Research Ethics & IRB Part 2
This is provides essential concepts and facts related to ethical research practices involving human subjects. Topics include the three foundational principles of the Belmont Report—Respect for Persons, Beneficence, and Justice—along with the history of research ethics (e.g., Nuremberg Code), types of IRB reviews (Exempt, Expedited, Full Board), and requirements for informed consent. Ideal for students, researchers, and faculty preparing to engage in ethical research or complete IRB applications.
Data are made anonymous by
Destroying all identifiers connected to the data.
Key Terms
Data are made anonymous by
Destroying all identifiers connected to the data.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which confidentiality procedure would protect against compelled disclosure of individually identifiable information?
Securing a Certificate of Confidentiality.
When a focus group deals with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group.
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
There was neither a violation of privacy nor a breach of confidentiality
Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data wou...
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:
Confidentiality of the prisoners' health status is maintained
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| Term | Definition |
|---|---|
Data are made anonymous by | Destroying all identifiers connected to the data. |
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which confidentiality procedure would protect against compelled disclosure of individually identifiable information? | Securing a Certificate of Confidentiality. |
When a focus group deals with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct? | The researcher cannot control what participants repeat about others outside the group. |
A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? | There was neither a violation of privacy nor a breach of confidentiality |
Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? | 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. |
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that: | Confidentiality of the prisoners' health status is maintained |
Which of the following statements about prison research is true? | Researchers may study the effects of privilege upgrades awarded by the prison. |
An investigator is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are: | Not an excessive incentive. |
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should: | Not approve this project because the prisoners are merely a population of convenience for the student. |
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research | Federal regulations do not require the documentation of minors' assent. |
According to Subpart D, research with children may be eligible for exemption when: | The research involves the use of educational tests |
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? | The research must pose no more than minimal risk. |
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? | 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. |
Parental notification, in lieu of active parental permission, is allowed when: | An IRB has approved a waiver of the requirement for parental permission. |
According to Subpart D, which of the following research activities with children would qualify for an exemption? | Research about educational testing |
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: | Provide parents certain rights over their children's educational records. |
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? | The Family Educational Rights and Privacy Act. |
Which of the following is the LEAST important activity when protecting human subjects in international research? | Assessing transportation conditions |
The age of majority in international research is determined by the | Laws, customs, and norms in the area in which the research will be conducted. |
Which of the following activities constitutes engagement in research? | Obtaining informed consent and conducting research interviews. |
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is: | Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers |
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? | 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. |
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? | Designing the survey so that subjects are not forced to answer one question before going to the next. |
To minimize potential risks of harm, a researcher conducting an on-line survey can: | Design the survey so that no direct or indirect identifiers are collected. |
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects? | 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. |
A HIPAA authorization has which of the following characteristics: | Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document. |
When required, the information provided to the data subject in a HIPAA disclosure accounting ... | must be more detailed for disclosures that involve fewer than 50 subject records |
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: | An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. |
Recruiting into research | can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity. |
HIPAA's protections for health information used for research purposes... | supplement those of the Common Rule and FDA. |
HIPAA | Health Insurance Portability and Accountability Act of 1996 |
HIPAA privacy protections supplement those of | other federal regulations (viz., the Common Rule and FDA), state law, and certification/accreditation requirements. |
HIPAA protects | protects identifiable health information (PHI) originating or held in covered entities. De-identified data is not protected, and not all identifiable health information is considered PHI either |
Under HIPAA, research activity using PHI generally requires | authorization. However, there are several alternatives that allow bypassing the authorization requirement. |
Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must be | understood by researchers when HIPAA applies |
If you're unsure about the particulars at your organization or have questions, | consult with your organization's IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization's Security Official. |
specified identifiers |
|
Vulnerable persons are | those who are less able to protect themselves than other persons in a given situation. |
The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, | Pregnant Women, Human Fetuses and Neonates (Subpart B), Prisoners (Subpart C) and Children (Subpart D). |
T/F | False |
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: | pressure from their co-workers, unions and employers. Pressure can be applied to workers in subtle ways such as an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs, etc. |
T/F | True |
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of: | Conflict of interest |
Significant financial interest can be defined as: | Equity/stock interests (regardless of value) in a non-publicly traded company. |
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is | Greater than $5,000 of ownership in any single public entity/public company. |
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold: | Any equity interest in a publicly held company that exceeds $50,000 |
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to: | Designated institutional officials |
What constitutes "research" according to HIPAA? | HIPAA defines research as any "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge |
Who enforces HIPAA's protections? | IRB |
Waivers and alterations of authorization requirement | •Use or disclosure of the PHI involves no more than minimal risk to the privacy of the research subjects, based on the following elements: |
Activities preparatory to research, decedents' information exceptions | •Where the PHI will be used solely for reviews preparatory to research (e.g., for protocol development) and will not leave the covered entity. |
T/F | True |
Grandfatherd research | if all informed consents and other legal permissions required at the time were in place before HIPAA took effect (April 2003 in most cases), and have not changed since, no new HIPAA authorization is required. |
minimum necessary standard | the uses/disclosures must be no more than the minimum required for the described research purpose |
accounting of disclosures | •A list of all protocols for which their PHI may have been disclosed, along with the timeframe for those disclosures. |
Characteristics of authorizations | •In "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision. |
T/F | True |
T/F | True |
Retrospective" research | use or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board |