Ethical and Regulatory Considerations in Nursing Research

Darrell Spurlock, Jr. PhD, RN, NEA-BC

May 22, 2014

Associate Professor of NursingMount Carmel College of Nursing

Note:Links to or images of news stories are for educational purposes only and are not intended as a commentary about or endorsement of particular individuals or organizations discussed in the stories, or whose ads may appear on the websites containing the stories.

The ideas presented here are the presenter’s alone and do not represent the opinion or view of other persons.

33

Presentation Objectives1. Identify authoritative ethical and

regulatory resources important to nurse researchers

2. Describe ethical considerations for nursing research

3. Differentiate research from quality improvement, from a regulatory perspective

44

Authoritative Ethical and Regulatory Resources

55

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

66

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.

77

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

88

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

99

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

1010

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

1111

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.

1212

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.

1313

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.

1414

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

1515

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

1616

Important Ethical Considerations

1717

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

1818

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

1919

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

2020

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.

2121

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

2222

Example advertisementfor a study paying up to $550 + some medicaltreatment related to thestudy

http://bit.ly/VULR7x

2323

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

2424

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.

2525

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”

2626

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.

2727

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

2828

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.

2929

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

3030

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

3131

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

3232 Available at: http://dejavu.vbi.vt.edu/dejavu/

3434

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

3535

Research & Quality Improvement: What’s the Difference?

3636

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

3737

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

3838

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

3939

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

4040

SUMMARY

4141

Ethical Decision Making in Research

Study Idea Ethical Research

Strong Research

Design

Ethics: Beneficence,

Human Dignity, Justice

State & Federal

Regulation of Research

Organizational Culture re:

Risk

IRB Approval (when required)

Transparency & Peer Review

4242

ReferencesAmerican 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:10.1891/1073-7472.14.1.17Rhodes, 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:10.1080/15265161.2011.615588Thompson, 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.xZeigler, 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

4343

ResourcesInstitute 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.aspx

National 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