scholarly journals Analysis of Faculty Knowledge of Human Subjects Protections in Research

2016 ◽  
Vol 6 (4) ◽  
pp. 20
Author(s):  
Anissa Ybarra ◽  
Lori Kupczynski ◽  
Marie-Anne Mundy ◽  
Stephen D. Oller
Keyword(s):  
Higher Education ◽  
Human Subject ◽  
Human Subjects ◽  
Statistical Tests ◽  
Statistical Significance ◽  
Human Subject Research ◽  
Human Subjects Research ◽  
Faculty Knowledge ◽  
Research Protections ◽  
Faculty Experience

Institutions of higher education are continually engaging in human subject research at the faculty and student level. It is extremely important that all research involving human subjects is in compliance with the UnitedInstitutions of higher education are continually engaging in human subject research at the faculty and student level. It is extremely important that all research involving human subjects is in compliance with the United States (U.S.) Federal Policy for the Protection of Human Research Subjects. If faculty and students are not following the guidelines for the ethical conduct of human subject research, their institution will be at risk of losing any federal funding acquired through these studies and risk the possibility of having all research shut down. The lack of faculty knowledge in the area of human subjects research protections has been considered non-compliance for human subjects research. The purpose of this study was to determine if a significant relationship exists between the areas of faculty research experience in higher education and knowledge of the Total Governing Principles of U.S. Codes and Regulations. The study sought to find if faculty experience in research could predict their knowledge of human subjects research protections. In order to test each hypothesis, two statistical tests were conducted. A Multiple Linear Regression (MLR) was utilized as well as a One-Way Multivariate Analysis of Variance (MANOVA). Findings indicated that there is no statistical significance between the amount of faculty experience in research and their knowledge of the U.S. Codes and Regulations for human subjects research protections. States (U.S.) Federal Policy for the Protection of Human Research Subjects. If faculty and students are not following the guidelines for the ethical conduct of human subject research, their institution will be at risk of losing any federal funding acquired through these studies and risk the possibility of having all research shut down. The lack of faculty knowledge in the area of human subjects research protections has been considered non-compliance for human subjects research. The purpose of this study was to determine if a significant relationship exists between the areas of faculty research experience in higher education and knowledge of the Total Governing Principles of human subjects research protections U.S. Codes and Regulations. The study sought to find if faculty’s experience in research could predict their knowledge of human subjects research protections. In order to test each hypothesis, two statistical tests were conducted. A Multiple Linear Regression (MLR) was utilized as well as a One-Way Multivariate Analysis of Variance (MANOVA). Findings indicated that there is no statistical significance between the amount of faculty experience in research and their knowledge of the U.S. Codes and Regulations for human subjects research protections. 

scholarly journals Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation

2020 ◽  
pp. 155626462096898
Author(s):  
Jacob Szpernal ◽  
Joseph Carroll ◽  
Ryan Spellecy ◽  
Jane A. Bachman Groth
Keyword(s):  
Informed Consent ◽  
Adverse Effects ◽  
Vision Research ◽  
Human Subject ◽  
Human Subjects ◽  
Pupil Dilation ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Attitudes And Practices ◽  
Institutional Review

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.

Human Subjects Research Protections

2015 ◽  
pp. 1-20
Author(s):  
John R. Baumann ◽  
Heather Mullins-Owens ◽  
David Russell ◽  
Amy Waltz
Keyword(s):  
Human Subjects ◽  
Human Subjects Research ◽  
Research Protections

scholarly journals Conditions of Legality of Medical Human Subject Research

Medicne pravo ◽  
2021 ◽  
pp. 69-77
Author(s):  
M. V. Mendzhul
Keyword(s):  
Human Rights ◽  
Medical Research ◽  
Human Genome ◽  
Human Subject ◽  
Human Subjects ◽  
Research Process ◽  
Embryo Research ◽  
Human Subject Research ◽  
Nuremberg Code

The article examines international acts and national legislation and highlights the conditions for the legality of medical research with human participation. The provisions of the Nuremberg Code (1947), the Helsinki Declaration of the World Medical Association «Ethical principles for medical research involv- ing human subjects» (1964), the Universal Declaration on the Human Genome and Human Rights (1997), the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997) and the Addi- tional Protocols to the Convention, Regulation of the European Parliament and of the Council (EU) No 536/2014. The support of the recommendation to ratify the Convention on Human Rights and Biomedicine and its additional protocols in Ukraine has been expressed. It has been established that international acts stipulate that the design and implementation of each human subject research must be clearly described in the research protocol. In addition, research protocols must be subject to prior review by the Ethics Committees. It has been substantiated that international acts set for medical research standards, which are based on the principles of respect for dignity and human rights, the priority of interests of the person over the interests of society or sci- ence, compliance with safety requirements and prevention of harm to humans, mandatory permission to conduct medical examination, research and control- lability of the research process and its results, compensation for any damage caused by medical research. Conditions of legality of medical research can be divided into general (obser- vance of which is always necessary if a person participates in experiments) and special (additional conditions of legality, which are put forward depend- ing on the field or object of research, namely in the field of experiments com- bined with medical care , human genome research, in vitro embryo research, in the field of clinical trials of drugs).

scholarly journals Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?

2013 ◽  
Vol 41 (2) ◽  
pp. 440-453 ◽  
Author(s):  
Brett A. Williams ◽  
Leslie E. Wolf
Keyword(s):  
Human Services ◽  
Human Subjects ◽  
Regulatory System ◽  
Research Subjects ◽  
Human Subjects Research ◽  
Common Rule ◽  
Department Of Health ◽  
Initial Interaction ◽  
Research Protections ◽  
The Common

The U.S. Department of Health and Human Services (HHS) has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers.

scholarly journals Confronting and Resolving an Ethical Dilemma Associated with a Practice Based Evaluation Using Observational Methodology of Health Information Technology

2010 ◽  
Vol 01 (03) ◽  
pp. 244-255
Author(s):  
H.A. Taylor ◽  
P.S. Sockolow
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Health Information Technology ◽  
Health Information ◽  
Human Subject ◽  
Human Subjects ◽  
Human Subject Research ◽  
Actual Case ◽  
Clinic Management ◽  
Institutional Review

SummaryAs the adoption of health information technology (HIT) has escalated, efforts to evaluate its uptake have increased. The evaluation of HIT often requires direct observation of health care practitioners interacting with the system. When in the field, the evaluator who is not a trained health care provider may observe suboptimal use of the technology. If evaluators have plans to share the results of the evaluation at the conclusion of the study, they face a decision point about whether to disclose interim results and the implications of doing so. To provide HIT evaluators with guidance about what issues to weigh when observing the implementation of HIT, this paper presents a study of an actual case and discusses the following considerations: (1) whether the evaluation of HIT is considered to be human subject research; (2) if the evaluation is human subject research, whether the Institutional Review Board will consider it exempt from review or subjected to expedited or full review; and (3) how interim disclosure to the clinic management impacts the research study. The recommendations to evaluators include use of a protocol for interim disclosures to patients, clinicians, and/or clinical management for both quality assurance initiatives and human subjects research.

Symposium on Human Subjects Research: Redux

2002 ◽  
Vol 30 (3) ◽  
pp. 358-360
Author(s):  
Jesse A. Goldner
Keyword(s):  
Quality Improvement ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Institutional Review ◽  
New Directions ◽  
Short Run ◽  
Research Protections ◽  
Review Boards

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

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