Hello, ailkilya-ga!
I really DO love your name, despite what it might sound like in
English!
You have asked for information pertaining to the United States
regarding research ethics. I have synthesized some material for you in
my own words which you may adjust to fit your needs. You might also
want to include further information from the referenced articles to
expand your research.
If you need further information or clarification, or if I have
misunderstood your request, please don't hesitate to ask and I will be
happy to help.
Sincerely,
umiat-ga
Google Search Strategy
protecting identity of subjects in social research
(The following paragraphs contain approximately 575 words.)
=====
Accurate disclosure of research findings should not permit guesswork
about a research participant's identity to go beyond mere speculation.
While speculation cannot be prevented, there are certain safeguards
that can be implemented to adequately protect individual identity.
When a research project in the United States involves gathering
"sensitive" information about a participant, research study organizers
who have access to the subject's identity may apply for a "Certificate
of Confidentiality". The Certificate can protect researchers and
others involved in the experiment from being held legally responsible
for revealing an individual's identity. The Certificate must be in
effect "during" the course of the research study in order to be
considered valid. (1)
A Certificate of Confidentiality does not offer absolute protection
to a research participant, however, especially when researchers deem
it necessary to voluntarily disclose sensitive information which may
protect the individual or the public. Voluntary disclosures may
include information relating to such issues as child abuse, potential
for violent acts and the threat of passing on a communicable disease.
The possiblity for disclosure of participant identity by research
study administrators must be clearly stated in an Informed Consent
form signed by the research participant. (1)
The Certificate also does not offer protection from identification
when the research participant provides written consent to allow such
disclosure, when the Department of Health and Human Services needs
necessary information for audit, program evaluation or investigation
of certain personnel, or to satisfy specific releases of information
required by the Federal Food, Drug, and Cosmetic Act. (1)
Individuals should not be coerced into participating in research
studies or remain uninformed about certain situations requiring
release of identifying information. Participants should be required to
sign an "Informed Consent" which advises them of the conditions under
which certain personal and sensitive information might be released.
This in no way implies that if such records are provided to
appropriate agencies, personal information will be released to the
public. Participants in studies can be given code numbers rather than
names and sensitive information such as medical records can be kept in
locked files and destroyed upon project completion to further protect
identity.(1)
The unintended disclosure of a research subject's identity,
especially when the research involves sensitive issues, can have
serious consequences. Thus, the level of protection should be relative
to the level of risk involved to the study participant.
"Confidentiality protections should be developed consistent with the
study design and the potential risk of harm from breaches of
confidentiality. As the risk incurred by disclosure increases, so
should the level of protection". (2)
"Protocols should be designed to minimize the need to collect
identifiable data by determining if there is a real need to collect or
maintain identifiers. In many situations, the data may be collected
anonymously or the identifiers can be removed and destroyed after
various data have been merged. Where it is necessary to collect and
maintain identifiable data, the data protection plan should describe
the appropriate level of confidentiality based on the potential
magnitude of the risk from disclosure. All members of the research
team should receive appropriate training. Physical security of the
data should be provided, and mechanisms for disposal and destruction
of all identifiable, confidential data not intended for archiving
should be developed". (2)
The research institution clearly has a serious responsibility to
monitor all studies conducted under its jurisdiction. "Host research
institutions should be cognizant of their obligations to actively
support the investigator in protecting all confidential information
from compelled disclosure or as otherwise agreed to in the data
protection plan." (2)
References Cited:
1. "CERTIFICATES OF CONFIDENTIALITY (NIAAA-SPECIFIC): PROTECTING THE
IDENTITY OF RESEARCH SUBJECTS". National Institute of Alcohol Abuse
and Alcoholism. (Updated: July 9, 2003)
http://www.niaaa.nih.gov/extramural/confidential.htm#research
2. "Issues in Confidentiality and Research Data Protections: A Report
and Draft Recommendations to NHRPAC Social and Behavioral Sciences
Working Group. American Sociological Association. (January 2002)
http://www.asanet.org/public/humanresearch/confident.html
Additional Reading
==================
"Protecting Human Research Subjects." National Human Genome Research
Institute.
http://www.genome.gov/10001752
(Read sections on "Privacy and Confidentiality Protections" and
"Publication Practices.")
"Protection of Participants in Behavioral and Social Science
Research."
http://obssr.od.nih.gov/IRB/protect.pdf
"Section 6: Protecting Human Subjects in Research."
http://www.adam-nij.net/files/sec6humansub.pdf
Additional Information
=======================
From Reference #1:
http://www.niaaa.nih.gov/extramural/confidential.htm#research
Identifying characteristics include:
name,
address,
any identifying number,
fingerprints,
voiceprints,
photographs,
genetic information or tissue samples,
or any other item or combination of data about a research subject
which could reasonably lead, directly or indirectly by reference to
other information, to identification of that research subject.
Sensitive information includes (but is not limited to)
information relating to sexual attitudes, preferences, or practices;
information relating to the use of alcohol, drugs, or other addictive
products;
information pertaining to illegal conduct;
information that, if released, could reasonably be damaging to an
individual's financial standing, employability, or reputation within
the community;
information that would normally be recorded in a patient's medical
record, and the disclosure of which could reasonably lead to social
stigmatization or discrimination;
information pertaining to an individual's psychological well-being or
mental health; and
genetic information or tissue samples. |
Clarification of Answer by
umiat-ga
on
08 Sep 2003 23:35 PDT
Hello again, ailkilya-ga!
You asked:
"Would you clarify how the need to report research data comes into
conflict with the need to keep a subject from possible harm?"
I hope this extra information will make my answer a bit clearer!
===
Reporting research results can pose a dilemma for researchers who do
not want to jeopardize the privacy of their study participants.
Certain research studies, particularly in the behavioral and social
sciences, often involve very sensitive and personal information that
could cause potential harm to a participant's business and personal
life if revealed. However, these same research studies are often
essential for compiling information that will help to define solutions
to some of society's serious problems.
For example, participants involved in research studies concerning
topics such as drug or alcohol abuse, sexual lifestyle, violent
behaviors, infertility problems, mental illness, etc. must be made to
feel that their identity will be protected in order to participate
freely in the study. And yet, the researcher must be able to extract
sensitive information from each participant to compile data and
formulate a conclusion that can be released in a public format. It is
extremely important that the identity of each participant remains
protected even though the final published research data will
undoubtedly contain very personal characteristics of the study
participants.
Therefore, the researcher is faced with the dilemma of how to conduct
the actual research and compile and publish the results without
revealing details which will allow individual participants to be
identified and suffer potential harm. This is why the protective
constraints around the process of research data compilation are needed
(as described in my initial answer). As stated previously, certain
protocols such as collecting data anonomously, collecting data via
code numbers rather than names, protecting and eventually destroying
data that could potentially identify participants, limiting the amount
of "identifying" data needed initially, and signing Certificate's of
Confidentiality can help to limit any potential breach of a
participant's privacy.
Genetic research is one area where the dilemma between reporting
research data and protecting individuals from emotional and social
harm is quite obvious.
As highlighed in the article previously referenced,
"Protecting Human Research Subjects." National Human Genome Research
Institute. http://www.genome.gov/10001752 ,
genetic research often carries risks to the individual. Not only are
emotional problems a serious consideration when research results are
revealed to the individuals themselves, but social cosequences can be
serious if identities are made public.
Excerpt:
"Psychological risk includes the risk of harm from learning genetic
information about oneself (e.g., that one is affected by a genetic
disorder that has not yet manifested itself)"
"Social risks include stigmatization, discrimination, labeling, and
potential loss of or difficulty in obtaining employment or insurance.
Changes in familial relationships are also social ramifications of
genetic research. For example, an employer who knew that an employee
had an 80 percent chance of developing HD in her 40s might deny her
promotion opportunities on the calculation that their investment in
training would be better spent on someone without this known
likelihood."
Further complications can arise when one family member is willing to
allow public release of genetic research results which will affect the
privacy of other family members who wish to remain anonymous.
Therefore, the researcher must be extremely cautious in balancing
individual protection and privacy against publication of research
data.
==
For further explanation, please read "POINTS TO CONSIDER" at the end
of the article.
http://www.genome.gov/10001752
It highlights some very important points that a researcher must
consider and anticipate before such a study begins. For example:
"Will the data be protected from disclosure to third parties, such as
employers and insurance companies? Will the data be stored in a secure
manner? Will the data be coded so as to protect the identity of
subjects? Is a request for a certificate of confidentiality
appropriate?"
"Do the investigator's publication plans threaten the privacy or
confidentiality of subjects? Has adequate consideration been given to
ways in which subjects' privacy and confidentiality can be protected?"
====
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