INFORMED CONSENT FORM
Mold Illness Questionnaire Validation
Study #MIQ-1
Sponsor Name: MoldIQ Research Initiative
Sponsor Address: 2811 Milton Ave #162, Janesville, WI 53545
Site Name: MoldIQ.org
Principal Investigator: Neil Nathan, MD and Jill Crista, ND
Introduction
You are being asked to voluntarily participate in a study being undertaken by the MoldIQ Research Initiative, and conducted by Neil Nathan, MD and Jill Crista, ND. The United States Food and Drug Administration (FDA) regulations require the investigator to obtain your signed agreement (consent) to participate in this project. In order for you to decide whether or not to participate in this study, you should understand the study procedures, risks and benefits so that you can make an informed judgment. The purpose of this informed consent form is to provide you with this essential information. In addition, you have the right to have your questions answered by study personnel. You will be given a copy of this form to download.
This consent form may contain words that you do not understand. Please ask the study contact to explain any words or information that you do not clearly understand. You may download an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.
Purpose of the Study
The purpose of this research is to gather meaningful clinical symptom data regarding mold-related illness. The aim of the study is to assess whether the mold illness questionnaire (MoldIQ) is a valid measurement tool as compared to currently employed mold and mycotoxin laboratory testing.
Our goal is to provide a validated clinical measurement tool to better identify mold-related illness. This research also has the potential to inform the design of future studies looking into the effects of indoor mold exposure on humans, with a future focus on developing accepted treatments.
Our hypothesis is that exposure to damp and/or water-damaged buildings negatively impacts human health beyond the current limited understanding of mold allergy, including but not limited to, the harmful health effects from mycotoxins and microbial metabolites.
Study Procedures
This project involves the collection of physician-reported patient data pertaining to symptoms, laboratory results, and optional environmental testing results using an online interface. We anticipate requiring 1500 completed participant submissions in order for the data analysis to be statistically significant.
The participant will answer questions about physical health symptoms and their living space. They will also be asked to submit digital copies of mold and/or mycotoxin medical laboratory results, as well as copies of environmental tests.
Symptoms are reported using a weighted questionnaire that was developed based on an existing validated questionnaire model for a similar complex chronic illness, and has been vetted by experts in the field of mold-related illness to most accurately represent those seen in patients with exposure to damp and/or water-damaged buildings.
Volunteer participants have the ability to record symptoms on the day they collect their laboratory sample, and then return to the platform at a later date to submit the results of those samples when the results are made available to the volunteer participant, with the idea being that the laboratory findings reflect the reported symptoms recorded on that day.
We have no facility requirements. Access to a computer with internet access is the only equipment needed. Dr. Crista will monitor for mail-in submissions and upload them to the data set as needed. This study is open access to practitioners and the public.
We've developed an intuitive web-based interface that allows for self-guided submission. We have the ability to modify the interface should we encounter repeated user interface issues based on participant feedback. Therefore, we don't anticipate that training of participants is required. We plan to run through the submission process with our volunteer physicians for their comfort and understanding and so that the most useful, accurate data is collected.
Inclusion Criteria
Participants must be 18 years or older.
Participant has one or more of the following laboratory tests which were meant to assess for possible mold-related illness:
- Visual contrast sensitivity (VCS) test results from SurvivingMold.com or VCSTest.com
- Mold allergy tests from any lab, such as Quest, Labcorp, Cyrex (IgE, IgG)
- Realtime Lab urine mycotoxin test
- Mosaic/Great Plains urine mycotoxin test
- Vibrant Wellness urine mycotoxin test
- MyMycoLab serum mycotoxin antibody test
Exclusion Criteria
Participants who are less than 18 years.
The participant has no laboratory tests to compare to symptoms.
Risks and Discomforts
Participants are encouraged to redact personal identifying information from any and all digital submissions. Due to the risk of receiving non-redacted information, all volunteers with access to back-end information/submissions will sign a confidentiality agreement in the case that personal identifying information is inadvertently shared by the study participant.
Submitted data will be stored on a private, secured database with 2-factor authentication login access, and backed up in a secured system.
Benefits
With the medical community not understanding or accepting the scope of the problem with damp and/or water-damaged building exposure, patients are being misdiagnosed or altogether dismissed, leading to continued worsening of their health status, including, in some cases, the development of dementia and cancer.
We aim to publish the findings and present the data at medical conferences. This will, in effect, raise awareness and if the data supports our clinical experience, overall acceptance of the detriments of exposure to damp and/or water-damaged buildings. If it is found that the questionnaire is validated to current accepted diagnostic tests, the questionnaire may then become a diagnostic tool to diagnose mold-related illness, similar to the Inflammatory Bowel Disease Questionnaire (IBDQ).
Cost to Subjects
The costs to the subject include any voluntary and/or recommended laboratory tests and/or environmental inspections and sampling. These costs are elected and managed by the participant, and are between the participant and the laboratory or inspection company. Neither the study’s principle investigators, sponsors, organizers, or reviewers are responsible or involved with these costs.
Compensation
There is no compensation for the subject.
Alternative Treatments
No treatments are offered in the study.
Confidentiality
You have a right to privacy, and any information obtained in this study that can be identified with your name will remain confidential as far as possible within state and federal law. The United States Food and Drug Administration (FDA), the Argus Independent Review Board or the sponsor may inspect and copy your medical records relating to this study, and the results of the study may be reported to the FDA and other health authorities.
Information
If you have any questions about this research project, you may send an email to support@drcrista.com. If you have any questions about your rights as a research subject, you may call the ARGUS Independent Review Board Chairman at (520) 298-7494. ARGUS IRB is an ethics committee that is established to help protect the rights and welfare of study subjects.
Voluntary Participation
Your decision whether or not to participate in this study is strictly voluntary. Refusal to participate will not involve penalty or loss, or affect your future relationship with site or your doctor. You are free to discontinue participation at any time. You may be discontinued from the study without your consent for safety reasons, or if you fail to comply with the conditions of the study. Site reserves the right to discontinue the study prior to inclusion of the intended number of patients, but intends only to exercise this right for valid scientific or administrative reasons. Any significant new findings developed during the course of this study that may relate to your willingness to continue to participate will be provided to you.
Authorization
I have read and understood the information provided. I have been given the opportunity to discuss this information with the MoldIQ Research Initiative, and have had my questions answered in language I understood. I meet all the study criteria. The risks and benefits have been explained to me. I understand that I will be given a copy of this consent form after signing it. I freely agree to participate in this study.
I understand that my participation is voluntary and that I may withdraw from the study at any time after signing this form without penalty. I also understand that I may be withdrawn from the study for non-compliance, or if it is determined that it is in my best interests to do so. I agree to abide by all subject instructions, reminders, and precautions given to me before and during the study.