Recent Bookmarks and Annotations
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Teaching Reading - Resource Topics - National Writing Project on 2009-03-29
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Urikaine DanielO 8 - Google Docs on 2009-03-22
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JSTOR: The English Journal, Vol. 92, No. 5 (May, 2003), pp. 73-75 on 2009-02-19
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Research with Children - SBR on 2009-02-18
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Therefore, children's assent to participate in research should be solicited when
children are capable of providing it.
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provisions for waiving parental permission for neglected or abused children
cannot violate federal, state, or local law. The permissibility of such waivers
may also be governed by institutional policies
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Records-Based Research on 2009-02-18
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- Place the subject at risk of criminal or civil liability.
- Be damaging to the subject's financial standing, employability, or
reputation.
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Investigators are generally asked to describe who will have access to
identifiable private information and how inadvertent disclosure will be
prevented
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it refers to an expectation or, in some cases, a legal right of
a person to control access to personal information about himself/herself.
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- A person could be
ostracized if community members learned that he or she had - been accused of
partner abuse.
- A parent could punish a
minor child if he/she discovered that the teenager was sexually active.
- A person's chance for a
promotion at work could be damaged by the discovery that he/she has a
psychiatric diagnosis, heart disease, cancer, or some other medical
condition
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Through the consent process, the investigator can describe directly to the
research subject the extent to which confidentiality---safeguarding information
based on trust---will be maintained. The research subject can then decide if
he/she will permit the use of information about himself/herself.
Research Integrity
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Some records-based research may need to use thousands of medical records, for
instance, when rare adverse events of a particular medication are the subject of
a study.
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If an IRB agrees that obtaining consent of the research subjects is not
feasible and determines that all federally required conditions have been met,
the IRB will approve research only if when it includes very clear data security
procedures. B
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When an IRB has determined that it is not practicable to obtain consent and the
risks of the research are reasonable in relation to the potential benefits of
the research, the investigator describes confidentiality protections to the IRB,
rather than directly to the subject.
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What kinds of codes or encryption will be used to separate research data from
subject identifiers?
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- For data being transmitted physically and/or electronically,
what encryption methods will be used?
- What procedures will be used for disposal/destruction of
documents?
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there are some instances in which such research is exempt from
the federal regulations (45 CFR 46). Records research can be
certified by an institution or IRB office as exempt when:
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- The sources of information
are publicly available or
- The information collected
is recorded by the investigator in such a way that the subjects cannot be
identified, directly or indirectly, through identifiers linked to the
subjects
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For example, publicly available data may be
available for purchase.
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the records must already be "existing," i.e., the information in the records
must have been collected already. If the investigator will be able to
identify the subjects directly from his/her research records, the research
cannot be considered exempt from review.
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However, in some cases, when the investigator does not have
access to identifying information on the subjects, research may be declared
exempt by an institution or IRB if a signed agreement is in place between the
investigator and the original record holder stating that identifiers will never
be given to the investigator.
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The most important point to
remember about "exempt research" is that a determination of exemption must be
made at the institutional level in accordance with institutional
policies
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According to DHHS regulations,
informed consent from the subject must be obtained unless all of the following
conditions are found and documented:
- The research involves no
more than minimal risk to subjects.
- The rights and welfare of
the subjects won't be adversely affected by the waiver of consent.
- The research could not
practicably be carried out without the waiver of consent.
- When ever appropriate, the
subjects will be provided with pertinent information after
participation
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Similarly, each state may have laws pertaining to particular kinds of records
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FRONTLINE: teacher center | PBS on 2009-02-18
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3 Challenges to Wiki Use in Instruction -- Campus Technology on 2009-02-18
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This means that gaps in design and purpose are not only demonstrated through
lack of (obvious) participation by students but also lack of viewable connection
to the overall purpose and meaning of a course. This frustrates students and
usually results in lack of motivation
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Well designed assignments are clearly based on the learning outcomes of a course
and also present meaningful purposes for students in their completion. That is,
students are further in their learning process after an assignment than they
were before it.
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Privacy and Confidentiality - SBR on 2009-02-17
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the Family
Educational Rights and Privacy Act (FERPA) is designed to protect the privacy of
students' educational records. And the Privacy Rule of the Health
Insurance Portability and Accountability Act (HIPAA) describes conditions under
which researchers can access and use private health information.
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The Common Rule states that in order to approve research the IRB shall
determine that, when appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
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privacy can be defined in terms of having control over the extent, timing, and
circumstances of sharing oneself (physically, behaviorally, or intellectually)
with others.
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Confidentiality procedures, as described during the informed consent process,
allow subjects to decide what measure of control over their personal information
they are willing to relinquish to researchers.
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It is not always the case that information provided by research participants
must be protected from unauthorized or inadvertent disclosure.
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private information" to mean "information about behavior that occurs in a
context in which an individual can reasonably assume that no observation or
recording is taking place, and information which has been provided for specific
purposes by an individual and which he or she can reasonably expect will not be
made public (for example, a school record)."
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individuals may identify private spaces in the midst of very public ones
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- The information is either not linked to the respondents' identities, that
is, it is anonymous, or
- The information is linked to the respondents' identities, but the nature of
the information is such that disclosure will not be reasonably expected to cause
harm. In other words, non-anonymous data recording can be exempt if any breach
of confidentiality would not cause harm beyond that encountered in everyday
life.
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For example, a researcher may videotape subjects when the subjects presume they
are on a break between study tasks. An ethical concern is whether an invasion of
privacy - a violation of the principle of respect for persons - could be
justified by the benefits of the study. Is the knowledge to be gained important
enough to involve the subjects without their consent? What, if anything, will
the subject be told later?
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If a survey instrument or an interview script contain questions that individuals
are likely to find intrusive, they must be informed about the nature of the
questions in advance
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The survey instrument or interview process must be designed so that a subject
can choose not to answer any question that makes him or her uncomfortable, or
that he or she wants to skip for any reason.
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Employee e-mail is not secure and some home accounts may be accessed by anyone
in the family. Telephone calls to subjects at home may also be of concern.
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In some cases it may be appropriate to educate subjects about how to prevent
possible violations of their privacy in their homes. For example, researchers
may counsel subjects to make sure their home computers are secure or to close
their browsers after completing an on-line survey on a sensitive topic
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Even though researchers can emphasize to all participants that the comments made
during the focus group session should be kept confidential (when the topic
warrants), researchers need to inform participants that it is impossible for the
researcher to promise that participants will not repeat comments outside the
group at some time in the future
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In recruiting for focus groups, it is important to inform prospective
participants how fellow participants are being selected. Privacy may or may not
be an issue in the course of the group discussion, depending
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If the topic is sensitive or personal, such as the fact that someone was
adopted, care should be taken so that potential subjects' privacy is not
violated. In this case, subjects assisting with recruiting could provide
information about the research to potential subjects, rather than giving the
researcher names of potential subjects
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- If subjects were chosen for the study due to a sensitive or stigmatizing
condition or participation in illegal activities, are procedures in place from
the very beginning to protect identities, such as a waiver of the requirement to
document consent?
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Would password protection be sufficiently protective, or would data encryption
be necessary in addition? Would the use of stand-alone computers, without
network access help prevent access by unauthorized users?
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are there limits to the promises of confidentiality that the researcher can make
to subjects due to state laws requiring researchers to report suspected child
abuse or neglect?
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the disclosure of these records to researchers involves securing written
authorizations from the potential subjects, although in certain clearly defined
circumstances the requirement to secure authorizations may be waived.
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Certificates of Confidentiality may be granted for studies collecting
information that, if disclosed, could have adverse consequences for subjects or
damage their financial standing, employability, insurability, or reputation. A
Certificate of Confidentiality will allow the investigator and others who have
access to research records to refuse to disclose identifying information on
individual research participants in civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or
local level.
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Informed Consent - SBR on 2009-02-17
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potential subjects may be illiterate. Researchers may not be able to achieve
scientifically valid results if they have to disclose the full purpose of a
study. Asking subjects to sign consent forms linking them to a study about
illegal activities could put them at risk of harm.
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The federal regulations provide sufficient flexibility to address some of
these concerns, particularly for research with no more than minimal risk. For
example, the regulations allow waivers and alterations of the requirements for
the consent and documentation processes.
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Giving subjects adequate time to consider their decisions
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The agreement is only to enter the study, as subjects may withdraw at any time,
or decline to answer specific questions or complete specific tasks.
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Documentation of consent provides a record that the initial process took place
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Assessing Risk in Social and Behavioral Sciences - SBR on 2009-02-17
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Unlike biomedical research studies or clinical trials, in which the sources of
risk may be more readily identifiable and quantifiable, risks associated with
participation in social and behavioral science research are often more elusive
and less predictable. However, this does not mean that these risks are any less
serious or less real. For example, discrimination due to an inadvertent
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risks associated with participation in social and behavioral science research
are often more elusive and less predictable.
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For example, studies comparing the average IQ of "racial" groups
or the prevalence of HIV-infected individuals in communities may stigmatize the
community being studied.
Module Contents:
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- Balancing risks and potential benefits
- Minimizing and managing risks
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social and behavioral sciences generally fall in three categories:
- Invasion of privacy.
- Breach of confidentiality.
- Study procedures
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if personal information is accessed or collected without the subjects' knowledge
or consent. Invasions of privacy can occur if a subject's participation in a
study is revealed without the subject's knowledge. For example, if an
investigator communicates via email with subjects in a study about recovering
from childhood sexual assault, family members with access to email may learn
about the assault
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For example, responding to questions about a sensitive topic or traumatic event
may be distressing to a subject, even if the information divulged is kept in
strict confidence.
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but from subjects themselves when data is collected in a group setting such as a
focus group. Even though participants are typically cautioned not to share
information outside the data collection setting, subjects should be made aware
that the researcher cannot guarantee confidentiality.
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Sometimes there is great disparity between the probability and the magnitude of
harm in a study
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the data are vulnerable in transit from an individual's PC to the web server
hosting the survey, much in the same way credit card information is vulnerable
during transit. Although the probability that the data could be "snatched" in
transit and identified is low, it could be done. The magnitude of the possible
harm is very high given the sensitivity of the information. (For more
information on managing risks in Internet-based research, see the module titled
"Internet Research.")
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For example, asking women if they have had abortions would carry very different
risks a country where abortion is a routine medical practice, a country where it
is illegal, and a country in which it is legal but the issue is fraught with
religious and political controversy.
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Purchasing tobacco products is generally illegal for persons under 18 years of
age. For adults, however, it is a health hazard, but not an illegal activity.
Thus, any assessment of the risk for teenagers will have to consider that the
research focuses on an illegal activity
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research indicates that when potential harms are severe, people tend to
overestimate the probability. And when potential harms are less severe, such as
embarrassment, people tend to underestimate the probability. A good consent
process will address these tendencies.
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- Remove all direct identifiers as soon as possible.
- Substitute codes for identifiers.
- Maintain code lists and data files in separate secure
locations.
- Use accepted methods to protect against indirect identification,
such as aggregate reporting or pseudonyms.
- Use and protect computer passwords.
- Encrypt stored data.
- Access and store data on computers without Internet connections.
4.2 Certificates of Confidentiality.
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A Certificate of Confidentiality will allow the investigator, and
others who have access to research records, to be protected from disclosing
identifying information on research participants in
- Civil,
- Criminal,
- Administrative,
- Legislative, or
- Other proceedings, whether at the federal, state, or local level.
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- Substance abuse or other illegal behaviors.
- Sexual attitudes, preferences, or practices.
- Genetic information.
- Psychological well-being.
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Certificates of Confidentiality do not override the requirement to
report the suspicion of child abuse or neglect, or any other state mandated
reporting requirements, such as elder abuse.
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