Module: Fundamental Issues

(7-18-11)

1. Risk

2. Informed Consent

3. Privacy and Confidentiality

Risks in social and behavioral sciences generally fall into 3 categories:

Invasion of Privacy

Breach of Confidentiality

Study Procedures

The information was entrusted to you by the individual; it was given to you “in confidence.”

The information is a special kind of knowledge because it might be: ◦ Intimate in nature

◦ Socially stigmatizing

◦ Damaging to employability

Confidentiality serves two purposes in research ◦ Confidentiality acknowledges respect for a person’s

sense of individuality and privacy

◦ Confidentiality is important in obtaining good data.

Information to which the public do not have access and about which you have a reasonable expectation public access is or can be restricted. You control the access to this information. ◦ Examples of privacy: Your home.

◦ Not private: Work, hospital room, public places.

Who possesses the information? ◦ If you possess private information about a research

participant, to disseminate that information without permission violates confidentiality.

◦ If you obtain data from patients’ charts without their permission, you violate privacy.

Invasion of privacy can occur if:

personal information is accessed or collected without the subjects’ knowledge or consent.

a subject’s participation in a study is revealed without the subject’s knowledge.

Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects’ psychological, social or economic status.

Elements of Risk:

Probability of Harm

Magnitude of Harm

Risks in research participation are specific to:

Time

Situation

Culture

Risks will differ according to subject populations.

The degree of harm may be different for different subject populations.

People, including researchers, tend to:

Underestimate risks involved in activities with which they are familiar.

Overestimate the benefit of things that are important to them.

Risks associated with research should be reasonable in relation to the anticipated benefits.

The benefits of research often lie in the importance of:

Knowledge to be gained

Contributions it makes to science

Contributions to society in general

Risks can be minimized in 3 ways:

Alternatives

Precautions

Contingencies

1. Collect data without identifiers. 2. Remove all direct identifiers as soon as

possible. 3. Substitute codes for identifiers. 4. Maintain code lists and data files in separate

locations. 5. Used accepted methods to protect against

indirect identification. 6. Use and protect computer passwords. 7. Access and store data on computers without

internet access.

Most people have the reasonable expectation: • that they be treated with respect as

autonomous individuals.

• that they have a right to make decisions about what will and will not be done to their persons.

• about what information they will share with others.

Basic elements of the consent process:

Full disclosure of the nature of the research and the subject’s participation.

Adequate comprehension on the part of the potential subjects.

The subject’s voluntary choice to participate.

1. Information that the study involves research. a) An explanation of the purposes of the

research and expected duration of the subject’s participation.

b) A description of the procedures to be followed.

c) Identification of any procedures that are experimental.

2. Description of any foreseeable risks or discomforts to the subject.

3. Description of the benefits to the subject or to others.

4. Disclosure if any alternative procedures or treatments that maybe advantageous to the subject.

5. Description explaining how the institution/manager will maintain confidentiality records.

6. For research involving more than minimal risk, a description of compensation provided and an explanation regarding whether medical treatment is available.

7. Contact information for individuals the subject may contact for further information about the research study and about the rights of research participants.

8. Statement that participation is voluntary.

1. Description of the costs a subject might incur.

2. Statement that any significant new findings that might be relate to a subject’s willingness to participate will be provided.

3. Consequences of a subject’s decision to withdraw from a study.

4. Circumstances where the subject’s participation may be terminated.

5. Statement that there may be unforeseeable risks.

6. Number of subjects.

Techniques that may be used to improve comprehension include:

Avoiding technical terms.

Translation.

Language appropriate to subjects’ age level.

Only legally competent adults can give consent.

Minors and incompetent adults cannot give consent.

Evaluation of competence must be done on a case-by-case basis.

Assent is the “knowledgeable agreement” to participate on the part of a potential subject.

Required whenever the potential subject has sufficient capacity to understand what is happening and express his/her wishes.

In order to be valid, consent must be free from all forms of coercion.

Forms of coercion:

Overt coercion

Social pressure

Requests from authority figures

Undue incentive for participation

Subject has legal and mental capacity to give consent.

Subject is provided sufficient opportunity to consider whether or not to participate.

Possibility of coercion or undue influence is minimized.

Language is understandable to the subject.

No “exculpatory” language is used.

It is recommended that consent forms meet 4 criteria:

1. Be brief, but have complete basic information.

2. Be readable and understandable to most people.

3. Be in a format that helps people comprehend and remember the information.

4. Serve as a script for the face-to-face discussions with potential subjects.

An IRB may approve a waiver or alteration of some/all consent requirements provided that:

• Research involves no more than minimal risk to subjects.

• Waiver will not adversely affect the rights and welfare of subjects.

• Research could not be carried out without the waiver.

• When appropriate, subjects will be provided with additional pertinent information after they have participated in the study.

1. Principle risks are those associated with a breach of confidentiality concerning the subject’s participation in the research, and the consent document is the only record linking the subject with the research.

2. Study participation presents minimal risk to the subject and the research involves no procedures requiring consent outside the context of participation in the study.

Privacy refers to our right to control access to ourselves and to our personal information.

Private vs. Public Behavior

Identifying and Recruiting Subjects

Obtaining Information through Covert Observation

Privacy of Third Parties

Privacy and Study Questions

Confidentiality refers to agreements made with subjects, through the consent process, about if and how information provided by the subjects will be protected.

Confidentiality Procedures

Indirect Identifiers

Research Using Existing Data Sets

Limits to Confidentiality

Certificates of Confidentiality