California Teachers Study

Every person who participates in a research study has specific rights that are protected by law. These protections and laws exist so that participants are fully informed and treated fairly throughout the research study. Every member of the California Teachers Study team is required to obey these laws.

 

In addition, the State of California has an “Experimental Subject’s Bill of Rights” to further strengthen these protections. Even though some California Teachers Study participants live outside California, this “Bill of Rights” is a great way to understand your rights as a research participant. Regardless of whether you live in California or in another state, we will continue to protect your rights as a research participant in the California Teachers Study based on the following principles.

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1. I have the right to be told what the research is trying to find out.

The goal of the California Teachers Study team is to identify what’s different between groups of women who develop certain diseases (for example, breast cancer or stroke) and groups of women who do not develop those diseases. Those differences can reveal clues about the causes of those conditions—and, in turn, how the conditions might be prevented or treated. Questionnaire 6 (“Q6”) will collect data about your health, well being, and lifestyle. The California Teachers Study will combine the data from Q6 with all of the other Study information. Researchers will then use those data to study specific types of cancer and other conditions that affect women.

2. I have the right to be told about all research procedures, drugs, and/or devices and whether any of these are different from what would be used in standard practice.

The overall California Teachers Study does not involve any specific research procedures, drugs, or devices. The California Teachers Study does not include any clinical care or medical treatment. Q6 is a self-reported questionnaire: participants are asked to read the survey questions and answer those questions as completely and honestly as they can.

3. I have the right to be told about any risks, discomforts or side effects that might reasonably occur as a result of the research.

There are no risks, discomforts, or side effects from completing Q6. Some of the questions deal with health topics that might be considered sensitive. Because we are collecting and storing data about health, there is a slight risk that those data might be seen. There is also a risk that identifying information about you might be mistakenly released. The Study team follows federal, state, and institutional regulations to protect your privacy and confidentiality.

4. I have the right to be told about the benefits, if any, I can reasonably expect from participating.

There are no individual benefits to participants who complete Q6.

5. I have the right to be told about other choices I have and how they may be better or worse than being in the research. These choices may include other procedures, drugs or devices.

Each participant can choose not to complete Q6. Participants can also choose to not complete specific questions within Q6.

6. I have the right to be told what kind of treatment will be available if the research causes any complications.

Completing Q6 is not expected to cause any complications. There will be no treatment made available to participants as part of Q6.

7. I have the right to have a chance to ask any questions about the research or the procedure. I can ask these questions before the research begins or at any time during the research.

If you have any questions about Q6, or about the California Teachers Study, you can email us at calteachersstudy@coh.org, call us at (800) 568-9471, or send a question via our Contact Us page.

8. I have the right to refuse to be part of the research or to stop at any time. This decision will not affect my care or my relationship with my doctor or this institution in any other way.

Every participant can choose for herself whether she wants to complete Q6. If a participant starts to complete Q6, she is free to stop at any time. Whether a California Teachers Study participant chooses to complete Q6 will have no effect on her health care.

9. I have the right to receive a copy of the signed and dated written consent form for the research.

The Institutional Review Board (“IRB”) at City of Hope is responsible for reviewing all research and protecting participants’ rights. The City of Hope IRB has reviewed Q6. In addition, certain types of research can occur without requiring every participant to sign an informed consent form. After reviewing Q6, the City of Hope IRB decided that California Teachers Study participants can complete Q6 without having to sign an additional informed consent document. The official language that we are required to provide, as part of that decision, is “The completion of the questionnaire portion of this study is approved for a Waiver of Documentation of Informed Consent under 45CFR46.117(c)(2) and Alteration of Authorization under 45CFR164.512(i)(2)(ii).”

10. I have the right to be free of any pressure as I decide whether I want to be in the research study.

Whether a California Teachers Study participant completes Q6 is her choice and her choice alone.

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