Northwest Center for Public Health Practice 1 PRACTICAL ETHICAL & LEGAL INFORMATION FOR DISASTER...

1Northwest Center forPublic Health Practice

PRACTICAL ETHICAL & LEGAL INFORMATION

FOR DISASTER MENTAL HEALTH RESEARCHERS


CHILD AND FAMILY

DISASTER RESEARCH

TRAINING AND

EDUCATION


Principal Investigators

• Betty Pfefferbaum, MD, JD University of Oklahoma Health Sciences

Center

• Alan M. Steinberg, PhD University of California, Los Angeles

• Robert S. Pynoos, MD, MPHUniversity of California, Los Angeles

• John Fairbank, PhDDuke University


Federal Sponsors

• NIMH National Institute of Mental Health

• NINR National Institute of Nursing Research

• SAMHSA Substance Abuse and Mental Health Services Administration


Randal Beaton, PhD, EMTAdopted/adapted from John A. Call, PhD, JDCrisis Management

Consultants


CASE EXAMPLE


You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some

survivors together for a group CISD session. She instructs you to go down the row of cots and select survivors,

particularly families with children, who appear upset and instruct them to assemble in a secluded corner of the gym

where some chairs have been set up. The session is to begin in about an hour.

What are the issues? What should you do?


• Provide practical legal & ethical information for front-line post-disaster mental health researchers (and practitioners)

Purpose


• Appreciate the ethical and legal aspects of different phases and different types of disasters

• Understand some of the legal & ethical issues impacting both disaster mental health services and disaster mental health researchers

Goals


Objectives

• Develop competencies in recognizing:• Ethical issues involving standard of

practice, informed consent, confidentiality, record keeping, and supervision in the

provision of disaster mental health services• Legal issues involving professional liability,

licensure, and HIPAA in the provision of disaster mental health services


Objectives

• Develop competencies in appreciating• The impact of states’ disaster related statutes

on the provision of disaster mental health services & research

• The impact of federal statutes (e.g., HIPAA) when conducting disaster mental health research

• The policies and guidelines that IRB's consider in approving human subject participation in disaster research


Review Basic Disaster Concepts

• Disasters have temporal phases

• Disasters typology

The phase and type of disaster interact with legal and ethical parameters


Psychosocial Phases of a Disaster

* From Zunin & Myers (2000)

*


Types Of Disasters

• Human made vs. Natural disaster

Human made-neglect vs. terrorism

• Immediate vs. Prolonged disaster

Natural-Hurricane vs. pandemic

Terrorism-Bioterrorism vs. explosion


Legal and

Ethical Issues


Questions?

• Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster?


CASE EXAMPLE


You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors

together for a group CISD session. She instructs you to go down the row of cots and select survivors, particularly families with

children, who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set

up. The session is to begin in about an hour.



Issues

• Standard of Practice? At this juncture there really is no community standard.


NIMH Guidance*(2002)

• Early, brief, focused intervention can reduce stress

• Selected cognitive behavioral approaches may help ASD, PTSD & depression

*http://www.nimh.nih.gov/publicat/massviolence.pdf


NIMH Guidance (2002)

• Early intervention in form of recitals of events and emotions do not consistently help; i.e., CISD is not necessarily helpful

• No evidence that EMDR as an early intervention as treatment of choice over other practices


APA Ethical Rules*Guidelines for Psychologists

• APA Ethical Rule § 2.01 & ASPPB Code of Conduct § III (A) (4)

• Psychologists provides services within the boundaries of their competence

• In emerging areas psychologists nevertheless take reasonable steps to ensure competence

*American Psychological Association Code of Ethics http://www.apa.org/ethics/code2002.html


APA Rule- Emergency Provision

• APA Ethical Rule § 2.02

• Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster? (Days or weeks following a disaster?)


Analysis

• Standard of Practice

• So if there is none, what is the Disaster Mental Health Professional supposed to do?


Recommended Guideline

ASPPB Code of Conduct* III(A)(4)states—”engage in ongoing consultation & inform clients of the innovative nature & known risks of the service”

*Association of State and Provincial Boards of Psychology Code of Conduct available at

http://www.ok.gov/OSBEP/documents/ASPPB_Code_of_Conduct_2005%5B1%5D.pdf


Issues

• Informed Consent

• It’s required; but how do I get it?


Rule

• APA Ethical Rule § 3.10, 10.01 & ASPPB Code of Conduct § III (D) (1)

• Psychologists must obtain informed consent before providing services

• For persons who are legally incapable of giving informed consent (e.g. children) psychologists must obtain informed assent*

*Exemplar of Informed Assent Form for child mental health study Claremont Grad School http://www.cgu.edu/include/Informed_Assent.Form.doc


Rule

• APA Ethical Rule §3.10, 10.01 & ASPPB Code of Conduct § III (D) (1)

• For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature & potential risks of the procedure


Analysis

• APA Ethical Rule § 3.10, 10.01 & ASPPB Code of Conduct §III (D) (1)

• Informed consent includes discussion of nature & course of treatment, fees, involvement of third parties, limits to confidentiality and the provision of sufficient opportunity for the client to ask questions


NCPTSD* Guidance

• Introduce yourself with your name and title, and describe your role. Ask permission to talk to them, and explain your objective of finding out whether there is anything you can do to make things easier, or helping with ways to help themselves feel better….When making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission. When speaking with a child in distress when no adult is present, it is important to find a parent or caregiver to let them know about your role and seek permission.

*National Center for PTSD Guidance for mental health providers in acute phase @ http://www.ncptsd.va.gov/ncmain/index.jsp


Conclusion

• Informed Consent is required for disaster mental health providers and researchers


Issues

• Confidentiality• Needs to be discussed; but can you

promise it?


Rule

• APA Ethical Rule § 4.01, 4.02 & ASPPB Code of Conduct § II (B), III (F)

• Psychologists must provide confidentiality to clients

• Psychologists must document the client’s consent or assent


Analysis

• Psychologists discuss with clients the relevant limits of confidentiality, the foreseeable uses of the confidential information.

• Unless not feasible, psychologists discuss the issue of confidentiality at the outset of the relationship

• Confidential information may only be disclosed with written permission, except upon court order or to conform with law


Conclusion

• Confidentiality is required within certain parameters, but there are limits to confidentiality; e.g, imminent harm to self or others– you MUST notify authorities. Also you MUST report child abuse and elder abuse to authorities. You may also communicate with other providers to ensure continuity of care.

•Refer to HIPAA Disclosures in an emergency document http://www.hhs.gov/ocr/hipaa/decisiontool/


Issues

• Record Keeping• It is required and it is probably not

being done correctly (or at all in some cases)


Rule

• APA Ethical Rule § 6.01, 6.02 & ASPPB Code of Conduct § III (A)(7)

• Psychologists must keep records & the records must be kept confidential


Analysis

• Records must include client’s name, the presenting problem(s) or purpose or diagnosis, fee arrangement, the date and substance of each service

• Records must include any evaluative result, notation & results of consults, a copy of reports, and any releases executed by the client

• Records must be kept for not less than five years


CASE EXAMPLE


You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls. A

woman with two elementary aged children are in line to obtain medication and one child, about 11 years old, is crying

hysterically. You, a Team Leader, instruct another mental health volunteer to intervene.

What are the legal and ethical ssues? What should you do?


• Record Keeping

• Licensure

• Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates

Issues

• Standard of Practice

• Informed Consent

• Confidentiality


You are a member of an organization (the organization could be religious based, professional based, or governmental based) that provides DMHWs who work with children and

families during the acute phase of a disaster. It has been your job to develop a database of volunteers, arrange and deploy volunteers when a disaster occurs, and act as a team leader

at the disaster site, shelter, etc. when the volunteers are deployed.



• Post-deployment screening

Issues

• Training & licensure

• Supervision

• Pre-deployment screening


What Special Laws Apply In Disasters?

• Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster.

See http://www.emacweb.org/?1530

• “Federalization” & the Federal Volunteer Protection Act (42 U.S.C. § 14501 et.seq.) AKA the Federal Volunteer Protection Act of 1997

See http://www.disastermh.nebraska.edu/files/Appendix-H-Federal_Volunteer_Protection_Act_pdf


Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers

if:

• The volunteer was acting within their scope of responsibility• The volunteer was properly license, certified or authorized to

engage in their disaster related activity or practice • The harm was not caused by willful or criminal misconduct, gross

negligence, reckless misconduct or a “conscious, flagrant indifference” to the rights or safety of the individual harmed by the volunteer; and

• This statute does not refer to “spontaneous volunteers” who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams.


Analysis & Conclusion

• Disaster related laws provide limited liability protection & waiver of state licensing requirements under certain circumstances


What Special Laws Apply In Pandemics & Bioterrorist Events?

• Model State Emergency Health Powers Act (MSEPHA)

• Washington, Oregon and Alaska have considered or passed some components of the MSEPHA


Public Health Law in the Age of Bioterrorism

• For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice

• This course may be accessed @ http://www.nwcphp.org/training/courses-exercises/courses/introduction-to-public-health-law

Course faculty: Patricia Kuzler, MD, JD, Associate Dean, University of Washington School of Law


Special Issues In Disaster Research

• Decisional capacity of potential participants

• Vulnerability of subjects

• Risks and benefits of research participation

• Informed consent


Recommended Disaster Research Guidelines

• When needed, formally assess decisional competence

• Train researchers to recognize emotional problems in subjects & have referral sources available

• Carefully assess study risk/benefits



• Involve community members in research planning

• Reduce likelihood that research is perceived as treatment

• Setting for informed consent should be safe



• Provisions for confidentiality should be explicit

• Should be explicit plans for training and mental health support of researchers and staff

• Inform subjects of study results



• Coordination among researchers and IRBs--• Proactive involvement of IRB’s in research

planning to remove barriers to timely data collection


Disaster ResearchThoughts, Issues & Recommendations

from the

University of Washington

HSD/IRB

UW Human Subjects DivisionRichard Brzustowicz, Administrator, RovingZan Manning, Administrator, Minimal RiskSharon Smith Elsayed, Asst. Dir. for Education & Communication

July 12, 2007


Acknowledgement

Disaster Research: Thoughts, Issues & Recommendations from the HSD/IRB

• Disaster mental health research poses unique

issues and challenges to researchers and to the

HSD/IRB.

• It is important that the unique issues and

recommended guidelines presented earlier be

understood, addressed and acted upon by all

involved disciplines.

• HSD is currently developing policies and

procedures to address special situations and

needs, like disaster research.


Thoughts


• The process of working with the HSD/IRB can be flexible, and is likely able to be less formal than might be expected.

• Proactive involvement of the HSD/IRB is encouraged and highly desirable.

• It is the preservation of the foundational principles of ethical research that is paramount to the HSD/IRB.


Foundational Principles Source: Belmont Report


• Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy.

• BeneficenceMaximize benefits and minimize harms.

• JusticeEquitable distribution of research costs and benefits.


Issues (not a comprehensive list)


• The Belmont principles may not carry equal importance or may even be in conflict with each other, depending on the research intent and design.

• Consent process – how to assure that it makes sense within the context of what has occurred and who is involved, potentially and in reality.

• Clarity regarding the distinction between the provision of service and the conduct of research.


Recommendations (again, not a comprehensive list)


• Proactive preparation and submission of an IRB application for approval in advance of a potential disaster, with annual renewal and modifications – as needed due to changes over time or in actual event circumstances.

• Keep specific aspects of the application and research protocol flexible in order to minimize the need for change.

• Work with institutions and individuals to lay the groundwork.

• Integrate research into normal routines, to the extent possible.

• Try-it-out in “controlled” approximations (marathons, drills, etc.)

• Consider applying for a Federal Certificate of Confidentiality.

Northwest Center for Public Health Practice 1 PRACTICAL ETHICAL & LEGAL INFORMATION FOR DISASTER...

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