Informed Consent:
Title of Research Study: Exertional myalgia, fatigue, and exercise tolerance in persons with an RYR1 mutation: a case-controlled questionnaire study.
Informed Consent Form:
Research Procedures
This is a research study that is conducted by a questionnaire asking about muscle pain, fatigue, and ability to exercise in persons with a variant form of the RYR1 gene. The purpose of the research is to look at exertional muscle pain (myalgia), fatigue, and exercise tolerance in persons with a known or likely RYR1 genetic variant compared to persons without a known RYR1 variant. This study receives no funding from any party.
1. Participants: Persons with a known variant type of RYR1 gene, and/or a condition called malignant hyperthemia, or have had tea or cola colored urine mostly after heavy exercise. We are also looking for people with none of these to serve as normal controls for the purpose of comparison. All ages and genders are invited to participate. Minors will need the permission of at least one parent or guardian and will also have to agree (assent) to participate in the study.
2. This study is a survey study that involves a questionnaire that is expected to take about 15 minutes or less to complete. The questionnaire can be filled out on-line or downloaded and completed as a paper copy.
3. Persons who participate in the study do so voluntarily and are under no pressure to participate. There are no costs to you or any other party. Persons who agree to participate may withdraw consent at any time without penalty or cost. However, once the questionnaire is submitted, it may be impossible to withdraw it because it may be impossible to link the questionnaire to the person who submitted it.
Risks:
4. The study has minimal risk to the participants because it only requires filling out a questionnaire. There is nothing else required of participants in this study.
5. There is always a slight chance that someone might feel upset after participating. Please note that if you do feel upset and would like to speak with someone, you can contact the George Mason Counseling and Psychological Services Center (CAPS) at (703) 993-2380.
Benefits:
6. Persons who participate in this study will not derive any direct benefit from participation. That is, they will not improve in anyway because of participating in this study. There is expected to be a general benefit to the knowledge about persons with RYR1 variants. That is, health care workers may be better able to assess the causes of muscle pain, unusual fatigue, and difficulty exercising because of this study. In appropriate cases, health care workers may be better able to treat people with muscle pain who have a variant RYR1 gene.
Confidentiality:
7. The data in this study will be confidential. The questionnaire is created on a Qualtrics data base platform.Participants names will not be known by anyone but the principal investigator and will not be used for any other purpose, including not for marketing or for recruitment for other studies. All questionnaires and data will be kept in an encrypted file in the cloud, available only to the principal investigator by password. Only the composite data (summary of the data) will be published. No individual data will be made public. All data will be deidentified thereby keeping the participant’s identity private.
8. The de-identified data acquired in this research study may be used for future or other research studies without additional informed consent.
9. The Institutional Review Board (IRB) committee that monitors research on human subjects may inspect study records during internal auditing procedures and are required to keep all information confidential.
10. The results of the study are expected to be published in a medical journal. The results of the study will also be made known through the RYR1 Foundation. All study data will be de-identified, that is, no personal identification will be published or made known.
Alternative to Participation
11. The only alternative to participation in this study is to not participate in the study. This study does not involve treatment so that any treatment of related conditions must be obtained through your own doctors.
Duration of Study
12. This research study is expected to be open for no longer than one year.
Conflict of Interest
13. The principal investigator Dr Robert Gerwin has no conflicts of interest with this study and will receive no financial benefits from this study. He participates in a teaching programs on myofascial pain and receives royalties from an on-line teaching program about myofascial pain through Trigger Points 3D.
Contact
14. This research is being conducted by Dr. Robert Gerwin in the Department of Bioengineering at George Mason University. You can contact the principal investigator Robert Gerwin MD any time at 301 728 7260 or by email: bbgerwin@gmail.com. You may contact the George Mason University Institutional Review Board office at 703-993-4121 or irb@gmu.edu if you have any questions or comments regarding your rights as a participant in the research.
15. This research has been reviewed according to George Mason University procedures governing your participation in this research. It has been determined to be exempt from IRB approval because it is only a questionnaire survey study and has minimal risk to participants.
Consent
I have read this form, and all of any questions that I may have, have been answered by the Dr. Gerwin or the research staff, and I agree to participate in this study.
Please go to the questionnaire (link below). Please check the block for either “I agrere” or the box for “I do not agree”. If you check the box for “I agree” then complete the questionnaire. If you check “I do not agree” you will be taken to the end of the survey. Please submit the survey whether you have completed it or not. All responses are confidential and anonymous. There is also a separate page for the link to the questionnaire.
Link to the RYR1 questionnaire: https://gmucehd.az1.qualtrics.com/jfe/form/SV_9WWSQ8YbZFcEzj0
For a minor or other person unable to give informed consent:
I hereby give permission for a minor or person unable to give informed consent themselves to participate in the research study entitled ‘Exertional myalgia, fatigue, and exercise tolerance in persons with an RYR1 mutation: a case-controlled study’. I acknowledge that I have read and agree to all of the conditions listed above, and that I have discussed this study and the request to complete an online questionnaire with the minor in a manner appropriate to the age and understanding of the minor, and that the minor assents (agrees) to participate. I recognize that some minors may not be able to complete part or all of the questionnaire and that I or another competent adult may complete the form on behalf of the minor. I hereby give my permission for the minor of the name of to participate in this study.
I hereby assent (agree) to participate in the research study entitled ‘Exertional myalgia, fatigue, and exercise tolerance in persons with an RYR1 mutation: a case-controlled study
By clinking on the link and proceeding to the questionnaire I consent to participate in the study.
You may keep this form for your personal records.