[Nationally standardized broad consent in practice: initial experiences, current developments, and critical assessment]. / National standardisierter Broad Consent in der Praxis: erste Erfahrungen, aktuelle Entwicklungen und kritische Betrachtungen.

BACKGROUND: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites. METHODS: The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use. In addition, inquiries and feedback from a large number of stakeholders were evaluated. RESULTS: The online surveys showed that 27 of the 32 sites have gradually introduced the consent documents productively, with a current total of 173,289 consents. The analysis of the implementation procedures revealed heterogeneous organizational conditions at the sites. The requirements of various stakeholders were met by developing and providing supplementary versions of the consent documents and additional information materials. DISCUSSION: The introduction of the MII consent documents at the university hospitals creates a uniform legal basis for the secondary use of patient data. However, the comprehensive implementation within the sites remains challenging. Therefore, minimum requirements for patient information and supplementary recommendations for best practice must be developed. The further development of the national legal framework for research will not render the participation and transparency mechanisms developed here obsolete.

Obstetrician-Gynecologists' Practices in Postpartum Sterilization Without a Valid Medicaid Consent Form.

OBJECTIVE: To explore the practices of obstetrician-gynecologists (ob-gyns) in the United States surrounding postpartum sterilization when the Medicaid consent form was not valid. METHODS: Using the American College of Obstetricians and Gynecologists' online directory, we conducted a qualitative study where we recruited ob-gyns practicing in 10 geographically diverse U.S. states for a qualitative study using semi-structured interviews conducted by telephone. We analyzed interview transcripts using the constant comparative method and principles of grounded theory. RESULTS: Thirty ob-gyns (63% women, 77% nonsubspecialized, and 53% academic setting) were interviewed. Although most physicians stated that they did not perform sterilizations without a valid Medicaid sterilization form, others noted that they sometimes did due to a sense of ethical obligation toward their patient's health, being in a role with more authority or seniority, interpreting the emergency justification section of the form more broadly, or backdating the form. The physicians who said that they never went ahead without a signed form tended to work at large institutions and were concerned with losing funding and engaging in potentially illegal or fraudulent behavior. CONCLUSION: Physicians' varied behaviors related to providing postpartum sterilization without a valid Medicaid consent form demonstrate that the policy is in need of revision. Unclear terminology and ramifications of the Medicaid sterilization policy need to be addressed to ensure equitable care.

COVID-19 highlights the policy barriers and complexities of postpartum sterilization.

Multiple barriers exist to sterilization in the postpartum period. One such barrier, the Medicaid Title XIX sterilization policy, requires publicly insured patients to complete a sterilization consent form at least 30 days prior to their scheduled procedure. While this policy was set in place in the 1970s to address the practice of coerced sterilization among marginalized women, it has served as a significant barrier to obtaining the procedure in the contemporary period. The COVID-19 pandemic has highlighted specific complexities surrounding postpartum sterilization and created additional barriers for women desiring this contraceptive method. Despite the time constraints to perform postpartum sterilization, some hospital administrators, elective officials, and state Medicaid offices deemed sterilization as "elective." Additionally, as the Center for Medicare and Medicaid Services (CMS) has revised telemedicine reimbursement and encouraged its increased use, it has provided no guidance for the sterilization consent form, use of oral consents, and change to the sterilization consent form expiration date. This leaves individual states to create policies and recommended procedures that may not be accepted or recognized by CMS. These barriers put significant strain on patients attempting to obtain postpartum sterilization, specifically for patients with lower incomes and women of color. CMS can support reproductive health for vulnerable populations by providing clear guidance to state Medicaid offices, extending the 180-day expiration of a sterilization consent form signed prior to the pandemic, and allowing for telemedicine oral consents with witnesses or electronic signatures.

Legal policies of organ transplantation in India: Basics and beyond.

The Organ Transplantation Act issued by the Government of India 1994 has undergone major and minor changes in the form of addition of rules and amendments in order to improve the Act to make it much acceptable legally. Over a period of time, with an increase in cadaver organ donations, the rules and policies with regard to the same have been defined and redefined over the years. In this article, the Act, the rules, the amendments, the quick essentials of approach, and the forms are reviewed.

Opioid prescription and postoperative outcomes in pediatric patients.

OBJECTIVES/HYPOTHESIS: To determine if the amount of opioid prescribed and postoperative outcomes after adenotonsillectomy changed following implementation of mandated opioid consent forms. STUDY DESIGN: Retrospective cohort study. METHODS: Patients undergoing adenotonsillectomy 6 months before and after implementation of mandated opioid consent forms at a tertiary-care pediatric hospital were studied. Demographics, operative data, weight-based opioid dosage, and postoperative outcome measures, including nursing calls, emergency department (ED) visits, hospital readmission, and bleed rates, were collected and analyzed. RESULTS: Of 300 patients, opioid prescription was provided for 211 patients (70.3%), 112 preconsent (74.7%) and 99 postconsent (66.0%). Mean (standard deviation) total opioid prescribed (milligrams/kilogram) was significantly higher preconsent 4.8 (5.6) than postconsent 3.2 (4.7), (P = .003). There were no differences between number of nursing calls (P = .134) or ED visits (P = .083). Interestingly, preconsent patients had more hospital readmission for pain/dehydration (odds ratio OR: 368, P = .016) and bleeding concerns (OR: 244, P = .003). CONCLUSIONS: A mandated consent form prior to opioid prescription was associated with decreased overall opioid prescription without resultant increase in postoperative complications in pediatric patients. These data provide support for minimizing opioid prescription on a systems-based level. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:1477-1481, 2019.

Electronic processing of informed consents in a global pharmaceutical company environment.

We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.

Maintaining proper dental records.

Referred to as Standard of Care, the legal duty of a dentist requires exercising the degree of skill and care that would be exhibited by other prudent dentists faced with the same patient-care situation. Primarily, the goal of keeping good dental records is to maintain continuity of care. Diligent and complete documentation and charting procedures are essential to fulfilling the Standard of Care. Secondly, because dental records are considered legal documents they help protect the interest of the dentist and/or the patient by establishing the details of the services rendered. Patients today are better educated and more assertive than ever before and dentists must be equipped to protect themselves against malpractice claims. Every record component must be handled as if it could be summoned to a court room and scrutinized by an attorney, judge or jury. Complete, accurate, objective and honest entries in a patient record are the only way to defend against any clinical and/or legal problems that might arise. Most medical and dental malpractice claims arise from an unfavorable interaction with the dentist and not from a poor treatment outcome. By implementing the suggestions mentioned in this course, dental health care professionals can minimize the legal risks associated with the delivery of dental care to promote greater understanding for patients of their rights and privileges to their complete record.

Adding injury to injury: ethical implications of the Medicaid sterilization consent regulations.

The need for contraceptive and family planning services is often unmet, especially among lower-income women. However, the history of the provision of these services is fraught with coercion and mistrust: in 1979, in response to forced sterilization practices among doctors working with poor and minority populations, the U.S. Department of Health, Education, and Welfare imposed regulations on the informed consent process for Medicaid recipients requesting sterilization. The government mandated, among other requirements, a 30-day waiting period between consent and surgery and proscribed laboring women from providing consent. Initially intended to prevent the exploitation of poor women, these rules have instead become a barrier to many women receiving strongly desired, effective, permanent contraception. More critically, the regulations are ethically flawed: by preventing women from accessing needed family planning services, the Medicaid consent rules violate the standards of beneficence and nonmaleficence; by treating publically insured women differently from privately insured women, they fail the justice standard; and by placing constraints on women's free choice of contraceptive methods, they run afoul of the autonomy standard. The current federal sterilization consent regulations warrant revising. The new rules must simultaneously reduce barriers to tubal ligation while safeguarding the rights of women who have historically suffered mistreatment at the hands of the medical profession. These goals could best be obtained through a combined approach of improved clinician ethics education and a new standardized sterilization consent policy, which applies to all women and which abolishes the 30-day waiting period and the prohibition on obtaining consent in labor.

Compensation for research-related harm: the implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees.

BACKGROUND: The issue of what type of compensation a research participant would be entitled to in a clinical trial when they have signed an informed consent document excluding certain forms of compensation recently came before our courts in the matter of Venter v Roche Products (Pty) Limited and Others (Case No. 12285/08). In this case, the court had to consider whether the plaintiff, Mr Venter, was entitled to claim for non-medical costs such as pain and suffering, loss of income and general damages, even though the informed-consent document expressly excluded such claims. OBJECTIVES: To set out the facts, issues and judgment in the case, concluding with a discussion of the implications of the judgment for research ethics committees (RECs). METHODS: Critical review of a judgment of the Western Cape High Court. RESULTS: The court concluded that Mr Venter's application for damages should be dismissed because he had voluntarily agreed to the limited compensation as set out in the informed consent form that had been approved by both the local RECs and the Medicines Control Council. CONCLUSIONS: The Venter case has shown that delictual claims for research-related injuries will not be successful if plaintiffs have agreed to limit their own rights through signing an informed-consent form that limits compensation. This places an important obligation on RECs to ensure that they carefully review compensation clauses in informed-consent documents and that these are made clear to potential research participants.

Bridging consent: from toll bridges to lift bridges?

BACKGROUND: The ability to share human biological samples, associated data and results across disease-specific and population-based human research biobanks is becoming increasingly important for research into disease development and translation. Although informed consent often does not anticipate such cross-domain sharing, it is important to examine its plausibility. The purpose of this study was to explore the feasibility of bridging consent between disease-specific and population-based research. Comparative analyses of 1) current ethical and legal frameworks governing consent and 2) informed consent models found in disease-specific and population-based research were conducted. DISCUSSION: Ethical and legal frameworks governing consent dissuade cross-domain data sharing. Paradoxically, analysis of consent models for disease-specific and population-based research reveals such a high degree of similarity that bridging consent could be possible if additional information regarding bridging was incorporated into consent forms. We submit that bridging of consent could be supported if current trends endorsing a new interpretation of consent are adopted. To illustrate this we sketch potential bridging consent scenarios. SUMMARY: A bridging consent, respectful of the spirit of initial consent, is feasible and would require only small changes to the content of consents currently being used. Under a bridging consent approach, the initial data and samples collection can serve an identified research project as well as contribute to the creation of a resource for a range of other projects.

"Who owns your poop?": insights regarding the intersection of human microbiome research and the ELSI aspects of biobanking and related studies.

BACKGROUND: While the social, ethical, and legal implications of biobanking and large scale data sharing are already complicated enough, they may be further compounded by research on the human microbiome. DISCUSSION: The human microbiome is the entire complement of microorganisms that exists in and on every human body. Currently most biobanks focus primarily on human tissues and/or associated data (e.g. health records). Accordingly, most discussions in the social sciences and humanities on these issues are focused (appropriately so) on the implications of biobanks and sharing data derived from human tissues. However, rapid advances in human microbiome research involve collecting large amounts of data on microorganisms that exist in symbiotic relationships with the human body. Currently it is not clear whether these microorganisms should be considered part of or separate from the human body. Arguments can be made for both, but ultimately it seems that the dichotomy of human versus non-human and self versus non-self inevitably breaks down in this context. This situation has the potential to add further complications to debates on biobanking. SUMMARY: In this paper, we revisit some of the core problem areas of privacy, consent, ownership, return of results, governance, and benefit sharing, and consider how they might be impacted upon by human microbiome research. Some of the issues discussed also have relevance to other forms of microbial research. Discussion of these themes is guided by conceptual analysis of microbiome research and interviews with leading Canadian scientists in the field.

Response to Frederic Bretzner et al. "Target populations for first-in-human embryonic stem cell research in spinal cord injury".

We address concerns raised in this issue by Bretzner et al. (2011) by explaining the rationale for including subjects with subacute, neurologically complete spinal cord injuries in the Phase 1 trial of GRNOPC1. We also present elements of the informed consent process that minimize the likelihood of therapeutic misconception.