Hipaa Authorization Has Which Of The Following Characteristics

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

HHS has reiterated in its guidance that use or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board. However, remember that you generally cannot proceed on your own without some approval from an IRB, Privacy Board, or other designated governing entity.

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:

If the data in question meet the definition of PHI and are being used for purposes that fall within HIPAA's definition of research, HIPAA generally requires explicit written authorization (consent) from the data subject for research uses. However, HIPAA provides several alternatives that can bypass such authorizations: The research involves only minimal risk. The research is used solely for activities preparatory to research. Only deceased persons' information is used. Only de-identified data is used. Only a "limited data set" is used, under an approved "data use agreement." It is "grandfathered" research where all legal permissions were in place before HIPAA took effect.

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

If you are unsure about the particulars, consult with your organization's IRB, Privacy Board, or privacy official. For data security issues, consult with your organization's security official. Consulting with an experienced colleague can always be helpful, but their advice is not authoritative. Do not assume that a representative of the funder will know all the rules, or that the generic advice of a professional association will be applicable to your organization's particular rules.

HIPAA's protections for health information used for research purposes...

Under HIPAA, a "disclosure accounting" is required:

HIPAA's relatively new data-focused protections, which took effect starting in 2003, supplement Common Rule and FDA protections; they are not a replacement. Institutional Review Board (IRB) protocol reviews using Common Rule and FDA criteria remain as before, including aspects related to data protection. IRBs may have the responsibility for addressing HIPAA's additional requirements in their reviews when those apply; or some responsibilities may be given to another kind of body that HIPAA permits (a Privacy Board) or to an institutional official that HIPAA requires (a privacy officer). These federal standards complement states' and accreditation bodies' requirements.

In addition to being limited to external disclosures, disclosure accounting is not required for disclosures made under authority of a consent/authorization, on the theory that the data subjects are aware of what they have expressly permitted for that research. Neither is an accounting required for disclosures to the data subject directly about him/herself. Nor is it required for limited data set disclosures subject to a data use agreement. Nor, finally, is any accounting required for de-identified information that no longer qualifies as PHI.

A HIPAA authorization has which of the following characteristics:

Authorizations are required unless the proposed use meets one of the exceptions listed in the HIPAA regulation. It is never at the researcher's discretion. When they are required, authorizations must be: In "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision. Executed in writing, and signed by the research subject (or an authorized personal representative). Authorizations must include a specific description of the PHI to be used or disclosed, the name(s) or other identification of persons involved in the research, and description of each purpose of the requested use or disclosure. Authorizations can be combined with other documents and can always be revoked by the data subject.

HIPAA includes in its definition of "research," activities related to:

Like the Common Rule, HIPAA defines research as a "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge" (Protection of Human Subjects 2018; Security and Privacy 2013).

The HIPAA "minimum necessary" standard applies...

Uses and disclosures of data for research that are allowed to bypass the authorization requirement are still subject to the "minimum necessary" standard - that is, the uses/disclosures must be no more than the minimum required for the described research purpose. A covered entity may rely on a researcher's documentation - or the assessment of an IRB or Privacy Board - that the information requested is the minimum necessary for the research purpose. By contrast, research information obtained using an authorization is not bound by the minimum necessary standard - on the theory that the data subject has given explicit permission in accordance with the signed authorization. However, be aware that while HIPAA may not require a minimum necessary justification at all times, an IRB's evaluation of risks and burdens on human subjects arguably does.

Recruiting into research ...

It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient's healthcare providers. If the contact will be made by someone other than the patient's healthcare provider, permission will be required.

Where fewer than 50 subjects' records are involved, the listing must be more specific and detailed, commensurate with the requirements for other kinds of PHI disclosure accounting, including: specific date(s) of disclosures; names of entities to which PHI was disclosed; description of the PHI involved in the disclosure; and purpose of the disclosure.

When required, the information provided to the data subject in a HIPAA disclosure accounting ...

HIPAA protects a category of information known as protected health information (PHI). PHI includes:

What procedures must be described in an agreement called an "assurance of compliance" with OHRP?

What are some considerations for a U.S researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee as well as the Big State University IRB?

A Researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

The age of majority in international research is determined by the

A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availably of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?

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.

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.

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.

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.

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.

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: -Educational. -Not an excessive incentive. -Of high quality. -Age appropriate.

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.

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.

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.

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.

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

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.

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.

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.

According to Subpart D, which of the following research activities with children would qualify for an exemption? Survey procedures Observation of public behavior when the researcher participates in the activities being observed. Interviews 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.

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.

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.

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.

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.

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.

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.

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. Including the institution's privacy policy on the survey site. Providing a thorough debriefing at the end of the study.

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.

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.

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.

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.

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.

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.

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. population health.

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: Pregnant Women Prisoners Children Workers

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

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

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. True False

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

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 Fraud Research Misconduct Malfeasance

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.

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

A conflict of interest implies: The elimination of bias. The actual involvement of bias. An awareness of bias. The potential for bias.

What are the 3 principles discussed in the Belmont Report?

What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

All of the following are true regarding the Belmont Report, EXCEPT:

The history of ethical regulations in human subjects research began with the

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?

Which of the following elements must be included in an informed consent?

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

How can faculty researchers avoid coercion of student subjects?

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?

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?

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?

Which of the following studies need IRB approval?

What is the Institutional Review Board (IRB) charged with?

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. B. Stanford Prison Experiment (Zimbardo). C. Tearoom Trade Study (Humphreys). D. The Harvard T3 study.

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.

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. Justice. B. Beneficence. 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: A. Beneficence. B. Justice. 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

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.

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.

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.

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.

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.

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.

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. d. Prisoners.

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.

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.

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.

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.

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.

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.

Risk should be evaluated solely by the magnitude or severity of expected harm, not probability. True False

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.

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.

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.

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.

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.

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.

Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? Citizenship. Directory information. Religious affiliation. SAT scores.

PPRA gives parents some level of control over their child's: Medical records Educational records Participation in third-party survey research or exposure to instructional materials developed by researchers Ability to opt out of health education (specifically, sexual health education)

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. The Family Educational Rights and Privacy Act. Subpart D of 45 CFR 46. The Protection of Pupil Rights Amendment.

If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)? Observation of public behavior when the researcher participates in the activities being observed Survey procedures Research about aptitude testing Interviews

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

The provisions of Subpart D must be applied to all research funded by the HHS (which includes NIH). However, not all federal agencies that have adopted the Common Rule have also adopted Subpart D. In addition to HHS, only the U.S. Food and Drug Administration and the Department of Education have adopted it. Institutions may elect to apply the subpart to all research, regardless of the source of funding.

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?

Research involving children may be expedited if the level of risk is no more than minimal and if the research falls into a category of research identified as eligible for expedited review. Therefore, unless the nature of the topic would raise the level to more than minimal risk to the adolescent subjects, the study previously approved for adults through expedited review procedures would also be eligible for expedited review. It is not necessary for adolescents to have obtained some adult rights through emancipation procedures, nor must the reading level of the subjects be predetermined in order for a study involving minors to be eligible for expedited review. Consent forms, including the readability of the information, must always be tailored to the particular subject population of a study.

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 identity of the subjects can be readily ascertained. Which of the following statements is true?

The exemption categories that may be used with children include observations of children in public settings, as long as the researcher does not participate in the activities being observed or record information in such a manner that the identity of the subjects can be readily ascertained. Research does not require full committee review when it involves children, unless it does not fall into an exempt or expedited category.

The specific Department of Health and Human Services (HHS) regulations that apply to research with children are known as:

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific Department of Health and Human Services (HHS) regulations that apply to research with children. Subpart B specifies Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, Subpart C specifies Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects and Subpart A is the Basic HHS Policy for Protection of Human Research Subjects (generally referred to as the Common Rule).

According to federal regulations, "children" are defined as:

According to the federal regulations, children are persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. Generally, though not always, the age of consent is the age at which minors reach the age of majority and are considered adults. In the United States, state law dictates the age of majority. In most states, the age of majority is 18. This means that a 17-year-old may be considered a child when applying the federal regulations for protecting research subjects.

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

Subpart D restricts the use of exemptions when children are research subjects. Research that involves interviews, surveys, or participant observation when the researcher interacts with the children is not eligible for exemption under Category 2.

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

The federal regulations do not require that child assent be documented. Therefore it is not necessary to request a waiver of a requirement to document assent. An IRB will determine whether and how documentation is required for a particular study. The document does not require parental input or parental review.

According to Subpart D, research with children may be eligible for exemption when:

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?

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:

Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems since Wardens of Juvenile prisoners - unlike those for adult prisoners - act in loco parentis for juvenile offenders. This statement is false because:

A researcher 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:

A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:

Which of the following statements about prison research is true?

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should NOT be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?

The 1974 National Research Act

Informed consent is considered an application of which Belmont principle?

Which of the following brought increased public attention to the problems with the IRB system?

Which of the following is included in the Nuremberg Code:

The National Research Act of 1974

Which of the following was the result of the Beecher article?

The use of prisoners in research is a concern under the Belmont principle of Justice because:

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:

IRB continuing review of an approved protocol must:

What statement about risks in social and behavioral sciences research is most accurate:

Identify the example of when situation and time are key to assessing risk of harm in a research study:

Additional safeguards that may be included in a social and behavioral study may include:

The primary purpose of a Certificate of Confidentiality is to:

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Destroying all identifiers connected to the data.

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 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?

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)?

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?

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

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

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

To minimize potential risks of harm, a researcher conducting an on-line survey can:

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

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?

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

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:

The HIPAA "minimum necessary" standard applies... Your answer : To all human subjects research that uses PHI.

According to the HHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:

A financial conflict of interest could involve:

A conflict of interest implies:

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:

The Data Manager should review the study protocol:

When designing a database and data collection instruments for a study, the Data Manager should:

Every member of a study team must define quality the same way in order to produce a high quality database.

Which member of a study team is ultimately responsible for the conduct of the study at a site?

Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported data are verifiable to source documentation?

In order for a quality process to work, study team members must understand all of the following EXCEPT:

Typical study conduct activities performed by the data manager include all of the following EXCEPT:

t what point should a Data Manager get involved with the database development?

Prior to locking a database, a data manager should ensure all data have been entered and all queries are resolved.

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

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?

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 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?

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?

Which of the following are the three principles discussed in the Belmont Report?

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

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:

The Belmont principle of beneficence requires that:

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?

Continuing review of an approved and ongoing protocol

According to the federal regulations, research is eligible for exemption, if

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

According to federal regulations, the expedited review process may be used when the study procedures pose:

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 researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

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 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 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 waiver of the requirement for documentation of informed consent may be granted when:

As part of the consent process, the federal regulations require researchers to:

Data are made anonymous by

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:

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

Census data (the final report as published by the Census Bureau) is an example of:

A medical record is an example of: