© 2019 The Kelsey Coalition

TAKE ACTION

Investigate Unethical NIH Study

In 2015, the National Institutes of Health awarded a $5.7 million dollar grant to four pediatric gender clinics for a five-year longitudinal study. ​Children in this study have been given risky hormonal treatments. There is no control group.

In mid-study (2017), the minimum age for cross-sex hormone inclusion was decreased from 13 to 8. This taxpayer-funded study poses the potential for serious and irreversible harms to children, including infertility. We suspect that informed consent laws were violated.

The Kelsey Coalition filed a formal urgent request with the Office for Human Research Protections (OHRP) on April 5 calling for an immediate moratorium pending an investigation. Please follow our Action Plan to write to the OHRP to encourage an expeditious response.

Write to the Office for Human Research Protections to demand an immediate moratorium pending an investigation.


Level of Urgency: Highest

Estimated Time: 5-10 minutes


Steps and Information Needed:


  • This

    is the original grant.

 

  • This

    is the information that was received from a recent FOIA request proving that In 2017, the minimum age for cross-sex hormone inclusion was decreased --mid-study-- from 13 to 8.


  • Ask OHRP to investigate whether informed consent laws designed to protect human research subjects (

    28 CFR §§116-117

    ) have been violated.


  • Ask OHRP to respond to t

    he request

    of the Kelsey Coalition for an immediate moratorium pending this investigation. 


  • Include a copy of

    our handout

    in your letter or email.


  • Consider adding your own professional or personal concerns.

 

  • Submit your request to:


Email: ohrp@hhs.gov


Mail:  Division of Compliance Oversight

          1101 Wootton Parkway, Suite 200, Rockville, MD, 20852 


Fax: (240) 453-6909

 

Contact every member of the Senate Committee on Health, Education, Labor and Pensions.

 

This Senate Committee has oversight over the NIH and the authority to conduct a hearing. Please inform them about the study and ask them to investigate by conducting a hearing. 

 

Level of Urgency: Medium

Estimated Time: 30-40 minutes


Steps and Information Needed:



  • This

    is the original grant.

 

  • This

    is the information that was received from a recent FOIA request proving that In 2017, the minimum age for cross-sex hormone inclusion was decreased --mid-study-- from 13 to 8.


  • Ask them to hold a hearing to investigate whether informed consent laws designed to protect human research subjects (

    28 CFR §§116-117

    ) have been violated.


  • Ask them to support t

    he request

    of the Kelsey Coalition calling for an immediate moratorium pending an investigation. 


  • Include a copy of

    our handout

    in your letter or email to explain our concerns.


  • Consider adding your own professional or personal concerns.


Write to your US Senators (2) and Representative (1)


Level of Importance: Lowest

Estimated Time: 15-20 minutes


Steps and information needed: 


  • Locate contact information for your Senators and Representative

    here.


  • Write a letter or email asking for an investigation about why taxpayer dollars are funding a study that cause serious and irreversible harm to children.


  • Ask them to support t

    he request

    of the Kelsey Coalition calling for an immediate moratorium pending this investigation. 



  • Consider adding your own professional or personal concerns.