Women’s Health Research Registry™ FAQs
- What is research?
- What is a clinical trial?
- What is a protocol?
- Who monitors the conduct of protocols?
- Who gets to be in a study?
- What is informed consent?
- What is assent?
- What are my rights as a research participant?
- What should I consider before agreeing to participate?
- Will it cost me anything to take part in a research study?
- How am I protected from injury in a study or a trial?
- How are research subjects protected?
- How do I contact the IRB?
- Do research participants get paid?
- What happens when the study is over?
- What is a randomized trial?
- If I withdraw from a randomized trial, will I be told if you received the placebo (an inactive, dummy pill), or the active drug?
- What is the Women’s Health Research Registry™?
- What is HIPAA?
- How does HIPAA apply to research?
- Who is eligible to participate?
- How do I participate?
- Why should I participate?
- Is my information confidential and where is it stored?
- Should I be worried about confidentiality when filling out the online survey?
- How often do I need to participate?
- What if I don’t have a computer or an email address?
- How would I be contacted if I were selected for a study?
- Do I have to give my contact information?
- How long will I remain in the Registry?
- What happens after I join the Registry?
What is research?
Research is a way to answer a question and to gain knowledge. We use knowledge gained from research to come up with new treatments. Medical practice is different from research. The main purpose of medical practice is to care for the health and well-being of patients. The main purpose of research is to test new scientific ideas or new treatments. Research may help individual participants, but this is not always the case.Back to Top
What is a clinical trial?
Doctors and scientists at Long Beach Memorial Medical Center take part in many different kinds of research studies. Some research does not include living human beings. Research that includes humans is clinical research. Clinical research helps researchers understand how best to treat patients or helps them learn more about a particular condition or disease. There are many different forms of clinical research. One common form is a clinical trial. In a clinical trial, researchers test new drugs, medical devices or treatments.Back to Top
Clinical trials may seek to discover new drugs, new ways of giving patients approved drugs, new combinations of approved drugs, new surgical techniques, devices, or biological products. Clinical trials are also conducted to test cutting-edge and novel therapies, like studies that involve gene therapy or gene transfer.
Clinical trials must be conducted before a new drug, biologic, or device may be marketed in the United States. The FDA regulates clinical trials. The FDA gives investigators permission to test a new drug, biologic or device under strict regulatory conditions.
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What is a protocol?
A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will answer the research question. A protocol also states how the research team will protect the health and well being of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.Back to Top
Who monitors the conduct of protocols?
Physicians, nurses, sponsors, auditors, statisticians, and federal and non-federal regulatory bodies carefully monitor the actual conduct and safety of protocols. This means that different groups are reviewing the safety and progress of each protocol on a regular basis. If any of these groups determine that there is a concern with how the study is conducted, the study will stop.Back to Top
Who gets to be in a study?
Each research study is different. Each study tries to find answers to a specific question. Researchers must follow strict rules to decide who may take part in research. Not everyone with the disease or problem that is being studied can take part in a research study. If your doctor thinks that you might qualify for a study, he or she may ask if you want to take part. Many patients also look for research studies on their own through web sites or support groups. The Long Beach Memorial Medical Center (LBMMC), Heart and Vascular Institute (MHVI), provides information on Clinical Research, www.memorialcare.org/womensregistry. To be included in research, you must agree to take part. You may drop out of a research study at any time, even if you already agreed to participate. Saying no to participating in research will not change your standard medical care at LBMMC in any way. If you have questions about participating, you may talk to your doctor or to another doctor who is not a member of the research team about your other choices.
Long Beach Memorial Medical Center also conducts non-medical or non-intervention types of research. You could be asked to participate in a study as a "normal control," you could be asked for permission to (allow researchers to collect information from your medical record, or you could be asked to simply fill out a questionnaire.
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What is informed consent?
Informed consent is the process that gives information to people who are thinking about taking part in research. After learning about the research, you should understand:- the purpose of the study
- the procedures involved in the study
- the possible benefits and risks of taking part in the study
- the rights of people who take part in research
- that taking part in research is your choice
- what you can do instead of taking part in the study
- how the research team will give you any new information that may be learned after you decide to take part in a study that might cause you to change your mind
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What is assent?
Research at Long Beach Memorial Medical Center includes children as well as adults. The law states that children cannot make their own decision about research. We, however, feel it is important that children but receive an explanation of the research and have a chance to ask questions. If your child's doctor tells you that your son/daughter must "assent" to participate, it is because we respect his/her rights as a person. "Assent" refers to the process by which we ask a child's agreement to participate. In most cases, investigators will obtain a child's assent if he or she is over the age of 7. It is important that the information shared with your child be understandable. The researcher will consider your child's age and maturity level when presenting information. Doctors and parents need to work together to help the child understand what a study involves.Adults who cannot legally make decisions for themselves may also agree to participate through an assent process. Researchers must also obtain the consent of an individual who represents such. Investigators want to make sure that the person whose mental abilities are impaired has some understanding of what will happen to him/her and can say no if he/she so chooses.
Sometimes assent is not required. In situations where the research may be the only way to help a patient with a life-threatening illnesses, assent is not required if the research is expected to be beneficial to the individual. Even so, researchers are encouraged to discuss the research with the individual patient.
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What are my rights as a research participant?
- You have the right to not take part in a research study.
- You have the right to drop out at anytime.
- You have the right to be given new information about the study.
- You have the right to ask questions at any time and have them answered as soon as possible.
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What should I consider before agreeing to participate?
- You may consider taking part in a study because:
- You may benefit from the best possible treatment or an experimental treatment that would otherwise not be available to you.
- The physicians and nurses will closely monitor your progress throughout the trial.
- You would be helping researchers to improve the treatments for future patients.
- The experimental treatment may not work for you, or it could make your condition worse.
- The experimental treatment may cause side effects that no one anticipated.
- Your health insurance may not cover research procedures.
- If the trial is randomized and includes a placebo (an inactive, dummy pill), you may not be given the experimental treatment.
- The amount of testing for efficacy and safety purposes may involve too many trips to the research office and take too much time.
- If I am ill, will this research help me?
- What are the risks?
- What is involved? What will I have to do?
- Will I be charged anything or compensated for my participation?
- How can I end my participation if I change my mind?
- What will happen when the study is over? Will I be told the results?
- Is the study controversial?
- Whom do I contact to express concerns or obtain information?
Will it cost me anything to take part in a research study?
Clinical trials test new drugs, devices, or treatments. In some cases, taking part will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.Back to Top
How am I protected from injury in a study or a trial?
You are protected first and foremost by being told honestly and without bias what the known and potential risks are for participating in the trial. This information will be submitted to you in a language you will be able to understand. There is an IRB requirement that every participant in a clinical trial be informed about the possible risks, benefits, and available alternatives. All of the information necessary to assist you in determining whether or not to participate in a clinical trial is provided in a document called the "informed consent document." This document informs you of how to let the investigator know if you think you are experiencing a problem with the research and what resources are available to help you.
You should ask any questions you may have about a clinical trial before signing the informed consent document. Even after you have signed the informed consent document to participate in a clinical trial, you should always speak to the investigator if you have questions or problems.
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How are research subjects protected?
The Memorial Health Services, Institutional Review Board (IRB) protects people in research studies. The IRB includes scientists, non-scientists, and community members. The IRB reviews, approves, and monitors all research at conducted at Long Beach Memorial Medical Center, and other MemorialCare® medical centers, in which people take part. This oversight keeps risks to research participants as low as possible. The IRB also keeps track of ongoing studies to make sure they are being done in the right way. The IRB requires that all researchers treat research participants with respect. The IRB protects your rights and welfare if you take part in a research study.Back to Top
How do I contact the IRB?
If you have a concern, complaint or compliment about research, please contact the Memorial Health Services, Research Administration. The IRB takes all complaints very seriously. The IRB investigates all complaints and concerns. You may contact the IRB at any time by calling (562) 490-3737, or mailing a letter to:
Office of Research Administration, Memorial Health Services
Long Beach Memorial Medical Center
280l Atlantic Avenue
Long Beach, CA 90806
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Do research participants get paid?
Some studies compensate participants for the time they spent participating in a trial; generally this amount is given to cover expenses for parking, transportation, meals, and possibly for lost work time; however, payment may not be substantial enough to constitute inducement to participate for monetary gain.Back to Top
What happens when the study is over?
At the end of a study, the researchers analyze the data that were collected from all participants throughout the study. Findings and data collected about you will be compared to other participants. In clinical trials, doctors and specialists in biostatistics would conduct the analysis and report the findings to scientific meetings and medical journals. Data will also be shared with experts and various government agencies responsible for the approval of new drugs, biologics and devices. Not all experimental treatments receive final FDA approval in the end.
What happens when the study is over also varies from study to study. Sometimes patients can remain on the study drug if they are responding to the new treatment; however, this is the exception rather than the rule. Generally, participation ends when the study ends because it might not be safe or effective to continue treatment based on what is known at the time. Clinical trial participants can withdraw from the study at any time without jeopardizing the rest of their standard medical care.
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What is a randomized trial?
Randomized is used to describe a research study that hopes to compare two or more different treatments or procedures. Randomized means that you will be assigned to a study group by chance, like flipping a coin.Back to Top
If I withdraw from a randomized trial, will I be told if you received the placebo (an inactive, dummy pill), or the active drug?
Most randomized trials will only disclose this kind of information when the study has been completely finalized; this is done to protect the integrity of the research data and results. If the trial is a "double-blind" trial, the doctor will not even know which substance you received. Most protocols will have information with respect to when a study will be "unblinded." If this is something that you want to know more about, ask the investigator what the study's policy is before you agree to participate.Back to Top
What is the Women’s Health Research Registry™?
A registry is a database comprised of information and/or tissues obtained from individuals. This information is collected in a standardized way so that it can be used in research; in this way, it is different from information collected typically by the patient's doctor. These registries are also called "banks." Registries are established for the purpose of collecting as much information as possible about a particular illness or a group of people. Some registries are very large and may include family members of people with specific illnesses. Agreeing to participate in a registry as a volunteer subject, allows researcher trying to answer new health questions, discover new drugs or devices, or understand gender differences among diseases that affect men and women. A registry could have information on 100 people or it could have information on 10,000 people. It is from registries and banks that many researchers develop new ideas for new research studies.Back to Top
What is HIPAA?
As part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which was originally passed as a means of maintaining healthcare coverage, Congress included Administrative Simplification provisions in HIPAA directed at standardizing how health care information and claims are processed and used. The privacy provisions (as well as the security provisions) were then added to HIPAA's Administrative Simplification provisions to protect how patient health information or "Protected Health Information" (PHI) is stored, transmitted and used.
"The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes. The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities."
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How does HIPAA apply to research?
It may be necessary for a researcher to create new health information about you or to review information in your medical records as part of your participation. Before being able to do this, the researcher must obtain your authorization to access your health information. As part of the informed consent process, you will receive a description of the type of health information to be viewed or created as part of the research, understand who will view the information, for what purposes, and for how long. After reviewing this information, you will be asked to grant permission for the use of your information by providing "authorization."
You have the right to revoke or withdraw your authorization for the researcher to use your identifiable health information. If you wish to revoke or withdraw your authorization, you must do so in writing, and provide that written revocation to the researcher to his/her mailing address. The researcher will no longer be able to allow you to participate in the research study and will stop collecting any additional identifiable health information about you. However, the researcher may, by law, continue to use the health information about you previously collected, as necessary to maintain the integrity of the research study and make reports to oversight agencies.
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Who is eligible to participate?
Any female who is over the age of 18 is encouraged to participate. All interested participants must review and submit the informed consent.Back to Top
How do I participate?
h2. You can join the Registry by completing a questionnaire (either online through our secure web-site, or by requesting a paper version).Back to Top
Why should I participate?
- To join a large group of women interested in women's healthcare issues.
- To help improve the health of future generations of women.
- To make yourself more aware of your own health issues.
- To help researchers learn more about the factors that affect our health, and in so doing help them improve prevention and treatment of our health conditions.
- To receive information from specialty physicians and researchers from our periodic newsletters.
- To gain access to groundbreaking studies for new medications and healthy lifestyle interventions.
Is my information confidential and where is it stored?
Yes, absolutely. The Registry investigators have applied for a Certificate of Confidentiality from the National Institute of Health. All data will be maintained in accordance with HIPAA guidelines (as currently defined) for patient confidentiality and privacy. Identifying data will be available to facilitate contact of subjects by approved researchers, to discuss research protocols for which they may be a match. All shared data sets and Patient Health Information (PHI) will be stored on a password-protected server only accessible by authorized researchers from the Center for Women’s Cardiac Health and Research, at the MemorialCare Heart and Vascular Institute.Back to Top
Should I be worried about confidentiality when filling out the online survey?
No. The survey operates from a secure web site using HTTPS with SSL encryption. The same level of security used for banking and health care sites.Back to Top
How often do I need to participate?
We ask that you update your Registry information just once a year. Our newsletters and emails will remind you to do so.Back to Top
What if I don’t have a computer or an email address?
You can call us at (562) 933-2460, the Center for Women’s Cardiac Health & Research. We will send you a paper copy of the survey along with a prepaid return envelope. We will contact you each year to update your Registry information. What happens to my paper survey after my information is stored in the database? Once we have secured your information in our database we destroy your paper survey. We only retain the paper copy of your consent forms.Back to Top
How would I be contacted if I were selected for a study?
When your health information and personal profile match the criteria for a research study, the Registry staff will send you a letter telling you that you appear to be qualified to participate in a particular research study. You will be provided a brief summary of the research project and will be given a reasonable period of time to decline the opportunity to be contacted by the researcher or their staff if you are not interested in participating in that particular study.Back to Top
Do I have to give my contact information?
Yes. The Registry staff needs your personal contact information in order to contact you if you have matched an upcoming research study. This identifying information is only shared with approved researchers once you have agreed to be contacted by the researcher. It is NEVER shared with outside parties (i.e. insurance companies, your doctor, vendors, etc). You can always call us at (562) 933-2460 the MemorialCare Heart and Vascular Institute, Women’s Health Research Registry™ with other questions.Back to Top
How long will I remain in the Registry?
You will be asked on an annual basis if you’d like to remain in the Registry and, if so, asked to update your profile. You have the right to decide, at any time, that you no longer want to continue your participation by contacting the Registry staff and asking to be removed from the Registry database. At any time, you may decide not to accept a researcher’s invitation to participate in a study; it will not affect your opportunity to participate in future studies or remain in the Registry database.Back to Top
What happens after I join the Registry?
When your health information and personal profile match the criteria for a research study, the Registry staff will send you an email or a letter telling you that you appear to be qualified to participate in a particular research study. You will be provided a brief summary of the project and will be given a reasonable period of time to decline the opportunity to be contacted by the researcher or their staff. You can notify the Registry at (562) 933-2460 or womenscardiachhealth@memorialcare.org to decline the invitation to be contacted about a particular study. If you do not tell the Registry that you decline to be contacted, your contact information-name, address, phone, and email address, (if supplied) will be provided to the researcher and they will contact you directly to discuss the entry requirements and other details of their study.It is the responsibility of the researcher to fully explain the details of their study including its risks and benefits and to obtain your consent to participate in their study. If you notify us that you are not interested in being contacted regarding a particular research project, we will respect your wishes and not give that study leader your contact information. Your name will remain in the Registry, and you will have the option to participate in other studies for which you may be eligible. You are never obligated to participate in a study even if you are contacted by a researcher to discuss further details. In some cases, researchers will analyze general state health trends using the Registry database. For these types of studies, no personal information will be disclosed that will allow a researcher to identify you in any way.
Researchers doing these types of studies will not have direct access to your information, but will work with Registry staff to look at population and statistical data by using a database that does NOT contain any identifying information. Because no personal identifying information is used for these studies, the Registry staff is not required to notify you of these types of projects.
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This Study is Approved by MHS Institutional Review Board IRB #633-09:
If you have questions regarding your rights as a research subject, call the Office of Research Administration at (562) 490-3728.
If you would like to send us mail or a fax, please contact:
Dr. Peggy Kalowes RN, PhD
Director
Center for Women’s Cardiac Health and Research
MemorialCare Heart & Vascular Institute
Long Beach Memorial Medical Center
2865 Atlantic Ave, Suite 210
Long Beach, CA 90806
Phone: (562) 933-2460
Fax: (562) 933-2462
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