Ethical and Professional Issues in Epidemiology

Dr. Faiza Abou El-Soud

Ass. Prof. of Community Health Nursing, CON-R

King Saud Bin AbdulAziz University for Health Sciences
 Learning Objectives
• Discuss the ethical obligations that investigators have to participants
in epidemiologic studies

• Explain privacy and confidentiality of health records in

epidemiologic studies

• Describe the scientific and ethical implications of classifying race

and ethnicity in epidemiologic studies

• Identify the issues associated with conflict of interest

• Recognize how the findings of epidemiologic studies are interpreted

and communicated to the public.
 Ethics and Epidemiology

• There is almost no step in the research process

in epidemiology in which
ethical issues do not exist.
 Ethics and Epidemiology

• There is almost no step in the research process

in epidemiology in which
ethical issues do not exist.
 Ethics and Epidemiology

Ethics for epidemiologists

involves an interplay between
the model of public health
(supporting the public good)
&
the model of medicine
(supporting the good of the individual).
 Ethical Principles
As Basis of Ethical GuidelinesIn Epidemiology

Respect for autonomy--(respect for decision-making

capacities of autonomous persons)

Non-malificience--(do not cause harm)

Beneficence-- (provide benefits and balance benefits

against risks)

Justice--(fairness in distribution of benefits and risks)

 Investigators’ Obligations to Study Subjects

I. Obligations to the subjects of research

• To obtain their informed consent
• To protect their privacy
• To maintain confidential information
• To protect their welfare
• To communicating the results of the study to the subjects

II. Obligations to society

• To avoid conflicts of interest
• To avoid bias
• To widen the scope of epidemiology
• To engage responsibilities with due determination
• To maintain public confidence
 Protecting Privacy and Confidentiality

• No absolute right to scientific knowledge

• Consent procedures are adequate for obtain consent from each
individual subject
• The privacy of subjects and the confidentiality of information
have been adequately protected
• Risks to subjects have been minimized and have been shown to
be justifiable by reference to anticipated benefits of the research
• Subjects who might be especially vulnerable to influence or to
harm have been protected by additional measures
• The selection of subjects is fair and reseach does not place an
undue burden on a particular class of subjects
• Plans have been included for the communication of study results
 Procedures designed to Protect the
Confidentiality of Subjects
The institutional review board (IRB) -
• Data retention must be approved by IRB or committee on
human research IRBs to help guard privacy and confidentiality.

• Study identifiers information are used not personal

information

• All results are published only in aggregate or group form so

that individuals are never identified.

• Maintaining privacy and confidentiality is regularly

emphasized to the research staff.
 Procedures designed to Protect the
Confidentiality of Subjects

Informed consent -
• It is required from study participants for all phases
of research, except review of medical records.
 Procedures designed to Protect the
Confidentiality of Subjects

Identified individual information

• Destroyed at the end of the study unless there is a
specific justification for retaining this information.
• Individual identifying information is not entered in
computer files, and individual identifiers are not
included in outline tabulations generated from
computerized data.
 Procedures designed to Protect the
Confidentiality of Subjects

Securely store data -

• Data obtained are stored under lock and key.
• Only study numbers are used on data forms.
• The key for linking these numbers to individual
names is kept separately under lock and key.
 Medical Records in Epidemiologic Studies

These records are needed for two main purposes:

For generating aggregate data or validate information obtained

by other means without contacting patients.

For identifying individual patients for subsequent follow-up

using means such as interviews or blood tests.
 Legislative Proposals for Medical Recods

The two proposals are as follows:

1. Patient consent should be required before investigators

are allowed access to medical records.

2. Data from medical records should be made available to

investigators without any information that would identify
an individual.
 Why would the first proposal, which requires patient
consent before investigators are allowed access to
medical records, make many studies impossible?

• Records must be reviewed to identify which patients meet the study criteria .

• Many studies are planned of only many years after a patient was hospitalized, so

informed consent could not have been obtained from the patient at that time. By the

time the study is later developed, many patients may have died or are not traceable.

• Certain patients refuse to be interviewed in epidemiologic studies, but the

nonparticipants can be characterized using data in their medical records so that

any biases resulting from their nonparticipation can be assessed.

 Why is information from medical records that identifies individuals’
essential for most epidemiologic studies?

Review of medical records is often the first step in identifying a group of

persons with a disease who will receive subsequent follow-up.

Identifying information is essential for linking the records of specific

individuals from different sources (such as hospital records, physicians’
records, employment records, and death certificates in studies of occupational
cancer).

Linkage of records is critical for generating unbiased and complete

information about each subject, in many types of epidemiologic
investigations.
Thank You