Additional Steps for Maintaining Public Trust in the FDA.

This letter responds to the essay "Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines," by Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman, in the special report "Time to Rebuild: Essays on Trust in Health Care and Science," in the September-October 2023 issue of the Hastings Center Report.

Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman Reply.

The authors respond to a letter by Mitchell Berger in the March-April 2024 issue of the Hastings Center Report concerning their essay "Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines."

Is sexual misconduct training sufficient in the UK's medical schools: Results of a cross-sectional survey and opportunities for improvement.

Objective: Sexual misconduct adversely affects the mental and physical health of millions of people each year and has been declared a global pandemic. Incidence in both educational and clinical settings remains high. In the last 5 years, the NHS spent over £4 million settling sexual misconduct-related claims. Effective prevention requires training across all stages of career, beginning in clinical school. Here, we explore training in the UK's medical schools to identify provision and areas for improvement. Design: Freedom of Information Act 2000 requests for data on training delivery and curricula content. Setting: 34 public UK universities offering medical education. Participants: not applicable. Main Outcome Measures: Provision and delivery of training, mode of delivery, theme, and continuation of training. Results: All 34 universities responded. Twenty-two identified offering training. Seventeen made it compulsory. A review of curricula identified, however, only 18 did more just than mentioned sexual misconduct. Nine offered training more than once. Twelve did not offer training, of which three identified no plans to offer such training in the future. The most common delivery modes for training were workshops and lectures. The training was most often within the sexual health curriculum, disconnecting it from professionalism. Conclusions: There is no standardisation of sexual harassment training across the UK's public medical schools. Many future doctors will not have received relevant education when they assume posts in the NHS. Considering the magnitude of this issue and its critical connection to professionalism and collegiality, universities and professional bodies urgently should address this deficiency.

Fit-testing of respiratory protective equipment in the UK during the initial response to the COVID-19 pandemic.

BACKGROUND: Public Health England guidance stipulates the use of filtering facepiece (FFP3) masks for healthcare workers engaged in aerosol-generating procedures. Mask fit-testing of respiratory protective equipment is essential to protect healthcare workers from aerosolized particles. AIM: To analyse the outcome of mask fit-testing across National Health Service (NHS) hospitals in the UK during the first wave of the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Using the Freedom of Information Act, 137 NHS hospitals were approached on May 26th, 2020 by an independent researcher to provide data on the outcome of fit-testing at each site. FINDINGS: Ninety-six hospitals responded to the request between May 26th, 2020 to October 29th, 2020. There was a total of 86 mask types used across 56 hospitals, 13 of which were used in at least 10% of these hospitals; the most frequently used was the FFP3M1863, used by 92.86% of hospitals. Overall fit-testing pass rates were provided by 32 hospitals with mean pass rate of 80.74%. The most successful masks, in terms of fit-test failure rates, were the Alpha Solway 3030V and the Alpha Solway S-3V (both reporting mean fit-test failures of 2%). Male- and female-specific pass and failure rates were provided by seven hospitals. Across the seven hospitals, 20.1% of men tested failed the fit-test for all masks used, whereas 19.9% of women tested failed the fit-test for all masks used. Failure rates were significantly higher in staff from Black, Asian, and Minority Ethnic (BAME) backgrounds 644/2507 (25.69%) across four hospitals. CONCLUSION: Twenty percent of healthcare workers tested during the first response to the pandemic failed fit-testing for masks. A small sample revealed that this was most prominent in staff from BAME backgrounds.

Systematic overview of Freedom of Information Act requests to the Department of Health and Human Services from 2008 to 2017.

BACKGROUND: The Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. We characterized FOIA requests to Department of Health and Human Services (HHS) agencies, including request outcomes, processing times, backlogs, and costs. METHODS: Using HHS FOIA annual reports, we extracted data on the number of FOIA requests received and processed by HHS agencies between 2008 and 2017, as well as request outcomes. Processing times were reported in three time increments, < 1-20, 21-60, or 61+ days, and trends in backlog status were also described. Information about costs and fees collected were aggregated. RESULTS: Between 2008 and 2017, 69.6% of 530,094 HHS FOIA requests were received by the Centers for Medicare and Medicaid Services (CMS), 18.9% by the Food and Drug Administration (FDA), and 11.6% by all other HHS agencies. During this period, CMS processed 374,728 requests, FDA 114,938, and other HHS agencies 61,890. CMS and FDA reduced backlogged requests by 9396 (89.7%) and 4289 (65.3%), respectively, leaving backlogs of 1081 and 2279 requests at the end of 2017. CMS fully or partially granted 60.3% of requests whereas FDA fully or partially granted 72.4%. Of all requests to CMS, 82.0% were considered simple and 18.0% complex; 82.2% of simple requests and 54.9% of complex requests were processed in 20 days, and 5.6% and 29.9% were processed in 61+ days. In contrast, 60.2% of requests to FDA were considered simple and 39.8% complex; 28.8% of simple requests and 9.0% of complex requests were processed in 20 days, and 58.3% and 81.5% were processed in 61+ days. The costs to HHS associated with FOIA requests totaled $446.4 million ($809 per processed request), increasing from $28.1 million ($423 per request) in 2008 to $53.3 million ($1544 per request) in 2017. In total, HHS collected $8.5 million in fees (1.9% of total costs). CONCLUSIONS: FOIA is frequently used to obtain information about HHS and its agencies. With growing costs, minimal fees collected, and lengthy processing times, HHS agencies' FOIA programs might be made more efficient through greater proactive record disclosure.

A cross-sectional study of all clinicians' conflict of interest disclosures to NHS hospital employers in England 2015-2016.

OBJECTIVE: We set out to document how NHS trusts in the UK record and share disclosures of conflict of interest by their employees. DESIGN: Cross-sectional study of responses to a Freedom of Information Act request for Gifts and Hospitality Registers. SETTING: NHS Trusts (secondary/tertiary care organisations) in England. PARTICIPANTS: 236 Trusts were contacted, of which 217 responded. MAIN OUTCOME MEASURES: We assessed all disclosures for completeness and openness, scoring them for achieving each of five measures of transparency. RESULTS: 185 Trusts (78%) provided a register. 71 Trusts did not respond within the 28 day time limit required by the FoIA. Most COI registers were incomplete by design, and did not contain the information necessary to assess conflicts of interest. 126/185 (68%) did not record the names of recipients. 47/185 (25%) did not record the cash value of the gift or hospitality. Only 31/185 registers (16%) contained the names of recipients, the names of donors, and the cash amounts received. 18/185 (10%) contained none of: recipient name, donor name, and cash amount. Only 15 Trusts had their disclosure register publicly available online (6%). We generated a transparency index assessing whether each Trust met the following criteria: responded on time; provided a register; had a register with fields identifying donor, recipient, and cash amount; provided a register in a format that allowed further analysis; and had their register publicly available online. Mean attainment was 1.9/5; no NHS trust met all five criteria. CONCLUSION: Overall, recording of employees' conflicts of interest by NHS trusts is poor. None of the NHS Trusts in England met all transparency criteria. 19 did not respond to our FoIA requests, 51 did not provide a Gifts and Hospitality Register and only 31 of the registers provided contained enough information to assess employees' conflicts of interest. Despite obligations on healthcare professionals to disclose conflicts of interest, and on organisations to record these, the current system for logging and tracking such disclosures is not functioning adequately. We propose a simple national template for reporting conflicts of interest, modelled on the US 'Sunshine Act'.

Professional Standards Review Organizations and confidentiality: the question of public access to medical peer review data through the Freedom of Information Act.

The degree of confidentiality to be accorded data gathered and analyzed by Professional Standards Review Organizations (PSROs) in the course of their medical peer review activities is a crucial and controversial issue in health policy. In late 1977, a consumer organization in Washington, D.C. sought access to data in the hands of the local PSRO through a lawsuit under the Freedom of Information Act, touching off a continuing debate throughout the country. That lawsuit is now on appeal. The courts, the Congress, and the Department of Health and Human Services have all been involved in the ongoing controversy. PSROs, practicing physicians, and health care consumers all have an interest in the outcome. This article analyzes the PSRO Program and its data confidentiality problems, examines in detail the lawsuit that sparked the controversy, and assesses the overall impact of this case on the PSRO program and on federal regulation of the health care system in general.

Can patients safely read their psychiatric records? Implications of freedom of information legislation.

OBJECTIVE: To assess how suitable psychiatric medical records are for access by patients. DESIGN: We examined a random selection of psychiatric records to identify features which we thought might be confusing or injurious to a patient reading his or her own record. RESULTS: Potentially offensive, alarming or upsetting entries were found in most records. CONCLUSION: Clinicians need to take care in recording information in medical records lest patients be adversely affected by the experience of reading their notes. Access should always be arranged in conjunction with a medical supervisor.

The effects of the Freedom of Information Act on research.

KIE: Use of the Freedom of Information Act can be potentially harmful to the security of research in progress. There is no protection from disclosure of information in grant applications; collected research data can be obtained and disclosed prematurely; and data supporting published research may be acquired and re-analyzed in a faulty manner. Greater secretiveness and competition will result from a requirement to surrender research data on demand. Scientists are urged to refrain from invoking FOIA.^ieng

Benavides v. U.S. Bureau of Prisons.

KIE: The U.S. Court of Appeals, District of Columbia Circuit, held that merely complying with government regulations regarding the release of medical records fails to satisfy the Bureau of Prisons' obligation to provide prisoners access to such information. Prisoners have an unqualified right of access to these records, provided the documents are deemed non-exempt by the Privacy Act of 1974. The obligation to disclose personal information to a patient is not alleviated by disclosure to a designated doctor or other third party. The court found that potential harm resulting from unrestricted access to medical or psychological records could be limited by special procedures, provided agencies guarantee the ultimate disclosure of the non-exempt information. The court reversed the district court's decision in favor of the Bureau and remanded the case for further proceedings consistent with the appeals court opinion.^ieng