DOCSLIB.ORG

IRB Approval Criteria: Confidentiality

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
IRB Approval Criteria: Confidentiality Office for the Protection of Research Subjects (OPRS) Institutional Review Board FWA# 00000083 201 AOB (MC 672) 1737 West Polk Street Chicago, IL 60612-7227 IRB Approval Criteria: Confidentiality Phone: 312 996-1711 Fax: 312 413-2929 Version: 1.3; Date: 02/21/2017 http://research.uic.edu/human-subjects-irbs/ Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair AAHRPP REF#: 160 AAHRPP Elements: II.3.E POLICY: I. The term “confidentiality” refers to the maintenance of the investigator’s agreement with the subject as to how a subject’s identifiable private information will be handled, managed, and disseminated. II. Most research studies require provisions for maintaining confidentiality of data. III. As a condition of protocol approval, the IRB determines that there are adequate provisions to protect confidentiality of information related to potential or current participants, throughout the study, including preliminary to the research, recruitment and enrollment, research participation and after conclusion of the research. IV. Researchers must incorporate within their protocols measures to maximize confidentiality to avoid unintentional and unauthorized release or other disclosures of identifiable private information. PROCEDURE: I. IRB Responsibilities A. The IRB in their review considers the nature, probability, and magnitude of harms that would be likely to result from an unauthorized release of the collected information. B. The IRB assesses the level of security and adequacy of protective measures required for each protocol based on the presence of identifiers, sensitivity of the data and risks of a breach. C. Provisions that the IRB may consider for maintaining confidentiality may include: 1. de-identification, 2. restricting PHI to a limited dataset, 3. substitution of code for subject identifiers, 4. storage of data in locked cabinets, 5. use of honest brokers, 6. encryption of electronic data, 7. storage behind a secure firewall, and Page 1 of 3 OVCR Document #0889 IRB Approval Criteria: Confidentiality, Version 1.3 8. statistical methods, such as a) inter-file linkage (i.e., procedures that eliminate linkage of data to unique identifiers), b) error inoculation (i.e., inserting random error into dataset to secure confidentiality while still allowing useful statistical analysis), c) top coding (i.e., replacing values above a certain level with a threshold value), d) bracketing and e) data brokering (e.g., a third party holds data and identifiers). UIC HSPP data security measures for PHI and other highly sensitive identifiable data are available in UIC HSPP policy Research Data Security). D. When identifiable data is obtained from participants in human subject research involving sensitive, stigmatizing or illegal characteristics, additional measures to protect confidentiality, such as waiver of documentation of consent or obtaining a certificate of confidentiality (refer to UIC HSPP Guidance for Investigators: Certificates of Confidentiality) should be considered. II. Investigator Responsibilities A. The investigator must document in the protocol and protocol application the identifiable data elements to be collected and the measures in place to secure the data throughout the study and at it end. B. Protocols should be designed to minimize the need to collect and maintain identifiable data about participants. If collection of identifiers is necessary, they should be removed and destroyed as soon as possible. C. The investigator must clearly disclose in the informed consent document the identifiable data elements to be collected, measures in place to secure the data, and circumstances under which confidential information may possibly be disclosed and to whom. III. National Institute of Justice Funded Research and Research Involving the Bureau of Prisons: Confidentiality A. Please refer to the UIC HSPP policy Research Involving Prisoners. REFERENCES: 21 CFR 56.111(a)(7) 45 CFR 46.111(a)(7) Page 2 of 3 OVCR Document #0889 IRB Approval Criteria: Confidentiality, Version 1.3 REVISION LOG: Version (#, date) Replaces (#, date) Summary of changes 1.1, 06/26/09 1.0, 10/15/08 Expanded agencies issuing certificates of confidentiality and inserted updated certificate of confidentiality language. 1.2, 04/03/2012 1.1, 06/26/09 Removed Certificate of confidentiality section to a separate guidance. Updated security measures looked at by the IRB and added NJI and Bureau of Prisons regulations.. 1.3, 02/21/17 1.2, 04/03/2012 Removed NJI and Bureau of Prisons regulations and replaced with referral to the Research Involving Prisoners policy. Addition of hyperlinks. Updating of logo. Page 3 of 3 OVCR Document #0889 .
Load more

Recommended publications
  • Confidentiality in Arbitration: Beyond the Myth Richard C
    University of Missouri School of Law Scholarship Repository Faculty Publications 2006 Confidentiality in Arbitration: Beyond the Myth Richard C. Reuben University of Missouri School of Law, [email protected] Follow this and additional works at: http://scholarship.law.missouri.edu/facpubs Part of the Dispute Resolution and Arbitration Commons, and the Evidence Commons Recommended Citation Richard C. Reuben, Confidentiality in Arbitration: Beyond the Myth, 54 U. Kan. L. Rev. 1255 (2006) This Article is brought to you for free and open access by University of Missouri School of Law Scholarship Repository. It has been accepted for inclusion in Faculty Publications by an authorized administrator of University of Missouri School of Law Scholarship Repository. Confidentiality in Arbitration: Beyond the Myth Richard C. Reuben* I. INTRODUCTION Confidentiality has long been part of the mythology of alternative dispute resolution (ADR). That is to say, one of the apparent virtues of ADR is that its processes have been viewed as confidential. This aspect of the mythology has come under more scrutiny in recent years, particularly in the mediation context.2 This is not surprising considering the popularity of mediation 3 and the centrality of confidentiality to the mediation process. 4 Confidentiality was the primary thrust of the Uniform Mediation Act (UMA), 5 and in their * Richard C. Reuben is an associate professor of law at the University of Missouri-Columbia School of Law. I would like to thank Chris Drahozal, Steve Ware, and the members of the Kansas Law Review for inviting me to participate in this symposium, and all of the symposium participants for their helpful comments.
    [Show full text]
  • Protecting Human Research Participants NIH Office of Extramural Research Introduction
    Protecting Human Research Participants NIH Office of Extramural Research Introduction Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. Who? This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research. What? This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Why? As a part of NIH's commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000.
    [Show full text]
  • The Hippocratic Oath and Principles of Medical Ethics
    MEDICINE AND PUBLIC POLICY The Hippocratic Oath and Principles of Medical Ethics Gilbert Berdine MD The Hippocratic Oath is associated with the morally right. This tradition remains in the modern practice of medicine, but over time fewer medical era. “As God is my witness I hereby pledge to …” can graduates have taken any form of the Hippocratic be found in modern rituals to stress the seriousness Oath. As of 2006, the State University of New York of purpose. Courts in the U.S. require prospective Upstate Medical School in Syracuse was the only witnesses to pledge their truthfulness: “Do you sol- U.S. medical school that administered the classic emnly swear or affirm that you will tell the truth, the version of the Hippocratic Oath to its graduates. The whole truth, and nothing but the truth, so help you Hippocratic Oath has been revised to make it more God?” This pledge becomes a source of contention in acceptable to modern schools, but the medical pro- a multi-cultural society as some members believe in fession no longer has a common set of promises that other deities. guide it. This article will look at the classic version of the Hippocratic Oath to see why it has been aban- Anyone who takes his or her religion seriously doned. Modern medical students wish to graduate would not pledge to a pagan god as this would be a into an ancient order of physicians, so they long for form of idolatry. This pledge is probably the main rea- a solemn ceremony, but it is difficult to craft a solemn son that the Oath has been abandoned in the modern ceremony that remains agreeable to a diverse group era, but what can take its place as a symbol of seri- of students.
    [Show full text]
  • Another Misunderstood Relation: Confidentiality and the Duty to Report Peter K
    Marquette University Law School Marquette Law Scholarly Commons Faculty Publications Faculty Scholarship 1-1-2001 Another Misunderstood Relation: Confidentiality and the Duty to Report Peter K. Rofes Marquette University Law School, [email protected] Follow this and additional works at: http://scholarship.law.marquette.edu/facpub Part of the Law Commons Publication Information Peter K. Rofes, Another Misunderstood Relation: Confidentiality and the Duty to Report, 14 Geo. J. Legal Ethics 621 (2001). Posted with permission of the publisher, The Georgetown Journal of Legal Ethics © 2001. Repository Citation Rofes, Peter K., "Another Misunderstood Relation: Confidentiality and the Duty to Report" (2001). Faculty Publications. Paper 292. http://scholarship.law.marquette.edu/facpub/292 This Article is brought to you for free and open access by the Faculty Scholarship at Marquette Law Scholarly Commons. It has been accepted for inclusion in Faculty Publications by an authorized administrator of Marquette Law Scholarly Commons. For more information, please contact [email protected]. Another Misunderstood Relation: Confidentiality and the Duty to Report PETER K. ROFES* INTRODUCTION: THE REPORTING DUTY AND ITS PARADOXES Over the past two decades, the duty imposed on most American lawyers to report the misconduct of their peers has garnered substantial attention across the professional landscape. From courts and state bar ethics committees to scholars, practitioners, and law students, the duty - once deemed a quaint aspirational guidepost of dubious practical importance - has increasingly engaged the resources of all segments of the profession. In particular, it would be no exaggeration to observe that the treatment of the reporting duty by courts and ethics committees has triggered a cottage industry of commentary, both in scholarly and professional journals and on the continuing legal education circuit.' * Professor of Law and Director of Part-time Legal Education, Marquette University Law School.
    [Show full text]
  • The Medlaw Update and Health Care Law Committee
    The newsletter of the Medical Liability The MedLaw Update and Health Care Law Committee 10/15/2018 Volume 23 Issue 2 Feature Article Deflating Plaintiffs’ Use of the Hippocratic Oath in Medical Negligence Cases By Matthew Moriarty Lawyers representing plaintiffs in medical neg- for simple sound bites they can later display to a jury. ligence cases often ask doctors about their Conceding these points can usually be avoided, however, having taken the Hippocratic Oath. They want because the Hippocratic Oath questions are built upon a to gain a simple concession from the physician complete myth; contrary to common belief, medical oaths that they swore to uphold the principle of “pri- do not contain such a statement of primary duty. mum non nocere,” which means “first do no harm.” Here is a typical exchange: A Short History of Medical Oaths Q: As part of your job, is one of your ultimate goals when The Hippocratic Oath is the earliest known expression of you have a patient who comes into the emergency room, to medical ethics in the western world. Like many ancient keep them safe from harm? texts, its origins are unclear and its evolution extensive. It Yes. is named after Hippocrates, a Greek physician who report- Q. And you take an oath to do that, right -- do no harm? edly lived from approximately 450–370 B.C.E. But modern scholars are quite certain he did not personally write the A. That is correct. That’s the Hippocratic Oath. oath, asserting the view that it was written by a Pythago- The concept that an oath can give rise to a duty, in and rean sect after studying what is known as the Hippocratic of itself, is not the problem.
    [Show full text]
  • Privacy and Confidentiality
    INSTITUTIONAL REVIEW BOARD THE UNIVERSITY OF UTAH Investigator Guidance Series PRIVACY AND CONFIDENTIALITY Description When thinking about privacy and confidentiality in the research context, distinctions should be made between the two issues. Privacy refers to persons and to their interest in controlling access of others to themselves. Privacy can be thought in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality is an extension of the concept of privacy, but it refers to the research participant’s understanding of (and agreement to) the ways that their identifiable information will be stored and shared. Identifiable information can include printed information, electronic data or media, or visual information (photographs, video records, etc.). The bottom line: Privacy refers to people; Confidentiality refers to data about people. The following are examples of methods used to protect privacy and confidentiality. Researchers will be asked to inform the IRB about the precautions and procedures employed to protect privacy and confidentiality with regard to his/her specific project. Different levels of protection are appropriate for different studies; the researcher should assume the IRB will require the highest level of protection for the most vulnerable population included in the study. Examples of Privacy Protections: • Interviewing participants about sensitive topics individually instead of in front of a group. • Interviewing the participant in their home or a private office instead of a public place. • Providing a private exam room for study procedures. • De-identifying photos, audio tapes, or videos tapes of the participant that will be made during the study.
    [Show full text]
  • Conference, Conciliation, and Persuasion: the Seventh Circuit’S Groundbreaking Approach to Analyzing the Eeoc’S Pre-Suit Obligations
    SEVENTH CIRCUIT REVIEW Volume 9, Issue 2 Spring 2014 CONFERENCE, CONCILIATION, AND PERSUASION: THE SEVENTH CIRCUIT’S GROUNDBREAKING APPROACH TO ANALYZING THE EEOC’S PRE-SUIT OBLIGATIONS LISA M. DELEON Cite as: Lisa M. Deleon, Conference, Conciliation, and Persuasion: The Seventh Circuit’s Groundbreaking Approach to Analyzing the EEOC’s Pre-Suit Obligations, 9 SEVENTH CIRCUIT REV. 370 (2014), at http://www.kentlaw.iit.edu/Documents /Academic Programs/7CR/v9-2/DeLeon.pdf. INTRODUCTION In 2013, the Seventh Circuit became the first circuit to explicitly reject an employer’s contention that an employment discrimination lawsuit should be dismissed because the Equal Employment Opportunity Commission (EEOC) failed to engage in out-of-court negotiation efforts with the employer before filing suit.1 In EEOC v. Mach Mining, LLC, the Seventh Circuit addressed the provision contained in Title VII of the Civil Rights Act of 1964 that requires the EEOC to satisfy certain conditions before it can file a discrimination lawsuit against an employer.2 One of these conditions is that the EEOC must engage in “informal methods of conference, conciliation, and persuasion.”3 The purpose of these pre-suit J.D. candidate, May 2014, Chicago-Kent College of Law, Illinois Institute of Technology; B.A., History and Legal Studies, Northwestern University. I would like to thank my professor, Hal Morris. I would also like to thank my family, especially my parents, Robert and Rose DeLeon, for all of their support. 1 EEOC v. Mach Mining, LLC, 738 F.3d 171, 172–73 (7th Cir. 2013). 2 Id. 3 Id. at 175.
    [Show full text]
  • EXAM QUESTIONS & ANSWERS LEGAL MEDICINE & MEDICAL Ethics Prepared by Prof. Ahmed Ammar
    EXAM QUESTIONS & ANSWERS LEGAL MEDICINE & MEDICAL ETHICs Prepared by Prof. Ahmed Ammar Arab Board, Bio-Ethics (medical Ethics questions) First part. Bioethics (general medical ethics) 1. The full version of the ‘Ought Implies ‘Can’ principle is ... a. Ought implies can, only when you can b. Ought implies can, and can not* c. Ought implies can (that’s it; what more do you want!) d. Ought implies can, and can implies ought e. Ought implies ought, and can implies can 2. Autonomy is one of the main principles of bioethics , which mean: a. Selfishness b. The right to be selfish c. Self-awareness d. Self-promotion e. Self-governance * 3. The four medical ethics principles which shared between Values Based Medicine and the principles of ethics, explained by Beauchamp and Childress are: a. Autonomy, privacy, respect, and confidentiality b. Veracity, privacy, beneficence, and nonmaleficence c. Autonomy, nonmaleficence, beneficence, and justice * d. Veracity, privacy, confidentiality, and fidelity e. Autonomy, veracity, nonmaleficence, and beneficence 4. Which of the following ethical issues form the foremost part of Hippocratic Oath? a. Confidentiality * b. Sexual boundaries c. Advertising d. Bribery e. Doctor’s rights 1 5. Paternalism among doctors is not an ethical attitude because it conflicts with a. Patient’s medical care b. Doctors’ tasks and duties c. Patient’s autonomy* d. Doctor’s autonomy e. Patient’s family rights 6. The concept of justice in ethics is: a. an obligation of the patient to the society. b. that the health resources must be distributed according to the principals of equity.* c. taken as patients right to choose or refuse treatment.
    [Show full text]
  • Donor Confidentiality Request
    2505 University Boulevard | P.O. Box 2230 | Ames, Iowa 50010-2230 phone 515.294.4607 | toll free 866.419.6768 | fax 515.294.6521 email [email protected] DONOR CONFIDENTIALITY REQUEST I/We, ______________________________________ have made or am/are contemplating making a gift, pledge or bequest commitment to the Iowa State University Foundation and hereby request that my/our identity not be disclosed by the foundation to the general public unless disclosure is required by law. I/We understand that the foundation generally wishes to encourage donors to allow their gifts to be publicized because publicity serves to encourage others to similarly support the foundation and Iowa State University, but that the foundation also recognizes and respects the desire of some donors not to have their identities disclosed to the public. I/We understand that as a result of this request, the only information the foundation will make available for general public examination is the amount and purpose of my/our gift(s), pledge(s) or bequest commitment(s), and that unless otherwise required by law my/our identity and other personal information will not be disclosed. I/We understand that I/we may withdraw this request as to any or all gifts, pledges or bequest commitments at any time. SCOPE OF REQUEST (complete only one of the following): This request shall apply to all gifts, pledges or bequest commitments I/we have made or may make at any time. This request shall apply only to the following specified gift(s), pledge(s) and/or bequest commitment(s) (use additional pages as needed): DURATION OF REQUEST: The foundation’s policy is that donor confidentiality will be preserved until the donor’s death.
    [Show full text]
  • Privacy and Confidentiality in Human Subjects Research
    Privacy and Confidentiality in Human Subjects Research March 29, 2008 Emory University IRB Sarah Putney Key Concepts: Privacy v. Confidentiality Privacy is a sphere of protection surrounding a person and his/her property or information, in which s/he can be let alone, without unwarranted interference or intrusion Confidentiality is the limited scope in which a person’s private information is shared with others Breach of confidentiality happens when a person’s private information is taken outside the scope of confidentiality by someone else (intentionally or not, with resulting harm or not) 2 Privacy, Confidentiality and the Belmont Report’s Big 3 Respect for persons (autonomy) Researchers actively protect subject’s privacy Comply with all applicable rules and laws, including HIPAA Researchers don’t breach confidentiality of subject’s private info Use appropriate data security measures 3 Privacy, Confidentiality and the Belmont Report’s Big 3 Beneficence Researchers maximize the benefits of the research to the subject, group, community or society Use of subject’s private info should be justified by benefit of research Researchers minimize harm from research, including breach of confidentiality and intrusions on privacy Data security Certificates of Confidentiality HIPAA compliance by covered entities and researchers working with them to use individually identifiable information 4 Privacy, Confidentiality and the Belmont Report’s Big 3 Justice Do the benefits of the research accrue to the persons whose individually identifiable,
    [Show full text]
  • GENETIC SECRETS: PROTECTING PRIVACY and CONFIDENTIALITY in the GENETIC ERA Mark A. Rothstein, Editor DISCLAIMER
    GENETIC SECRETS: PROTECTING PRIVACY AND CONFIDENTIALITY IN THE GENETIC ERA Mark A. Rothstein, editor DISCLAIMER This report was prepared as an account of work sponsored by an agency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, makes any warranty, express or implied, or assumes any legal liability or responsi- bility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Refer- ence herein to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, ream- mendation, or favoring by the United States Government or any agency thereof. The views and opinions of authors expressed herein do not necessarily state or reflect thost of the United States Government or any agency thereof. DISCLAIMER Portions of this document may be illegible electronic image products. images are produced from the best available original document. .. GENETIC SECRETS: PROTECTING PRIVACY AND CONFIDENTIALITY IN THE GENETIC ERA TABLE OF CONTENTS Page No. 1 Foreword - Arthur C. Upton Part I. Background CHAPTER 1 8 Genes, Genomes and Society Leroy Hood and Lee Rowen CHAPTER 2 47 Genetic Privacy: Emerging Concepts and Values Anita L. Allen, CHAPTER 3 101 Genetic Exceptionalism and "Future Diaries": Is Genetic Information Different from Other Medical Information? Thomas H. Murray Part 11. The Clinical Setting CHAPTER 4 125 Genetic Privacy in the Patient-Physician Relationship David Orentlicher CHAPTER 5 154 A Clinical Geneticist Perspective of the Patient-Physician Relationship Eugene Pergament CHAPTER 6 183 Privacy in Genetic Counseling Barbara B.
    [Show full text]
  • Clergy Counselors and Confidentiality: a Case for Scrutiny
    REGULAR ARTICLE Clergy Counselors and Confidentiality: A Case for Scrutiny Ezra E. H. Griffith, MD, and John L. Young, MD, MTh As religious organizations contribute increasingly to community mental health, counseling by clergy acquires greater significance. As a result, clergy confront from time to time ethics challenges resulting from the need to balance a commitment to clients and an obligation to follow the requirements of religious doctrine. The recent New York case of Lightman v. Flaum highlights an example of this dilemma. A woman who asked two rabbis (Flaum and Weinberger) for help in her marriage complained that they had violated the confidentiality she expected of them. The rabbis requested summary judgment based on religious grounds, and the trial court rejected their request. The state’s highest court concurred with an appeal court’s reversal of the trial court. We discuss the arguments raised in this case about the extent to which clergy may owe a duty of confidentiality to those who consult them for psychological help, and we also consider the religion-based arguments that would fashion an exception to confidentiality in this unique context. J Am Acad Psychiatry Law 32:43–50, 2004 Courts have insisted on treading lightly, if at all, in the case of Lightman v. Flaum,5 in which two rabbis disputes that arise from the interaction of clergy with were accused of breaching a parishioner’s confiden- their parishioners. This judicial caution is particu- tiality and bruiting abroad what she had told them in larly evident when clergy assert that their conduct, confidence when she consulted them for help with which was at the heart of the quarrel, was of a reli- her deteriorating marriage.
    [Show full text]