Effective Date: July 10th, 2022
Thank you for considering participation in scientific research to help advance the study of the relationship between the presence of certain human gene SNPs and the experience of long term side effects from Isotretonoin. This Informed Consent relates to research that will be performed by Health Insights LLC using the data gathered in this study. By choosing to participate in the study, you acknowledge that you understand and agree to this document.
Full Informed Consent
1. What is the MTHFR Accutane Research Study?
The MTHFR Accutane Research Study is a research study designed to look for a statistically significant incidence of known MTHFR gene mutations in the population of individuals who self report that they are suffering long term side effects after haven taken Isotretinoin. Long term side effects include, but are not limited to:
- Suicidal Thoughts
- Obsessive Thoughts
- Addiction/Compulsive Behavior
- General Health Decline
- Low Libido/Sexual Dysfunction
- Poor Digestion
- Ongoing sensation or experience of not being able to get enough energy from food
- Poor mental health
- Poor emotional health
- Vitamin D Insufficiency
The study looks at other gene mutations besides the MTHFR gene. The full list of genes is found in the FAQ section on the research study page.
2. What am I agreeing to if I consent?
By giving consent to participate in the study, you agree to submit a saliva sample to Ancestry.com which involves agreeing to their terms and conditions. You also agree to then download the raw DNA data produced from your DNA test, as a .txt. file, and upload it to SeekingHealth.com for the purpose of generating the Strategene DNA report. Furthermore, you agree to answer an extensive, anonymous health questionnaire. You agree to submit the anonymous health questionnaire to Health Insights LLC for research purposes as well as the “Advanced Tables” section of your DNA test results (anonymously) from the Strategene report.
3. Who conducts the research?
John Nicoll, owner of Health Insights LLC will be the primary person conducting the research. He may call upon data analysts as well as doctors or other health care providers to review the anonymous health data as part of the research project. By participating in the study you agree to allow your anonymous health data to be viewed by these individuals only.
4. What Data is used?
5. How is my Data used and shared if I give consent?
If you decide to participate, Health Insights will use your anonymous health data to look for genetic patterns relating to long term side effects after taking Isotretinoin. Your anonymous health data will not be shared except with data analysts or doctors participating in the study of the collected research data.
6. How is my Data protected?
To ensure anonymity, each participant is assigned a 5 digit participant ID number. This number is used in lieu of a name on the submitted questionnaire. All collected data will be encrypted and stored on an offline data storage device (not connected to the internet). Data submitted to this study is received at a HIPAA compliant email address and is not stored online once received.
7. If I consent, will Health Insights LLC contact me?
Health Insights LLC may contact you from time to time, at the email address you provide, to request additional information for the research study, or to see if you would like to participate in a follow up study. You are not required to respond to any requests from us about the research study – the choice is yours. If you do not respond or do not want to provide additional information for the study, Health Insights LLC may continue to use your data as permitted by this Informed Consent but for no additional purpose.
8. Are there any risks to me?
There are no physical risks involved with in participating in the research study. Providing a DNA sample to Ancestry.com and downloading the resulting raw DNA file and then uploading that file to SeekingHealth.com does involve some privacy risks. You should carefully review these risks on each of their websites before choosing to participate in this study. This can be done by reviewing their privacy policies and terms of conditions.
9. Are there any costs if I consent? Do I receive compensation or other benefits if I consent?
Yes there are costs. Please see the “Study Cost” section on this page. You will not be compensated for participating in this research study.
10. Do I have to consent to the research study?
No, your participation is voluntary. No one is required to participate in the study.
Health Insights may terminate the research study at any time without notice to you. In that event, your data will continue to be protected as described in this Informed Consent.
11. What is my alternative to participating?
Your alternative is not to participate in the research study.
12. Can I withdraw from the research study?
Your answers in the research study questionnaire data will be inserted into a research database for this study. The data is anonymous. Once your answers have been included in the research database, there is no way to withdraw.
This Informed Consent does not have an expiration date. If you do not withdraw consent, it will remain in effect until you withdraw or the research study is ended.
13. Hold Harmless
As a study participant you agree to hold harmless Health Insights LLC its officers, agents, employees, and servants from all claims, suits, or actions of every name, kind, and description, brought for, or on account of: (A) any sanctions, penalties, or claims of damages resulting from Health Insights LLC’s failure to comply with the requirements set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and all Federal regulations promulgated thereunder, as amended, or (B) any other loss or cost, including but not limited to that caused by a data breach as a result of hacking.
14. Who can I contact about the research study?
Health Insights LLC
3080 29th Street, Unit 14
Boulder, CO 80301