HC 101
LECTURE
CHAPTER 3: COMMUNITY INVOLVEMENT IN PUBLIC HEALTH
WHAT IS A COMMUNITY?
ð A social entity made of people or families who have the
following characteristics:
 Live in the same geographical area
 Share common goals or problems
 Share similar development aspirations
 Have similar interests or social network or
relationship at local level
 Have common leadership and tradition
 Have common system of communication
 Share some resources - water, school etc
 Are sociologically and psychologically linked
COMMUNITY PARTICIPATION
ð A process by which a community mobilizes its own
resources, initiates and takes responsibility for its own
development activities and share in decision making for and
implementation of all other development programs for
overall improvement of health status
ð It is a key to the successful organization of public health
care
ð Through the process, the people gain greater control over
the social, political and economic and environmental factors
determining health
AIMS IN COMMUNITY PARTICIPATION
• The community develops self-reliance
• The community develops critical awareness
• The community develops problem solving skills
TYPES OF PARTICIPATION
• PASSIVE – (Manipulation)
• ACTIVE – (Consultation)
• INVOLVEMENT – (Community control)
PASSIVE PARTICIPATION
ð In this type of participation, individuals or families are mere
spectators
ACTIVE PARTICPATION
ð In this type or participation, they may be carrying out some
tasks in a program but are not involved with the final
decision making in what is to be done
ð Final decision in such cases are made by people who are not
members of the community in such situations
ð The community does not develop a sense of self-reliance
COMMUNITY PARTICIPATION & INVOLVEMENT
ð In this type of participation, the community is involved in all
aspects of the program.
ð This type of approach enables the community to participate
willingly to improve its own health status.
ð It is important for community to participate in every stage
of health program for it to have long lasting results i.e.,
thinking, planning, acting, and evaluating
ð Empowers and enables the community to make informed
decisions in matter affecting their health or development
INVOLVEMENT
ð Entails involving the community in planning,
implementation, management and evaluation of programs
ð Contribute towards a feeling of responsibility in such a
program
ð Active partnership is established between a development
program within the community and the community itself
ð Contributes to the attainment of community responsibility
and accountability overall development programs
DIMENSIONS IN COMMUNITY PARTICIPATION
• Involvement of all those affected in decision making about
what should be done and how
• mass contribution to the development efforts i.e., to the
implementation of decision
• sharing in the benefits of the program
COMMUNITY PARTICIPATION IN DIFFERENT SITUATION
TOP-DOWN APPROACH
ð decisions are made by senior persons in health services, so
called “experts”
 ð research may be carried out through surveys to what
community thinks or believe to be the problem but at the
end it is usually the health workers who makes the decision
on what goes into the program based on medically defined
needs
ð all decision making and priorities are set by external agency
BOTTOM-UP APPROACH
ð members of the community make the decision
PRIMARY HEALTH CARE
• The ALMA-ATA DECLARATION in 1978
ð extended the notion of appropriate health care beyond
that of simply providing decentralized services
ð also considered need to tackle economic and social
causes of ill-health

THE NEED FOR COMMUNITY APPROACH Health education and community participation are essential
ingredients of Public health (WHO)
ð the need to shift the emphasis from the individual to the
community
TYPES OF COMMUNITY GROUPS
ð due to many influences on a behavior are at the community
level and not under the control of individuals SELF HELP GROUPS
ð these include:
i. social pressure from other people through norms ð run by people for their own benefits e.g., cooperatives,
ii. shared culture and the local social economic church saccos, etc
situation
PRESSURE GROUPS

DRAWING ON LOCAL KNOWLEDGE ð A group of self-appointed citizens taking action on what

they see to be the interests of the whole community putting
ð communities often have detailed knowledge about their
on pressure to improve the school, get garbage collected,
surroundings
do something about a dangerous road, etc.
ð it makes sense to involve communities in making plans
because they know local conditions and the possibilities of TRADITIONAL ORGANIZATIONS
change
ð well established groups, usually meeting the needs of a
MAKING PROGRAMS LOCALLY RELEVANT AND particular section of the community, others rotary club,
ACCEPTABLE mothers union, parent-teacher associations, and church
groups.
ð if the community is involved in choosing priorities and
deciding on plans, it is much more likely to become involved WELFARE GROUPS
in the program and take up the services
ð exist to improve the welfare of a group
DEVELOPING SELF RELIANCE, CONFIDENCE, ð ex. feeding programs, medical missions
EMPOWERMENT AND PROBLEM-SOLVING SKILLS

ð the enthusiasm that comes from community participation

can lead to greater sense of self-reliance for the future
ð the feeling of community solidarity and self-reliance from
participating in ecisions over their own future through a
water project can lead to future activities

BETTER RELATIONSHIP BETWEEN HEALTH WORKERS AND

COMMUNITY

ð community participation leads to a better relationship

between the community and the health workers instead of
servant master relationship
ð there is TRUST and PARTNERSHIP
HC 101
LECTURE
CHAPTER 3: PUBLIC HEALTH ETHICS
DEFINITION OF ETHICS
ð The discipline of dealing with what is good and bad, with
moral duty and obligation
ð A set of moral principles or values
ð The principle of conduct governing an individual or group
ð A Dictionary of Epidemiology, 4th ed, 2001 (J.M. Last (ed)):
“The branch of philosophy that deals with distinctions
between right and wrong – with the moral consequences of
human actions”
ETHICS
 Medical ethics - (patient-centered)
 Public health ethics – (community/population-centered)
 Research ethics - (subject-centered)
PRINCIPLES OF ETHICAL PRACTICE OF PUBLIC HEALTH
(Adapted from PH Leadership Society, 2002)
ð PH should address the causes of disease and requirements
for health
ð PH must respect the rights of individuals
ð PH should seek input from communities
ð PH should strive for health for all
ð PH should base policies on evidence
ð PH should obtain community consent for implementation of
policies/interventions
ð PH should respond to health problems in a timely manner
ð PH must respect diverse values, beliefs and cultures
ð PH programs should enhance the physical and social
environment
ð PH should protect the confidentiality of individuals and
communities whenever possible
ð PH must assure the professional competence of their
employees
ð PH should engage in collaborations that build public trust
and are effective
PUBLIC HEALTH AND POWER
ð The need to use power to ensure health
ð What should be the limits of that power?
PUBLIC HEALTH ACTION
ð The Luandry of Human Rights!
• Incarceration of infectious individuals e.g. typhoid
Mary
• Quarantine of contacts (China H1N1)
ð Right to privacy vs. mandatory disease reporting
• (STDs, HIV)
ð Persuasion vs. coercion vs. manipulation
ð Personal autonomy vs. community action
• e.g. fluoridation of water
ð Regulation of personal behavior
• e.g. mandatory condom use in brothels (Thailand,
Nevada)
ð Proportionality – cost versus benefit
CONFLICTING PUBLIC HEALTH GOALS
 Protect the uninfected
 Protect the infected
JUSTIFICATION OF RESEARCH IN HUMANS
ð Impossible to reach important conclusions without
studying humans
• Human physiologic studies, because animal
responses often are not the same
• Epidemiological studies, because They depend on
human susceptibilities and human interactions
• Drugs for treating humans because animal
experiments don’t always predict human responses
ð If you’re going to treat humans, you must study humans
ð Corollary: If you’re going to treat certain kinds of humans,
then you must perform studies with them, for example
Children, mentally impaired, ethnic groups, elderly,
women, and pregnant women)
HISTORY OF THE ETHICAL RESEARCH MOVEMENT
THE NUREMBERG CODE (WORLD WAR II)
ð Informed consent is absolutely essential
ð Qualified researchers must use appropriate research
designs
ð There must be a favorable risk/ benefit ratio
 ð Participants must be free to stop at any time
THE DECLARATION OF HELSINKI
WORLD MEDICAL ASSOCIATION (1964, 1975, 1983, 1989, 1996, 2002)
ð “The well-being of the subject should take precedence over
the interests of science and society”
ð Consent should be in writing
ð Use caution if participant is in dependent relationship with
researcher
ð Limited use of placebo, especially if treatment is available
ð Greater access to benefit once research is concluded
COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL
SCIENCE (CIOMS) GUIDELINES 1993, 2002
Nuremberg => Helsinki => CIOMS
ð Informed consent
ð Research in developing countries
ð Protection of vulnerable populations
ð Distribution of the burdens and benefits
ð Role and responsibilities of ethics committees
THE BELMONT REPORT (THE U.S. NATIONAL COMMISSION FOR THE
PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND
BEHAVIORAL RESEARCH, 1978)
Ethical Principles and Guidelines for the Protection of Human Subjects
of Research:
 Respect for persons
 Beneficence
 Justice
BASIC PRINCIPLES OF RESEARCH ON HUMAN SUBJECTS
RESPECT FOR PERSONS
• Choices of autonomous individuals should be respected
• People incapable of making their own choices should be protected
• Voluntary subjects need adequate information for decision making
BENEFICENCE
• Participation in research is associated with a favorable balance of
potential benefits and harms
• Maximize possible benefits, minimize potential harm
JUSTICE
• Participation in research is associated with a favorable balance of
potential benefits and harms
• May not exploit or exclude vulnerable individuals who may benefit
without good reason
• The risks must be shared across all groups in society
ASSESSMENT OF BENEFITS AND RISKS
ASSURE THAT BENEFITS OUTWEIGH RISKS
ð Research must be justified on the basis of a favorable
benefit/risk assessment for the research participant.
ð Benefits must outweigh risks
ð This is similar to the principal of beneficence or “do no
harm.” Researchers must protect participants from harm
and maximize their well-being
RISK AND BENEFIT DEFINED
ð A “risk” refers to a harm or likelihood of a harm. The
degree of severity of a possible harm may be unclear
ð A “benefit” refers to a positive value that accrues to the
participant and/or to the society. The precise degree of
gain that might accrue to the participant and/or to the
society may be uncertain
TYPES OF RISKS AND BENEFITS
ð Risks or harms and benefits may be physical (pain or
injury), psychological, social, economic, or legal
ð Risks or benefits of research may apply to individual
participants, families, groups or organizations,
communities, or nations
ð Risks and benefits to the research participant usually carry
the most weight
GENERAL PRINCIPLES
ð There is absolutely no justification for inhumane treatment
of participants
ð Risks to participants should always be reduced to the
maximum extent possible
ð If a significant risk is involved, justification of the research
must be examined with particular care
ð Whenever vulnerable persons are participants, the need to
involve them must be carefully demonstrated
INFORMED CONSENT
WHAT IS INFORMED CONSENT?
ð Informed consent is … “consent given by a competent
individual who:
i. has received the necessary information
ii. has adequately understood the information
 iii. after considering the information, has arrived at a
decision without having been subjected to
coercion, undue influence or inducement, or
Intimidation”
INFORMED CONSENT AS A PROCESS
Informed consent is a communication process:
ð Between the researcher and the participant
ð Starts before the research is initiated
ð Continues throughout the duration of the study
ESSENTIAL ELEMENTS OF INFORMED CONSENT:
DESCRIPTION OF THE RESEARCH
ð That it is a research study
ð Objectives of the study
ð Expected responsibilities of participant
ð Procedures involved
ð Study duration (and possibility of early termination)
ð Explanation of features of the research design, such as
randomization or placebo
DESCRIPTION OF RISKS
ð Includes physical, social, and psychological risks
ð Anticipated or foreseeable risks, pain or discomfort, or
inconvenience to the individual (or others) associated with
the research
ð Includes risks to health or well-being of subject’s spouse,
partner, and/or family
ð Culturally appropriate
DESCRIPTION OF BENEFITS
ð “Benefit to subject or others reasonably expected to result
from the research” (Common Rule)
ð This can include direct medical benefit to participants and
expected benefits of the research to the community or
larger society, or contributions to scientific knowledge
ð Whether, when, and how any products or interventions
proven by the research to be safe and effective will be
made available to subjects once research is ended, and
whether they will be expected to pay for them
CONFIDENTIALITY
ð Provisions that will be made to ensure respect for privacy of
subjects and confidentiality of records in which subjects are
identified
ð Limits of confidentiality, what persons or organizations may
have access to the information, and possible consequences
of breaches of confidentiality
ð When appropriate, policies about disclosure of results of
genetic tests; e.g., certificate of confidentiality
ð Special cultural circumstances
COMPENSATION
ð Available compensation in case of research-related injury,
and whether there is any uncertainty about funding;
whether there is compensation for death or disability
ð What treatment is available and cost
ð Whether payment will be provided for participation, and if
so, how much (fair payment for time, travel or
inconvenience)
ð Must not be coercive
PARTICIPANT CONTACTS
ð Provide contact for research-related questions
ð Provide contact for concerns about rights as a participant
ð Contacts must be realistic and viable
VOLUNTARY PARTICIPATION
ð Absolutely voluntary
ð Right to discontinue at any time
ð No penalty for refusal
Circumstances Must…
ð Give subject sufficient opportunity to consider the decision
ð Minimize possibility of coercion or undue influence
Language Must…
ð Be understandable to subject or representative (test for
comprehension)
ð Language must NOT
• Waive subject’s rights
• Release investigator, sponsor, or institution from
liability
FACTORS INFLUENCING VOLUNTARY CONSENT
ð Vulnerability to incentives
ð Impact of community pressure (e.g., routine community
testing)
ð Perceived power of investigators
ð Inability to understand research requirements

RESEARCH IN POPULATIONS AND COMMUNITIES WITH LIMITED
RESOURCES
Ethical requirements for International Public Health Research
1. Social or scientific value
2. Scientific validity
3. Fair subject selection
4. Favorable risk-benefit ratio
5. Independent review
6. Informed consent
7. Respect for potential and enrolled subjects
TWO RESPONSIBILITIES
Prior to conducting research in a population or community with
limited resources the researcher/sponsor should:
1) Ensure the research responds to the health needs and
priorities of the target community.
2) Ensure any product developed will be made available to the
community.
RESPONSIVENESS TO COMMUNITY HEALTH NEEDS
ð It is not sufficient to determine disease prevalence and that
new research is needed.
ð If successful interventions result from the research they
must be made available to the community.
ð If this is not done, the research is exploitative.
MAKING A PRIOR AGREEMENT
ð Before the research begins, a plan should be offered in
which the proposed product is made available to the host
nation upon completion of the study.
ð Participants should include representatives of the nation’s
government, local authorities, community members, and
NGO groups.
COMPREHENSIVENESS OF THE AGREEMENT
ð The agreement should include payments, royalties,
distribution costs, subsidies, technology, and intellectual
property.
ð In some cases, international organizations, public and
private, may also be included in the discussions.
THE ETHICS OF CONDUCTING RESEARCH IN DEVELOPING
COUNTRIES
ð When, if ever, should investigators use the standards of
care/ethics of developing countries vs. developed countries
(e.g., Tanzania drug trials)?
ð Are investigators responsible for the health of their
participants?
ð Can participants in developing countries understand
informed consent (e.g., is there an expectancy of benefit or
treatment even if not stated in the informed consent)?
ð Is it ethical to do research in developing countries on issues
relevant to developed countries but not relevant to
developing countries?
REQUIREMENTS FOR COMMUNITY APPROVAL
ð Community must have legitimate, empowered
spokesperson(s)
ð Community must have a common health-related culture
ð A communication network for the community must be in
place
RESEARCH CONTROVERSIES IN DEVELOPING COUNTRIES
ð Are placebo groups ethical?
ð Should placebos reflect international or local standards of
care?
ð Should participants be assured care beyond the trials – if so,
for how long?
ð Should care be provided to the trial community?
ð Should trials be evaluated for scale-up feasibility before
implementation?
SEX WORKER DEMANDS
ð Lifetime care if she becomes HIV-infected or suffers side
effects
ð Health insurance for 30 years
ð More counseling
ð Free female condoms
EVALUATION OF “OPTOUT”/ROUTINE TESTING
ð HIV is primarily spread by persons who do not know they
are infected
ð A large proportion of those infected do not know their
status
ð Testing is associated with stigmatization, community
rejection and family discord
ð Cannot access treatment if don’t know HIV status
“OPT-OUT”/ROUTINE TESTING ETHICAL ISSUES
ð Does routine testing violate human rights?
ð Does respecting the right to refuse testing violate the
human rights of others?
PRIVACY VS. CONFIDENTIALITY
PRIVACY METHODS TO MAINTAIN CONFIDENTIALITY

ð “a: the quality or state of being apart from company or
observation: seclusion
ð b: freedom from unauthorized intrusion <one's right to
privacy>”
ð is about people
PRIVATE INFORMATION
ð 45 CFR 46.102(f): 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.
IRB CONSIDERATIONS: METHODS TO PROTECT PRIVACY
ð Allow face-to-face interview participants to provide
information in writing or by using a computer keyboard,
instead of orally (e.g., ACASI)
ð Use telephone touch tones for responses to sensitive
telephone interview questions
ð Participants can use headphones and portable audio player
to listen to questions
ð Restrict access to data (password protect, lock)
ð If data stored on a computer; maintain on a standalone
computer; no network connection
ð Use encryption software, if data is accessed it is unable to
be deciphered
ð Minimize storage of subject identifiable data on a laptop
computer which can be lost or stolen
ð Certificates of Confidentiality – protects data from being
subpoenaed
ð Waiver of Documentation of informed consent
ANONYMOUS
ð Anonymous: Data collected from individuals who were not
identified at the time of collection.
ð Unlinked or anonymized: identifiers were available when
the data were collected or stored, at some point, the
identifiers were unlinked. Thus, unlinked data lack
identifiers or codes that can link the data to identifying
information or particular individuals.
ANONYMOUS – WHY DOES IT MATTER?
ð Collecting anonymous data or anonymizing data after
collection may serve as most appropriate method to protect
subjects’ confidentiality.
ð Secondary analysis of anonymous data does not require IRB
review or certification of exemption.

CONFIDENTIALITY

ð “… pertains to the treatment of information that an

individual has disclosed in a relationship of trust and with
the expectation that it will not be divulged to others in
ways that are inconsistent with the understanding of the
original disclosure without permission.”

OHRP IRB Guidebook, Chapter III-D.

CONFIDENTIALITY RISKS

ð Confidentiality protections should be commensurate with

the potential risk of inadvertent disclosure of the
information
ð A breach of confidentiality of sensitive research data may
pose risk of:
• Social stigmatization or discrimination
• Damage to financial standing, employability or
reputation
• Prosecution for criminal behavior
ð Sensitive data may be subject to subpoena if not protected
by a Certificate of Confidentiality
HC 101
LECTURE
CHAPTER 3: PUBLIC HEALTH POLICY

INTRODUCTION  Identify priority targets for policy development

POLICY  A set of principles guiding decision making
PUBLIC POLICY  policy of governments
HEALTH POLICY health promotion, health protection, health services
HEALTHY PUBLIC POLICY
ð From health promotion movement
ð Use of policy in all sectors to promote health
ð Policy can also contribute to disease prevention and treatment at
all levels
ð Analytical epidemiology
 Individual-level and population-level causes
2. ASSESSMENT OF POTENTIAL INTERVENTIONS
ð Identify potential policy interventions
ð Synthesize existing knowledge regarding their effectiveness
ð Contribute relevant new research
ð Assess the potential of each approach
3. POLICY CHOICES

POLICY INSTRUMENTS ð Project impact of potential interventions on the health of the

population
ð Legislation and regulations  Computer simulations of different interventions
ð Taxation and financial incentives ð Assist the process of consensus development
ð Information and coordination
ð Provision of direct service
4. POLICY IMPLEMENTATION

THE BASIS OF POLICY ð Help to set targets for the chosen policies
ð Values ð Inform needs-based resource allocation for health services
ð Ideology ð Guide development of information systems
ð Politics
ð Evidence 5. POLICY EVALUATION
 Not usually the main influence on policy, but worth
fighting for ð Assess the impacts of policies
 The main contribution of epidemiology ð Monitor future health

POLICY ANALYSIS EPIDEMIOLOGY & HEALTH POLICY

ð The process of predicting the impacts of possible policies and EXAMPLES:
evaluating past policies
ð Epidemiology can make a major contribution to both steps ð Healthy People 2010 (and Health 21)
 goal-setting, targets
TUGWELL’S ITERATIVE LOOP ð Global Burden of Disease
1. Burden of illness  ethical basis, DALYs
2. Etiology or causation ð Public Health Status and Forecasts in the Netherlands
3. Community effectiveness  integrated process
4. Efficiency
5. Synthesis & Implementation OBJECTIVES
6. Monitoring of Program
7. Reassessment
To provide students with:
POLICY CYCLE
ð knowledge of how health policy is developed and used;
ð knowledge of epidemiologic methods relevant to the
1. ASSESSMENT OF POPULATION HEALTH development of health policy; and
ð the skills to use that knowledge, in collaboration with
ð Demography, population dynamics policy-makers
ð Descriptive epidemiology:
 Measure the health of the population
HEALTH POLICY DEFINED
 Identify trends and patterns
 Assess health risks ð Health policies are public policies or authoritative decisions
 Assess health needs that pertain to health or influence the pursuit of health
 ð Health policies affect or influence groups or classes of REGULATORY POLICIES
individuals or organizations
ð Policies designed to influence the actions, behaviors, and
decisions of others to ensure that public objectives are met
PUBLIC VS. PRIVATE POLICYMAKING
ð Five main categories of regulatory policies
PUBLIC POLICY i. Social regulations
ii. Quality controls on the provision of health
ð Policy that is established by the federal, state, and local services
levels of government iii. Market-entry decisions
iv. Rate or price-setting controls on health service
PRIVATE POLICY
providers
v. Market-preserving controls
ð Policy that is established by private organizations
ð For example, MCOs and JCAHO SOCIAL REGULATIONS

FORMS OF HEALTH POLICIES ð These regulations are established in order to achieve

socially desirable outcomes and to reduce socially
LAWS undesirable outcomes
ð A rule of conduct or action prescribed or formally ð Examples
recognized as binding or enforced by a controlling authority  Environmental protection
ð Enacted by any level of government  Childhood immunization requirements
ð Can also be referred to as a program  No smoking
 For example, the Medicare program
QUALITY CONTROLS
RULES/REGULATIONS
ð Designed to guide the implementation of laws ð These regulations are intended to ensure that health
ð Can be made in the executive branch by the organizations services providers adhere to acceptable levels of quality in
and agencies responsible for implementing laws the services they provide and that producers of health-
related products meet safety and efficacy standards
OPERATIONAL DECISIONS ð Example
ð Operational decisions are made by the executive branch of  FDA regulation of pharmaceuticals
the government as a part of the implementation of a law  New Pay for Performance (P4P) regulations
ð Normally these decisions consist of protocols and
procedures that follow the implementation of a new law MARKET-ENTRY RESTRICTIONS
ð These decisions tend to be less permanent than rules or
regulations ð These regulations focus on licensing of practitioners and
organizations
JUDICIAL DECISIONS ð Example
 Certificate of Need programs
ð These are policies that are created as a result of a decision  Physician credentialing (Hospital privileges)
made in the court system
ð For example, an opinion listed in 1992 by a DHHS RATE OR PRICE-SETTING CONTROLS
administrative law judge stated that a hospital was in
violation of the Rehabilitation Act Amendments of 1974 ð These regulations are designed to control the growth of
prices
ð Example
MACRO POLICIES
The federal government’s control of the rates of
ð Macro policies are broad and expansive and help shape a reimbursement to hospitals that participate in the Medicare
society’s pursuit of health in fundamental ways program
ð Example: FDA regulation of pharmaceuticals
MARKET-PRESERVING CONTROLS
CATEGORIES OF PUBLIC HEALTH POLICIES
ð These regulations establish and enforce rules of conduct for
market participant
ALLOCATIVE POLICIES
ð Example
ð Designed to provide net benefits to some distinct group of  Antitrust legislation
class of individuals or organizations, at the expense of
others(?), in order to ensure that public objectives are met
ð In general, allocative policies come in the form of subsidies
ð Examples: Medicare and Medicaid policies, Federal aid to
medical schools