Implications of the Revised Common Rule for Qualitative Health Research: Opportunities, Concerns, and Recommendations

2021 ◽  
pp. 104973232110611
Author(s):  
Jill Owczarzak ◽  
Katherine C. Smith
Keyword(s):  
Qualitative Research ◽  
Health Research ◽  
Behavioral Interventions ◽  
Behavioral Science ◽  
Human Subjects ◽  
Important Change ◽  
Research Subjects ◽  
Common Rule ◽  
Qualitative Health Research ◽  
Ethical Oversight

In January 2019, revisions to federal regulations that outline requirements for ethical oversight of human subjects research (The Revised Common Rule) went into effect. These revisions reflect major changes in thinking about risk and protection of research subjects. The Revised Common Rule (RCR) considerably curtails federal oversight of social and behavioral science, with most non-interventional research and “benign” behavioral interventions becoming exempt from mandated Institutional Review Board (IRB) approval, although determination of exemption remains with IRBs. As two qualitative health researchers serving on IRBs, we consider how this contraction of federal oversight dovetails with longstanding criticisms of IRB oversight of qualitative research. We explore the passage of the RCR as a point of potentially important change in procedure and principle in relation to ethical oversight of qualitative health research. We identify challenges and opportunities with these changes at the institutional, professional, and individual levels for ethical and impactful qualitative research.

Points of Hesitation

2011 ◽  
Vol 4 (2) ◽  
pp. 209-218 ◽  
Author(s):  
Julianne Cheek
Keyword(s):  
Qualitative Research ◽  
Human Rights ◽  
Social Justice ◽  
Health Research ◽  
Critical Issue ◽  
Qualitative Inquiry ◽  
Qualitative Health Research ◽  
Over Time

Qualitative health research has long had as one of its mantras a commitment to, and focus on, human rights and social justice. However over time, it is possible that such centrality can have the effect of creating a sense of the familiar, and with such familiarity assumptions about how human rights and social justice are being advanced through the process of qualitative inquiry. A sense of comfort or even complacency can emerge that may sometimes obstruct or prevent us from pausing to think deeply and re-examine these assumptions and how they impact on our thinking and actions as qualitative researchers. This paper aims to surface questions designed to produce points of hesitation able to assist in exploring the critical issue of how qualitative research does, and might, fit with an agenda based around the advancement of human rights and social justice. Using examples from my own research I explore and reflect on issues that have troubled me and subsequently forced me to hesitate and think deeply about what may have seemed self evident or given.

scholarly journals The relevance of philosophical hermeneutics in qualitative research

1996 ◽  
Vol 1 (3) ◽  
pp. 3-9
Author(s):  
Nicholas Procter
Keyword(s):  
Qualitative Research ◽  
Full Text ◽  
Health Research ◽  
Philosophical Hermeneutics ◽  
Qualitative Health Research ◽  
The Way

Within a framework informed by the rhetoric of contemporary ethnography, philosophical hermeneutics, and nursing scholarship, this article focuses on the way data could be interpreted in qualitative health research. Opsomming Binne 'n raamwerk, omvorm deur die retoriek van kontemporere etnografie; filosofiese hermeneutiek en verpleegkundige vakkunde, fokus hierdie artikel op die wyse waarop data binne kwalitatiewe gesondheidsnavorsing, geinterpreteer kan word. *Please note: This is a reduced version of the abstract. Please refer to PDF for full text.

scholarly journals Qualitative Research Ethics: Enhancing Evidence-Based Practice in Physical Therapy

2010 ◽  
Vol 90 (4) ◽  
pp. 615-628 ◽  
Author(s):  
Anne Townsend ◽  
Susan M. Cox ◽  
Linda C. Li
Keyword(s):  
Health Care ◽  
Qualitative Research ◽  
Physical Therapy ◽  
Research Ethics ◽  
Health Research ◽  
Research Study ◽  
Ethical Issues ◽  
Evidence Based Practice ◽  
Evidence Based ◽  
Qualitative Health Research

BackgroundIncreasing challenges to health care systems and the prominence of patient-centered care and evidence-based practice have fostered the application of qualitative approaches in health care settings, prompting discussions of associated ethical issues in a range of disciplines.ObjectivesThe purposes of this work were to identify and describe the application and value of qualitative health research for physical therapy and to identify ethical considerations in a qualitative research study.DesignThis was a qualitative interview study with telephone follow-ups.MethodsForty-six participants were interviewed about their early experiences with rheumatoid arthritis. They also were asked what motivated them to volunteer for the study. To inform the discussion of ethics in qualitative health research, this study drew on the in-depth interviews, took a descriptive approach to the data, and applied the traditional ethical principles of autonomy, justice, and beneficence to the study process.ResultsEthical issues emerged in this qualitative health research study that were both similar to and different from those that exist in a positivist paradigm (eg, clinical research). With flexibility and latitude, the traditional principle approach can be applied usefully to qualitative health research.ConclusionsThese findings build on previous research and discussion in physical therapy and other disciplines that urge a flexible approach to qualitative research ethics and recognize that ethics are embedded in an unfolding research process involving the role of the subjective researcher and an active participant. We suggest reflexivity as a way to recognize ethical moments throughout qualitative research and to help build methodological and ethical rigor in research relevant to physical therapist practice.

scholarly journals The relevance of philosophical hermeneutics in qualitative research

1996 ◽  
Vol 1 (3) ◽  
Author(s):  
Nicholas Procter
Keyword(s):  
Qualitative Research ◽  
Health Research ◽  
Philosophical Hermeneutics ◽  
Qualitative Health Research ◽  
The Way

Within a framework informed by the rhetoric of contemporary ethnography, philosophical hermeneutics, and nursing scholarship, this article focuses on the way data could be interpreted in qualitative health research. OpsommingBinne 'n raamwerk, omvorm deur die retoriek van kontemporere etnografie; filosofiese hermeneutiek en verpleegkundige vakkunde, fokus hierdie artikel op die wyse waarop data binne kwalitatiewe gesondheidsnavorsing, gemterpreteer kan word.

Themes, Theories, and Models

2018 ◽  
Vol 28 (3) ◽  
pp. 339-345 ◽  
Author(s):  
David L. Morgan
Keyword(s):  
Qualitative Research ◽  
Health Research ◽  
Theory Building ◽  
Low Level ◽  
Qualitative Health Research

Although theory building is often described as the ultimate goal of qualitative research, an examination of articles in Qualitative Health Research ( QHR) shows that themes are actually the typical format for reporting results. In addition, articles that rely on themes often present low-level theories in the form of models that connect these themes. Because models have received less attention than either themes or theories, this article concentrates on summarizing four different kinds of models: hierarchies, timelines, processes, and cycles. In each of these cases, it presents both a general illustration of such a model and a realistic example from a published article in QHR. It concludes with a call for greater recognition of the role that models play in capturing the results of qualitative research.

scholarly journals Enabling qualitative research data sharing using a natural language processing pipeline for deidentification: moving beyond HIPAA Safe Harbor identifiers

JAMIA Open ◽  
2021 ◽  
Vol 4 (3) ◽  
Author(s):  
Aditi Gupta ◽  
Albert Lai ◽  
Jessica Mozersky ◽  
Xiaoteng Ma ◽  
Heidi Walsh ◽  
...  
Keyword(s):  
Qualitative Research ◽  
Natural Language Processing ◽  
Natural Language ◽  
Language Processing ◽  
Health Research ◽  
Qualitative Data ◽  
Research Data ◽  
Computational Techniques ◽  
Safe Harbor ◽  
Qualitative Health Research

Abstract Objective Sharing health research data is essential for accelerating the translation of research into actionable knowledge that can impact health care services and outcomes. Qualitative health research data are rarely shared due to the challenge of deidentifying text and the potential risks of participant reidentification. Here, we establish and evaluate a framework for deidentifying qualitative research data using automated computational techniques including removal of identifiers that are not considered HIPAA Safe Harbor (HSH) identifiers but are likely to be found in unstructured qualitative data. Materials and Methods We developed and validated a pipeline for deidentifying qualitative research data using automated computational techniques. An in-depth analysis and qualitative review of different types of qualitative health research data were conducted to inform and evaluate the development of a natural language processing (NLP) pipeline using named-entity recognition, pattern matching, dictionary, and regular expression methods to deidentify qualitative texts. Results We collected 2 datasets with 1.2 million words derived from over 400 qualitative research data documents. We created a gold-standard dataset with 280K words (70 files) to evaluate our deidentification pipeline. The majority of identifiers in qualitative data are non-HSH and not captured by existing systems. Our NLP deidentification pipeline had a consistent F1-score of ∼0.90 for both datasets. Conclusion The results of this study demonstrate that NLP methods can be used to identify both HSH identifiers and non-HSH identifiers. Automated tools to assist researchers with the deidentification of qualitative data will be increasingly important given the new National Institutes of Health (NIH) data-sharing mandate.

Currents in Contemporary Ethics

2005 ◽  
Vol 33 (1) ◽  
pp. 154-159 ◽  
Author(s):  
Mark A. Rothstein
Keyword(s):  
Privacy Protection ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Common Rule ◽  
Privacy Rule ◽  
Institutional Review ◽  
The Common ◽  
Protection Of Human Subjects ◽  
Privacy Issues

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.

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.

The Invisible Vulnerable: The Economically and Educationally Disadvantaged Subjects of Clinical Research

2003 ◽  
Vol 31 (1) ◽  
pp. 149-153 ◽  
Author(s):  
T. Howard Stone
Keyword(s):  
Human Subjects ◽  
Disabled Persons ◽  
Federal Regulations ◽  
Research Subjects ◽  
Undue Influence ◽  
Common Rule ◽  
Educationally Disadvantaged ◽  
Mentally Disabled ◽  
The Common ◽  
Protection Of Human Subjects

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

scholarly journals The need for adequate ethical guidelines for qualitative health research

2008 ◽  
Vol 13 (2) ◽  
pp. 303-311 ◽  
Author(s):  
Iara Coelho Zito Guerriero ◽  
Sueli Gandolfi Dallari
Keyword(s):  
Qualitative Research ◽  
Social Change ◽  
Health Research ◽  
Hypothesis Test ◽  
Ethical Guidelines ◽  
Ethical Implications ◽  
Qualitative Health Research ◽  
History Of ◽  
The Way

This paper discusses adequacy as to the application of Brazilian guidelines, Resolution 196/96¹ and complementaries to qualitative health researches, considering that these are based on non-positivistic paradigms. Frequently, decisions about the research are made together with the studied community. There is a concern with justice and social change. And, since subjectivity can be considered their privileged instrument, such researchers seek a balance between objectivity and subjectivity, discussing how to overcome the researcher's view. We have studied the application and the concept of research found in international and in the Brazilian guidelines. We have noticed that they adopt a positivist conception of research, which establishes 1) the hypothesis test, 2) that all procedures are previously defined by the researcher; 3) neutrality of the researcher and of the knowledge produced. We will present some characteristics of qualitative research; the ethical implications in the way as qualitative research is conceived in non-positivist paradigms and a brief history of these guidelines. Our conclusion: it is inadequate to analyze qualitative researches using these documents, and we suggest the design of specific guidelines for them.

Sign in / Sign up

Export Citation Format

Share Document