Human Subjects & Research

Understanding the protection of human subjects, HSRC, and the nature of the process.

Definition of Research

“Research” means

–a systemic investigation–designed to develop or

contribute to generalizable knowledge

Research includes research development, testing, evaluation -- i.e., pilot studies

Definition of Human Subject

• a living individual about whom an investigator conducting research obtains

(1) data through intervention or interaction with the individual, OR

(2) identifiable private information, i.e. codes, social security numbers, name, etc.

• Subjects have a reasonable expectation of privacy

Why?

• 1947: Nazi physicians are tried at Nuremberg, German, resulting in the Nuremberg Code

• Tuskegee, Alabama, untreated syphilis studies in uninformed, poor, black males are denied treatment even after a treatment is found, thru 1972!

More ...

• 1940s experiments injecting plutonium into human research subjects; secret radiation experiments; poor and mentally retarded children deceived about their treatments.

• 1950s: GIs are ordered near ground zero in nuclear tests without their knowledge of possible effects.

Ethical issues in human subject research

From the Belmont Report

• Autonomy

• Beneficence

• Justice

Of critical importance --

• Adequate preparation is taken to protect the privacy and confidentiality of subjects.

• Informed consent.• Adequate provisions are made for

the ongoing monitoring of the subjects’ welfare.

Autonomy

• Each person should be given the respect, time and opportunity to make his/her own decision.

• No pressure or coercion.• How will vulnerable populations

make an informed decision?• CHOICE

Beneficience

• Essentially the well-being of all study participants.

• Protect participants from harm.

• “maximize possible benefits and minimize possible harms” … Belmont Report

• Weighing benefits to society versus the possible risks.

Justice

• Who bears the risk, who is equal and who is not, who should receive the benefits?

• Participant selection may not be EXCLUSIVE unless scientifically justified.

Circumstances requiring review

• conducted by faculty, staff, or students;

• involves College students, staff, or faculty as subjects;

• performed on the campus;

• performed with or using College facilities or equipment

• satisfies a requirement imposed by the College for a degree or completion of a course of study;

What does this mean at Fredonia?

• All research at SUNY Fredonia that involves humans, human tissue, or records gathered on human subjects requires IRB (HSRC) review. This is true regardless of funding source or area of research.

HSRC responsibilities

• Identification of risks• Determination that risks are

minimized• Determination that “risks to

subjects are reasonable in relation to anticipated benefits.”

• Determination that subjects are adequately informed about “any reasonably foreseeable risks or discomforts.”

HSRC review criteria

• Risks to the subjects are minimized.

• Risks to the subjects are reasonable in relation to anticipated benefits.

• Selection of subjects is equitable.

• Informed consent is sought from each participant or legally authorized representative (LAR), and is properly documented.

Identifying risks

• Social and psychological risks are REAL risks.

• HSRC should not and do not rely on researchers to identify risks.

• There are two sources of harm:

– breach of confidentiality

– participation in the research

Breach of confidentiality

• Confidentiality and anonymity are not the same

• Names are not the only identifiers

• Subject participation in the research may need to be kept confidential as well as their data

Psychological & social harm

• Emotional distress• Psychological trauma• Invasion of privacy• Embarrassment• Loss of social status• Loss of employment

How do you minimize risk?

• Precautions• Safeguards• Alternatives

Informed

Consent

Informed consent

• The process should empower subjects to make their own determination about risk.

• Risks should be explained in terms that the subjects can relate to.

• Consent process should not do more harm than the research.

8 Required Elements

1. Statement that study is research and information on purposes, duration, procedures and/or experimental procedures

2. Reasonably foreseeable risks or discomfirts

3. Benefits which my reasonably be expected

4. Alternative procedures 5. How confidentiality will be maintained

8 Required Elements (cont’d.)

6. For more than minimal risk, compensation for injuries

7. Contact names - at least one not associated with the research is recommended

8. Statement that participation is voluntary and the subject can withdraw at any time without penalty or loss of benefits to which the subject is otherwise entitled

In General

• There is no such thing as “passive consent”– consent is required – Written consent MAY be formally waived

• There is no such thing as a “secondary subject”– if an investigator obtains “identifiable

private information” about a living individual, the individual is a human subject, regardless of the source

Researcher responsibility

• to educate the participants about risks and benefits

• to obtain their consent before involving them in your research

• to keep them informed

This is the "informed consent process."

Consequences of Non-Compliance

• Restrictions on Assurance• Suspension of Assurance/Research• Negative publicity• Warning letters• Loss of public confidence in

research• Personal financial loss• Disciplinary action