CITI SG

Who is responsible for reporting an adverse event to the IRB? a. PI b. Research Assistant c. Coordinator d. Data manager

a

True or False: 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

True or False: All instances of bias in a study can be prevented

false

True or False: Electronic surveys help avoid transcription errors

true

Is the following scenario an example of misconduct?: An investigator who gives a talk at a state-wide meeting forgets to acknowledge his collaborators (yes/no?)

no

true or false: When a research project includes the collection of biological samples, all planned future uses the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject

true

According to federal research misconduct policies, what is the maximum number of consecutive words that one can use before it is classified as an instance of plagiarism? a. 14 b. 5 c. There is no official, federal standard for the number of consecutive words that can be used d. 7

c

Unless the subject matter is considered common knowledge, citations are necessary when writing about: a. Your own earlier published ideas, but not your earlier published data or methodologies b. Methodologies but not data c. Ideas but not data d. Ideas, methodologies, or data from other authors and also your own previously published ideas, methodologies, or data

d

In any collaboration, data ownership is typically determined by: a. The individual who does the most work on the project b. The research team with access to the best lawyers c. The type and source of funds used to support the project d. The relevant department chairs

c

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - a. Leave the meeting immediately b. Disclose their potential COI and may answer questions, but recuse themselves from voting c. Disclose their potential COI, but not answer any questions about the study - d. Disclose their potential COI and not participate in any action

b

HIPAA's protections for health information used for research purposes... a. May be used at the institution's discretion instead of the Common Rule and FDA protections b. Supplement those of the Common Rule and FDA c. Only apply to research conducted inside covered entities d. Replace those of the Common Rule and FDA for human subjects protection

b

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? a. College students b. Prisoners c. The elderly d. Adults with decisional impairments

b

Which of the following examples is the most likely to be considered an institutional conflict of interest? a. A department hiring its new chair from a rival school b. A senior official serving on a board of a company that donates to the institution c. A faculty member owning equity in a private company d. A staff member at an institution owning stock in a private company

b

The Belmont principle of beneficence requires that: a. Risks to subjects are reasonable in relation to anticipated benefits b. Risks are managed so that they are no more than minimal c. Subjects derive individual benefit from study participation d. The study makes a significant contribution to generalizable knowledge

a

The defining characteristic of a mentor is someone who: a. Pays for a trainee's research projects b. Advises a trainee on which academic courses to take - c. Advises a trainee on how to complete paperwork for graduation d. Takes a sincere interest in the growth and development of a trainee

d

True or False: All participants in a study are expected to experience the study in the same way. Therefore, an adverse event in one sub-population is always an adverse event in another

false

True or False: Good Clinical Practice (GCP) is an approach used by researchers to only care for participants who are involved in a drug, device, or biologic trial

false

True or False: To make sure that enough participants are enrolled in your study, it is appropriate to persuade a participant after he has said he does not want to participate.

false

Which of the following is a correct statement about the balance among prevention, detection, and response (PDR)? a. The greater the sensitivity and quantity of the data at issue, the more carefully the balance among these three must be evaluated b. Organizations have no discretion in deciding their levels of security practice c. If preventive measures are in place, it is not necessary to have measures focused on detection and response d. If detection and response measures are in place, it is not necessary to have measures devoted to prevention

a

Which of the following is most directly related to successful mentoring? a. A working relationship in which the mentor harshly criticizes the trainee's work b. Someone who is committed to the professional development of the trainee - c. The absence of boundaries in the mentor-trainee relationship d. A passive mentoring relationship on the part of the trainee

b

Which of the following is most likely to own the data resulting from a research project? a. A faculty member working on a federally-funded project b. The organization that receives federal funding for a project c. A technician who collected the data d. A graduate student working under the direction of a faculty member

b

The typical first main phase in response to a research misconduct allegation is called: a. Remediation b. The adjudication c. The inquiry d. The audit

c

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB? a. No, this does not need to be reported because the subject had the heart attack when they were home, not at the focus group b. No, this does not need to be reported because it is unrelated to participation in the study c. No, this does not need to be reported because the subject recovered d. No, this does not need to be reported because two weeks have passed

b

Which of the following is the primary criterion for authorship? a. Obtaining financial support for the work b. Having read a draft of the manuscript before it is published c. Correcting grammatical mistakes in the manuscript d. Having made a significant intellectual contribution to the work

d

Which of the following is true regarding an acknowledgments sections? a. An acknowledgments sections is necessary for disclosing if research is supported by federal funds, but the section is not necessary if a corporate sponsor supports research - b. The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship c. It is the norm that individuals should not be asked whether they want to be listed in the acknowledgments sections - d. Journals typically request that the person who provides financial support for the research be listed as an author instead of being listed in the acknowledgments sections

b

Which of the following is true regarding research misconduct? a. The U.S. government is required to reveal publicly the identity of any person who commits misconduct b. Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct c. Funding agencies normally perform their own misconduct inquiry before the institution becomes involved d. A central federal agency handles all cases of research misconduct

b

true or false: Patients have to provide an additional, specific authorization for training uses and disclosures of their information

false

A reviewer's main responsibility is to: a. Behave professionally b. Be friendly c. Contact the authors when the review is completed d. Avoid criticizing the work of other researchers

a

Which category of health information does HIPAA extend "extra" protections, with a requirement for separate authorization? a. Psychotherapy notes b. AIDS/HIV and STD information c. Pregnancy-related information d. Genetic information

a

How are the ethical standards for student uses and disclosures of patients' health information different from those for regular members of the healthcare workforce? a. Lower because students deserve some slack b. Ethical standards are obviously the same c. Some would say it is higher, because patients do not always benefit from students' access to their data

c

If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as: a. An institutional conflict of interest b. A financial conflict of interest c. A personal conflict of interest d. Research misconduct

c

An idea is most likely to represent "common knowledge" if: a. The idea has been around for more than a decade b. It can be readily obtained in an encyclopedia c. The idea has already appeared in a published work d. It can be safely assumed that the readers and the author are both thoroughly familiar with the idea and its source

d

Which of the following is true regarding the reporting of research results? a. Details of data selection procedures should be omitted from publications unless requested b. A delay in reporting research results is not allowed by the U.S. government c. Details of study design and execution should be omitted from publications unless requested d. Clear specification of the methods and procedures used is essential

d

true or false: The federal regulations at 45 CFR 46 provide additional protections for subjects who are workers/employees to protect them from potential risks of harm

false

A participant in a study assessing the effect of relaxation techniques on overall mood has come to you with feelings of depression. The study began two weeks ago, but the participant has reported feeling depressed for the last several months. Because your team has defined a study-specific adverse event reporting plan, you know that depressive thoughts are a possibility for participants. How would you classify this event? a. Related, expected, non-serious b. Unrelated, unexpected, non-serious c. Related, unexpected, serious d. Unrelated, expected, non-serious

a

According to Subpart D, research with children may be eligible for exemption under Category 2 when: a. The research involves the use of educational tests b. The children will be interviewed by the researcher c. The children will be asked to complete a survey d. The research with children will involve participant observation with researcher interaction

a

Which of the following is generally allowed in most organizations? a. Social networking if done for approved business-related purposes b. File sharing via peer-to-peer sites, provided the site is accessed via an approved search engine c. Online shopping for personal purposes, provided personal time is used d. Game playing, provided the site is accessed via an approved search engine

a

Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly? a. The author can contact the editor with their concerns b. The author should ask the editor to reveal the identities of the reviewers c. The author should contact the reviewers directly d. Nothing; by submitting to the peer review process, authors agree to accept the outcome

a

Which of the following is true? a. Federal regulations include treatment-related uses and disclosures in a large category (along with payment and healthcare operations) that require no specific permission from patients b. HIPAA is silent on this issue c. Federal regulations (under HIPAA) require separate, independent consent or authorization for treatment-related uses and disclosures

a

Which of the following most accurately describes U.S. federal policy related to RCR instruction? a. Some federal agencies have RCR policies but they differ in terms of the particular format of training that is required b. No federal agencies require RCR training for the grants that they fund; the training is optional c. Only those federal agencies that support biomedical research require RCR training d. All federal agencies are required to have an RCR policy related to grants that they fund

a

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship? a. The trainee must take an active role in the relationship and clearly communicate needs and expectations b. The trainee is too junior to have any responsibilities in the mentoring relationship - c. The trainee's primary role is to avoid seeking the mentor's advice in order to grow as a researcher

a

Which of the following statements most clearly illustrates the principle of beneficence? a. Determining whether the benefits of a study outweigh the risks b. Obtaining the subject's consent to participate c. Providing detailed information about the study d. Making sure that the selection of subjects includes people from all segments of the population

a

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identify of the subjects can be readily ascertained. Which of the following statements is true? a. This research would be eligible for expedited IRB review because the researcher is not interacting with the children and the playground is public b. This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting c. This research would be eligible for expedited IRB review because the researcher is participating in the activities observed d. This research would require full committee review because it involves children

b

As a first step, what must be done before enrolling a young child in a research protocol? a. The child must be given an incentive for participating b. The risks and benefits must be explained to the child's parents or legally authorized representative c. Federal regulations do not allow children to be enrolled in research d. The risks and benefits have to be explained to the child

b

The HIPAA "minimum necessary" standard applies... a. To all human subjects research that uses PHI b. To all human subjects research that uses PHI without an authorization from the data subject c. To all human subjects research d. To all research where the data crosses state lines

b

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to: a. All research that is more than minimal risk b. All research funded by HHS c. All research funded by any federal agency d. All research involving children

b

What is the most appropriate process for research collaborators to use in determining which journal they should submit their work to? a. Submit the work to several journals that represent the interests of all the authors b. The research team should discuss the issue early on and while the project is ongoing c. It is appropriate to submit the work to any peer-reviewed journal d. Obtain advice from the Technology Transfer Office

b

Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request? a. The financial interests of all research administrators at an academic center b. The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service c. The conflicts of commitment of researchers funded by the U.S. Public Health Service d. The financial interests of all faculty at an academic center

b

Which of the following is a good practice for controlling computer access? a. Logging into systems with a shared user ID or password b. Picking strong passwords and protecting them appropriately c. Leaving the device on and unlocked to make sure the work team members can use the device when you are at lunch d. Storing access tokens in a central unlocked location

b

Which of the following is a good security practice for web browsing? a. Browsing sites using links sent in emails without taking steps to assure the destination is safe b. Exercising caution before downloading files or any other clicking activity at a website c. Only browsing sites provided in email links - d. Avoiding updates to web browsers because they might erase your browsing history and reprogram your desktop

b

Which of the following most accurately describes a conflict of commitment? a. It occurs when a researcher is not sure whether to renew a contract with an employer b. It occurs when outside activities interfere with obligations to one's primary employer c. It occurs when an individual allows personal beliefs to interfere with objectivity d. It occurs when researchers have a financial interest related to their research

b

Which of the following represents plagiarism? a. Listing someone as an author who did not actually contribute to the publication b. Presenting someone else's ideas or words and claiming them as one's own - c. Selectively presenting data that support the key findings of a paper d. Failing to report all of a study's conditions

b

Which of the following statements is true regarding the regulations that govern research? a. International research is governed by the United Nations instead of any specific country's regulations b. The research of an international graduate student enrolled at a U.S. university is not governed by U.S. regulations unless the student plans to publish the results c. U.S. funded research collaborations are often governed by U.S. regulations no matter where the research takes place d. International research collaborations involving U.S. funded researchers are not governed by U.S. regulations when the work takes place at a private university

c

. Which statement best describes information that must be included in a consent form? a. A copy of the researcher's grant proposal b. A description of where the research may be published c. A literature review d. A description of the research's potential benefits and risks

d

A medical record is an example of: a. Public behavior b. Private behavior c. Public information d. Private information

d

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: a. The employer may encourage or deny participation of workers b. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results c. The research study's finding could affect an employee's pay, benefits, or promotion potential d. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization e. All of the above

e

Which of the following most accurately describes an institutional conflict of interest? a. It occurs when the interests of an institution can bias its decision-making b. It is a term used interchangeably with conflict of commitment c. It is typically considered to be an academic honor code violation d. It is a form of research misconduct in accordance with federal policy

a

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? a. Officials of the institution may overrule an IRB approval b. Department chairs can overturn an IRB disapproval c. Officials of the institution may overturn an IRB disapproval d. Institutional priorities take precedence over all IRB determinations

a

A PI is struggling to set a timeframe for follow-up study visits. She thinks a check-in one month after an initial visit is appropriate, but her coordinator recommends that the follow-up occur at two months. What should be written in the IRB protocol to accommodate both opinions? a. One month- the IRB will require exact specifications b. One month plus or minus one week- a range like this will minimize later deviations, but include enough specificity within the IRB protocol c. 3 months- it is beneficial to "pad" the estimate, so it will never run over the time listed in the IRB protocol

b

You overhear someone say the following about Good Clinical Practice (GCP) in the hallway: "GCP is mostly just meant to curb abuses by unscrupulous researchers who make bad decisions in response to pressure to discover the next big thing." What could you say in response to this? a. That's right; GCP are very rigorous rules that every researcher must follow b. That's not quite right, because GCP is really more about the behavior of participants...NOT about the behavior of researchers c. It's true that GCP was developed in part to concerns about unethical behavior, but overall it aims to ensure that clinical trials are carried out in a way that protects participants and ensures high quality study data

c

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: a. Institutional vulnerability b. Social vulnerability c. Communicative vulnerability d. Economic vulnerability

d

According to the U.S. Public Health Service regulations, investigators are required to disclose travel sponsored or reimbursed by: a. A government agency b. A U.S. institution of higher education c. An academic teaching hospital d. A publicly-traded company

d

Kate, a new RA, couldn't find a private place and is talking loudly with potential participants with other people nearby. Is Kate following good privacy best practices? Yes/no?

no

True or False: Enrolling a participant in a study and collecting data from him prior to his completion of the consent process- is an invasion of privacy

true

Is the following scenario an example of misconduct?: In describing her focus group procedure, an investigator copied and pasted language from her existing published article to a new manuscript without citation. Yes/no?

yes

A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that: a. All prisoners receive HIV testing b. Confidentiality of the prisoners' health status is maintained c. A medical doctor serves as co-investigator d. The survey instrument is standardized

b

According to the federal regulations, research is eligible for exemption, if: a. All the subjects are adults and the risk is minimal b. The research falls into one of eight categories of research activity described in the regulations c. Participation in the research will involve ten minutes or less of the subjects' time d. The researcher is experienced in the field of inquiry

b

At a minimum, how often are investigators funded by the U.S. National Institutes of Health required to receive conflict of interest training? a. Annually b. Every four years c. Every two years d. Once per career stage

b

Proper paraphrasing of a sentence written by someone else may be accomplished by: a. Changing present tense to past tense or changing from active to passive voice b. Using your own words and writing voice to express the idea conveyed in the sentence c. Changing a sentence's subject and predicate around d. Removing the first word and last word and inserting two or three words elsewhere

b

Reviewers have a responsibility to promote ethical peer review by: a. Revealing their identity to the authors of the manuscript or grant proposal b. Preserving the confidentiality of the submission c. Using the information contained in a reviewed manuscript to further their own research - d. Seeking the help of others in the research team to perform the review

b

Which example of research with prisoners would be allowable under the regulations? a. Investigating genetic biomarkers as predictors of intelligence b. Examining age at first arrest as a predictor of adult criminal history c. Determining safety of a new formulation of deodorant d. Examining the use of financial incentives to improve compliance with dentist appointments

b

Which of the following best describes when a protocol may be eligible for expedited review by the IRB? a. The study includes only healthy research subjects b. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government c. The study is required for a student research project d. The study does not require written consent

b

Which of the following is true regarding the U.S. Federal Research Misconduct Policy? a. The standard of innocent until proven guilty does not apply in misconduct cases b. The Policy covers conflicts of interest and the misuse of grant funding c. To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly d. Misconduct must be proven beyond a reasonable doubt

c

Which of the following is true regarding the traditional peer-review process: a. Under double-blind review, the identity of the reviewer is revealed to the author b. Under single-blind review, the identity of the reviewer is revealed to the author c. Under single-blind review, the identity of the author is revealed to the reviewer d. Under double-blind review, the identity of the author is revealed to the reviewer

c

Which of the following is true? a. The federal "minimum necessary" standard for information use and disclosure applies to treatment with the same force that it applies to everything else b. The "minimum necessary" standard does not apply to treatment-related uses and disclosures at all. It is completely waived c. The "minimum necessary" standard applies to treatment-related uses, but not treatment-related disclosures, so as to avoid any interference with information exchanges among practitioners

c

Which of the following most accurately describes an institutional conflict of interest a. It occurs when two or more departments within a college are competing for the same research funding b. It occurs when two or more institutions are competing for the same research funding c. It occurs when an institution's financial or non-financial interests could interfere with its research activities d. It occurs when two or more researchers within a department are competing for the same research funding

c

Which of the following situations is most likely to constitute an instance of plagiarism? a. Summarizing a published article in a short paragraph, adding a citation, and including this in a paper b. Taking a paragraph word-for-word, enclosing it in quotation marks, adding a citation, and including this in a paper c. Summarizing a published article in 2-3 distinct paragraphs and including this in a paper d. Thoroughly paraphrasing a paragraph, adding a citation, and including this in a paper

c

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: a. Approve this project since the risk appears to be no more than minimal b. Approve this project because the superintendent is the ultimate authority on what happens in his facility c. Approve this project but submit it for federal review - d. Not approve this project because the prisoners are merely a population of convenience for the student

d

A research collaboration can be enhanced by: a. Avoiding the issue of which journal to target since research team members might disagree b. Limiting the communication between researchers and industry partners c. Waiting to discuss authorship issues until after data collection d. Discussing intellectual property issues while the collaboration is forming

d

Organizations covered by the federal HIPAA privacy law are expected to: a. Ensure that patients are aware of their privacy rights as a research subject b. Help patients understand their various treatment options c. Prohibit incidental disclosures of protected health information d. Protect the health information under their control, train their workers in how to protect information, and help patients exercise their rights under the law

d

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are: a. Ethical integrity and legal compliance b. Sustainability and innovation c. Quality and quantity d. Intellectual merit and broader impact

d

Use of social media tools and other new technologies to facilitate training-related communications is: a. Specifically allowed by the federal HIPAA statute in 1996 b. Generally allowed, as long the patient's name or medical record number is not included c. Generally prohibited, no matter the context d. Depends on the organization's policies, so you should check with your organization's officials about what is allowed or prohibited

d

Which author is normally responsible for sharing reprints of a publication with readers? a. The first author b. The last author c. The author who has made the most significant contribution d. The corresponding author

d

Which of the following is a good security practice for email? a. Reply to all messages as quickly as possible to avoid the inbox becoming too full b. Accessing links in all emails regardless of the source to make sure important information is not missed c. Sending sensitive information in email messages or in attachments to such messages, as long as a legally binding confidentiality notice is included d. Exercising care with every email message received, especially email containing file attachments that may be infected

d

Which of the following most accurately describes data lifecycle management (DLM)? a. It refers to the obligation to share data imposed by professional journals b. It refers to the obligation to uphold data confidentiality imposed by federal law c. It refers to the data collection requirements of a particular organization d. It refers to the tools and processes for handling data during a research study and after it concludes

d

Which of the following most accurately describes good mentoring practice? a. Informing trainees that faculty are the only individuals who have enough experience to serve as mentors b. Informing trainees that they must rely on their adviser for all mentoring c. Avoiding being a mentor unless one works in the same research field as a trainee d. Encouraging trainees to receive mentoring from a collection of individuals

d

Which of the following most accurately describes the main goal of RCR education and training? a. To teach researchers about technical methods and laboratory techniques b. To provide guidance regarding how grant funding may be spent c. To increase funding for scientific research d. To promote greater awareness of proper research practice and research ethics

d

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines? a. Acquiring funding for a research project is sufficient to warrant authorship b. The first author is the only person who is held publicly responsible for the contents of the paper c. Conducting the technical aspects of the research is sufficient to warrant authorship d. Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgements sections

d

Which of the following statements most accurately describes the mentoring relationship? a. A mentoring relationship must not turn into a friendship or else it is a failure b. Mentoring relationships happen naturally and do not require work c. Graduate students, but not mentors, gain from the mentoring relationship d. Mentors teach trainees about aspects of academic life that are not covered in textbooks

d

Which of these is not generally a good practice for fax machine use? a. Whenever possible, faxes are sent only to machines at known locations, where the security of the receiving machine can be assured b. All faxes containing sensitive information include a cover sheet identifying the recipient and including a confidentiality notice. When possible, digital fax to email should be used with confirmed email addresses - c. Tested, pre-programmed fax numbers are used (whenever possible) to reduce dialing errors when sending. All new fax numbers are confirmed by voice call before first use - d. Sensitive faxes- inbound or outbound- are left sitting in or around the machine

d

Which statement most accurately describes a conflict of commitment? a. It involves a monetary gain by one party over another party b. It occurs when an institution does not follow the financial rules from a funding resource c. It can only occur between an institution and an outside organization d. It occurs when outside activities interfere with one's responsibilities to an employer

d

Within the context of RCR, social responsibility primarily refers to: a. The obligation to be collegial to coworkers b. The obligation to participate in political activities, such as running for government office c. The obligation to share data with other researchers in a timely manner d. The obligation to design technology or acquire information in ways that take into account what effects those actions may have on society

d

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB? a. Yes, this must be reported because it involved a subject in a research study and it is up to the IRB to determine if it was related to participation b. Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm c. No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study d. No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study

c

A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is: a. A valid use of a statistical technique referred to "snowball sampling" wherein the inclusion of the first subject leads to the recruitment of another one subject b. Acceptable only when the researcher's IRB grants a special waiver c. Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners d. A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher

c

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: a. Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk b. Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk c. Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk d. Expected, related or possibly related to the research, suggests the research puts others at greater risk

c

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way to home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe? a. Within 24 hours b. Within two weeks c. Within 48 hours - d. Promptly

d

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? a. 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 b. The new research would need full review by a convened IRB because children are a protected population c. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors d. 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

d

According to federal regulations, the expedited review process may be used when they study procedures pose: a. More than minimal risk, but the study replicates previously approved research b. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting 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

According to the U.S. Federal Research Misconduct Policy, fabrication involves: a. Failing to list a collaborator as an author b. Mismanaging research funds c. Using another person's ideas or words without giving appropriate credit d. Making up data or results and recording or reporting them

d

Information security's goals are sometimes described by the letters "CIA." Which of the following is correct definition of C, I, or A? a. A is for availability, which refers to the ability of legitimate users to access their data when needed b. I is for integrity, which refers to the accuracy of the data for its intended use, the security-equivalent of terms like validity and reliability c. C is for confidentiality, which refers to limiting data access to appropriate persons for appropriate purposes d. All of the above e. None of the above

d

A researcher 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. Feel that their privacy has been invaded d. Lose their employment

a

True or False: Your study team can begin participant related activities, such as recruitment before a protocol is approved by the IRB

false

A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of: a. Respect for persons b. Beneficence c. Justice

a

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct? a. Plagiarism b. Harassing a co-worker c. Gift authorship d. Conflict of interest

a

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: a. Obtains, uses, studies, analyzes, or generates identifiable private information b. Obtains, uses, studies, analyzes, or generates identifiable public information c. Observes public behavior d. Obtains, uses, studies, analyzes, or generates de-identified private information

a

When a patient enters a clinical facility, they must inevitably surrender control of their information for a broad range of uses and disclosures. In the circumstances where the patient retains control of information, which of the following is true? a. If the person controls a decision about treatment, he/she controls information about the information associated with it b. When a patient is too young or incapacitated, the clinician may designate a personal representative to make information decisions on the patient's behalf c. Discussions with patients' families now require explicit written permission from the patient, or his/her personal representative

a

For health information privacy and security, are the legal and regulatory requirements for students different from those for regular members of the healthcare workforce? a. No, students must meet the same standards as a regular member of the workforce performing the same tasks - b. Yes, but students are subject to a lower standard of performance because they are in training c. Yes, but students must meet a higher standard of performance

a

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes: a. Identifiable health information that is created or held by covered entities and their business associates b. Any identifiable health information c. Identifiable health information that is created or help by covered entities and their business associates that operate across state lines d. Identifiable health information that is created or held by covered entities and their business associates, provided the data subject is a US citizen

a

In regard to reporting privacy or security problems, are the requirements for students the same as for regular workers? a. Yes. Like any other member of the workforce, students are obligated to report problems they are not in a position to correct b. No. It is assumed that students are always supervised, and supervisors have the responsibility to report problems

a

In the U.S. privacy protections for health information come from: a. Federal, state, local, and private certification organizations' requirements b. Only federal laws (for example, HIPAA) c. Only state laws d. Only private certification organizations' requirements (for example, those of The Joint Commission

a

In the research context, the term validity most commonly refers to: a. Whether operationalized terms actually measure what they purport to measure b. Whether funding has been obtained for the project c. Whether a project has been approved by an oversight board d. Whether a project is worth pursuing

a

Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because: a. Both subparts apply, as these individuals are under the legal age of consent and are incarcerated b. The need for the signatures of both parents outweighs the two subparts c. Subpart C still applies, as the potential subjects are juveniles d. Only subpart C applies because of the need for assent forms, as a result of in loco parentis status for juveniles

a

The main focus of NIH's conflict of interest policy is: a. Financial conflicts of interest b. Personal conflicts of interest c. Conflicts of conscience d. Academic conflicts of interest

a

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: a. Determined by the institution in its written policies and procedures b. Included in the consent process c. Stated in the human subject protection regulation, but not in the drug or device regulations - d. Determined by research staff

a

Under HIPAA, an organization is required to do which of the following? - a. Appoint a Privacy Officer to administer HIPAA rules - b. Appoint a Conflict of Interest (COI) Committee to administer HIPAA rules c. Appoint an Institutional Review Board (IRB) to administer HIPAA rules d. Appoint a Patient Advocacy Group to administer HIPAA rules

a

What is the primary responsibility of oversight bodies (such as an IRB or IACUC)? a. To determine compliance with regulatory requirements, including those relating to protecting research subjects b. To determine if authorship credit has been correctly specified c. To ensure that a study is methodologically and technically sound d. To assess whether the research team has completed data management training

a

Which of the following is a standard core component of an institutional conflict of interest policy? a. A section on the disclosure process b. A section on confidentiality and privacy c. An external communications plan section d. A section on budget management

a

Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities? a. Use of full names in public areas or an intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification b. Names or other information that could identify individuals are avoided whenever possible, in case a conversation is overheard c. Whenever possible, conversations involving sensitive information should take place in a non-public areas where they cannot be easily overheard d. Sensitive conservations that must take place in public areas are conducted discreetly and as quietly as the environment allows

a

Which statement best describes the role of an IRB: a. A committee that reviews different types of human subjects research b. A committee that reviews all biomedical research c. A committee that reviews all types of research d. A committee that reviews an institution's conflict of interest policies

a

With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category does information related to research, marketing, and fundraising go? a. Uses or disclosures that generally require specific written authorization b. Uses or disclosures that generally require oral agreement only c. Uses or disclosures that can generally occur without any specific permission from the patient

a

Choose all that apply. The International Conference on Harmonization (ICH), held in 1990, laid out a foundation of guidance for all clinical research, including minimum standards for: a. Protecting participants b. Ensuring quality data c. Hiring study staff

a and b

A waiver of the requirement for documentation of informed consent may be granted when: a. The investigator has no convenient place to store signed consent forms separate from the research data b. Potential subjects might find some of the research questions embarrassing, personal, or intrusive c. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality d. The subjects are literate in their own language; however, they do not read, write, or speak English

c

According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: a. Beneficence b. Respect for persons c. Justice

c

An adverse event is: a. Always an unexpected event b. Always an event that happens as the result of participation in a study c. Any untoward medical event that occurs during a study, but may not be caused by a study

c

Which of the following is true about conflicts of interest? a. A project must be funded by an external source in order for any conflicts of interest to be present b. Researchers are not permitted to have any conflicts of interest c. Conflicts of interest increase the likelihood of bias d. A financial dimension must be present in order for it to be a conflict of interest

c

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: a. Must be conducted by a convened IRB b. Is limited to review of unanticipated problems c. Must occur within 12 months of the approval date d. Is not required unless additional risks have been identified

c

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: a. A designated privacy official (a.k.a., "Privacy Officer") b. An organizational IRB or Privacy Board c. An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue d. A designated security official (a.k.a., "Security Officer")

c

Recruiting into research... a. Always requires a written authorization for ANY contact with the patient b. Never requires a written authorization c. Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity d. Is entirely at the investigator's discretion

c

Security measures are sometimes described as a combination of physical, technical, and administration (PTA) safeguards. Which of these would be considered a technical safeguard? a. Policies about who is granted access to what types of data b. Locked doors and other physical barriers c. Measures including device data encryption, anti-malware software, and communications encryption d. Legal-regulatory requirements

c

What does the federal provision for "incidental uses and disclosures" mean? a. Accidental uses and disclosures are never subject to penalties in treatment contexts, even if there is negligence b. Accidental uses and disclosures are not subject to penalties provided reasonable administrative, physical, and technical safeguards are in place c. Accidental uses and disclosures are not subject to penalties provided reasonable safeguards are in place and there has been no negligence

c

When a privacy problem is discovered, which of the following is true? a. Only healthcare workers are protected from intimidation for retaliation for reporting - b. Only patients are protected from intimidation or retaliation for reporting - c. Healthcare workers and patients are protected from intimidation or retaliation for reporting

c

Which of the following is a key reason why international collaborations can be challenging a. There are currently no international ethical guidelines for research b. Federal agencies are not permitted to encourage international collaborations c. The collaborators may have different disciplinary and cultural backgrounds and practices d. International collaboration is rare and is on the decline

c

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include: a. Keeping the key linking names to responses in a secure location b. Requiring all members of the research team to sign confidentiality agreements - c. Reporting data in aggregate form in publications resulting from the research d. Destroying all identifiers connected to the data e. All of the above

e

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: a. If personal identifiers will be retained and used in the data analysis b. If the study results, if any, will be included in the employee's personnel records c. Who will have access to the data d. How the data will be collected and secured e. All of the above

e

Which of the following is a good practice if one wishes to avoid "social engineering" attacks? a. Taking appropriate steps to confirm a person's (or site's) identity for any transaction that involves sensitive data b. Using strict procedures when it is necessary to exchange an authentication credential like a password, PIN, account number, or other personal data that is critical to establishing personal identity c. Being cautious any time someone asks for sensitive information, whether by phone, fax, email, or even in person. It could be a scam - d. Not opening attachments or clicking on links in messages, emails, or on websites unless absolutely sure of the source's authenticity e. All of the above

e

Choose all that apply. Printed materials should include: a. The basics of the study b. Accurate information c. Eye-catching graphics d. A promise of a cure

a, b and c

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? a. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality b. The researcher cannot control what participants repeat about others outside the group c. If group members know each other confidentiality is not an issue d. Using pseudonyms in reports removes the concern about any confidences shared in the group

b

Which of the following is best practice when conducting a focus group? - a. Conduct the focus group in an open, public setting so that participants don't feel as if they are "being watched" - b. Remind participants that what is said within the group setting should not be shared outside of the group in order to protect everyone's privacy, although privacy cannot be guaranteed c. Call participants by name during the session to build rapport. Ask everyone to state their first and last name when speaking so you can have a record for your transcript of who said what

b

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections a. Children, prisoners, and terminally ill b. Pregnant women, prisoners, and mentally disabled c. Pregnant women, prisoners, children - d. Prisoners, children, and elderly

c

True or False: Privacy considerations vary from culture to culture

true

True or False: All amendments to a clinical protocol must be submitted, and prior to implementation, approved by your IRB

true

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: a. Respect for persons b. Justice c. Beneficence

a

Which of the following are methods used to ensure participant comprehension? Choose all that apply. a. Sending a copy of the consent form ahead of time for the participant to review b. Using the 6th to 8th grade reading level when writing consent c. Asking the participant to summarize or explain certain elements in their own words d. Asking a family member to be present in order to give consent on behalf of the participant

a, b and c

The U.S. Public Health Service (PHS) requires institutions to: a. Post the significant financial interests of all researchers to a publicly available website b. Block faculty from owning any equity interest in a company that sponsors research c. Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them d. Collect information about the significant financial interests of all faculty and staff

c

Which of the following statements is true regarding the reporting of outside interests and the management of conflicts? a. The institution must report identified financial conflicts of interest to the U.S. Office of Research Integrity b. Investigators are responsible for developing their own management plans for significant financial interests c. Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project d. Investigators must disclose all of their financial interests regardless of whether they are related to a research project

c

Which of the following statements is true? a. Federal agencies require institutions to have policies on both conflict of commitment and conflict of conscience b. All institutions have conflict of conscience policies because they are required by state governments c. Many institutions have conflict of commitment policies even though they are not strictly required to by federal agencies d. Federal agencies require institutions to have a conflict of conscience policy

c

Which statement most accurately describes a conflict of conscience? a. It occurs when a financial reward is provided for outstanding work b. It occurs when financial interests bias research c. It occurs when an individual's personal beliefs could affect the performance or outcome of research d. It occurs when researchers have two or more responsibilities to complete at the same time

c

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? a. There was both a violation of privacy and a breach of confidentiality b. The subjects' privacy has been violated c. Confidentiality of the data has been breached d. There was neither a violation of privacy nor a breach of confidentiality

d

As part of the consent process, the federal regulations require researchers to: a. Describe penalties that may be imposed for nonparticipation b. Provide a list of the IRB members who reviewed the protocol - c. Recommend that potential subjects discuss their decision to participate with family members d. Provide potential subjects with information at the appropriate reading comprehension level

d

Identify the example of when situation and time are key to assessing risk of harm in a research study: a. Research on the prevalence of retired individuals who have been harassed in different academic disciplines b. A survey with educators on their experience about implementation of a novel preschool program c. A study asking women if they have completed an advanced degree and what city they were born in d. A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers in the United States

d

Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of: a. Economic vulnerability b. Therapeutic misconception c. Deferential vulnerability d. Medical vulnerability

d

The COI management plan aims to: a. Reduce IRB review burden when a COI is disclosed b. Eliminate all COIs in research when a COI is disclosed c. Address disclosure of COIs in multi-center research when a COI is disclosed d. Provide procedures or extra steps to be taken to minimize the risk of bias when a COI is disclosed

d

What is the term for management controls that are built into a research study (for example, independent data analysis)? a. Required controls b. Mandated controls c. Objective controls d. Inherent controls

d

Which of the following is a best practice for ensuring data quality? a. Collect as much data during a participant visit as possible, regardless of their safety b. Make an executive decision on missing data so the PI doesn't need to get involved c. Check participant files at the end of a study to ensure completeness d. Use a checklist to ensure that assessments and interventions are carried out according to the protocol

d

Which of the following is a standard management strategy for an institutional conflict of interest? a. Contact the federal government so that it can decide the appropriate course of action b. Contact the relevant state government so that it can decide the appropriate course of action c. having the institution divest its interests in every private company d. Restricting the conflicted individuals from making decisions connected to the institutional conflict of interest

d

Which of the following statements most accurately describes a mitigation report? a. A report from an institution telling the U.S. Public Health Service how bias will be minimized before a research project begins b. A report from the U.S. Public Health Service to an institution of what must be done to deal with financial conflicts of interest of its PHS-funded researchers c. An annual report to the U.S. Public Health Service of all the significant financial interests of the institution's PHS-funded researchers d. A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest

d

True or False: A consent form is a legal document that can be signed by an adult 18 years and older; whereas an assent form allows minors to convey their own independent decision about participation

true

True or False: Following Good Clinical Practice (GCP) is one way to help minimize your risk of non-compliance

true

True or False: Maintaining a detailed study log that identifies the interviewers making phone calls, tracks the number of phone calls they made, and when, and includes written notes for the next shift of interviewers is an example of GCP

true

True or False: Not all adverse events are always classified as serious

true

True or False: Participants are more likely to leave a study if they find involvement to be a hassle

true

True or False: The use of other strategies beyond the consent form (such as videos and comprehension checks) can help enhance understanding of what study participation will involve

true

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. 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 b. 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 c. 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 d. In the event of any distress you may have related to this research, you will be given access to appropriate resources

a

A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of: a. Public behavior b. Private Information c. Public Information d. Private Behavior

a

According to the U.S. Public Health Service, the definition of the term "investigator": a. Includes anyone involved in the conduct or reporting or research b. Refers only to the principal investigator and laboratory technicians c. Refers only to the principal investigator d. Includes faculty but not students

a

According to the federal regulations, which of the following studies meets the definition of research with human subjects? a. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests b. 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 - c. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department d. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university

a

An example of an individual financial COI is: a. A researcher's spouse hold equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study b. A researcher's spouse works at the same university as the researcher c. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza d. A researcher's 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher's ongoing projects

a

Choose the correct statement below regarding study priorities a. The highest priority in a study is placed on the safety of a participant followed by the collection of good data b. The highest priority in a study is placed on the collection of good data followed by the safety of a participant c. The safety of a participant and the collection of good data are equally important

a

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? a. Securing a Certificate of Confidentiality b. Using data encryption for stored files c. Waiving documentation of consent - d. Using pseudonyms in research reports

a

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. 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 b. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees c. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study d. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants

a

Which of the following are consequences of research misconduct? Choose all that apply. a. Removal from study team b. Grant funds returned c. Barred from conducting research d. Name placed on Office of Research Integrity website

a, b, c and d

A graduate student mentee from another department comes to you with allegations that a research assistant (RA) on her team seems to be falsifying data. What is your guidance? a. Any suspicion of research misconduct should be immediately reported. Encourage her to go to the IRB to open a formal investigation b. Ask if she has talked to the RA to understand more about the situation. If so, affirm that she has done the right thing by bringing the issue to someone she trusts (you!). If after hearing about the situation, you agree that it does need to be investigated, encourage her to report it up the chain c. Tell her that she is taking a personal risk and that it is best to stick to her own responsibilities. She should leave it to the PI to note the data discrepancy d. Tell her to go to the PI with the allegations so that the issue can be appropriately reported up the chain

b

According to the U.S. Public Health Service, which of the following would be considered a significant financial interest? a. Travel expenses reimbursed by a U.S. institution of higher education b. An equity interest valued at $5,000 owned by the investigator's spouse in company that produces products related to the investigator's institutional responsibilities c. An equity interest valued at $10,000 or more that is not related to the investigator's institutional responsibilities d. Income from the university where the investigator is currently employed

b

According to the federal regulations, which of the following studies meets the definition of research with human subjects? a. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the U.S. between 1820-1845 to track the numbers of immigrants from certain ethnic groups b. A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression c. 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 d. A researcher conducts a linguistic study of comments posted on a local public blog

b

Additional safeguards that may be included in a social and behavioral study may include: a. Requiring a legally authorized representative to provide signed consent for an incapacitated subject b. Remove all direct identifiers from the data as soon as possible c. Requiring pregnancy tests before administration of the study drug d. Frequent monitoring of the subject's heart through ECG after administration of the study drug

b

An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle? a. Beneficence b. Justice c. Respect for persons

b

Unfortunately, a participant has decided to leave the study. What is the first step you should take? a. Ask the participant to help find a replacement b. Refer to your clinical protocol to review the process for participants who are withdrawing c. There is no action required- the study will be fine without one participant

b

Which is true of inducements in research? a. Offering $10 for an hour long research study constitutes undue inducement b. 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 c. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons d. Like coercion undue inducement is easy for IRBs to determine

b

Which of the following is most likely to be considered a conflict of commitment? a. A new graduate is deciding between job offers from two institutions b. A researcher cancels laboratory meetings in order to perform consulting work c. A senior researcher has to resolve a dispute between two junior researchers d. A researcher takes part in political activities during weekends

b

Which of the following is the most appropriate way to handle a conflict of conscience relating to a project? a. Follow all of the federal regulations relating to conflicts of conscience b. Notify relevant parties that a conflict may exist and seek advice about whether to accept or decline the project c. Report the issue to the institution's research misconduct office d. Remain quiet about the conflict and continue with one's work

b

Which of the following statements most accurately describes the disclosure process for institutional conflicts of interest? a. An institution's institutional conflicts of interest must be revealed to all of its external funding sources b. The manner for disclosing institutional conflicts of interest varies depending on institutional policy c. The statutes of most states require institutional conflicts of interest to be disclosed to the public d. Federal regulations require institutional conflicts of interest to be disclosed to the public

b

A discrepancy in the data entered during a study has been detected. Who should decide what value is correct? Choose all that apply. a. The person inputting the data b. The PI or Data Manager c. The person who is NOT entering the data

b and c

What are some ways to securely store study data files? Choose all that apply a. Store backup files on a portable storage device in a locked office b. Store files on a secure data server c. Keep all physical files in a locked file cabinet in a locked office d. Keep all electronic study data in a password-protected computer files

b, c and d

A PI has added an additional physical test to her study. The new test involves slightly different risks to her study participants. What is her best course of action? a. Call each participant immediately and explain the new test and any possible risk, then obtain their verbal consent to continue participation in the study b. To ensure that all participants receive the same verbiage, she must mail a revised consent to each participant with the new information highlighted c. She must revise the consent form, then review the new form with each participant in a face-to-face conversation d. She must submit a revised consent, highlighting the new test and any associated risk, to her IRB, and continue using the same methods previously used

c

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 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 b. 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 c. 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 d. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality the students were randomly assigned scores that were not related to their actual performance

c

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 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 b. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes c. 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. If it is the best interests of the community that the children participate in the study, parental permission is optional

c

According to the U.S. Public Health Service, a "significant financial interest" includes royalty income paid to an investigator and its disclosure is required: a. Regardless of the source of the income b. Only if it relates to income from governmental agencies c. Except if that income is from the institution that currently employs the investigator d. Only if it relates to income from publicly traded companies

c

An investigator received $4,000 of consulting income from a publicly-traded drug company over the past 12 months. The investigator also owns stock in that company valued at $2,000. The investigator is submitting a grant to the National Institutes of Health that involves evaluating the effectiveness of a drug produced by the same drug company. Which of the following is true? a. The investigator does not have a significant financial interest related to the grant because the consulting income is less than $5,000 b. The investigator does not have a significant financial interest related to the grant because the stock's value is less than $5,000 c. The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest d. The value of stock is not calculated when determining significant financial interests

c

Institutions are required by the U.S. Public Health Service to do which of the following: a. Eliminate any and all conflicts of interest b. Update their financial conflict of interest policy every four years c. Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest d. Apply the same financial conflict o

c

Marika has been working with a group of participants for several months and she's gotten to know them quite well. She has especially enjoyed working with Mr. Grummell. During a recent exercise study, Markia offered him a few extra words of encouragement. What has Markia done wrong? a. She was too nice to Mr. Grummell b. She didn't do anything wrong. Part of her job is to make participants comfortable and encourage them during a study c. She deviated from the clinical protocol by offering extra words of encouragement to only one participant d. She became too attached to a participant in her study

c

Risk of harm in social and behavioral sciences generally fall in three categories, which are: a. Invasion of privacy, adverse reaction to study drug, and discrimination b. Study procedures, breach of confidentiality, and loss of employment c. Invasion of privacy, breach of confidentiality, and study procedures d. Breach of confidentiality, loss of autonomy, and study procedures

c

The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a: a. Physical vulnerability b. Institutional vulnerability c. Cognitive or communicative vulnerability d. Economic or social vulnerability

c

What is the simplest way to assess which of your recruiting efforts work best? a. Most recruiting efforts have the same success rate- evaluate your own by comparing the cost and time to implement each one b. Visit your flyer locations on a daily basis to see how many are being picked up c. Ask potential participants how they heard about the study d. Search "successful recruitment methods" on the internet

c

Which of the following is a best practice for ensuring treatment fidelity in a behavioral intervention? a. Encourage participants to return for multiple studies by offering rewards b. Record participant interactions and compare them on a day-to-day basis c. Compare current IRB protocol verbiage to previously submitted and IRB-approved protocols for consistency d. Create SOPs from scratch for each study to ensure accuracy

c

Choose the three main ways misconduct is committed in a research setting a. Pretend b. Prejudice c. Falsification d. Fabrication e. Plagiarism

c, d and e

An example of an institutional COI is: a. The organization's president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the organization b. The organization gives scholarships to some post-doctoral researchers c. One of the organization's deans is the vice-chair of the organization's IRB d. An industry sponsor pays for the construction of a new research laboratory at the organization

d

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

Which of the following is true regarding the U.S. Public Health Service and its approach to the disclosure of significant financial interests. a. Any income from a mutual fund must be disclosed b. Any equity interest contained in a retirement account must be disclosed c. Any equity interest owned by the investigator's cousins must be disclosed d. Any equity interest in a non-publicly traded company must be disclosed

d

Which of the following most accurately describes the status of U.S. federal regulations on institutional conflicts of interest? a. They are administered by the Office of the Inspector General (OIG) b. They are administered by the Public Health Service (PHS) c. They are administered by the Department of Health and Human Services (HHS) - d. No federal agency has promulgated institutional conflict of interest regulations

d

Which of the following statements is true? a. Participants cannot speak about their experience to people outside of the study b. Participation in a research study can cure the participant's disease c. Once a participant has consented to being involved in a study, his participation is mandatory d. Because participation in a social and behavioral research study is voluntary, a participant may choose to withdraw at any time

d