Advocacy for TGI Research Participants

YOUR RIGHTS AS A TGI RESEARCH PARTICIPANT

You should take as much time as you want to think about your decision and ask questions if there is anything you don’t understand. As a research volunteer, you have many rights that protect you.

California Bill of Rights for Research Participants

As a participant in a research study, you have the right:

I have the right to be told what the research is trying to find out.
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.
I have the right to be told about any risks, discomforts or side effects that might reasonably occur as a result of the research.
I have the right to be told about the benefits, if any, I can reasonably expect from participating.
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.
I have the right to be told what kind of treatment will be available if the research causes any complications.
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.
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.
I have the right to receive a copy of the signed and dated written consent form for the research.
I have the right to be free of any pressure as I decide whether I want to be in the research study

What information should the researcher give to me?

The researcher will usually give you the information listed below. The information that is followed by an asterisk (*) will be given to you only for medical studies.

why the research is being done
why you are being asked to participate
how long your participation will last
what will happen during the research (what you will do, the drugs you will take, etc.)
how the research is different from your usual medical care (research is not the same as treatment)*
any expected risks or discomforts that you may experience
how information about you will be protected
any potential benefits
any expected costs to you or your insurance provider*
other choices you have if you don’t want to participate. This includes other treatment options that may help you*
medical treatment you will receive in case of a bad reaction or unwanted response related to the research*
reasons you might be asked to leave the research
if any of the researchers have conflicts of interest
what the researchers will do with genetic testing results
what will happen to any samples provided (such as blood or urine) after the study is complete
who can help you with problems or give you more information about the study or your rights

What are participants commonly asked to do?

Participants help researchers in many different ways. Depending on the goals of the research, participants might be asked to do things like:

take part in interviews (sometimes as part of a group)
complete questionnaires, tests or special tasks
allow access to private information (such as medical records or school records)
let researchers observe behavior
complete physical, psychological or other kinds of examinations
give blood, saliva, urine or other samples
take experimental drugs or use experimental medical devices

Medical research has built into it many layers of protection for you as a research volunteer. Researchers must ask you or your legal representative if you agree before you are added in a research study. Doctors, nurses and medical staff have a code of ethics they follow while taking care of you. Medical researchers must also follow codes of ethics for medical research involving humans. There are rules that have been developed over the decades to protect the rights of research participants. Institutional Review Boards (IRB) protects your safety and rights before and while you take part in a study. The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (DHHS) also have laws that regulate how volunteers are protected in research.

What is an Institutional Review Board?

Since 1966, the United States Department of Health and Human Services (DHHS), formerly called the Department of Health, Education and Welfare (DHEW), has required prior review and approval of all research using human subjects that is funded by federal agencies. The review is done by a committee usually called an Institutional Review Board. Between 1974 and 1978, the National Commission on Protection of Human Subjects of Biomedical and Behavioral Research met and issued a series of reports and recommendations resulting in revised regulations issued by DHHS in January of 1981.

The United States Food and Drug Administration (FDA) was simultaneously developing its own regulations, which were also issued in January of 1981 and have since been revised, most recently in October 1996. DHHS issued revised regulations in March of 1983 and again in June of 1991. These regulations, which provided standards for review of human research activities by what are known commonly called Institutional Review Boards (IRBs) now apply to all activities involving human subjects at all Ascension Seton locations where research occurs.

You have every right to ask for a copy of the Researcher's Institutional Review Board guidelines, website, and information on how you may file a formal complaint, if necessary.

Sources:

An FAQ On Institutional Research Protections

Medical advances, State and Federal policies are dependent on research and much of this research relies on patient participants. An individual who participates in research not only receives a potentially helpful treatment, they also generously help others who may need access to care in the future. It is because of past research participants that we have the treatments and policies available today.

People who participate in research studies, or trials, do so voluntarily and are known as research volunteers or research participants or research subjects. Some trials are for adults only, while others are open to children and adolescents who may participate if permission is provided by a parent or guardian. The length of a research study varies according to the questions it is trying to answer, and ranges from a few hours to several years.

To help you decide, a member of the research team will explain details of the research study to you. They will give you an informed consent document describing important information about the study. You will have the opportunity to ask questions about the study before you make a decision to participate or not. You should consider the informed consent thoughtfully and discuss it with family and friends, with another doctor or with other people you trust, such as TGI mentors and organizations. Some studies may seem “positive” for the TGI community, but we need to ask how this will affect access to care and future policies. This is where seeking guidance from TGI mentors and/or organizations may come in handy.

Dangerous Transgender Research Study from 2021

To review the original letter sent on January 20, 2021 to our TGI Community and Allies, click here.

Read the latest update as of May 2022 here.

January 27th, 2021

Dear Trans, Gender Non-Conforming and Intersex (TGI) Community Members,

In early December 2020, researchers at UCLA Semel Institute for Neuroscience and Human Behavior reached out to TGI people across Southern California who are active in the community, work in advocacy, or work for organizations that provide care, resources, or safety for folks who are transgender and nonbinary. According to their email, the purpose of this meeting was to request feedback on a brain imaging study including set up, appropriate and inclusive materials, and ways in which the study team can respectfully connect with community organizers and partners. During the meeting, we learned that this study is already underway with approval by the UCLA Internal Review Board (“IRB”) (#11-000459).

We strongly recommend that transgender community members and LGBTQ organizations do not advertise or participate in this study. We have grave concerns about the unethical research design.

The research design purposefully causes mental health distress in order to trigger “dysphoria.” This includes having participants wear tight leotards and taking photographs of their body. We were asked for input about low retention of trans participants and found the researchers unable to comprehend why this study is harmful. The researchers are falsely advertising this study without clarity about the expectations of participants and without consideration of the need for direct access to mental health after care.

We object to the purpose of the study and it’s potential consequences on access to care for transgender people. The researchers claim that their study could help transgender people, but their own research materials suggests they are developing tools that may curtail access to gender-affirming treatment. Further, Principal Investigator, Dr. Jamie Feusner, is also currently funded to study Body Dysmorphic Disorder (BDD) and anorexia nervosa. He describes his broader research as seeking to understand phenotypes of aberrant perceptual and emotional processing that cross diagnostic boundaries of conditions involving body image such as BDD, eating disorders, and gender dysphoria. We object to the view that transgender people have an aberrant body image condition or that brain imaging of traumatic response could ultimately “help” trans people. It is suggestive of a search for medical “cure,” which can open the door for more gatekeeping and restrictive policies and practices in relation to access to gender-affirming care. At a time in which trans lives are under attack, we find this kind of research to be misguided and dangerous.

Gender Justice LA and the California LGBTQ Health and Human Services Network demand the immediate suspension of recruitment and research for a UCLA brain imaging study until further review by the Institutional Review Board (IRB), due to its unethical research design for Transgender, Gender Non-Conforming, and Intersex (TGI) participants who have induced episodes of gender dysphoria and mental health distress after participating in the study.

Furthermore, we call on UCLA to:

Immediately cease the recruitment of participants and the use of the misleading title "The UCLA Transgender Research Program."
Call on the Vice Chancellor for Research, Dr. Roger Wakimoto, to appoint an ad hoc committee to investigate the community expressed concerns pursuant to Policy and Guidance: Complaints, Concerns and Suggestions, and Reports of Undue Influence Regarding the Conduct of Human Participants Research. The ad-hoc committee should include representation of transgender people. The findings and outcomes of the investigation should be made available to the public.
Conduct a thorough assessment of the Institutional Review Board (IRB) focused on aligning IRB decision-making with UCLA's commitments to equity, diversity, and inclusion.
Create clear research guidelines that include the participation of transgender researchers and policy advocates on scientific advisory boards and community advisory boards for any trans related research.

As members of the TGI community, we realize that we are in need of research to fill the gaps in our access to care. However, we must remain vigilant that any research that is conducted does not impact our community negatively in terms of opening the door for potential policies that excludes us from society.

To sign on to this letter and stand with the transgender community in solidarity, please fill out the google form and submit your organizations' logo.

Thank you for standing in solidarity with the transgender community.

To sign-on as an LGBTQ/TGI community organization, complete this google form.

To read and sign-on as a UCLA researcher/member of the scientific community, view the letter and complete this google form.

Thank you to those who have already signed on to this letter!

Learn more about Gender Justice LA

To review the public complaint sent to UCLA, click here.

To view the letter sent to Dr. Roger Wakimoto, UCLA Vice Chancellor of research, click here.

To sign-on as an LGBTQ/TGI community organization, complete this google form.
To read and sign-on as a UCLA researcher/member of the scientific community, view the letter and complete this google form.

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