|Data are made anonymous by|
-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.
|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 of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?|
-Using data encryption for stored files.
-Securing a Certificate of Confidentiality.
-Waiving documentation of consent.
-Using pseudonyms in research reports.
|Securing a Certificate of Confidentiality|
|When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?|
-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.
|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
-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.
|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 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.
|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 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.
-Of high quality.
|Not an excessive incentive.|
|An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:|
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.
|Confidentiality of the prisoners’ health status is maintained.|
|Which of the following statements about prison research is true?|
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.
|Researchers may study the effects of privilege upgrades awarded by the prison.|
|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:|
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.
|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?|
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.
|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
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
|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?|
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 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?|
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.
|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:|
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.
|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?|
Observation of public behavior when the researcher participates in the activities being observed.
Research about educational testing
|Research about educational testing|
|The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:|
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.
|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 No Child Left Behind Act.
Subpart D of 45 CFR 46.
The Protection of Pupil Rights Amendment.
The Family Educational Rights and Privacy Act.
|The Family Educational Rights and Privacy Act|
|Which of the following is the LEAST important activity when protecting human subjects in international research?|
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.
|Assessing transportation conditions|
|The age of majority in international research is determined by the|
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.
|Laws, customs, and norms in the area in which the research will be conducted.|
|Which of the following activities constitutes engagement in research?|
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.
|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:|
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.
|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 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.
|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.
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.
|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:|
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.
|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?|
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.
|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 covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:|
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.
|Data that does not cross state lines when disclosed by the covered entity.|
|Under HIPAA, a “disclosure accounting” is required:|
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.
|for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.|
|HIPAA protects a category of information known as protected health information (PHI). PHI includes:|
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.
|identifiable health information that is created or held by covered entities.|
|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.
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.
|must be more detailed for disclosures that involve fewer than 50 subject records.|
|HIPAA includes in its definition of “research,” activities related to …|
anything a researcher does in a federally-supported laboratory.
development of generalizable knowledge.
quality assessment and improvement.
|development of generalizable knowledge.|
|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, except:|
|When workers are asked to participate in a research study, vulnerabilities related to the subject’s employment may include:|
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
|All of the above|
|Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker’s retention of a job, insurance or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:|
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
|All of the above|
|When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.|
|The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:|
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
|Any equity interest in a publicly held company that exceeds $50,000|
|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
|Conflict of Interest|
|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/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.
|Greater than $5,000 of ownership in any single public entity/company.|
|The most important ethical concerns related to conflicts of interest in research are:|
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
|Ensuring the objectivity of research and the protection of human subjects|
|A conflict of interest implies:|
The elimination of bias.
The actual involvement of bias.
An awareness of bias.
The potential for bias.
|The potential for bias.|
|What are the 3 principles discussed in the Belmont Report?||Respect for Persons|
|What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?||Determining that the study has a maximization of benefits and a minimization of risks.|
|All of the following are true regarding the Belmont Report, EXCEPT:||The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.|
|The history of ethical regulations in human subjects research began with the||Nuremberg Code|
|Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?||Faculty Advisor/Research Mentor|
|Which of the following elements must be included in an informed consent?||All foreseeable risks and discomforts.|
|Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?||Exempt|
|How can faculty researchers avoid coercion of student subjects?||Avoid using their own students in their research|
|A student is conducting a research project that involves using a survey. The survey asks participants about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?||Exempt Review|
|A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?||Full Board Review|
|A master’s degree candidate needs to conduct a research project for her master’s thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stock and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?||Not Human Subjects|
|Which of the following studies need IRB approval?||Studies collecting data about living individuals.|
|What is the Institutional Review Board (IRB) charged with?||– Protecting the rights and welfare of human subjects.|
– Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed.
– Reviewing subject recruitment materials and strategies.
|Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?|
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
|A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.|
|The Belmont principle of beneficence requires that:|
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.
|D. Potential benefits justify the risks of harm.|
|Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:|
C. Respect for persons.
|C. Respect for persons|
|According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:|
C. Respect for persons.
|Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?|
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
|b. Ensuring that risks are reasonable in relationship to anticipated benefits.|
|According to the federal regulations, which of the following studies meets the definition of research with human subjects?|
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.
|d. 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?|
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.
|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.|
|According to the federal regulations, which of the following studies meets the definition of research with human subjects?|
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.
|d. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.|
|According to the federal regulations, which of the following studies meets the definition of research with human subjects?|
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.
|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.|
|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:|
a. Identifiable public information.
b. De-identified private information.
c. Identifiable private information.
d. Observations of public behavior.
|c. Identifiable private information.|
|According to the federal regulations, research is eligible for exemption, if|
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.
|c. The research falls into one of six categories of research activity described in the regulations.|
|In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?|
a. College students.
b. Adults with decisional impairments.
c. The elderly.
|According to federal regulations, the expedited review process may be used when the study procedures pose:|
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.
|d. No more than minimal risk and the research activities fall within regulatory categories identified as eligible.|
|Continuing review of an approved and ongoing protocol|
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.
|d. Must occur within 12 months of the approval date.|
|Which of the following statements about the relationship between an institution and the institution’s IRB(s) is correct?|
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.
|c. Officials of the institution may overrule an IRB approval.|
|An investigator wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:|
a. Experience emotional or psychological distress.
b. Lose their legal status.
c. Lose their employment.
d. Feel that their privacy has been invaded.
|a. Experience emotional or psychological distress|
|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:|
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.
|d. Obtain a waiver of documentation of informed consent.|
|The primary purpose of a Certificate of Confidentiality is to:|
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.
|d. Protect identifiable research information from compelled disclosure.|
|Risk should be evaluated solely by the magnitude or severity of expected harm, not probability.|
|What statement about risks in social and behavioral sciences research is most accurate:|
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.
|d. Risks are specific to time, situation, and culture.|
|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?|
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.
|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 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?|
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.
|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.|
|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. 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.
|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.|
|A waiver of the requirement for documentation of informed consent may be granted when:|
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.
|d. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.|
|As part of the consent process, the federal regulations require researchers to:|
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.
|. d. Provide potential subjects with information at the appropriate reading comprehension level.|
|What must you file before conducting human clinical trials with an experimental drug?||IND application (Form FDA 1571)|
|During the clinical development phase of the IND process, what must sponsors do?||Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with:|
copies of new protocols
Annual Progress reports
|this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND.||Form FDA 1572|
|What is the timeline of drug development?||Preclinical trials, IND Submission,|
Clinical Development (Phase I-III), NDA submission,
Marketing (Phase IV)
|When does a sponsor submit the IND?||Prior to clinical development phases (human trials). *30 day process.|
|What is the NDA?||New Drug Application, submitted prior to Phase IV marketing phase.|
|How long does the NDA submission take?||6 months – 2 years.|
|What is determined for a drug in the preclinical phase||Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying.|
|How long does FDA have to review IND submission?||30 days|
|How long is the clinical development phase (Phase 1-III) in process for IND?||6-7 years.|
|Determine the trial phase:|
– Assess toxicity
– Determine drug’s PK and PD profiles
– Determine doses resulting in sufficient biological level of drug
|Determine the trial phase:|
– Determine drug’s effectiveness (primary goal)
– Determine long-term drug safety
– Confirm findings
|Determine the trial phase:|
– Determine drug’s short-term risk (safety) (primary goal)
– Examine preliminary effectiveness of drug
|Determine the trial phase from the subject population:|
Controlled studies enrolling limited numbers of patients
|Determine the trial phase from the subject population:|
Controlled and uncontrolled studies (but typically placebo-controlled and double-blinded) enrolling larger patient numbers.
|Determine the trial phase from the subject population:|
Normal healthy volunteers unless toxicity prevents exposure (e.g, cancer drugs). In this, case patients with end-stage disease might be enrolled.
|If an IND application is submitted and the FDA has not contacted the physician within 30 days after acknowledging receipt, can the trial start?||Yes, one of two conditions must be met.|
1. 30 days elapsed since FDA received IND application and no hold as been placed.
2. Correspondence has ben received from FDA allowing the trial to start.
|What must be provided to investigators before they beginning conducting trials at their site?||Protocol and Investigator’s Brochure|
|What regulation must a PI comply with in order to use an edc system for a clinical trial?||21 CFR Part 11|
|21 CFR 56.115(b)|
|21 CFR 312.57|
|21 CFR 312.62|
|21 CFR 812.140|
|What happened because of the concern and confusion regarding interpretation of Part 11in 2003.||FDA withdrew all the guidance documents related to Part 11, while re-examining.|
They then issued: Guidance for Industry: Part 11, Electronic Records; Electronic Signatures-Scope and Application (2003) and Guidance for Industry: Computerized Systems Used in Clinical Investigations (2007). ** The 2007 guidance “supplements the 2003 guidance”
|Development of most new drugs from discovery to marketing approval usually takes:||9 years or more|
|The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 patients in each arm. Which of the following best describes the clinical phase of this study?||Phase 2|
|Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?||Phase 3|
|Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?||Preclinical|
|Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?||Phase 1|
|For a Phase 1 new drug study in humans, what is the primary source of the data included in the initial Investigator’s Brochure?||Preclinical data|
|What is ICH’s more specific name?||International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.|
|what is the goal of the ICH?||to minimize redundant research. and standardize technical guidelines and requirements.|
|Define the term: an individual, or judicial or other body, authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedures involved in the research||Legally Authorized Representative (LAR)|
|an unplanned excursion from the requirements of the protocol that is not implemented or intended as a systematic change.||Protocol Deviation (or Violation)|
|What are the 6 regulatory and pharmaceutical industry groups that have representatives working for ICH?||-European Commission (EC)|
-European Federation of -Pharmaceutical Industries’ Association (EFPIA)
-Ministry of Health, Labor, and Welfare, Japan (MHLW)
– Japan Pharmaceutical Manufacturers Association (JPMA)
– US Food and Drug Administration (FDA)
– Pharmaceutical Research and Manufacturing of America (PhRMA)
|How do the World Health Organization (WHO) and the European Free Trade Association (EFTA) [represented by Swissmedic, and Health Canada participate with ICH?||As observers.|
|How is the ICH governed?||a Steering Committee|
|Who supports the ICH?||the ICH Secretariat|
|Who provides the ICH secretariat?||The International Federation of Pharmaceutical Manufacturers Association (IFPMA)|
|How many seats on the Committee does each of the 6 working groups of ICH have?||2|
|who nominates other nonvoting participants to attend ICH steering Committee meetings?||The observer groups (WHO, Health Canada, and EFTA)|
|Is the ICH GCP regulation or guideline?||Depends, several countries adopted it as law, but the U.S FDA adopted it only as guidance. (Federal Register, Vol. 62, MAY 9, 1997)|
|What are the four main categories covered by ICH guidelines?||Q: Quality topics (chemical and pharmaceutical assurance)|
S: Safety topics: in vitro and in vivo preclinical research
E: Efficacy topics: relating to research in human subjects
M: Multidisciplinary topics: those that do not fit uniquely into one of the above categories.
|What are the expert working groups responsible for?||developing specific guidelines.|
* The ICH then provides an efficient process and format to standardize the new requirements across agencies and countries.
|ICH E6 guideline pertains specifically to what||the conduct of clinical research to support marketing applications for drugs.|
|Provides a unified standard for designing, conducting, recording, and reporting research involving human subjects.||ICH E6 guideline for good clinical practice.|
|What are the two important goals of the ICH E6 standard?||To assure that|
1: The rights, well-being, and confidentiality of trial subjects are protected.
2: Trial data are credible.
|Where do the ethical principles followed by ICH GCP guidelines originate from?||the Declaration of Helsinki|
|What ethical principles stem from the Declaration of Helsinki?||in notes….|
|If planning to market drugs outside the US, what guidance must a PI follow while conducting the clinical trial?||ICH E-6 Good Clinical Practice.|
|Can an employee at the research site be witness to a patient’s consent?||No, they are involved in the trial. Witness must be “a person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial”|
|What must a witness do before the consent process starts?||Read the consent form and other written information provided to the participant. They must also determine whether the participant has any other questions and should sign the impartial witness signature block on the consent document.|
|If following ICH guidelines who all should sign the consent form between the subject, witness, and person obtaining consent.||All of them.|
Oversee research involving human subjects to assure the protection of their rights, safety, and welfare.
|FDA or ICH: requires the consent form to include a statement that “monitors, auditors, the IRB/IEC, and the regulatory authorities will be granted access to the subject’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject is authorizing such access||ICH GCP|
|FDA or ICH: Treatment alternatives only need to be listed in the consent form||FDA|
|FDA or ICH: requires that the potential benefits and risks of the alternatives should also be included in the consent form.||ICH|
|What does the ICH E6 guidelines require in a consent form for treatment arms.||Description of each arm, the likelihood of being assigned to each of the study arms, and an explanation of ” the subject’s responsibilities”|
|Does FDA require description in consent if research provides no expected benefit?||No, only an explanation of expected benefits of the research?|
|What does ICH require in terms of benefits in the ICF?||If there is no intended clinical benefit to the subject, Section 4.8.10(h) requires that the subject be made aware.|
Consent form should describe the anticipated prorated payments to subjects (recommended for FDA as well)
|Is assent required for both FDA and ICH?||Yes, and the consent of the parents.|
|Define Assent||The agreement of someone who cannot consent for his or herself.|
|When is there a valid reason not to require assent?|
|FDA vs. ICH when enrolling an adult who is unable to consent for him or herself.||ICH E6 requires assent along with permission from their LARs. Not required by FDA.|
|ICH or FDA:|
Only subjects who are able to consent for themselves are allowed to enroll in non-therapeutic research studies (a trial in which there is no anticipated direct clinical benefit to the subject.
|When can ICH allow subjects to be enrolled that cannot consent for themselves? (Exceptions)||studies where:|
– the objectives cannot be met without including these subjects.
the foreseeable risks to the subject are low as is the negative impact.
– the study is not illegal AND
The IRB/IEC has specifically agreed to include these subjects.
FDA requires Investigator to inform the subject’s primary physician about the subject’s participation in the trial if subject has a PCP and if the subject agrees to the primary physician being informed.
|False, this is a requirement of ICH E6 guidelines.|
|FDA or ICH requirement:|
IRB/IEC is required to review
-written ICF and updates
– trial protocols/amendments
– subject recruitment procedures (advertisements)
– written information to be provided to subjects
Info about payments and compensation to subjects
– CVs and qualifications
– any other docs IRB/IEC may require to fulfill its responsibilities
|ICH E6 Guideline. FDA not clear in requirements for IRB/IEC review of documents.|
|Per FDA requirements, what is required of the IRB/IEC?||to review the consent form (21 CFR 56.109) and to keep “copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents.|
|A primary purpose of the ICH is to:|
– require publication of negative trial results.
– develop mandatory worldwide regulations for drug development.
– require FDA registration of worldwide clinical trials.
– minimize the need for redundant research
|Minimize the need for redundant research.|
|The ICH GCP guidelines:|
– set standards for the design, conduct, monitoring and reporting of clinical research.
– guarantee that a submission in any ICH region will be approved for marketing.
– require certification of clinical research sites and investigators
– replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S.
|Set standards for the design, conduct, monitoring and reporting of clinical research.|
|The ICH E6 GCP describes standards that apply to:|
-Investigators, sponsors, and IRBs.
– Research sponsors only
– Investigators only
– IRBs only
|Investigators, sponsors, and IRBs.|
|In the United States, following the ICH E6 GCP is:|
– Voluntary for FDA-regulated drug studies.
– Mandatory for studies conducted outside the United States.
– Mandatory for investigational device studies.
– Mandatory for drug studies.
|Voluntary for FDA-regulated drug studies|
|The FDA will apply:|
– The ICH E6 GCP standards
– The Code of Federal Regulations
– Local IRB requirements
– State law where the sponsor’s headquarters are located.
|The code of federal regulations|
|What is the legal status of ICH in the U.S.?||It is a guideline|
|Regarding subject signature on consent forms, which is true about dates?||Both the FDA and ICH require|
|ICH requires a witness when enrolling illiterate subjects, true or false?||True|
|Regarding probability of assignment to trial arms in consent forms, which is true?||Only ICH recommends.|
|When is there “Sponsor-investigators”||Investigator-initiated trials of investigational drugs.|
|Who addresses the role of “Sponsor-investigators?”||FDA|
|means in addition to producing the drug, the company also supplies the investigator with the drug for use in the study||Drug Supplier/Manufacturer|
|means the entity who takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity, including a company, an academic organization, or an individual. The intent of the sponsor’s IND is to allow testing for marketing approval of the drug. These are generally considered commercial or corporate INDs. Note: the sponsor is often but not always the entity that funds the clinical research.||Sponsor|
|means an individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational drug is being administered, used, or dispensed. The sponsor-investigator assumes all of the responsibilities of the sponsor as well as all the responsibilities of an investigator as outlined in the Form FDA 1572 (see the module, Investigator Obligations in FDA-Regulated Research). Usually, the intent of the sponsor-investigator trial is to gain scientific knowledge without seeking market approval for the drug. These are considered investigator-initiated or sponsor-investigator trials.||Sponsor-investigator|
|Usually, the intent of the sponsor-investigator/investigator-initiated trial is to||gain scientific knowledge without seeking market approval for the drug.|
|the regulation stating: exception from informed consent for emergency research||21CFR 50|
|What can Investigators reference when unsure if an IND is required for a study of an approved drug?||IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer OR seek opinion from FDA.|
|Form FDA ______: Statement of the Invesitgator||1572|
|Form FDA ____: Investigational New Drug Application, NDA||1571|
|detailed requirements for the content and format of an IND can be found in||21 CFR 312|
|what can be cross-referenced when the manufacturer of an IND already has an active IND for the drug being studied?||Chemistry, manufacturing, and controls (CMC) information|
Pharmacology and toxicology information
Previous human experience with the drug
|Form: contractual agreement between the sponsor and FDA.||FDA 1571|
|21 CFR 56||IRBs|
|The content for an IND for studies of marketed products is the same as the content for studies of new drugs, with the following exception:||a copy of the approved labeling (including the package insert) can be provided in lieu of the Investigator’s Brochure.|
|what are the three types of protocol amendments?||-new sponsor protocol|
-a change in an existing protocol when the entire sponsor protocol is not revised
– identifying and adding new investigator to a study
|submitted when new toxicology, chemistry, or other technical information is available. Study discontinuation is also submitted as this.||Information amendments|
|When do Annual Reports need to be submitted to the FDA?||within sixty (60) days of the anniversary date that the IND went into effect.|
|The following are purposes of what:|
-The rights and well-being of human subjects are protected.
-The reported trial data are accurate, complete and verifiable from source documents.
-The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.
|When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?|
A. IND renewal application
B. Adverse Event Summary Report, but only from unblinded portions of studies (“open-label IND safety report”)
C. IND report
D. Marketing plan (i.e. annual updated projection of sales and profits)
|C. IND report|
|Which of the following is a criterion for determining if a study of an approved drug is exempt from the require of an IND?|
A. The study intends to invoke an exception from informed consent.
B. The study involves a route of administration that significantly increases the risks to the patient.
C. The study is not intended to be reported to FDA to support a new indication or support a labeling change.
D. The study intends to involve more than 100 patients in a study.
|C. The study is not intended to be reported to FDA to support a new indication or support a labeling change.|
|Which of the following reports must be filed using an FDA Form 1572?|
A. Annual Reports
B. Addition of a new investigator
C. Protocol amendments
|B. Addition of a new investigator.|
|the tool used to record data collected during a clinical trial||CRF, case report form|
|document that includes information needed for potential subjects to have sufficient info to provide informed consent to participate in a clinical trial. The FDA regulations and ICH E6 describe the information that must be included in the consent form.||Informed Consent Document|
|any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects.|
” Assure the protection of the rights and welfare of the human subjects.
|All info in original records and certified copies of original records of clinical findings ETc||source data.|
|Initial documentation of data in a clinical study and includes recorded observations, laboratory reports, medical records, etc.||Source Document.|
|This agreement is a contract that defines both the terms of study conduct and the financial agreements||CTA (Clinical Trial Agreement)|
|When is it necessary for an investigator to complete and sign a new 1572?||– when participating in a new protocol that has been added to the IND|
– When a new investigator is added to the study.
|What needs to be done when there are other changes to information contacted on a signed and dated 1572? (IRB/IEC address change, addition of a clinical research lab)||investigator should document the changes in the clinical study records and inform the sponsor of the changes, so that the sponsor can appropriately updated the IND.|
|ICH or FDA, requires submission of up to date curriculum with changes?||ICH|
|clinical trials of drugs or devices from which the data will be submitted to the FDA to support a marketing application or relied upon by the FDA to establish effectiveness.||“covered clinical studies”|
|For purposes of financial disclosures, the term (blank) includes anyone who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the (blank).||Investigator|
|21 CFR 54||Financial Disclosure by Clinical Investigators|
|The investigator’s financial interests with the pharmaceutical company (sponsor) or to the outcome of the clinical investigation is reported directly to the FDA by:|
A) The investigator’s institution
B) The investigator
C) The IRB
D) The sponsor
|D. The sponsor|
|In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to:|
A) Maintain a contract with the sponsor
B) Maintain records indefinitely
C) Report to the FDA any adverse events that occur.
D) Conduct or supervise the investigation personally
|D. Conduct or supervise the investigation personally.|
|Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the:|
|The investigator must report adverse events to the:|
D) IRB only
|When must the investigator update the IRB about the progress of a trial?|
A) During the conduct of the study and at termination
B) During the conduct of the study only
D) At study termination only
|A) During the conduct of the study and at termination|
|Which of the following is an investigator’s commitment to the sponsor?|
A) Submit documents to sponsor for yearly approval to continue the study
B) Retain study documents for 3 years after study completion at the site
C) Provide the financial disclosure document directly to FDA
D) Submit a new FDA form 1572 to sponsor as needed
|D) Submit a new FDA form 1572 to sponsor as needed|
|“…any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries”||Biological Product (Biologic)|
|“…a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use” (ICH GCP E6 Section 1.33).||Investigational Drug|
|“…a new drug, antibiotic drug, or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes” (21 CFR 312.3).||Investigational New Drug (IND)|
|Which of the following is an important component of drug accountability?|
A) Environmental controls
B) Drug shipping and disposition records
C) Patent expiration date
D) Manufacturer’s compounding procedures
|Drug shipping and disposition records|
|Who has ultimate responsibility for an investigational product?||Investigator|
|Investigational product dispensing or administration info for the sponsor is recorded on the:||Case Report Form|
|The packaging of investigational drugs should ideally|
A) look like a marketed product
B) allow subjects to identify placebo pills
C) be designed to help with subject compliance
D) be attractive so the study coordinators will use it
|be designed to help with subject compliance|
|Where is info on storage requirements for the investigational product usually found?|
A) on the product code-breaker label
B) In the CRF directions
C) In the drug accountability log
D) In the study protocol
|in the study protocol|
|A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?||Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug|
|Which of the following statements in a consent form is an example of language that appears to waive a subject’s rights?||I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.|
|An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual’s legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:||The investigator and another physician who is not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.|
|Under which circumstance does the FDA allow verbal consent prior to participation in a research study?||The study is minimal risk.|
|Which of the following should take place during periodic site visits?||Identification of protocol violations|
|Which of the following best describes when the majority of CRF data are verified against source record information?||Periodic site visits.|
|When should the sponsor-monitor conduct the most detailed review of the study protocol with the site’s study staff?||Site initiation visit.|
|The FDA requires retention of investigational drug study records for:||At least 2 years after the investigational drug’s approval by the FDA.|