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.
INFORMED CONSENT DOCUMENT — AGREEMENT TO BE IN A RESEARCH STUDY
| Field | Information |
|---|---|
| Study Title | The effects on sleep quality of 1:4 dual-extract Reishi tincture |
| Study Author | Emma Roberts, Matthew Amsden |
| Principal Investigator | Matthew Amsden |
| Sub-Investigator for Adverse Events | Dr. Viral Patel |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | £28 GBP |
| Included Products & Services | - Organic Reishi Tincture (50 ml) 60 day supply |
| Outcome Measures | PROMIS Sleep Disturbance Scale Neuro-QOL Fatigue Short Form Perceived Stress Scale (Past Week Version) |
| Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
INTRODUCTION & SUMMARY
You are being asked to join a research study about the effects of a specific type of Reishi mushroom tincture on sleep quality and stress. Your participation is entirely voluntary.
If you choose to join, you will take 1 ml of Bristol Fungarium’s 1:4 dual-extract Reishi tincture each evening for 50 days, 30 minutes before bedtime. You will complete surveys before and after the study to measure changes in your sleep, fatigue, and stress.
PURPOSE OF THE STUDY
The purpose of this study is to learn whether daily use of a 1:4 dual-extract Reishi tincture improves sleep quality (including duration, time to fall asleep, number of night wakings, and restfulness) and reduces perceived stress. This will help us understand whether Reishi can be a useful natural option for sleep and stress management.
WHAT YOU WILL DO AS PART OF THIS STUDY
If you agree to take part, you will:
- Take 1 ml of the Reishi tincture every evening, 30 minutes before bed, either directly under your tongue or in a small glass of water.
- Complete the baseline surveys before starting.
- Complete the follow-up surveys at the end of the 50 days.
- Let Efforia know about any side effects or problems.
- You may leave the study at any time by contacting help@efforia.com.
RISKS, DISCOMFORTS & BENEFITS
Possible Side Effects
Not all risks are known for all personal circumstances. Potential participants should do their own research.
Participants should not operate heavy machinery within several hours of usage.
| Risk | Likelihood | Summary |
|---|---|---|
| Allergic Reaction (rash, swelling, difficulty breathing) | Low | May occur in people allergic to mushrooms. Seek emergency care if severe. |
| Gastrointestinal upset | Low | Possible nausea, diarrhea, or stomach discomfort. |
| Drowsiness or dizziness | Low | May affect ability to drive or operate machinery. |
| Increased bleeding risk | Low | May affect people taking blood thinners or with blood disorders. |
Who Should Avoid This Study
Some people may be at increased risk. Efforia strongly discourages these individuals from joining the study. Please consult your local medical professional before proceeding.
| Category | Why |
|---|---|
| Pregnant, planning pregnancy, or breastfeeding | Safety not established |
| Allergic to mushrooms | Risk of allergic reaction |
| On blood thinners or with blood clotting disorders | Increased bleeding risk |
| With liver conditions | Rare reports of liver toxicity |
Possible Benefits
You may experience improved sleep quality, less stress, and better daytime energy. The study may also help others by contributing to research on natural sleep and stress remedies. Benefits are not guaranteed.
PRIVACY & CONFIDENTIALITY
Your personal information and responses will be kept confidential, stored securely, and used only for research purposes. Results may be shared publicly in a way that does not identify you.
STUDY-RELATED INJURY CARE & COMPENSATION
Efforia will not offer financial compensation or free medical care if you are injured from participating. You are responsible for any medical costs.
IN CASE OF MEDICAL EMERGENCY
Seek immediate medical care by calling emergency services (for example, 999 in the UK). Inform Efforia afterward by emailing help@efforia.com.
ALTERNATIVES TO PARTICIPATION
You may choose not to participate. You can purchase and use Reishi tincture outside of this study without completing the study activities.
YOUR RIGHTS AS A PARTICIPANT
- Right to Privacy: Your data will be kept secure and confidential.
- Right to Your Results: You will have access to your individual study results.
- Right to Withdraw: You may leave the study at any time without penalty.
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.
New Information and study results
If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
CONFLICT OF INTEREST
The study authors may have a commercial interest in Efforia and/or the products being tested.
We affirm that the study is conducted for research purposes and to contribute to public knowledge.
DATA PROTECTIONS
What You Can Do to Improve Privacy
Use a secure device and internet connection to complete surveys.
Who Will Have Access to Your Data
Only the research team and authorized Efforia staff.
What Will We Do With Your Data
Your de-identified data may be used in future research and shared with the public.
Confidentiality & Privacy
The researchers will only use and share information that is needed for the study.
Researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because people outside the study team may need to look at your study records.
Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies. The purpose of using and sharing your information is to make sure the study is done properly. Signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.
CALIFORNIA EXPERIENTIAL RESEARCH SUBJECT’S BILL OF RIGHTS
You have the right to:
- Be informed of the nature and purpose of the study.
- Receive an explanation of procedures and any potential risks or benefits.
- Ask questions and receive answers at any time.
- Leave the study at any time without penalty.
QUESTIONS OR CONCERNS
- For questions about the study, contact: help@efforia.com
- For questions about your rights as a participant, contact: ethics@efforia.com
CLOSING
This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.
If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
Efforia and Efforia IRB have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Efforia IRB 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.