-Destroying all identifiers connected to the data.
-Requiring all members of the research team to sign confidentiality agreements.
-Keeping the key linking names to responses in a secure location.
-Reporting data in aggregate form in publications resulting from the research.
-Using data encryption for stored files.
-Securing a Certificate of Confidentiality.
-Waiving documentation of consent.
-Using pseudonyms in research reports.
-If group members know each other confidentiality is not an issue.
-Using pseudonyms in reports removes the concern about any confidences shared in the group.
-The researcher cannot control what participants repeat about others outside the group.
-If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
-There was neither a violation of privacy nor a breach of confidentiality
-The subjects’ privacy has been violated.
-Confidentiality of the data has been breached
-There was both a violation of privacy and a breach of confidentiality.
-A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.
-A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
-A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
-In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
-Not an excessive incentive.
-Of high quality.
The survey instrument is standardized.
Confidentiality of the prisoners’ health status is maintained.
All prisoners receive HIV testing.
A medical doctor serves as co-investigator.
Participation in research can be considered during parole hearings.
Researchers may study the effects of privilege upgrades awarded by the prison.
It is permissible for risks to be higher than those that would be accepted by non-prisoners.
The regulations prohibit compensating prisoners.
Approve this project but submit it for federal review.
Approve this project since the risk appears to be no more than minimal.
Not approve this project because the prisoners are merely a population of convenience for the student.
Approve this project since the superintendent is the ultimate authority on what happens in his facility.
Parents must approve written documentation.
To protect minors documentation is always required.
Documentation is required unless waived by an IRB.
Federal regulations do not require the documentation of minors’ assent.
The research involves the use of educational tests
The children will be interviewed by the researcher.
The research with children will involve participant observation with researcher interaction.
The children will be asked to complete a survey
Parents must be notified that the study is taking place.
The students must be offered an optional classroom activity.
An independent consultant must approve the waiver.
The research must pose no more than minimal risk.
The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population.
The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.
Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
The new research would need full review by a convened IRB because children are a protected population.
The researcher anticipates a low response rate.
An IRB has approved a waiver of the requirement for parental permission.
The researcher has conducted a similar study at another institution.
The superintendent of schools and the principals have approved the study.
Observation of public behavior when the researcher participates in the activities being observed.
Research about educational testing
Ensure that surveys do not ask school children to provide sensitive information about their parents.
Provide parents certain rights over their children’s educational records.
Give school principals the right to discuss students’ behavioral problems with their parents.
Allow school counselors to access students’ grades.
The No Child Left Behind Act.
Subpart D of 45 CFR 46.
The Protection of Pupil Rights Amendment.
The Family Educational Rights and Privacy Act.
Determining if the research might present unique risks to subjects given local socio-economic conditions.
Considering local customs, norms, and laws.
Assessing transportation conditions
Consulting with members of the community from which subjects will be recruited.
Legal drinking age where the research will take place.
Laws in the state where the researchers’ institution resides.
Laws, customs, and norms in the area in which the research will be conducted.
The research sponsor.
Providing potential subjects with written information about a study.
Obtaining informed consent and conducting research interviews.
Informing prospective subjects about the availability of research.
Obtaining subjects’ permission for researchers to contact them.
People assume pseudonymous on-line identities, such as an avatar in an MMORPG.
Online studies do not require the documentation of informed consent.
Recruiting, consenting and debriefing subjects takes place on-line, and may require little to no interaction with the subjects.
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
A linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings.
A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her.
A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time.
A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Designing the survey so that subjects are not forced to answer one question before going to the next.
Giving examples in the consent process of the kinds of questions that will be asked.
Providing a thorough debriefing at the end of the study.
Specify that all respondents must be legal adults.
Suggest that subjects print a copy of the informed consent form for their records.
Comply with the survey software’s Terms of Service agreement.
Design the survey so that no direct or indirect identifiers are collected.
Downloading a publically available dataset that includes high school students’ academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states.
Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual’s social network.
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects’ significant others to be a part of the focus group.
Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted.
Use of decedents’ information, with certain representations by the researcher.
Data that does not cross state lines when disclosed by the covered entity.
Activities preparatory to research, with certain representations by the researcher.
Limited data set with an approved data use agreement.
for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
for all research where the data crosses state lines, otherwise state law applies.
for all human subjects research that uses PHI.
solely at the principle investigator’s discretion.
identifiable health information that is created or held by covered entities, provided the data subject is a US citizen.
identifiable health information that is created or held by covered entities.
any identifiable health information.
Identifiable health information that is created or held by covered entities that operate across state lines.
must be more detailed for disclosures that involve fewer than 50 subject records.
is always the same, regardless of the number of records involved.
is limited to the information elements the data subject specifically requests.
is at the discretion of the organization, given its accounting policies.
anything a researcher does in a federally-supported laboratory.
development of generalizable knowledge.
quality assessment and improvement.
Unions may encourage employees to participate with the expectation that “entitlements” may follow from study results.
The research study’s finding could affect an employee’s pay, benefits or promotion potential.
The employer may encourage or deny participation of workers.
Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization.
All of the above
Who will have access to the data.
If personal identifiers will be retained and used in the data analysis.
How the data will be collected and secured.
If the study results, if any, will be included in the employee’s personnel records.
All of the above
Any equity interest in a publicly held company that exceeds $5,000
Any equity interest in a publicly held company that exceeds $30,000
Any equity interest in a publicly held company that exceeds $50,000
Any equity interest in a publicly held company that exceeds $15,000
Conflict of Interest
Greater than $5,000 of ownership in any single public entity/company.
$25,000 and 5% of ownership in any single entity/company.
Greater than $2,000 or 2% of ownership in any single entity/company.
Greater than $10,000 or 5% of ownership in any single entity/company.
Maintaining a supply of volunteers for research studies and their active involvement in research
Ensuring the objectivity of research and the protection of human subjects
Protecting proprietary information and fidelity to contracts with sponsors
Establishing open dialog with sponsors and security of study records
The elimination of bias.
The actual involvement of bias.
An awareness of bias.
The potential for bias.
– Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed.
– Reviewing subject recruitment materials and strategies.
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. Tearoom Trade Study (Humphreys).
D. The Harvard T3 study.
A. The study makes a significant contribution to generalizable knowledge.
B. Subjects derive individual benefit from study participation.
C. Risks are managed so that they are no more than minimal.
D. Potential benefits justify the risks of harm.
C. Respect for persons.
C. Respect for persons.
a. Providing detailed information about the study to potential subjects.
b. Ensuring that risks are reasonable in relationship to anticipated benefits.
c. Ensuring that the selection of subjects is fair.
d. Ensuring that subjects understand that participation is voluntary
a. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.
b. A researcher conducts a linguistic study of comments posted on a local public blog.
c. A researcher uses the Customs Office’s passenger lists for ships bringing immigrants to the US between1820-1845 to track the numbers of immigrants from certain ethnic groups.
d. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
a. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership.
b. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
c. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.
d. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.
a. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.
b. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.
c. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger’s comments on a similar topic in a weekly magazine.
d. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
a. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.
b. The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided.
c. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
d. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.
a. Identifiable public information.
b. De-identified private information.
c. Identifiable private information.
d. Observations of public behavior.
a. All the subjects are adults and the risk is minimal.
b. The investigator is experienced in the field of inquiry.
c. The research falls into one of six categories of research activity described in the regulations.
d. Participation in the research will involve 10 minutes or less of the subjects’ time.
a. College students.
b. Adults with decisional impairments.
c. The elderly.
a. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.
b. More than minimal risk, but the study replicates previously approved research.
c. Any level of risk, but all the subjects are adults.
d. No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
a. Is limited to review of unanticipated problems.
b. Must be conducted by a convened IRB.
c. Is not required unless additional risks have been identified.
d. Must occur within 12 months of the approval date.
a. Institutional priorities take precedence over all IRB determinations.
b. Department chairs can overturn an IRB disapproval.
c. Officials of the institution may overrule an IRB approval.
d. Officials of the institution may overturn an IRB disapproval.
a. Experience emotional or psychological distress.
b. Lose their legal status.
c. Lose their employment.
d. Feel that their privacy has been invaded.
a. Have the subject sign the consent form under an assumed name.
b. Obtain a Certificate of Confidentiality.
c. Code the subjects’ responses.
d. Obtain a waiver of documentation of informed consent.
a. Prevent subjects from knowing the purpose of a study.
b. Allow law enforcement to investigate abuse cases.
c. Protect researchers from disclosing conflicts of interest.
d. Protect identifiable research information from compelled disclosure.
a. If a study offers potential benefits, it is not necessary to minimize risks.
b. Anonymizing data effectively manages the risk of creating emotional distress.
c. There are never any risks.
d. Risks are specific to time, situation, and culture.
a. The therapist creates her clients’ records; therefore, she does not need parents’ permission to use the information for research purposes.
b. If it is the best interests of the community that the children participate in the study, parental permission is optional.
c. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn’t have to ask the parents for permission.
d. The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.
a. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.
b. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
c. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
d. In the event of any distress you may have related to this research, you will be given access to appropriate resources.
a. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects’ attention on the material.
b. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
c. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
d. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
a. The subjects are literate in their own language; however, they do not read, write, or speak English
b. Potential subjects might find some of the research questions embarrassing, personal, or intrusive
c. The investigator has no convenient place to store signed consent forms separate from the research data
d. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
a. Describe penalties that may be imposed for non-participation.
b. Recommend that potential subjects discuss their decision to participate with family members.
c. Provide a list of the IRB members who reviewed the protocol.
d. Provide potential subjects with information at the appropriate reading comprehension level.