Citi Program

Informed Consent - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	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?
Your answer	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.
Result	Correct
Comment	When a care provider becomes a researcher, both the child clients and their parents may not feel free to choose not to participate in the provider's study. A researcher who is also a care provider needs to be very clear that a decision not to participate in a study, or to allow records to be used, will not affect the care provided in the future. The fact that the therapist has access to her clients' records as a clinician does not entitle her to use information in the records for research purposes without parental permission and child assent. A school authority's permission to conduct the research does not replace the need for permission or assent. Finally, the children's right to choose cannot be overridden in the pursuit of an indeterminate community interest.

Question 2

Question	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?
Your answer	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.
Result	Correct
Comment	A statement in a consent form that says that subjects who agree to take part in the research waive their legal rights constitutes exculpatory language. Statements about the voluntary nature of consent, about the possible need to remove subjects from a study in order to protect their welfare, and statements about providing referrals do not waive subjects' rights.

Question 3

Question	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:
Your answer	A study in which subjects were assigned to study activities based on an undesirable or unflattering personal physical characteristic as assessed by members of the research team.
Result	Correct
Comment	If subjects were to learn that the research team assigned them to study conditions based on a perceived undesirable or unflattering personal physical characteristic, the knowledge that their appearance was judged negatively by the research team could be very distressing and, therefore, it would not be appropriate to inform subjects after the study about how they were assigned. In the other studies, informing subjects about the actual research procedures after the completion of the study would be unlikely to cause harm and would be appropriate.

Question 4

Question	A waiver of the requirement for documentation of informed consent may be granted when:
Your answer	The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
Result	Correct
Comment	The requirement to document informed consent can be waived if the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The requirement may also be waived if the study poses no more than minimal risk to subjects and involves no procedures for which written consent is normally required outside of the research context. With regard to non-English speakers, if documentation is required, investigators must provide informed consent materials in the subjects' language. If a researcher anticipates that subjects might be embarrassed by questions, this concern should be addressed in the consent process. Finally, identifying secure storage space for consent forms is an investigator's responsibility.

Question 5

Question	As part of the consent process, the federal regulations require researchers to:
Your answer	Provide potential subjects with information at the appropriate reading comprehension level.
Result	Correct
Comment	Researchers must provide information to subjects in a manner that facilitates comprehension. Therefore, the material must be written at the appropriate reading comprehension level. Researchers may not impose penalties for non-participation because to do so would violate the ethical principle of respect for persons. In some circumstances it may be appropriate to ask subjects to discuss the research with their families before making a decision about whether to participate, but it is not a regulatory requirement. Finally, researchers are not required to provide a list of the IRB members who reviewed the research.

 

Privacy and Confidentiality - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 4 of 5 quiz questions.

Question 1

Question	When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
Your answer	The researcher cannot control what participants repeat about others outside the group.
Result	Correct
Comment	It is not possible for a researcher to promise confidentiality in a focus group setting. Participants may choose to repeat sensitive information outside the group setting even if they have signed confidentiality agreements. This is true even if the participants know each other. Using pseudonyms in the report does not remove concerns about what group members might say outside the group.

Question 2

Question	Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects’ privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
Your answer	A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
Result	Incorrect
Correct Answer	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.
Comment	No agreements were made regarding confidentiality with the subjects who were unknowingly audio-taped; whose interactions were recorded, or whose cocaine use was revealed by another. Therefore, there was no breach of an agreement about confidentiality, but the subjects’ right to decide who can access their personal information was violated. If a researcher told subjects that only he or she would have access to identifiable data and then gives identifiable data to others that action constitutes a breach of confidentiality and a violation of privacy – the subjects’ right to control who has access to personal information.

Question 3

Question	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?
Your answer	Securing a Certificate of Confidentiality
Result	Correct
Comment	Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.

Question 4

Question	Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:
Your answer	All of the above
Result	Correct
Comment	Reporting data in aggregate form can help protect the identity of subjects (but does not make the data anonymous). Keeping keys in secure locations and requiring members of the research team to sign confidentiality agreements are methods for protecting identifiable information. Researchers can also remove all identifying information from the data and completely disconnect any links between the subjects and data about the subjects.

Question 5

Question	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?
Your answer	There was neither a violation of privacy nor a breach of confidentiality.
Result	Correct
Comment	The subjects’ privacy has not been violated because the identity of subjects was not included in the file. The confidentiality of the data has not been breached because the data could not be linked to identifiers. Therefore, the correct answer is that there was neither a violation of privacy nor a breach of confidentiality. The release of aggregate data with no identifiers does not constitute a violation of privacy or a breach of confidentiality.

Research with Prisoners - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 3 of 5 quiz questions.

Question 1

Question	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:
Your answer	Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
Result	Correct
Comment	Because prisoners are vulnerable by their incarceration, it is necessary that research with prisoners does not impose further constraints on voluntariness of their decisions. Researchers must enhance the voluntariness of a prisoner’s consent by minimizing the influence of other people, especially staff or prisoners who may exercise arbitrary authority over these potential subjects. Subject selection needs to be fair within the population that potentially meets the study criteria. Using staff or prisoners to help select subjects leads to undue influence and coercion. This methodology is not “snowball sampling.” There is no waiver for this type of recruitment.

Question 2

Question	Which example of research with prisoners would be allowable under the regulations?
Your answer	Examining the use of financial incentives to improve compliance with dentist appointments.
Result	Incorrect
Correct Answer	Examining age at first arrest as a predictor of adult criminal history.
Comment	Examining age at first arrest is the correct answer. This reason for conducting research falls under the first category, “Study of the possible causes, effects, and processes of incarceration, and of criminal behavior.” Working with de-identified data, this study would be minimal risk – there is no intervention and the confidentiality risk is low. None of the other answers fall within one of the categories of allowable research. While these other studies have possible merit, there is no acceptable rationale for including prisoners. There is no benefit to the prisoners as individuals or as a group.

Question 3

Question	A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by an interview. The IRB must ensure that:
Your answer	Confidentiality of the prisoners' health status is maintained.
Result	Correct
Comment	By participating in the research, it is possible that subjects will become publicly identified as HIV-positive. This breach of confidentiality could lead to negative consequences for the prisoner. One method for the investigator to preserve this confidentiality is to interview a larger sample of offenders, some of whom are HIV-positive and some who are not. While the survey should be validated and reliable, it does not have to be standardized. Because the research is behavioral only, there is no need for a medical doctor. The prison's HIV testing procedures are not part of the study.

Question 4

Question	Which of the following statements about prison research is true?
Your answer	The regulations prohibit compensating prisoners.
Result	Incorrect
Correct Answer	Researchers may study the effects of privilege upgrades awarded by the prison.
Comment	Because studies of the effects of processes of incarceration are allowed under the regulations, researchers may study the effects of privilege upgrades awarded by the prison. The regulations do not prohibit payment of prisoners for their participation. However, the amount of compensation cannot constitute undue influence to participate. Many correctional institutions may prohibit payment. The decision to participate in research may not be considered during parole hearings, as this practice would clearly constitute undue influence to participate. The regulations require that IRBs determine that risks involved in research with prisoners are commensurate with risks that would be accepted by non-prison volunteers.

Question 5

Question	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:
Your answer	Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
Result	Correct
Comment	This population is considered doubly vulnerable due to their age and status as prisoners. Both subparts need to be carefully considered. There is no in loco parentis status for prisoners. Having a warden give consent would violate the basic tenets of informed consent. The regulations also prohibit the involvement of staff in prisoner selection for research. Parental signatures are not required.

Research with Prisoners - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	Which example of research with prisoners would be allowable under the regulations?
Your answer	Examining age at first arrest as a predictor of adult criminal history.
Result	Correct
Comment	Examining age at first arrest is the correct answer. This reason for conducting research falls under the first category, “Study of the possible causes, effects, and processes of incarceration, and of criminal behavior.” Working with de-identified data, this study would be minimal risk – there is no intervention and the confidentiality risk is low. None of the other answers fall within one of the categories of allowable research. While these other studies have possible merit, there is no acceptable rationale for including prisoners. There is no benefit to the prisoners as individuals or as a group.

Question 2

Question	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:
Your answer	Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
Result	Correct
Comment	This population is considered doubly vulnerable due to their age and status as prisoners. Both subparts need to be carefully considered. There is no in loco parentis status for prisoners. Having a warden give consent would violate the basic tenets of informed consent. The regulations also prohibit the involvement of staff in prisoner selection for research. Parental signatures are not required.

Question 3

Question	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, which the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
Your answer	Not an excessive incentive.
Result	Correct
Comment	Mothers who may have recently separated from their children may find the prospect of doing something special for their children more important than making a considered decision about becoming a research subject. Thus the toys may be an undue influence to participate. The issue of the toys being educational, of high quality, and age appropriate are not the focus of the study. The IRB focus needs to be on any undue influence on the women.

Question 4

Question	A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by an interview. The IRB must ensure that:
Your answer	Confidentiality of the prisoners' health status is maintained.
Result	Correct
Comment	By participating in the research, it is possible that subjects will become publicly identified as HIV-positive. This breach of confidentiality could lead to negative consequences for the prisoner. One method for the investigator to preserve this confidentiality is to interview a larger sample of offenders, some of whom are HIV-positive and some who are not. While the survey should be validated and reliable, it does not have to be standardized. Because the research is behavioral only, there is no need for a medical doctor. The prison's HIV testing procedures are not part of the study.

Question 5

Question	Which of the following statements about prison research is true?
Your answer	Researchers may study the effects of privilege upgrades awarded by the prison.
Result	Correct
Comment	Because studies of the effects of processes of incarceration are allowed under the regulations, researchers may study the effects of privilege upgrades awarded by the prison. The regulations do not prohibit payment of prisoners for their participation. However, the amount of compensation cannot constitute undue influence to participate. Many correctional institutions may prohibit payment. The decision to participate in research may not be considered during parole hearings, as this practice would clearly constitute undue influence to participate. The regulations require that IRBs determine that risks involved in research with prisoners are commensurate with risks that would be accepted by non-prison volunteers.

Research with Children - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
Your answer	All research funded by HHS
Result	Correct
Comment	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.

Question 2

Question	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.
Your answer	True
Result	Correct
Comment	The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children.

Question 3

Question	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?
Your answer	The research must pose no more than minimal risk.
Result	Correct
Comment	One of the four criteria for waiving parental permission is that the research must pose no more than minimal risk. Although it may be appropriate to notify parents that the study is taking place, and many researchers do so, it is not required by the regulations when a waiver of parental permission has been approved. While children must provide assent to participate, depending upon the age of the children there are multiple strategies for accommodating children who do not want to participate other than alternate classroom activities. It is not required that an independent consultant approve waivers of parental permission.

Question 4

Question	According to Subpart D, research with children may be eligible for exemption under Category 2 when:
Your answer	The research involves the use of educational tests
Result	Correct
Comment	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.

Question 5

Question	According to federal regulations, “children” are defined as:
Your answer	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.
Result	Correct
Comment	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.

Research in Public Elementary and Secondary Schools - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	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)?
Your answer	Research about aptitude testing
Result	Correct
Comment	Subpart D, Additional HHS Protections for Children, specifically prohibits the use of exemption for research involving survey procedures, interview procedures, or participant observation when the researcher participates in the activities being observed.

Question 2

Question	In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:
Your answer	FERPA, PPRA, and Subpart D of the federal regulations
Result	Correct
Comment	FERPA, PPRA, and Subpart D of the federal regulations also govern research in the public schools.

Question 3

Question	If research in a private school is directly funded by the Department of Education, then:
Your answer	PPRA applies.
Result	Correct
Comment	If research in a private school is directly funded by the Department of Education, PPRA applies, regardless of the risk level of the research (more than minimal or no more than minimal). A private school that does not receive any federal funding is not subject to the provisions of FERPA or PPRA.

Question 4

Question	Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?
Your answer	Directory information.
Result	Correct
Comment	Schools may disclose, without consent, directory information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students that directory information is not protected, and they must allow parents and eligible students a reasonable amount of time to request that the school not disclose directory information about them. FERPA allows schools to disclose identifiable records without permission to certain parties, including organizations conducting research initiated by a school district or a state department of public instruction.

Question 5

Question	PPRA gives parents some level of control over their child’s:
Your answer	Participation in third-party survey research or exposure to instructional materials developed by researchers
Result	Correct
Comment	PPRA gives parents some level of control over their child's participation in third-party survey research or exposure to instructional materials developed by researchers. FERPA gives parents certain rights with respect to their children's educational records. The ability to opt out of health education would be an institutional, local or state law, and is not covered in this module about research. The access to medical records would be covered under Health Insurance Portability and Accountability Act (HIPAA) and is not covered in this module as it does not relate to research in public schools.

International Research - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?
Your answer	If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
Result	Correct
Comment	A great deal of research in the social and behavioral sciences may qualify for exemption, depending upon institutional policy. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Federal regulations do not require exempt research to be reviewed by an institution’s IRB or an institutional official – those decisions are left to institutional policy.

Question 2

Question	What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
Your answer	In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
Result	Correct
Comment	The points to consider when obtaining informed consent in non-U.S. settings include in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Sometimes, in non-U.S. communities, people other than the individual taking part in the research may be required to give permission before the potential subject may be asked to participate. These individuals may include a spouse, a head of household, or a group leader. However, another individual's permission should not substitute for a subject's voluntary informed consent unless an IRB or equivalent local review committee has waived that consent process. The witness signature line is an issue in documentation of informed consent; ensuring that the consent process does not slow down recruitment is an issue in study design and not a non-U.S. setting specific issue; and maintaining confidentiality is a privacy/confidentiality issue.

Question 3

Question	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 availability 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?
Your answer	No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.
Result	Correct
Comment	No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. An institution is not engaged if its only involvement is to provide space for the U.S. researchers to conduct their own research.

Question 4

Question	Which of the following activities constitutes engagement in research?
Your answer	Obtaining informed consent and conducting research interviews.
Result	Correct
Comment	If an institution obtains informed consent and conducts research interviews it is engaged in research.

Question 5

Question	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?
Your answer	Will the researchers have collaborators at the research site abroad?
Result	Correct
Comment	There are several factors that determine what kinds of review are needed for international research, including if the researchers have collaborators at the research site abroad. If international research is carried out without the involvement of foreign collaborators the research may be reviewed by the researcher’s home institution. The need for local review will be determined by policies and regulations rather than by U.S. law. When U.S. researchers collaborate with researchers at foreign institutions, determining the appropriate review type and method depends on whether the collaborating institution is engaged in the research. The other responses are incorrect because they do not help the IRB determine where the research should be reviewed.

Internet-Based Research - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 4 of 5 quiz questions.

Question 1

Question	Revelations about the Facebook Emotional Contagion study highlights what key ethical consideration to conducting research using social media?
Your answer	Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites’ terms of use.
Result	Correct
Comment	The researchers who carried out the emotional contagion study did not secure individual consent from the 700,000 Facebook used whose news feed they manipulated. Instead, they relied on language in the terms of use Facebook users agreed to (“analysis, testing, [and] research”) as a means to argue they did not need to consent each individual. Participants did not realize by agreeing to be a Facebook user, they had agreed to let Facebook use them and their information for research purposes without their consent.

Question 2

Question	Researchers designing online studies should consider the following with respect to participant protections.
Your answer	There is no one, right way to secure informed consent online.
Result	Incorrect
Correct Answer	Re-identification methods are unique to internet-based research.
Comment	One of the biggest risk of harm to subjects taking part in social and behavioral sciences research is the inadvertent disclosure of private identifiable information that could damage their reputations, employability, insurability, or subject them to criminal or civil liability. In most internet-based research, the primary risk of harm is loss of confidentiality. Because re-identification methods are unique to internet-based researchers, researchers need to carefully consider how to best ensure participant protections when designing online studies.

Question 3

Question	What consideration should researchers take into account when designing an online study that presents participants with misleading information?
Your answer	Researchers cannot guarantee that participants reached the end of the study, and read and understood the debrief.
Result	Correct
Comment	Incorporating a funneled debriefing process followed by an actual debriefing script could mitigate any potential harms stemming from presenting participants with false information. However, participants will only be presented with this information if they fully complete the study, arrive at the debriefing state, and read it. Because online research involves little-to-no contact interaction between researcher and participants, there is no guarantee a participant has been told which information was true and which was false.

Question 4

Question	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:
Your answer	Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Result	Correct
Comment	Information posted on-line could, conceivably, be accessible to anyone with an internet connection. However, people may post their private identifiable information on-line without the intention of this information being public. Private identifiable information that can be accessible to anyone can create the potential for several different risks of harm to subjects who may not be aware that their information is public. Assuming a pseudonymous on-line identity does not pose any risks of harm to subjects. Though it is true that researchers can recruit, consent and debrief subjects on-line with little to no-interaction, this in of itself, would also not pose any risks of harm to subjects. Similarly, waiving the documentation of consent does not pose any potential risks of harm to subjects, and is not unique to internet-based research.

Question 5

Question	Which of the following methods could be considered a “best practice” in terms of informing respondents how their answers to an on-line survey about personal information will be protected?
Your answer	The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.
Result	Correct
Comment	Although there are no guaranteed methods to assure absolute confidentiality of research data collected on-line, some internet-based research experts have identified “best practices” for describing commonly accepted confidentiality protections, such as including explanations about how data are transmitted from the subject to the investigator, how the investigator will maintain and secure the data. Consent processes should also include a discussion to emphasize that there is no way to guarantee absolute confidentiality if data are of a personal or sensitive nature.

Internet-Based Research - SBE

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 4 of 5 quiz questions.

Question 1

Question	Revelations about the Facebook Emotional Contagion study highlights what key ethical consideration to conducting research using social media?
Your answer	Users of social media sites, like Facebook, may not fully understand all of the terms to which they are agreeing to when accepting a sites’ terms of use.
Result	Correct
Comment	The researchers who carried out the emotional contagion study did not secure individual consent from the 700,000 Facebook used whose news feed they manipulated. Instead, they relied on language in the terms of use Facebook users agreed to (“analysis, testing, [and] research”) as a means to argue they did not need to consent each individual. Participants did not realize by agreeing to be a Facebook user, they had agreed to let Facebook use them and their information for research purposes without their consent.

Question 2

Question	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:
Your answer	Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Result	Correct
Comment	Information posted on-line could, conceivably, be accessible to anyone with an internet connection. However, people may post their private identifiable information on-line without the intention of this information being public. Private identifiable information that can be accessible to anyone can create the potential for several different risks of harm to subjects who may not be aware that their information is public. Assuming a pseudonymous on-line identity does not pose any risks of harm to subjects. Though it is true that researchers can recruit, consent and debrief subjects on-line with little to no-interaction, this in of itself, would also not pose any risks of harm to subjects. Similarly, waiving the documentation of consent does not pose any potential risks of harm to subjects, and is not unique to internet-based research.

Question 3

Question	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?
Your answer	Designing the survey so that subjects are not forced to answer one question before going to the next.
Result	Correct
Comment	Voluntary participation in research includes the right to withdraw from a study at any time and the right to choose not to answer questions. On-line surveys that force subjects to answer one question before going to the next violate the requirement that all participation in research be voluntary. Providing contact information for the researcher, privacy policies, and description of the survey are important, but they do not address the requirement.

Question 4

Question	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?
Your answer	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.
Result	Incorrect
Correct Answer	A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Comment	The study in which the researcher pretends to be a cancer survivor involves deception and research without any informed consent process. Therefore, the study raises concerns about the ethical principle of respect for persons. Any compromise of the principle should be justified by any scientific benefit to be derived from the study. When a support group or a blog is open to any and all readers, it can be argued that the communications posted are not intended to be private and can therefore be observed and recorded without informed consent. The researcher studying interracial adoptees used the internet in a manner comparable to posting a flyer on a bulletin board.

Question 5

Question	To minimize potential risks of harm, a researcher conducting an on-line survey can:
Your answer	Design the survey so that no direct or indirect identifiers are collected.
Result	Correct
Comment	In most internet-based research, the primary risk of harm is a breach of confidentiality. A simple way to help maintain the confidentiality of a subjects’ identity is not to collect direct or indirect identifiers. Suggesting to subjects that they should print a copy of the informed consent form does not protect them from an inadvertent breach of identifiable responses. Similarly, complying with the Terms of Service does not protect against a breach. Specifying that all subjects be of legal adult age does not ensure compliance.

Unanticipated Problems and Reporting Requirements in Social and Behavioral Research

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	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?
Your answer	Promptly
Result	Correct
Comment	OHRP guidance (2007) states that the federal regulations do not specify a timeframe for reporting, except to say this must be done "promptly." For a more serious incident, this may mean reporting to the IRB within days. For a less serious incident, a few weeks may be sufficient. Researchers should check with their local IRB to determine their institution’s procedures.

Question 2

Question	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 was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB?
Your answer	No, this does not need to be reported because it is unrelated to participation in the study.
Result	Correct
Comment	An unanticipated problem, in keeping with OHRP’s guidance, is unexpected, related or possibly related to the research, and puts subjects or others at greater risk of harm. What matters here is that the heart attack was not related to the focus group research and does not meet reporting criteria.

Question 3

Question	According to OHRP, a problem is an “unanticipated problem” when it meets which of the following criteria:
Your answer	Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk
Result	Correct
Comment

Question 4

Question	Researchers must report potential unanticipated problems that involve risks to others directly to the:
Your answer	Institutional Review Board (IRB)
Result	Correct
Comment

Question 5

Question	The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
Your answer	Determined by the institution in its written policies and procedures
Result	Correct
Comment

Populations in Research Requiring Additional Considerations and/or Protections

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 4 of 5 quiz questions.

Question 1

Question	When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Your answer	Is there a power differential between researchers and subjects?
Result	Correct
Comment	IRBs should assess if there is a power differential and if it would affect the potential subjects, making them vulnerable to coercion. According to the module authors, it is important for IRBs to ask researchers to fully describe the population to be studied and the situations in which the potential research subjects find themselves. This should answer both the question about the intrinsic factors or attributes as well as the situational forces that may give rise to different types of vulnerability. The other responses should also be considered by the IRB during their review of the research, but do not relate to identifying if the subject population is vulnerable.

Question 2

Question	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:
Your answer	Economic vulnerability
Result	Correct
Comment	Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Participation in research offers the possibility of payment or attainment of healthcare or other services that are otherwise not available, and induce persons to enroll in a research study when it might be against their better judgment and when otherwise they would not do so. These inducements to enroll threaten the voluntary nature of consent and raise the danger of exploitation. Prospective subjects who belong to undervalued social groups may be subject to social vulnerability. The perception of these groups as less valuable to society could lead to reduced concern (by researchers) for risks of harm and burdens on those groups, and increase the risk of exploitation. Prospective subjects in research who are subject to the formal authority of others may have an institutional vulnerability. These individuals have the cognitive capacity to consent but may not be able to make a truly voluntary choice, and may be unduly influenced (or coerced) to participate when they otherwise might not have done so. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a cognitive or communicative vulnerability.

Question 3

Question	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:
Your answer	Cognitive or communicative vulnerability
Result	Correct
Comment	Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a cognitive or communicative vulnerability.

Question 4

Question	Which is true of inducements in research?
Your answer	Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
Result	Correct
Comment	Inducements are offers that influence people to make decisions, or do things they would not otherwise do. Inducements and the influence they cause may be acceptable, or they may be “undue,” and the distinction is not always clear or universally agreed upon. Offering $10 may be acceptable for an hour-long research study; offering $1000, or a better grade in a class, is probably not appropriate. In general, inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes such that they do not appropriately consider the risk-benefit relationship of the research.

Question 5

Question	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:
Your answer	Therapeutic misconception
Result	Incorrect
Correct Answer	Medical vulnerability
Comment	Medical vulnerability arises when prospective subjects have serious health conditions for which there are no satisfactory standard treatments. Subjects with serious health problems may not be able to adequately weigh the risks and potential benefits of the research. Subjects are at risk of exploitation because they may overestimate potential benefit. Deferential vulnerability is similar to institutional vulnerability, but the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Therapeutic misconception occurs when subjects blur the roles played by physician-researchers and fail to appreciate the difference between research and treatment.

Cultural Competence in Research

Belhaven University - Faculty Advisors, Graduate Students and Researchers

Quiz Results

You correctly answered 5 of 5 quiz questions.

Question 1

Question	Cultural competence in research is defined as the ability of researchers to provide high quality research that takes into account:
Your answer	The diversity of population’s values, beliefs and behaviors when developing research ideas, conducting research and exploring applicability of their findings.
Result	Correct
Comment	Cultural competence in research is the ability of researchers to provide high quality research that takes into account the culture and diversity of a population when developing, conducting and interpreting research findings. Cultural competence in research plays a critical role in study design and implementation processes, including the development of research questions and hypotheses, outreach and recruitment strategies, consent activities, data collection protocols, analyzing and interpreting research findings, and drawing conclusions. Altogether, cultural congruence in these research processes helps to ensure the research is applicable to diverse populations and if necessary can be adapted to meet the target population’s social, cultural and linguistic needs.

Question 2

Question	Trust and transparency are critical to successful and culturally competent research. In the research setting, establishing trust in diverse communities does NOT require:
Your answer	Limiting public transparency and accountability
Result	Correct
Comment	When conducting research with diverse communities, involving community members in decisions about key aspects of the research, promoting feelings of ownership within the community, maintaining public accountability and transparency, and assuring appropriate ethics oversight creates trust in study participants. Diverse populations more easily adopt interventions that were developed in research in which they may have participated, developed trust through transparency and was aligned as closely as possible to prevailing cultural factors.

Question 3

Question	In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research developed ethical principles and guidelines for the protection of human subjects for research. The purpose of these guidelines was to:
Your answer	Provide a framework for use in the resolution of ethical problems arising from research involving human subjects.
Result	Correct
Comment	The three principles, as outlined in the Belmont Report, require culturally competent research-related interactions with study participants: First, respect for persons requires researchers to assure autonomy and protect those with diminished autonomy. Second, beneficence requires favorably balancing physical, emotional, economic, stigmatization, and confidentiality risks and potential benefits of research participation. Risks and benefits differ according to multiple factors and circumstances that vary widely across diverse communities, and minority populations may be more vulnerable to risks. Third, justice for the individual requires fair recruitment practices. Disadvantaged groups should be protected from being asked to participate in research for convenience or socioeconomic status.

Question 4

Question	Overcoming challenges to cultural competence in research requires that: (Check ALL that apply)
Your answers	- Investigators examine and understand historical contexts for study populations before initiating research study design. - Early-phase study design should take into account race, ethnicity and cultural factors. - IRB membership should include representatives of large communities and cultural groups as representatives.
Result	Correct
Comment	Some research may not hold immediate clinical relevance or application to practice, but such studies lay the scientific foundation for research that develops treatments or directly influences health interventions. It is important that early-phase studies build an understanding of, and take into account, differences that can be attributed to race, gender, age, and other cultural factors. Engaging diverse communities in research requires building trust and, as importantly, understanding, that can only be developed over time. Inclusion of diverse study participants should occur early in the study development process to increase cultural congruence of study methods and likelihood of success in study recruitment and retention.

Question 5

Question	NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. This inclusion is to ensure that:
Your answer	Valid analyses of differences in intervention effects can be accomplished.
Result	Correct
Comment	In 1994, the National Institutes of Health (NIH) established policy for the inclusion of women, children, and members of minority groups and their subpopulations in biomedical and behavioral clinical studies. Public Law 103-43 requires that women and minority subjects “be included in all clinical research studies, as appropriate for the scientific goals of the work proposed.” The goal is to ensure that minority individuals are included in clinical trials “in numbers adequate to allow for valid analyses of gender and/or racial/ethnic differences in intervention effects.”