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HHS Agency Failing to Protect Humans Taking Part in Research Experiments

Feb. 1, 2018

HHS Agency Failing to Protect Humans Taking Part in Research Experiments

Public Citizen Calls on Sen. Grassley to Examine Agency Responsible for Overseeing Human Research

WASHINGTON, D.C. – Congressional lawmakers should examine the Office for Human Research Protections (OHRP) – an agency within the U.S. Department of Health and Human Services (HHS) – over its failure to adequately protect people who are enrolled in human experiments, Public Citizen said today.

A report issued in July 2017 by the HHS Office of Inspector General (OIG) found a significant drop in OHRP compliance oversight investigations, Public Citizen noted in a letter to U.S. Sen. Chuck Grassley (R-Iowa).

Public Citizen called on Grassley to broadly examine the adequacy of OHRP’s compliance oversight activities and demand that the agency cease abusing its discretion when deciding whether to initiate evaluations of noncompliance allegations. The OIG report indicates that OHRP routinely bypasses its own procedures for investigating allegations of misconduct – which in turn signals to the research community that there is little chance the agency will investigate even serious allegations of regulatory violations, said Dr. Michael Carome, director of Public Citizen’s Health Research Group, and Dr. Sidney Wolfe, the Health Research Group’s co-founder and senior adviser.

Grassley recently expressed concern to HHS over an unethical clinical trial that involved testing an experimental vaccine on humans without proper protections required by U.S. law. In the past three years, Public Citizen has submitted formal complaints to OHRP over serious allegations of noncompliance – spanning five clinical trials, including the SUPPORT trial involving premature babies and the MINT trial involving heart attack patients – and in each case, OHRP refused to open a formal oversight evaluation, the letter states.

“OHRP’s enforcement of regulations for the protection of human subjects has become moribund,” Carome said. “Human research subjects can no longer depend on OHRP to meet its obligation to protect their rights and welfare by consistently and transparently enforcing the regulations.”