What is a clinical study and why are studies done?
Before a new treatment is approved and put on the market, it must undergo rigorous testing to ensure it is safe and effective. This testing is conducted as part of a clinical study, during which volunteers are given the prospective treatment — under strict guidelines and regulations that the researchers must follow. Besides safety and efficacy, clinical studies help researchers determine how much improvement the treatment offers participants, the proper form and how long the treatment takes to cause an improvement, and much more. Without clinical research, there can be no new treatments. Clinical studies are essential to advance health care.
Why join a study?
People have many reasons for joining a study. Some people like the feeling that, by joining, they are helping make new treatments available for all. Some studies need participants who are suffering from a disease or condition. In these cases, these people often participate in hopes of finding a better treatment. Basically, participants in clinical studies can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
How do I decide whether or not to participate in a research project?
Participation is a personal decision. As a potential subject, you are encouraged to weigh the risks and benefits of participation and to ask the researcher any questions you may have about the study. Please keep in mind that research participation is always voluntary and never required. As a potential research subject, you should never feel pressured to participate. You have the right to take all the time you need to decide whether or not you want to participate, you can talk to friends and family about the decision, and you can always say no.
What does “informed consent” mean? What are its essential components?
Fully informing participants of the risks, benefits, and procedures involved in a study is a standard requirement in research with human participants. Ethically and legally, consent is not considered to be “informed” unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual’s decision to willingly participate in a research protocol. Note: you do not give up any of your legal rights when you sign the informed consent document and join a study.
What is a “Principal Investigator” or “PI”?
The PI, or Principal Investigator, is the individual responsible for the design, preparation, conduct, and administration of a research grant/study. The PI is also the person responsible for making sure everything is done properly.
The PI of this study is Jesse Fann MD, MPH, a board-certified psychiatrist and Medical Director of the Department of Psychosocial Oncology at the Fred Hutchinson Cancer Center (Fred Hutch). He is a Professor in the Department of Psychiatry and Behavioral Sciences and Adjunct Professor in the Departments of Rehabilitation Medicine and Epidemiology at the University of Washington.
Along with the PI, there is a team of research staff who help with study operations and/or collecting and analyzing data. Key members of the research team are identified on the front page of the Consent Document.
Are there benefits to being in a research study?
Not everyone who participates in a research study will benefit personally. Often however, your participation in a research study will be of benefit to humanity by helping researchers learn more about certain diseases or conditions and their treatment. In some studies, however, you may benefit if the experimental approach makes your disease or symptoms stop progressing or lessens their effects on you.
Are there risks to being in a research search study?
Research studies may involve some degree of risk. A study like this one that asks you to fill out questionnaires, has only minor risks, such as answering questions that make you uneasy. The research team is required to explain to you the foreseeable risks of being in the study before you decide whether or not to be in the study. That’s part of the “informed consent” process
What will I be asked to do?
You will be asked to participate in this study for up to 12 months. The length depends on when in the course of your cancer treatment you enrolled in the study. You may be asked to use a new application on your phone, tablet or computer that will allow you to share information more easily with your Clinical Social Worker. You will be asked to complete a 15 to 30-minute questionnaire at baseline, 3 months, 6 months and 9 months through an on-line secure HIPAA compliant link or, if you prefer, by phone, video conferencing, or in person with research staff or on paper. You may be asked to participate in an interview or focus group about the new technology and/or to have a treatment session recorded to help us understand how the new technology is used. You would need to give specific permission for either of those latter activities to occur.
Your cancer care at the center/clinic will be the same and you will receive psychosocial care whether you participate in this study or not.
Will I be paid to participate?
While you will not be paid to participate in this study, in appreciation for your participation we will offer you a choice of 2 electronic gift cards upon completion of key study procedures. The value of these gift cards are as follows: $50 for completion of the baseline questionnaire, $25 for the 3-month questionnaire, $50 for the 6-month questionnaire and $25 for the 9-month questionnaire. If you are selected to be interviewed or join a focus group about the new technologies and you agree to participate, you will be given an additional $45 electronic gift card.
What if I change my mind after the start of the study and want to stop participating?
If you agree to participate in a study, you are a volunteer and you have the right to withdraw from the study at any time for any reason without penalty. You also have the right to ask that your study data not be used in the analysis of the study.
How do I withdraw from the study?
To withdraw from this study, you can simply email the researchers at scopestudy@uw.edu to let them know of your decision. If you are willing, please share the reason why you are leaving as it may help us identify or address any protocol, technology or staffing issues. But giving a reason why is by no means required.
What if I don’t like something about the study?
You can contact the University of Washington’s Human Subjects Division (UWHSD), the division that oversees all UW research, and anonymously report complaints or research misconduct. You can reach UW HSD at (206) 543-0098 or hsdinfo@uw.edu. You can also contact the study research team at scopestudy@uw.edu or 206-616-3032, or the study’s Principal Investigator Jesse Fann at 206-606-1030 or fann@uw.edu.
What if I have questions, comments, or concerns after the study is completed?
You may contact the research team in general at scopestudy@uw.edu or 206-616-3032, the study PI, the study research coordinator, research assistant, or any of the investigators listed on the front page of the consent document any time before, during, or after your participation. You may also contact the UW Human Subjects Division (contact information provided in the response above and on the Consent Document)
What if something bad happens to me while I am a research participant?
In case of an emergency, call 911 or the National Suicide Prevention Lifeline at 1-800-273-8255 immediately. If it is not an emergency, please contact your Clinical Social Worker as soon as possible.
What protection exists for research participants?
In order to protect persons who volunteer for research studies, a number of safeguards are in place to make sure that research meets strict guidelines for safety and ethical conduct of the work. All proposed research that involves human participants must be reviewed and approved by an impartial body, known as an Institutional Review Board (IRB), before the study can begin. Our study was reviewed by the UW’s IRB, part of the UW’s Human Subjects Division. IRB members include a mix of scientists, health care providers, and at least one nonscientist. Most of them are affiliated with the UW, but some are community members who have no connection with the UW. IRB committees must comply with established policies and procedures specified by state and federal laws and regulations. Their primary purpose is to assure that the safety, welfare and rights of research participants are protected. In addition, as a volunteer in a study, you are free to withdraw your participation at any time and bring any concerns that you may have to the attention of the Principal investigator, the study’s Research Coordinator/Assistant or the UW Humans Subjects division. Contact information is available on the front and last page of the Consent Document.
Will my participation in research and the data collected be kept private and confidential?
Absolutely. Researchers are required to protect your privacy and keep all information confidential. The primary way by which this is done is to assign unique study identification (ID) numbers to all participants so that names or other identifying information do not appear in research databases. Further, access to the data is limited to only those staff who are directly related to the study. If a researcher wants to use any information they obtain in the course of the study for education or training, they must obtain specific permission. Research data is also stored in password protected encrypted files on secure servers at the University of Washington.
The exception to the rule regarding confidentiality is that researchers may be required to report information to:
- a member of the federal government who needs it in order to audit or evaluate the research;
- individuals at the University of Washington, the funding agency, and other groups involved in the research, if they need the information to make sure the research is being done correctly;
- legal authorities, if we learn of child abuse, elder abuse, or the intent to harm yourself or others.
Will I be told the results of the study?
We do not plan on informing participants of results at the end of the study. Keep in mind it will be years before papers with the results would be published. You may, however, keep up with the study and summary results at http://www.clinicaltrials.gov.