Clinical trial: NCT04493892
Section: Confidentiality
Subsections: Confidentiality

Any information obtained during this study will remain strictly confidential. Complete confidentiality cannot be promised. Despite all of our efforts, unanticipated problems, such as a stolen computer may occur, although highly unlikely: Please note the following process will be adhered to for ANY and ALL aspects of the study in which your research data is labeled with your unique code number. For this study your code numbers will include your study ID and your specimen ID:
Overall: The research file that links your name or any information that can identify you to the code number will be kept in a locked file cabinet, an encrypted data file, and/or CUIMC IRB approved and encrypted hard or shared drives. Questionnaires and biospecimens will be stored using your unique code number and not be directly linked to your name or any information that can identify you to the code number. Questionnaires, biospecimens, and recorded sessions will be kept in a locked file cabinet, an encrypted data file, and/or CUIMC IRB approved and encrypted shared drives. Only the principal investigator and study staff who have CUIMC IRB approval for this study will have access to these files. Your name or any of your information that can identify you will not be used in any reporting of the study results.  
Questionnaires:The information you provide in the questionnaires will be assignedwith your unique code number and not include your name or any information that can identify you.  
Recorded Sessions (Transcription): In order to protect your privacy, the transcription company will only receive a recording of the session that includes the image of your face (if you choose to keep the camera on) and the name you provide when you register for the session (your zoom user name). This is so they can create a "script" of the conversations that takes place during the recorded group sessions and keep track of who saidwhat. The transcription company will receive the recording through a secure file transfer system. Our contract with the transcription company will require that recordings be destroyed as soon as the script of the session is submitted to and approved by the CUIMC research team. Study collaborators will only have access to the 'script' and not the recordings. The image of your face and user name will be attached to your study ID. The files linking your image and user name to your study ID will be kept in an encrypted data file and/or a CUIMC IRB approved and encrypted hard or shared drive. Only CUIMC IRB approved research staff will have access to the files. Your image, name, or any of your information that can identify you will not be used in any reporting of the study results.  
Biospecimen: The urine collection receptacles will have labels with a prepopulated code number (your specimen ID). Dr. Kurt Pennell, study collaborator and director of the 231 Engineering Research Center at Brown University and his team will analyze the biospecimens. Before sending your specimen to our collaborators, we will deidentify the specimen, meaning we will remove your name and any other personally identifiable information from the biospecimen before our collaborators at Brown receive them. Any unused samples will be destroyed by Brown University or mailed back to us at CUIMC. Your biospecimens will not be used for whole genome sequencing in this study.  
The following people and/or agencies will be able to look at, copy, use and share your research information as part of these organizations' responsibility to ensure the protection of human subjects in research:
- The principal investigator, Columbia University Medical Center and New York-Presbyterian Hospital study staff and other medical professionals who may be evaluating the study.  
IRB-AAAS9968 (Y02M03)  
  

3 - JUNE 2020
- Authorities from Columbia University and New York-Presbyterian Hospital, including the Institutional Review Board ('IRB'). An IRBis a committee organized to protect the rights and welfare of people involved in research.  
- The Federal Office of Human Research Protections ('OHRP')
We will be using the Columbia University registered Visa Debit Card incentive system that is approved by the Columbia University Irving Medical Center IRB. Only for payment purposes will those facilitating this secure system have access to your personal information.
Clinical trial: NCT04493892
Section: Duration of Study Involvement
Subsections: Duration Of Participation

Participation duration: Group sessions will be between 1.5-2.5 hours and follow-up sessions will be 30 minutes each. These will take place over approximately 10 months. Alternative Procedures You have the choice not to participate in any part of thisresearch study and can withdraw at any time without repercussions. Study Procedure **Summary**
We will mail, email, and/or text you study materials in advance of your first group session.  
If you volunteer to participate in this study, we will ask you to participate in 1-2 recorded group sessions on Zoom.  
During the group session(s),wewill provide you with an educational presentation and informational materials on chemical ingredients in personal hair care products and how you can reduce exposure to these chemicals.  
We will also ask you to complete two follow-up sessions over the phone at the end of your third trimester and about 1month postpartum. During these follow-up sessions and throughout the study, we will ask you to complete questionnaires, which will ask you basic questions about yourself, as well as your knowledge, attitudes, and opinions on the products you use. You can choose not to answer or to skip any of the questions.  
We may ask you for a urine sample at session 1 and at each follow-up session. We will ask you to mail your urine sample in the provided pre-paid mailing kit back to us or we will collect the sample at the in-person group session (whichever is feasible).  
Each phase of the study is voluntary, and you can withdraw at any time by contacting the Principal Investigator, Dr.Jasmine McDonald. See the Contact Information section for contact details.  
IRB-AAAS9968 (Y02M03)  

3 - JUNE 2020
Clinical trial: NCT04493892
Section: Participant's Rights
Subsections: Statement Of Consent

I understand that my participation is voluntary and that I can withdraw from the study at any time without repercussion. I have reviewed the above information and agree to enter this research study. Signing/E-Consenting thisform does not waive any of my legal rights.  
The research study has been explained to me. I agree to participate in the research study as described above. I confirm I
have been informed that if I have any questions or concerns about the study or believe I have sustained injury as a result of participating, I can contact Dr. Jasmine McDonald, the Principal Investigator of the study. I confirm that Dr. McDonald's contact information has been provided so that I can review the matter and identify the medical resources which may be available to me, should the need arise.  
By consenting, you grant permission for your information to be made available to: Columbia University, Columbia University's Institutional Review Board (IRB), and the Office of Human Research Protections (OHRP); as part of these organizations responsibility to ensure the protection of human subjects in research.  
Your signature on this form grants the investigator named above permission to record you as described above during participation in the above-referenced study.The investigator will not use the recording(s) for any other reason than that/those stated in the consent form without your written permission. I will receive an electronic or hard copy of this consent form for my records after completion.
Clinical trial: NCT04493892
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Study Risks And **Discomforts**

There is a chance you may feel uncomfortable answering some of the questions on the questionnaires. You have the right to refuse to respond to any questions you do not wish to answer. The information you provide on the questionnaire will be kept entirely confidential. However, any time personal information is released, there is a possibility of your confidentiality being compromised. We have developed strict guidelines to safeguard the confidentiality of any information obtained during this study from you. The Confidentiality Section provides details on who will have access to your information and how we will protect your information.
Clinical trial: NCT04493892
Section: Procedures
Subsections: Study **Procedures**

If you volunteer to participate in this study, we will ask you to attend 1-2 group recorded sessions taking place on a video conferencing tool called Zoom. You will learn about the different chemicalsin hair care products during the group sessions.  
We will also ask you to participate in at least two follow-up phone appointments. Each time, you will be asked to complete questionnaires and possibly provide a urine sample.
Clinical trial: NCT04493892
Section: Voluntary Participation
Subsections: Please Choose To Provide Consent Or Choose Not To Provide Your Consentto The **Following Options:**|Voluntary Participation

I agree to the storage of my data and samples at CUIMC in identifiable form after completion of this study. I understand that my data and samples will only be given to researchers in deidentified form or coded. I agree to the use of my data and samples for future research and/or testing that may or may not be related to this study. I understand that my data and samples will only be given to researchers in deidentified form or coded.

Participation in this research study is voluntary. You may refuse to participate or withdraw from the study at any time without being penalized. Signing this form does not waive any of your legal rights. You may choose to prevent further use of your data in future studies by requesting this in writing. Please see Contact Information of the Principal Investigator below.