic reactions to the materials used in the devices.
Maximum dosages for CJC-1295 have been explored in clinical settings, with doses ranging up to several hundred micrograms per administration without severe adverse effects, although individual tolerance can vary significantly.
Serious Adverse Events (SAEs)
Theoretical side effects | Relative incidence | Recovery |
---|---|---|
Incidence of Cancer (CJC-1295) | Low to Moderate | Potentially Permanent |
Exacerbation of Chronic Disease | Low | Variable |
Death | Very Low | N/A |
Life-threatening Experience | Very Low | N/A |
Hospitalization | Low | Variable |
Disability or Permanent Damage | Low | Potentially Permanent |
Congenital Anomaly/Birth Defect | Very Low | Potentially Permanent |
Required Intervention | Low | Variable |
Frustration and irritation | Low | Subsides with use |
Efforia's Limitations in Providing Direct Medical Support
Efforia does not provide direct medical support or emergency services. Participants are encouraged to establish a plan for accessing medical care in their local area in the event of an adverse reaction or emergency.
Long-Term Dependence Issues
No long-term dependence has been observed with the use of CJC-1295 in the current literature. However, dependency behaviors are not well studied for this compound, and participants should monitor for any psychological or physical dependency signs.
Legality and Compliance
The use of CJC-1295 may be subject to scrutiny under the World Anti-Doping Association (WADA) and the National Collegiate Athletic Association (NCAA) as it can affect performance metrics. It is also important to consider the legality of these substances in your local jurisdiction and any corporate workplace policies that might affect your participation in this study.
Privacy & Security Risks
We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. You should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/
There may be very certain limits to the rights of your privacy: we may reach out to local help if we have reason to believe you may be a harm to yourself and/or others. Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.
What to do if you have a study related injury
If you experience a study-related injury, you should seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, have any side effects, or have a study-related injury after you've received any necessary treatment. We want to ensure others are aware of potential risks.
Study related injury care and compensation
Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.
In the case of medical emergency
In the cace of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.
Alternatives to Participating in the Study
Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.
Your Rights as a Participant
Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.
Privacy and Confidentiality
You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.
Right to Your Own Results
Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.
The Right to Leave a Study without Penalty at Any time
If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.
Conflict of Interest Statement
As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.
Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.
How we Reduce Conflicts of Interest
It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.
Consequences of Conflict of Interest Non-Compliance
Should a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this platform and payments may not be refunded.
By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.
Data Protections
Efforia is committed to protecting your data. We collect, use, and protect your data in compliance with data protection laws.
What you can do to improve your privacy and security
As part of participating in this study, you will receive notifications via email, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your email accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy.
Who will have access to your data?
Efforia will have access to your data. There may be partners who also have access to your data (like labs and connected health devices).
What will we do with your data?
We will use your data to show you your personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.
California Experiential Research Subject’s Bill of Rights
You can learn more about your rights by reviewing the Efforia privacy policy: https://efforia.com/privacy-policy/
Who to Contact for Questions or Concerns
If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:
HELP@EFFORIA.COM
(646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.
If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.
Univo IRB
4509 Creedmoor Road Suite 403
Raleigh, NC 27612
info@univo-group.com
(919) 910-7743
Additional questions and closing
Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Univo have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.
If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.