CITI Training
A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:
Both the magnitude (or severity) and the probability (or likelihood) of harm. Risk must be determined by assessing both the magnitude (or severity) and the probability (or likelihood) of harm. Both elements must be considered. Although the probability that an individual subject could be identified is low, the magnitude of the possible harm is high given the sensitivity of the information.
Electronic informed consent forms (eICFs) are increasing in popularity and offer many benefits to the researcher. Which of the following describes a benefit from eICFs to the researcher?
Decreases the chance for errors by ensuring there are no missed sections (for example, check boxes, signature and dates) The benefits of eIC for researchers include decreasing the chance for errors by ensuring there are no missed sections. The other responses are all potential benefits, but they are potential benefits for the subjects (consenting remotely, consenting with an interactive program instead of reading a form, consenting with a large enough font size for the subject to read the form).
Data are made anonymous by
Destroying all identifiers connected to the data. Reporting data in aggregate form, while protecting the identity of subjects, does not make the data anonymous. Keeping keys in secure locations and requiring members of the research team to sign confidentiality agreements are methods for protecting identifiable information but they do not involve destroying all identifying information so that the link between identity and data is gone forever. The only way to render data entirely anonymous is to remove all identifying information from the data and completely disconnect any links between the subjects and data about the subjects.
To minimize the risk of HIPAA breaches, an organization can put which of the following systems into place:
Encryption and authentication To minimize risk of hacking, encryption and authentication are two systems that can be put into place.
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. The federal regulations do not require that child assent be documented. Therefore it is not necessary to request a waiver of a requirement to document assent. When an IRB determines that assent is required for a study, the IRB will also determine whether and how assent will be documented. The assent document does not require parental input or parental review.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally fall in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually. Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs may specify a shorter review period. It is the responsibility of the principal investigator to hold signed consent forms in confidentiality. Copies of these forms are not required by federal regulation to be reviewed by the IRB. Please note, however, that an institution's local policy may require copies of signed consent forms as part of the IRB continuing review process.
According to federal regulations, "children" are defined as:
Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. According to the federal regulations, children are persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. Generally, though not always, the age of consent is the age at which minors reach the age of majority and are considered adults. In the United States, state law dictates the age of majority. In most states, the age of majority is 18. This means that a 17-year-old may be considered a child when applying the federal regulations for protecting research subjects.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure. Certificates of Confidentiality protect sensitive information provided by research subjects from civil, criminal, or administrative subpoena.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level. Researchers must provide information to subjects in a manner that facilitates comprehension. Therefore, the material must be written at the appropriate reading comprehension level. Researchers may not impose penalties for non-participation because to do so would violate the ethical principle of respect for persons. In some circumstances it may be appropriate to ask subjects to discuss the research with their families before making a decision about whether to participate, but it is not a regulatory requirement. Finally, researchers are not required to provide a list of the IRB members who reviewed the research.
Additional safeguards that may be included in a social and behavioral study may include:
Remove all direct identifiers from the data as soon as possible. When a possible disclosure of subjects' responses is the primary source of potential harm, collecting data anonymously may provide the best protection and removing direct identifiers is an additional safeguard. The other responses are additional safeguards, but refer to studies that may involve investigational drugs or are biomedical and not social behavioral.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution.
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
The changes must be immediately implemented for the health and well-being of the subject. All amendments involving changes to IRB-approved protocols must be reviewed and approved in advance of implementation, unless changes must be put in place immediately to respond to an unexpected risk or problem arising during the course of a study.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. A cognitive scientist studying the effect of moods on problem-solving behaviors is asking a research question and is interacting with living individuals. Questioning a superintendent of schools to acquire data about the ethnic composition of a school system is asking "about what" questions rather than "about whom" questions (if a study proposed interviewing the superintendent of public schools about his or her experience in the field of education or about his or her perceptions about the current problems within the school system and possible solutions, the questions would become "about whom"). Analyses of public behavior such as writing for a blog or a newspaper do not meet the definition because there is no interaction or intervention with a human subject and no collection of private information. Finally, in the class exercise described, the intention is pedagogical (to learn how to conduct and interview) rather than to answer a research question.
Which of the following constitutes both a breach of 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. No agreements were made regarding confidentiality with the subjects who were unknowingly audio-taped; whose interactions were recorded, or whose cocaine use was revealed by another. Therefore, there was no breach of an agreement about confidentiality, but the subjects' right to decide who can access their personal information was violated. If a researcher told subjects that only he or she would have access to identifiable data and then gives identifiable data to others that action constitutes a breach of confidentiality and a violation of privacy - the subjects' right to control who has access to personal information.
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
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. If subjects were to learn that the research team assigned them to study conditions based on undesirable or unflattering physical characteristics, the knowledge that their appearance was judged negatively by the research team could be very distressing and, therefore, it would not be appropriate to inform subjects after the study about how they were assigned. Informing subjects about the actual research procedures in the other studies would be unlikely to cause them harm.
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
All research funded by HHS The provisions of Subpart D must be applied to all research funded by the HHS (which includes NIH). However, not all federal agencies that have adopted the Common Rule have also adopted Subpart D. In addition to HHS, only the U.S. Food and Drug Administration and the Department of Education have adopted it. Institutions may elect to apply the subpart to all research, regardless of the source of funding.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. In the study of the effects of evoking stereotypes on subsequent performance, the researcher has a research question and will be manipulating the behavior of individuals. An in-house study conducted with the intention of improving a department's mentoring programs is not research with human subjects, but rather program improvement. Receiving data with no identifiers is not research with human subjects because there is no interaction or intervention with a living human being and no collection of private identifiable data. In addition, creating a report for a membership organization does not involve a research question, as defined by the federal regulations, so it too is not research with human subjects.
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study Research investigators are responsible for retaining signed consent documents, IRB correspondence, and research records for at least three years after completion of the research. Because research records are the property of the institution, local institutional policy or sponsoring agency requirements may dictate these records are kept longer. The sponsor and the IRB office should be contacted to make sure that the minimum of three years meets their requirements.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:
Obtain a waiver of documentation of informed consent. If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the research.
According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:
Obtains, uses, studies, analyzes, or generates identifiable private information. In order to meet the definition of research with human subjects a researcher must obtain data about a living individual through interaction or intervention or, alternatively, obtain individually identifiable private information. If a researcher obtains public information or de-identified information about individuals, and has not interacted or intervened with the individuals, those individuals are not considered human subjects for the purposes of the research.
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
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. A statement in a consent form that says that subjects who agree to take part in the research waive their legal rights constitutes exculpatory language. Statements about the voluntary nature of consent, about the possible need to remove subjects from a study in order to protect their welfare, and statements about providing referrals do not waive subjects' rights.
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?
The IRB will not review this study because it is not research as defined by the federal regulations. This proposal is obtaining data from human subjects, but this project is not research, because it is not "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." This project will not be reviewed by the IRB.
A waiver of the requirement for documentation of informed consent may be granted when:
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The requirement to document informed consent can be waived if the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The requirement may also be waived if the study poses no more than minimal risk to subjects and involves no procedures for which written consent is normally required outside of the research context. With regard to non-English speakers, if documentation is required, investigators must provide informed consent materials in the subjects' language. If a researcher anticipates that subjects might be embarrassed by questions, this concern should be addressed in the consent process. Finally, identifying secure storage space for consent forms is an investigator's responsibility.
Which of the following is an example of a multimedia aid that a researcher could utilize during the consent process to increase subject comprehension and retention of information?
Video clips demonstrating how a procedure would be conducted A video clip demonstrating how a procedure would be conducted is an example of a multimedia aid that a researcher could utilize. Interactive eIC programs or apps incorporate multimedia aids to enhance the face-to-face consent process for the purpose of helping subjects make fully informed decisions about participation in a study. Many of the available eIC programs incorporate interactive web-based programs with built in functions to pause or stop to write down questions, small video clips, interactive quizzes and access an online dictionary within the eIC. However, a live health information forum, short printed quizzes or having a member of the research study team read the informed consent form to the subject in person, usually do not use the newest multimedia tools described above.
Dr. Smith is consenting a subject using an electronic informed consent form on a tablet device. If the subjects sign their name electronically on the tablet, will that be a legally valid signature?
Yes, if properly obtained an electronic signature can be considered an original for the purposes of recordkeeping. OHRP does not mandate the type of signature method that must be used so long as it produces a legally valid signature. Instead, researchers are permitted to select the type of technology they wish to use. "One method of allowable electronic signatures in some jurisdictions is the use of a secure system for electronic or digital signature that provides an encrypted identifiable 'signature.' If properly obtained, an electronic signature can be considered an 'original' for the purposes of recordkeeping." (HHS 2011)
Dr. Apple wants to study a drug to manage diabetes in adolescents. The researcher plans to use an electronic informed consent (eIC) form presented on a tablet device. Per FDA guidance on the "Use of Electronic Consent in Clinical Investigations" (2016), can adolescent subjects assent using an electronic device?
Yes, the eIC process can be used for assent The eIC process can be used to obtain assent from pediatric subjects (when required) and parental permission from their parent(s) or guardian. The general requirements for informed consent, found in 21 CFR § 50.25, 50.27, and 50.55, apply to parental permission.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
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. The study in the 4th grade classrooms about the relationship between the time of day reading is taught and reading comprehension does meet the definition of research with human subjects. The study is designed to contribute to generalizable knowledge about student performance and the research question can only be answered using a systematic investigation. Information collected by the playground designer does not involve any information about human subjects even though it does involve interaction between the designer and school staff. An analysis of aggregate data doesn't involve interactions with living individuals nor the collection of private identifiable data. An economic feasibility study will gather information from people with relevant information and expertise but does not meet the definition of research with human subjects, because the intention of the study is to answer "about what" questions rather than "about whom" questions.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
Securing a Certificate of Confidentiality Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
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. When a care provider becomes a researcher, both the child clients and their parents may not feel free to choose not to participate in the provider's study. A researcher who is also a care provider needs to be very clear that a decision not to participate in a study, or to allow records to be used, will not affect the care provided in the future. The fact that the therapist has access to her clients' records as a clinician does not entitle her to use information in the records for research purposes without parental permission and child assent. A school authority's permission to conduct the research does not replace the need for permission or assent. Finally, the children's right to choose cannot be overridden in the pursuit of an indeterminate community interest.
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests Subpart D restricts the use of exemptions when children are research subjects. Research that involves interviews, surveys, or participant observation when the researcher interacts with the children is not eligible for exemption under Category 2.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group. It is not possible for a researcher to promise confidentiality in a focus group setting. Participants may choose to repeat sensitive information outside the group setting even if they have signed confidentiality agreements. This is true even if the participants know each other. Using pseudonyms in the report does not remove concerns about what group members might say outside the group.
According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations. Expedited review procedures are appropriate only for protocols that present no greater than "minimal risk" to subjects and involve only procedures included in federally specified categories. Population considerations, such as healthy volunteers, are only relevant insofar as they affect the assessment of risk. The IRB may not conduct an expedited review for the convenience of either the IRB or a student researcher, if the protocol is otherwise not eligible.
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. The subjects' privacy has not been violated because the identity of subjects was not included in the file. The confidentiality of the data has not been breached because the data could not be linked to identifiers. Therefore, the correct answer is that there was neither a violation of privacy nor a breach of confidentiality. The release of aggregate data with no identifiers does not constitute a violation of privacy or a breach of confidentiality.
The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research.
True The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children.
