Ethics Committee Experience with Emergency Exception from Informed Consent Protocols

2007 ◽  
Vol 2 (3) ◽  
pp. 23-30 ◽  
Author(s):  
Nicole M. DeIorio ◽  
Katie B. McClure ◽  
Maria Nelson ◽  
K. John McConnell ◽  
Terri A. Schmidt
Keyword(s):  
United States ◽  
Public Opinion ◽  
Informed Consent ◽  
Community Involvement ◽  
Human Subjects ◽  
Ethics Committee ◽  
Public Disclosure ◽  
Federal Regulations ◽  
Community Consultation ◽  
Consultation Process

Since 1996, U.S. federal regulations allow research without informed consent to study emergency conditions, if there is currently no satisfactory treatment for the condition, no time to obtain advance consent from the patient or representative, and if there is community involvement through a public disclosure and community consultation process. REB experiences since then are unknown. We surveyed REB chairpersons at the 126 United States medical schools to quantify reviewed protocols and identify attitudes about the rule, to better understand the rule's impact on REBs. Sixty-nine surveys were returned (55%). Fifty-two respondents reviewing human research had heard of the Rule. Forty-eight percent (25/52) had reviewed such a study; 40% of those had rejected at least one. Seventy-eight percent believe the rule protects human subjects, and 88% feel prepared to implement them. REB views differed from public opinion on how best to enact notification and consultation.

Maximizing value and minimizing barriers: Patient-centered community consultation for research in emergency settings

2016 ◽  
Vol 14 (1) ◽  
pp. 88-93 ◽  
Author(s):  
Christopher B Fordyce ◽  
Matthew T Roe ◽  
Neal W Dickert
Keyword(s):  
United States ◽  
Informed Consent ◽  
High Risk ◽  
The United States ◽  
Institutional Review Boards ◽  
Community Consultation ◽  
Patient Centered ◽  
Consultation Process ◽  
Institutional Review ◽  
The Impact

Background: Patients with cardiac arrest and other life-threatening emergencies are unable to provide prospective consent for clinical trials. In the United States and other countries, regulations permit an exception from the requirement for informed consent in emergency settings. However, many potential barriers exist, as evidenced by the scarcity of US trials conducted under exception from the requirement for informed consent. One persistent challenge is the requirement that investigators consult communities prior to study approval. Methods: To improve the community consultation process for emergency studies under exception from the requirement for informed consent, we propose that prioritizing engagement of individuals who have experienced the condition under study, or are at high risk for the condition, fulfills regulatory goals and represents the interests of potential enrollees and the community without impeding research. Results: Prioritizing patients engages individuals who are more likely to understand the concerns and experiences of study subjects, to appreciate risks and benefits of the study, and to understand the impact of the disease and intervention on patients’ lives than are members of the general public. Similarly, those explicitly at high risk are more likely to identify as potential participants and may impart some level of accountability on the investigator. Finally, the most logical community of relevance is defined by a combination of condition-related experience and living in the area where a study will be conducted; geographic and condition-related communities should not be treated as distinct. In this sense, patients, their family members, and individuals at high risk within the catchment area represent the appropriate “community.” Conclusion: Exception from the requirement for informed consent regulations have advanced the goal of improving care for emergency conditions, but common interpretations of the community consultation requirement threaten research in the United States. Focusing on the goals of learning from and demonstrating respect for those most directly affected by a study through engaging people most connected to the condition of interest will make community consultation more valuable, better inform institutional review boards, and increase efficiency.

Meeting Unique Requirements: Community Consultation and Public Disclosure for Research in Emergency Setting Using Exception from Informed Consent

2021 ◽  
Author(s):  
Neal W. Dickert ◽  
Kathleen Metz ◽  
Michael D. Fetters ◽  
Adrianne N. Haggins ◽  
Deneil K. Harney ◽  
...  
Keyword(s):  
Informed Consent ◽  
Emergency Setting ◽  
Public Disclosure ◽  
Community Consultation

When Scientists Deceive: Applying the Federal Regulations

2009 ◽  
Vol 37 (2) ◽  
pp. 344-350 ◽  
Author(s):  
Collin C. O'Neil ◽  
Franklin G. Miller
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Federal Regulations ◽  
Human Subjects Research ◽  
Legal Requirement ◽  
Research On Human Subjects ◽  
Material Information ◽  
The U.S

Informed consent is a basic ethical and legal requirement for human subjects research. The U.S. federal regulations governing research on human subjects stipulate general requirements for informed consent. Investigators are required to disclose to prospective subjects material information about the purpose, procedures, and likely consequences of the study, among other things. However, investigators sometimes employ deception for methodological reasons. In order to keep subjects’ responses unbiased, investigators deceive subjects about such things as the fact that they are taking part in research, the purpose of the research, the research interventions or interactions, or the likely consequences of those interventions or interactions. When investigators deceive subjects about such aspects of a study, the study fails to meet these general requirements for informed consent.

scholarly journals Preliminary Experience With Social Media for Community Consultation and Public Disclosure in Exception From Informed Consent Trials

Circulation ◽  
2013 ◽  
Vol 128 (3) ◽  
pp. 267-270 ◽  
Author(s):  
Shannon W. Stephens ◽  
Carolyn Williams ◽  
Randal Gray ◽  
Jeffrey D. Kerby ◽  
Henry E. Wang
Keyword(s):  
Social Media ◽  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation

Implementing Emergency Research Requiring Exception From Informed Consent, Community Consultation, and Public Disclosure

2007 ◽  
Vol 50 (4) ◽  
pp. 448-455.e4 ◽  
Author(s):  
Joshua G. Salzman ◽  
Ralph J. Frascone ◽  
Bobette K. Godding ◽  
Terry A. Provo ◽  
Elie Gertner
Keyword(s):  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation ◽  
Emergency Research

scholarly journals Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

2014 ◽  
Vol 12 (1) ◽  
pp. 67-76 ◽  
Author(s):  
Maija Holsti ◽  
Roger Zemek ◽  
Jill Baren ◽  
Rachel M Stanley ◽  
Prashant Mahajan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation

scholarly journals Minimising Community Opposition to Wind Farm Developments in New Zealand: Opportunities in Renewable Energy Planning

2021 ◽  
Author(s):  
◽  
Christian Berg
Keyword(s):  
New Zealand ◽  
Community Involvement ◽  
Wind Farm ◽  
Public Involvement ◽  
Planning Process ◽  
Wind Farms ◽  
Benefit Sharing ◽  
Community Consultation ◽  
Consultation Process ◽  
Public Opposition

<p>The erection of wind turbines, depending on their location, could significantly interfere with appreciated landscape values of a community, and consequently lead to its objection to a proposed wind energy project. This study explores possible options, which can be applied within the community consultation process to reduce the likelihood of substantial public opposition to wind farm developments in New Zealand. The research topic was chosen to support wind farm planners and decision makers in the consultation process for wind farm developments in order to increase public acceptance of a proposed project, to evaluate possibilities of benefit sharing and public involvement, to select the most appropriate level of community participation in the planning process and consequently to enhance the ability in gaining resource consent under the Resource Management Act 1991. The investigation covers the sequential development of public attitudes towards wind farms, the wider spectrum of public opposition, including vocalised reasons and hidden arguments, community consultation approaches and the different levels of public involvement. The applied methodology for this research comprises a case study approach concerning a New Zealand wind farm including an analysis of submissions made into the resource consent process, follow-up interviews with affected stakeholders, an interview with a wind farm developer, and a comprehensive text analysis. There are various opportunities to increase acceptance of wind farms including aesthetical design, sensitive siting, a pro-active approach, stakeholder analysis, participation and community ownership schemes. The results also demonstrate that increased community involvement may potentially satisfy consulted stakeholders, but could jeopardise obtaining resource consent under the current planning regime.</p>

scholarly journals Minimising Community Opposition to Wind Farm Developments in New Zealand: Opportunities in Renewable Energy Planning

2021 ◽  
Author(s):  
◽  
Thesis Depositor
Keyword(s):  
New Zealand ◽  
Community Involvement ◽  
Wind Farm ◽  
Public Involvement ◽  
Planning Process ◽  
Wind Farms ◽  
Benefit Sharing ◽  
Community Consultation ◽  
Consultation Process ◽  
Public Opposition

<p>The erection of wind turbines, depending on their location, could significantly interfere with appreciated landscape values of a community, and consequently lead to its objection to a proposed wind energy project. This study explores possible options, which can be applied within the community consultation process to reduce the likelihood of substantial public opposition to wind farm developments in New Zealand. The research topic was chosen to support wind farm planners and decision makers in the consultation process for wind farm developments in order to increase public acceptance of a proposed project, to evaluate possibilities of benefit sharing and public involvement, to select the most appropriate level of community participation in the planning process and consequently to enhance the ability in gaining resource consent under the Resource Management Act 1991. The investigation covers the sequential development of public attitudes towards wind farms, the wider spectrum of public opposition, including vocalised reasons and hidden arguments, community consultation approaches and the different levels of public involvement. The applied methodology for this research comprises a case study approach concerning a New Zealand wind farm including an analysis of submissions made into the resource consent process, follow-up interviews with affected stakeholders, an interview with a wind farm developer, and a comprehensive text analysis. There are various opportunities to increase acceptance of wind farms including aesthetical design, sensitive siting, a pro-active approach, stakeholder analysis, participation and community ownership schemes. The results also demonstrate that increased community involvement may potentially satisfy consulted stakeholders, but could jeopardise obtaining resource consent under the current planning regime.</p>

Disability, Vulnerability, and the Capacity to Consent

2019 ◽  
pp. 67-76 ◽  
Author(s):  
Stephanie Patterson ◽  
Pamela Block
Keyword(s):  
United States ◽  
At Risk ◽  
Informed Consent ◽  
Civil Rights ◽  
Personal Autonomy ◽  
Human Subjects ◽  
Mental Disability ◽  
Cognitive Disability ◽  
Disabled People ◽  
Ability To Consent

Does having a diagnosis of intellectual or cognitive disability automatically render a person vulnerable and unable to give informed consent to participate in research? Discussions over a proposed change in United States Federal Human Subjects language brought these issues into keen focus. People who are identified as having a cognitive or mental disability may be no more at risk for abuse in participating in research than non-disabled people and may have equal ability to provide informed consent. We assert that a focus on the ability to consent and power to resist manipulation is a more helpful dividing line than a disability or impairment category. We ask the question: How do we assure personal autonomy when the mechanisms to establish capacity are discriminatory and in violation of a person’s civil rights.

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