57 research outputs found
Investigatorsā Successful Strategies for Working with Institutional Review Boards
This study was designed to identify successful strategies used by investigators for working with their Institutional Review Boards (IRBs) in conducting human subjects research. Telephone interviews were conducted with 46 investigators representing nursing, medicine, and social work. Interview transcripts were analyzed using qualitative descriptive methods. Investigators emphasized the importance of intentionally cultivating positive relationships with IRB staff and members, and managing bureaucracy. A few used evasive measures to avoid conflict with IRBs. Few successful strategies were identified for working with multiple IRBs. Although most investigators developed successful methods for working with IRBs, further research is needed on how differences in IRB culture affect human subjects protection, and on best approaches to IRB approval of multi-site studies
Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?
In 2010 Largent, Wendler and Emanuel proposed the āconsent substitute modelā for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: (1) the research addresses the patientsā urgent medical needs (2) the riskābenefit ratio is favorable (3) there are no known conflicts with patientsā values or interests (4) cumulative net risk is minimal and (5) consent is given as soon as possible. We review national and international ethics laws, regulations and guidelines to determine (a) whether they accord with the consent substitute modelās five conditions and (b) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonisationās Guideline for Good Clinical Practice and the World Medical Associationās Declaration of Helsinki, are revised to include more specific provisions on emergency medical research
Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards
Although critically ill patients represent a vulnerable group of individuals, guidelines in research ethics assert that ethically acceptable research may proceed with such vulnerable subjects if additional safeguards are in place to minimize the risk of harm and exploitation. Such safeguards include the proper obtainment of informed consent that avoids the presence of the therapeutic misconception and the assessment of decisional capacity in critically ill patients recruited for research. Also discussed in this review are additional safeguards for such vulnerable subjects, as well as the issues involved with proxy consent. Heightened awareness to principles of ethics and provision of additional safeguards to enhance protections of vulnerable subjects would help to maintain the public trust in the research endeavor
Participant Perceptions of Twitter Research Ethics
Social computing systems such as Twitter present new research sites that have provided billions of data points to researchers. However, the availability of public social media data has also presented ethical challenges. As the research community works to create ethical norms, we should be considering usersā concerns as well. With this in mind, we report on an exploratory survey of Twitter usersā perceptions of the use of tweets in research. Within our survey sample, few users were previously aware that their public tweets could be used by researchers, and the majority felt that researchers should not be able to use tweets without consent. However, we find that these attitudes are highly contextual, depending on factors such as how the research is conducted or disseminated, who is conducting it, and what the study is about. The findings of this study point to potential best practices for researchers conducting observation and analysis of public data
About Research Participation
This website focuses on informing and educating the public about research and research participation. As an organization whose mission is to protect research participants and promote public trust in the research enterprise, OHRP is uniquely suited to help potential research participants navigate sometimes complicated considerations associated with research participation. The About Research Participation website has many useful resources in both English and Spanish. Our videos are the most popular and cover a diverse range of topics from clinical trials, randomization, informed consent, to institutional review boards. The website also provides a downloadable list of questions potential research participants could take with them to ask researchers. Finally, there is also a set of infographics to explain the protections research participants could expect.U.S. Department of Health & Human Serviceshttps://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/index.htm
- ā¦