Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects?

Answer: Conducting an online 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.

Which of the following methods could be considered a “best practice” in terms of informing respondents how their answers to an online survey about personal information will be protected?

Answer: The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.

Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?

Answer: Conducting an online 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.

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?

Answer: 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 online survey can:

Answer: Design the survey so that no direct or indirect identifiers are collected.

The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?

Answer: An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

The federal regulations define both a human subject and research separately, but both definitions must be met to qualify as human subjects research. Thus, research with human subjects is defined as a systematic investigation (intent to contribute to generalizable knowledge) involving living individuals about whom a researcher conducting research obtains information through intervention or interaction with the individual, and uses, studies, or analyzes the information or obtains, uses, studies, analyzes or generates identifiable private information (Protection of Human Subjects 2018). Conducting an online focus group with live human beings to research familial support systems would therefore meet the definition of research with human subjects.

Answer: Analyzing the number of visits to a website provides information about the website itself not about the people who visit it and does not meet the federal definition of research with human subjects. Neither does gathering information about deceased individuals. Using data that is publically available and de-identified is no longer private or personally identifiable, and would also not meet the federal definition of research with human subjects.

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?

Answer: Designing the survey so that subjects are not forced to answer one question before going to the next.

Voluntary participation in research includes the right to withdraw from a study at any time and the right to choose not to answer questions. Online surveys that force subjects to answer one question before going to the next violate the requirement that all participation in research is voluntary.

Answer: Providing contact information for the researcher, privacy policies, and a description of the survey are important, but they do not address the requirement.

Which of the following online 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?

Answer: 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.

The study in which the researcher pretends to be a cancer survivor involves deception and research without any informed consent process. Therefore, the study raises concerns about the ethical principle of respect for persons. Any compromise of the principle should be justified by any scientific benefit to be derived from the study.

Answer: When a support group or a blog is open to any and all readers, it can be argued that the communications posted are not intended to be private and can therefore be observed and recorded without informed consent. The researcher studying interracial adoptees used the internet in a manner comparable to posting a flyer on a bulletin board.

Which of the following methods could be considered a “best practice” in terms of informing respondents how their answers to an online survey about personal information will be protected?

Answer: The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.

Although there are no guaranteed methods to assure absolute confidentiality of research data collected online, some internet-based research experts have identified “best practices” for describing commonly accepted confidentiality protections, such as including explanations about how data are transmitted from the subject to the investigator, how the investigator will maintain and secure the data.

Answer: Consent processes should also include a discussion to emphasize that there is no way to guarantee absolute confidentiality if data are of a personal or sensitive nature.

The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?

Answer: An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

Investigators use the internet as a research tool when they actively engage, or interact, with their participants online. This can include distributing an instrument via email or hosting a web-based survey on an online survey provider, recruiting subjects from online panels, conducting interviews on-line, facilitating focus groups in private chat rooms, and posting on-line experiments or interventions on web-based service providers.

Answer: 

Researchers endeavouring to conduct an online study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is:

Answer: Individuals may post private identifiable information about themselves online without intending it to be public and available to researchers.

The information posted online could, conceivably, be accessible to anyone with an internet connection. However, people may post their private identifiable information online without the intention of this information being public.

Answer: Private identifiable information that can be accessible to anyone can create the potential for several different risks of harm to subjects who may not be aware that their information is public. Assuming a pseudonymous online identity does not pose any risks of harm to subjects. Though it is true that researchers can recruit, consent and debrief subjects online with little to no interaction, this in of itself, would also not pose any risks of harm to subjects. Similarly, waiving the documentation of consent does not pose any potential risks of harm to subjects, and is not unique to internet-based research.

To minimize potential risks of harm, a researcher conducting an online survey can:

Answer: Design the survey so that no direct or indirect identifiers are collected.

In most internet-based research, the primary risk of harm is a breach of confidentiality. A simple way to help maintain the confidentiality of a subjects’ identity is not to collect direct or indirect identifiers.

Answer: Suggesting to subjects that they should print a copy of the informed consent form does not protect them from an inadvertent breach of identifiable responses. Similarly, complying with the Terms of Service does not protect against a breach. Specifying that all subjects be of legal adult age does not ensure compliance.

A researcher’s membership on an advisory board with an organization sponsoring research can create a COI because:

Answer:It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s success

During an Institutional Review Board (IRB) meeting, an IRB member who may have a potential COI with a study under review should:

Answer:Disclose their potential COI and may answer questions, but recuse themselves from voting

The COI management plan aims to:

Answer: Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed

What is the term for management controls that are build in to a research study (for example, independent data analysis)?

Answer:Inherent controls

A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.

Answer:No later than the time of proposal submission

An example of a COI is:

Answer:An industry sponsor pays for the construction of a new research laboratory at the organization

The FDA regulations governing disclosure of individual COIs require:

Answer:Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

Answer:There may be bias by the peer reviewer as to the area of research

Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities?

Answer:Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification.

Which of these is not a good practice for physical security?

Answer: To preserve good customer relations, visitors are generally allowed access to all areas of a facility unless it appears they are doing something suspicious.

Which of these is not generally a good practice for fax machine use?

Answer:Sensitive faxes — inbound or outbound — are left sitting in or around the machine.

Security measures are sometimes described as a combination of physical, technical, and administrative (PTA) safeguards. Which of these would be considered a technical safeguard?

Answer: Measures including device data encryption, anti-malware software, and communications encryption.

Which of these is not generally a good practice for telephone use?

Answer: Using voicemail systems and answering machines that do not require a password or PIN for access.

Under HIPAA, “retrospective research” (a.k.a., data mining) on collections of PHI generally …

Answer: Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

If you’re unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

Answer: An organizational IRB or Privacy Board, privacy official (“Privacy Officer”), or security official (“Security Officer”), depending on the issue.

An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:

Answer:A breach of confidentiality.

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects.

Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects?

Answer:The researcher will not be interacting/intervening with subjects and the data has no identifiers.

As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient’s information; however, the “key” to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?

Answer:The study is human subject research which is eligible for expedited review.

As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient’s information; however, the “key” to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?

Answer:The study is human subject research which is eligible for expedited review.

An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:

Answer:A breach of confidentiality.

NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?

Answer:High potential for individual benefit from participating in research

n considering NBAC’s analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Answer:Situational cognitive vulnerability

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four?

Answer:Physical control, coercion, undue influence, and manipulation

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections:

Answer:Pregnant women, prisoners, children

Which is true of inducements in research?

Answer:Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Answer: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.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Answer:A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Answer:An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

Census data is an example of:

Answer:Public information.

According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:

Answer:Identifiable private information.

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates’ friends, family members and business acquaintances. The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?

Answer:The IRB will not review this study because it is not research as defined by the federal regulations.