Ethical and Regulatory Considerations in Nursing Research

1. Ethical and Regulatory Considerations in Nursing Research May 22, 2014 Associate Professor of NursingMount Carmel College of Nursing Darrell Spurlock, Jr. PhD, RN, NEA-BC

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3. Presentation Objectives Identify authoritative ethical and regulatory resources important to nurse researchers Describe ethical considerations for nursing research Differentiate research from quality improvement, from a regulatory perspective

4. Authoritative Ethical and Regulatory Resources

5. ANA Code of Ethics for Nurses • Available online at http://bit.ly/anacode • Because nursing research is an element of nursing practice, the ANA Code of Ethics for Nurses with Interpretive Statements (2001) is applicable • General principles from the Code apply to many domains of nursing research practice • Respect for human dignity • The right to self-determination • Relationships to patients

6. ANA Code of Ethics for Nurses • Provision 3.3: Protection of research participants • Self-determination & informed consent • Right to discontinue research participation • Research conducted by qualified persons • Research should be reviewed by a review board (e.g., IRB) • Special attention/protections for vulnerable groups: children, prisoners, pregnant women, students, etc.

7. ANA Code of Ethics for Nurses • Provision 7.1: Advancing the profession • Nurses have an education- and role-specific responsibility to contribute to the advancement of the profession • Example: Nurse researchers should contribute to the profession through the development of knowledge for nursing practice

8. US Office of Human Research Protections of the US Dept. of HHS

9. US Office of Human Research Protections of the US Dept. of HHS • OHRP (pronounced as oh-harp) is the main federal agency overseeing the protection of human subjects in the United States • OHRP regulates & provides guidance to the system of Institutional Review Boards (IRBs) existing within the US • IRBs are institutional committees; their decisions are local but they are guided by federal law, federal policy guidance, and ethical principles, in addition to local organizational context

10. US Office of Human Research Protections of the US Dept. of HHS • The “Common Rule” is the federal policy, adopted by a wide range of federal agencies involved in research, which provides oversight of human subjects research • 45 CFR 46 Subpart A is the “Common Rule” • Subpart A: Basic Policy for Protection of Human Subjects • Subpart B: Additional Protections for Pregnant Women, Fetuses, and Neonates • Subpart C: Additional Protections for Prisoners • Subpart D: Additional Protections for Children • Subpart E: Registration of IRBs

11. Key Definitions from Federal Policy • 45 CFR 46 § 102(d): Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

12. Key Definitions from Federal Policy • 45 CFR 46 § 102(f): Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains(1) Data through intervention or interaction with the individual, or(2) Identifiable private information.

13. Key Definitions from Federal Policy • 45 CFR 46 § 102(f): Intervention includes both physical procedures by which data are gathered (for example,venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

14. US Food and Drug Administration • FDA regulates research involving human subjects where drugs or devices are involved • Main regulations are contained in 21 CFR 50 • The terms drugs and devices are defined in FDA rules; most nursing research does not involve drugs or devices subject to FDA regulation (e.g., new indications for drugs) • FDA also regulates nutrient content claims and health claims • FDA regulations can be found at http://bit.ly/fda-regs

15. Professional Organizations • Professional organizations may have adopted guidelines for the ethical conduct of research, usually referencing the Belmont Report • Examples: American Psychological Association, American Association of Critical Care Nurses, National Council on Measurement in Education • Some guidelines explicitly state they apply only to members of their organization, but are still fruitful for guidance outside the discipline

16. Important Ethical Considerations

17. Informed Consent • Informed consent is a process whereby research participants agree to participate in a research study • The steps include explaining elements of the study, the risk to the participant, and answering questions they may have • Documentation of informed consent can (and normally does) include participants signing a consent form; exceptions can be granted by an IRB

18. Informed Consent • Consent should be viewed as a continuous process; having a signed consent in the record does not obligate the participant to continue in the study, nor the researcher to continue the subject’s enrollment • Consent may be handled differently in different situations • Agreeing to provide data implies consent • Parents/relatives giving consent for a minor or incompetent person • Children must normally assent to be involved in a study

19. Deception, Inducement, & Coercion • Deception in research involves deceiving research subjects about some part of the study for the express purpose of gathering data which might be impossible to collect if subjects were aware of their participation in the study • Some feel deception is never justified; others feel if the risks are minimal and the possible benefits are high, deception might be justified • Deception seems rarely used in nursing research; it is more common in research on basic human behavior

20. Deception, Inducement, & Coercion • Example of deception in nursing research: A nurse studying therapeutic touch recruits participants to a study where they are informed they will receive therapeutic touch by a trained practitioner and then be given several questionnaires along with having their vital signs taken. But only “sham” touch therapy by a non-trained person was given. After all the questionnaires and measurements were taken, subjects were informed of the sham touch therapy and debriefed on the reasons for the deception. They were then asked to rate their feelings about the deception and give final consent for their data to be included in the study.

21. Deception, Inducement, & Coercion • Inducement in research is the practice of offering some incentive, usually significant, for a subject’s participation in the research • Inducement normally involves being paid a significant amount of money to join and participate in a study; for some clinical trials in healthy persons, payments are often >$1,000 • Subjects may also be offered free medical care, free medications, or other gifts • Concern centers around the voluntariness of participation if inducements are offered

22. Example advertisementfor a study paying up to $550 + some medicaltreatment related to thestudyhttp://bit.ly/VULR7x

23. Deception, Inducement, & Coercion • Coercion is a parallel concept to inducement (they are perhaps not conceptually distinct) but typically involves participation in research in order to avoid loss (of favor, points, quality of life, social status, etc.) • Investigators must take steps to avoid coercion since participation in studies is strictly voluntary • Various OHRP resources on coercion: http://bit.ly/ohrp-coercion

24. Deception, Inducement, & Coercion • Example of situation where coercion is used: A nursing professor designs a new tool to measure students’ comfort with learning new procedures. The professor needs to test the tool in a sample of students, and so offers extra credit to students who participate in the instrument development study. Students not participating in the study are offered no alternative methods to earn extra credit points.

25. Research on Illegal Activities • Illegal activities are often of interest to nurse researchers • Example: Illegal drug use, illegal sexual behavior (e.g., abuse), etc. • Participants may expect – and deserve – privacy and confidentiality • Researcher’s duty can conflict when certain laws apply • Study substance abuse by licensed healthcare professionals in the context of a “duty to report”

26. Research on Vulnerable Populations • Federal regulations afford special protections to children, neonates, pregnant women, & prisoners • Any subject who is vulnerable requires special consideration to minimize harms which come with group membership – e.g., subject who is critically ill and cannot give consent • Researchers must be ready to specifically indicate the special precautions taken with these subjects and how their rights are protected, they have not been coerced, etc.

27. Research on Existing Documents & Tissues • Currently, much research on existing data, or biological specimens already existing qualifies for exemption from 45 CFR 46 oversight • Some data have already been collected for research, thus the term secondary data analysis • Some data might have been collected for non-research purposes • Students records • Hospital medical records • Tumor specimens for biopsy

28. Research on Existing Documents & Tissues • Research that may qualify for exemption from 45 CFR 46: • Educational research such as instructional strategies, comparing effectiveness • Research on educational tests, survey procedures, observations of public behavior • Research on existing data, documents, biological specimens • Demonstration projects • Program evaluation • Taste and food quality studies • Assuming studies don’t involve more than minimal risk to subjects, don’t involve protected groups, etc.

29. Research on Existing Documents & Tissues • Other regulations may still apply in the case of research on existing data • HIPAA applies for using patient medical records from covered entities • Thus, patients must either consent for their patient data to be used in research or research can request a waiver from an IRB or HIPAA privacy board to obtain consent individually for each patient • HIPAA waivers are the normal procedure for retrospective medical record research

30. Research on Existing Documents & Tissues • New rules were proposed by OHRP in 2011 intended to strengthen protections and unburden institutions from existing requirements • The comment period expired and recent reports indicate that due to a lack of agreement on many issues, new proposed rules are to be issued soon • An extensive Hastings Center special issue has been dedicated to Human Subjects Protection policy and is freely available at: http://bit.ly/hastings-report

31. Publication & Authorship • Much recent news has been made around publishing false data – prime cases of researcher misconduct • Some data were made up entirely with little or no actual data collected • Another area of ethical lapse has been in the practice of “ghostwriting” where professional writers, often paid by industry sponsors, write papers which are submitted as being written by well-respected scientists and physicians

32. Available at: http://dejavu.vbi.vt.edu/dejavu/

34. Publication & Authorship • When working with collaborators on a paper, agree up front about each person’s role, their contributions, and what will happen if things change along the way • Consider agreeing on a formal set of guidelines for authorship, such as those published by the International Committee of Medical Journal Editors: http://www.icmje.org/ethical_1author.html • Authorship should always be given based on the substantive contributions to the work; students and faculty must agree on this at the outset of their work

35. Research & Quality Improvement: What’s the Difference?

36. Research & Quality Improvement • As quality improvement efforts have become more sophisticated, the results of QI projects have become more useful evidence for practice • Some have questioned QI efforts when patient data is collected in a rigorous way, statistical analysis of QI data is conducted, and the reports are published in peer-reviewed journals – how is this different from research which needs IRB approval? • A classic case was the Keystone Collaborative Project to reduce CLABSI

37. The Keystone Collaborative Project • Johns Hopkins and the Michigan Health & Hospital Association Keystone Center collaborated to implement a bundle of evidence-based CLABSI-reducing practices into 67 hospital ICUs • Hand washing • Using full-barrier precautions • Chlorhexidine use • Avoiding femoral site insertion • Removing unneeded catheters ASAP • Median rates of catheter infections decreased from 2.7/1000 catheter days to 0

38. Research & Quality Improvement • OHRP found the JH-MHA Keystone project to be research, perhaps in addition to QI • One key finding was that data were collected prospectively • Also, data were de-identified when sent to JH, but not when collected by who were ostensibly study staff at Michigan hospitals. • Pronovost and colleagues (PI on above study) – and many others – are arguing for a revised ethical oversight system which respects the rapid evolution of our hospitals into learning healthcare systems where the distinction between research and practice is less clear

39. Research & Quality Improvement • OHRP maintains decision trees which are often helpful in deciding if a project is research subject to review:http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html • Specific address of QI vs. Research is here:http://answers.hhs.gov/ohrp/categories/1569

40. Summary

41. Ethical Decision Making in Research Strong Research Design State & Federal Regulation of Research IRB Approval (when required) Study Idea Ethical Research Transparency & Peer Review Ethics: Beneficence, Human Dignity, Justice Organizational Culture re: Risk

42. References American Nurses Association (ANA). (2001). Code of ethics for nurses with interpretative statements. Silver Spring, MD: Author. Larkin, R. M. (2011). Federal regulations for prison-based research: An overview for nurse researchers. Journal Of Nursing Law, 14(1), 17-20. doi:10.1891/1073-7472.14.1.17 Rhodes, R., Azzouni, J., Baumrin, S., Benkov, K., Blaser, M. J., Brenner, B., & ... Zweig, A. (2011). De minimis risk: A proposal for a new category of research risk. American Journal Of Bioethics,11(11), 1-7. doi:10.1080/15265161.2011.615588 Thompson, D. A., Kass, N., Holzmueller, C., Marsteller, J. A., Martinez, E. A., Gurses, A. P.,…Pronovost, P. J. (2012). Variation in local Institutional Review Board evaluations of a multicenter patient safety study. Journal for Healthcare Quality, 34(4), 33-39. doi:10.1111/j.1945-1474.2011.00150.x Zeigler, V. (2011). Ethical considerations in pediatric critical care research. Critical Care Nursing Clinics of North America, 23(2), 377-384. doi:10.1016/j.ccell.2011.04.005

43. Resources Institute of Medicine. (2012). Best care at lower cost: The path to continuously learning health care in America. Retrieved March 1, 2013, from http://iom.edu/Reports/2012/Best-Care-at-Lower-Cost-The-Path-to-Continuously-Learning-Health-Care-in-America.aspxNational Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: Department of Health, Education, and Welfare. Publication OS 78-0012, 1978). http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html NIH Office of Extramural Research, Free Research Ethics Training: http://phrp.nihtraining.com/users/login.php American Association of Colleges of Nursing. (2006). Position Statement on Nursing Research. Retrieved March 1, 2013 from: http://www.aacn.nche.edu/publications/position/nursing-research