Basic Concepts Reading

1. Three Major Ethical Principles for Human Research

Respect for Persons:

Obligation to treat individuals as independent, self-governing

entities

Obligation to obtain voluntary informed consent from

participants = The researcher must respect the individual's
decision on choosing whether to participate in research or not;
The researcher cannot ignore or invalidate the individual's
decision.

Researcher must give special recognition and deal respectfully

with people who are immature, incapacitated, or whose selfgovernment and independence is autonomous. = Necessity to
protect individuals with limited capacities from harm;
Provision of consent for individuals with limited capacities
should be sought from the proper authorities; Extra care must
be taken to minimize research risks, sometimes exclusion
from participation in research is necessary.
Beneficience:

Obligation to protect the participants to the fullest extent to

secure their well-being.

Obligation to maximize the benefits expected to result from

the research for the participants and especially for society.

Researchers and IRBs are required to assess the risks of harm

and the probability of benefits in a systematic manner.
Justice:

Obligation to show fairness in selection of research

participants = Distribution of the burdens of the research and
benefits of the research must be seriously considered when
fairly selecting research participants.

Researches are required to select participants in a fair, neutral

manner for particular studies.

Funding agencies are required to consider the distribution of

burdens and benefits across society, and ensure certain
groups are not systematically excluded from or included in
research.

2. Difficulty in estimating the amount of harm or benefits research

subjects may experience is due to the surrounding reasonable
disagreements and subjectivity involved in the process of
determining the type of harm, extent of harm, likelihood or
probability of harm, and possible pariticipation benefits for specific
research protocols. Difficulty in estimating risk for many types of
nonphysical harms in the absence of an ideal foundation of
evidence.
Six types of harm:
1. Physical Harm = death, injury, pain, suffering, discomfort
(possible results from researching experimental drugs or
experimental methods of assisting incapacitated individuals;
also may result from breach of confidentiality and targeting by
criminal or deviant entities such as gangs)
2. Psychological harm = negative self-perception, emotional
suffering (anxiety/shame), impaired thoughts or behaviors
(agreeing to hateful statement under pressure from research
environment)
3. Social Harm = negative effects on relationships/interactions
with other people (result from breach of confidentiality;
participants' answers become known to others), discriminatory
behavior resulting in loss of insurance/employment from
knowledge of research study results, stigmatization or
ostracism due to knowledge of individual's participation in
research study or findings from research study
4. Economic Harm = financial loss (due to transportation or
child care costs to have time to participate in study), loss of
employment (similar to social harm results), or possible side
effects from the other harms (lawsuits that result from breach
of confidentiality)
5. Legal Harm = arrest, conviction, incarceration, civil lawsuits
(results from breach of confidentiality in studies about
criminal or deviant activities; result from required reporting of
particular criminal or deviant behaviors due to state law)
6. Dignitary Harm = results when individuals are treated as
means to an end instead of people deserving respect for their
own values and preferences; occurs in research studies that do
not appropriately obtain informed consent

SBES and biomedical research can provide two kinds of benefits:

1. When knowledge about humans and human societies helps
decision making in the public and private sectors by
individuals, households, business, organizations, and
governments. (Psychological research and appropriate stimuli
needed to develop comprehensive, social, and emotional skills;
Economic decision-making research and how people respond
to financial incentives; Survey research and indications of
consumer-spending and confidence in the economy that are
important forecasters of economic growth or recession)
2. Study Procedure or how research study is conducted;
opportunity for education, gaining access to information, and
opportunity to earn esteem of other participants and the
research team; these benefits can be meaningful to
participants and help build positive long-term relationships
with a research program

3. The IRB process has led to the evolution of the construct of a

standard "minimal risk", and this construct plays a significant role in
determining the type of review that the IRB will use for each
presented research protocol.

Minimal risk, as defined by the Common Rule, means that "the

probability and magnitude of harm or discomfort anticipated in
the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance
of routine physical or psychological examinations or tests."

The construct of minimal risk is ambiguous because it is an issue

that should not be hastily concluded; The issue of minimal risk
should be debated so that an appropriate consensus is reached in a
timely manner, and the continued debate of research ethics can also
lead to useful guidance for IRBs and researchers in the
determination of research protocols that fit within the construct of
minimal risk.

4. Two Major Criticisms of IRBs; the problem of determining the risk

in a research protocol and acting appropriately on the
determination:

1. IRBs are overloaded and underfunded; Consequently they

are hard pressed to fully carry out their responsibilities for
protecting human participants in research studies that use

protocols which do not fit within minimal risk.

2. IRBs spend too much time on scrutinizing minimal-risk

research; This is possibly due to the heightened scrutiny of IRB
operations by federal government and media in light of highly
publicized deaths of research participants. This over-review of
minimal-risk research interferes with the ability or IRBs to
properly review "higher risk" research

5. How do SBES studies compare to biomedical studies in terms of their

methods and level of risk?
5. SBES Study Methods & Level of Risk vs. Biomedical Study Methods
& Level of Risk
SBES Research Methods: uses wide variety of methods; most
present disciplines encompass multiple methods; individual research
projects usually use two or more types of measurement.
Biomedical Research Methods: uses wide variety of methods; does
not use some types of research as frequently or infrequently as
SBES.
Contrasts: Self-administered questionnaires = 59% of SBES
protocols, 21% of Biomedical protocols; Double-blind experiments =
3% of SBES protocols, 25% of Biomedical protocols