Centering (patients with) Fibroids Participant Form 

Page 1

Please complete this form if you are interested in being a participant in Boston Medical Center's Centering(patientswith)Fibroids Research Program. These answers will help our team determine your eligibility for the program. If you have any questions or concerns, please reach out to Program Manager Salma Mohamed at salma.mohamed@bmc.org or call (857) 574-9967.

PLEASE REVIEW THE CONSENT INFORMATION BELOW BEFORE PROCEEDING TO OUR PARTICIPANT ELIGIBILITY SURVEY 


You are being asked to voluntarily answer some questions to see if you might qualify to be enrolled in a research study. We are asking you to be in this study because you are a person with female sex assigned at birth with a history of symptomatic uterine fibroids and receiving medical care at Boston Medical Center. We are doing the research to create and implement a patient education and support program for women with uterine fibroids. We also want to understand the characteristics of women with uterine fibroids at BMC and explore your experience with this new program.

You are being asked to voluntarily answer some questions to see if you might qualify to be enrolled in a research study. We are asking you to be in this study because you are a black person with female sex assigned at birth with a history of symptomatic uterine fibroids and receiving medical care at Boston Medical Center. We are doing the research to create and implement a patient education and support program for black women with uterine fibroids. We also want to understand the characteristics of the black women with uterine fibroids at BMC and explore your experience with this new program.


If you agree, we will ask you some questions about yourself, your symptoms from uterine fibroids and your availability to participate in this study. You may feel some discomfort or embarrassment about answering these personal questions, but please know that you may end the screening at any time.


Confidentiality

We will be keeping your answers on file for our records. We will store paper files in locked filing cabinets. We will store electronic files in computer systems with password protection and encryption.

If you agree to answer our screening questions, we will share your answers with the following groups of people:

  • People who do the research or help oversee the research.
  • People from Federal and state agencies, as required by law. Such agencies may include the U.S. Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, and the Massachusetts Department of Public Health.
  • Any people if you give us separate permission allowing us to give them your answers.

If you are in immediate danger of hurting yourself, the study team will try to work with you on a plan to keep you safe. Because study staff will be trying to protect you, it is possible that your information will be shared with others as part of a plan for safety.

We might share your answers where we have removed anything that we think would show your identity. There still may be a chance that someone could figure out that the information is about you. Such sharing includes:

  • Publishing results in a medical book or journal.
  • Using research data in future studies, done by us or by other scientists.

Use and Sharing of Your Health Information

The research team has to use and share your health information to do this study. By agreeing to be screened for this study, you are giving us your authorization (permission) to use and share health information that may identify you.

Health information that might be used or shared during this research includes:

  • Information that is in your hospital or office health records. The records we will use or share are those related to the aims, conduct, and monitoring of the research study.
  • Health information from interviews or forms filled out as part of this screening.

The reasons that your health information might be used or shared with others are:

  • To do the screening for the research described here.
  • To make sure we do the research according to certain standards set by ethics, law, and quality groups.
  • To protect you. As we explained above, if you are in immediate danger of self-harm, it is possible that your information will be shared with others as part of a plan for safety.

The people and groups that may use or share your health information are:

  • Researchers involved in this research study from Boston Medical Center, Boston University, and/or other organizations
  • Other people within Boston Medical Center and Boston University who may need to access your health information to do their jobs such as for treatment, research administration, payment, billing, or health care operations
  • People or groups that the researchers use to help conduct the study or to provide oversight for the study
  • The Institutional Review Board that oversees the research and other people or groups that are part of the Human Research Protection Program that oversees the research
  • Research monitors, reviewers, or accreditation agencies and other people or groups that oversee research information and the safety of the study
  • The sponsor(s) of the research study and people or groups they hire to help them do the research
  • Other care providers and public safety authorities who may be involved in helping to protect you if you express thoughts about self-harm.

We ask anyone who gets your health information from us to protect the privacy of your information. However, we cannot control how they may use or share your health information. We cannot promise that they will keep it completely private.

The time period for using or sharing your health information:

  • The time period is not known, because research is an ongoing process. We cannot give you an exact date when we will either destroy or stop using or sharing your health information.

Your privacy rights are:

  • You have the right not to allow us to use and share your health information for research. If you do not agree, you cannot be screened for the research. This is because we need to use the health information to do the research. Your decision not to agree will not affect any treatment, health care, enrollment in health plans, or eligibility for benefits.
  • You have the right to withdraw your permission to use or share your health information in this research study. If you want to withdraw your permission, you must write a letter to the Principal Investigator. If you withdraw your permission, you will not be able to take back information that has already been used or shared with others. This includes information used or shared to do the research study or to be sure the research is safe and of high quality. If you withdraw your permission, you cannot continue to be in the study.
  • When the study has been completed for everyone, you have the right to request access to the health information that we used or shared to make your treatment or payment decisions. If you ask for research information that is not in your medical record, we might not give it to you, but we will explain why not. You may use the contact information on the first page of this form to find out how to get your health information. You may also contact the HIPAA Privacy Officer at Boston Medical Center at DG-privacyofficer@bmc.org / Boston University at HIPAA@BU.EDU.

Subject’s Rights

Saying yes to this screening and the sharing of your health information does not mean you have to be in the study. Your participation is completely up to you. You can decide to start answering the questions but then stop at any time. Your decision will not affect your ability to get health care or payment for health care. It will not affect your enrollment in any health plan or benefits you can get. However, if you don’t answer all the questions, you may not be able to be in the research study.


If you have any questions, please ask them now or at any time you can contact Nyia Noel, MD at nyia.noel@bmc.org or 617-414-7300. If you would like more information about your rights as a research subject, you may call 617-358-5372 or email medirb@bu.edu. You will be talking to someone at the Boston Medical Center/Boston University Medical Campus IRB. The IRB is a group that helps monitor research.


Signatures

By signing this permission form, you are indicating that

  • you have read this form (or it has been read to you)
  • your questions have been answered to your satisfaction
  • you voluntarily agree to participate in this screening
  • you permit the use and sharing of information that may identify you as described, including your health information.







Page 2