Reference no: EM131556453

Health care ethics and medical law Required Response to Option 1:

In a substantive post, explain why you agree or disagree with your colleague's discussion as to whether the determination was right or wrong. Provide additional supportive evidence as to your agreement or disagreement. Your responses should be at least 100 words.

IRB Case: An ethnographic study of homeless adolescents

Type of Institution: Large Academic Institution

Type of IRB: Social/Behavioral IRB

Type of Case: Ethical/Regulatory

Author: Associate Director of Research Compliance From the Editors:

The planning and implementation of sociological research involving transient populations is often extremely challenging for investigators and mandates the adoption of creative approaches to recruitment, safety, consenting and data management. IRB's must concomitantly seek the correct balance between strict adherence to and reasonable alterations from the Common Rule, to enable conduct of research that is both safe for participants as well as scientifically valid.

This case demonstrates several important ethical, legal and regulatory concerns that must be managed jointly by the IRB and the investigators in order for research to properly take place. Background In cities throughout the United States, one can readily find groups of homeless adolescents and young adults who congregate on city squares and greens. Often these youth have been victims of abuse in their homes and thus frequently exhibit a variety of emotional and physical problems including depression, substance abuse, and violence.

Much research is currently being conducted to explore both the causes of youth homelessness as well as interventions aimed at re-integrating these individuals into society. It is vitally important in constructing therapeutic interventions to more fully understand how and why these youth became homeless and how they cope with their circumstances.

Study Design A Ph.D. candidate in Sociology proposed to study the environmental culture and organizational strategies of homeless youth and young adults who congregate in a particular city square in a major urban center located in the Northeastern United States. The study planned to conduct 30 semi-structured, open-ended interviews which were to be audiotaped. The researcher also planned for ten participants to keep a journal of their daily activities for a period of two weeks and upon completion, the journals would be collected by the investigator for use in his analysis.

Recruitment The investigator intended to recruit these youths by directly approaching them in the city square, describing the research and asking if they would be willing to participate in the study. Consent The investigator proposed to waive signed informed consent and sought to obtain verbal consent after description of the study and provision of an information sheet describing the details of the study and some of the essential elements of informed consent.

There were no plans to compensate study participants in any way. Ethical/Regulatory Issues Three ethical, legal and regulatory issues arose during IRB review of this proposal.

How would the investigator adequately obtain informed consent from minors? The title of the project indicated the investigator planned to study adolescents yet throughout the protocol, he indicated that only those youth over the age of 17 would be eligible for enrollment.

It was unclear to the IRB why he planned to recruit only those youth over 17 years of age, and what method would be used to verify participants' ages. As part of the presentation to the IRB, the researcher expressed concern that the IRB would not approve the study if he sought to enroll participants under the age of 18 because of the inability to secure parental permission for study participation.

The only possible mechanism to verify a participant's age in this study was self-report, as this population frequently does not possess drivers' licenses or other common forms of identification.

Additionally, the researcher voiced fears that asking for some form of identification from these youths would likely created distrust and constitute a dis-incentive for study participation.

IRB Decision: Since subjects were to be asked to self-report their age and the researcher possessed no easy and effective approach to verify their ages, the IRB determined it most appropriate to waive the requirement to obtain permission from the parents/guardians as per 45 CFR 46.408(c).

They agreed that the research was designed for conditions and for a subject population for which parental or guardian permission was not a reasonable requirement to protect the study subjects. The IRB also determined that the use of verbal consent in conjunction with an information sheet was an appropriate mechanism for protecting this population and was not inconsistent with federal, state or local law.

They also expressed concern that use of a signed informed consent would likely be the only record linking the subject with the research and might potentially harm subjects secondary to a breach of confidentiality. After discussing these various considerations, the IRB decided it was appropriate to approve a waiver of signed consent as per 45 CFR 46.117(c)

(1). Each subject would be asked, however, whether he/she desired documentation of study participation and if so, written informed consent would be obtained with a copy provided to the subject.

What were the potential risks to these youth from study participation? Were there also possible risks to the researcher during the conduct of the study?

Concerns were raised regarding whether approaching homeless youths in view of others in the public square might be misinterpreted. Some might mistake the researcher for the police or other type of official which could potentially place the participant at risk for social or physical harm due to being ostracized from the group secondary to involvement with perceived official-looking persons. Such misinterpretations might also endanger the investigator given the propensity for these adolescents to not readily trust adults given their past experiences. They may also suffer from various forms of mental illness and substance abuse, may have been victims of violence, or have violent tendencies themselves.

The researcher was also not completely clear how and where the interviews would take place and how a secure, private environment could be assured. In addition to the direct audiotaped interviews, the study involved completion of a daily activities journal for two weeks for 10 of the 30 youths enrolled in the project, including documentation of their thoughts and feelings about being homeless and some description of their day-to-day experiences.

Given the intensely private nature of these journals, the IRB expressed concern about how the privacy and confidentiality of these journals could be established and maintained.

IRB Decision: The researcher informed the IRB of his prior informal contacts with this population which had been the main stimulus for the research. He noted his familiarity with the location and informed the IRB that this particular public square generally had heavy pedestrian traffic and a strong police presence thereby creating an environment considered to be reasonably safe for both participants and the researcher.

At the insistence of the IRB, the investigator revised the exclusion criteria to exclude prospective participants whom he considered were either possibly under the influence of drugs or alcohol or whose behavior was sufficiently ambiguous to prevent the researcher from obtaining a reasonable level of comfort for his safety. To safeguard the prospective participants, the investigator planned to approach only groups of youths rather than individuals thereby reducing the likelihood of being mistaken for a law enforcement officer or other official who might engender mistrust in these youths. He planned to conduct interviews at a location adjacent to but off the square, in a public but quiet location to optimally protect participants' privacy.

Given the student's familiarity with the location, the IRB considered him well suited to locating appropriate places where the interviews could be conducted in a reasonably discreet manner, affording as much privacy and confidentiality as is possible in such an environment. The IRB determined that the researcher's knowledge of the population and the location minimized the potential for harm to either subjects or the investigator.

They also felt that the social risk to the participants, such as the potential to be ostracized, were adequately addressed in the investigator's plan to approach the participants as a group rather than individually, to ensure that his presence would not be misunderstood. The IRB was satisfied that the potential physical risks to the participants and researcher had been considered and managed.

The researcher had an adequate plan to secure the audiotapes, and to destroy them at the completion of the study. No identifiers would be recorded. The data collected in the written journals was of concern because it was unclear how the participants could maintain confidentiality for the two-week period due to their living circumstances. The participant was provided the option of returning the journal at any time to the researcher in person at a mutually agreed upon time and place, or to return it by mail in a pre-stamped envelope.

The IRB determined that because the journal was an optional component of the research and participants were able to refuse to participate in this part of the study or terminate it as desired, it was felt to be acceptable for this part of the project to be retained in the research. The researcher was forbidden, however, to record any identifiers in either the interviews or the journals and was required to destroy the tapes and journals at the completion of the study.

What were the statutory obligations of the researcher in reporting cases of child abuse and neglect? What were his ethical obligations to the study participants should he discover evidence of abuse, problems with drug and alcohol use or significant mental illness?

Research conducted out of state requires knowledge of and adherence to state regulations of the state in which the research is being conducted. The researcher proposed to conduct his research in another state and the reporting requirements for that state were unclear to the IRB.

For instance, because the target population has a high rate of drug and alcohol abuse and members of this population are at an increased risk of being victims of crime, what was the investigator's responsibility to report crimes discovered during the course of the research? What if he discovered a minor runaway or evidence of child abuse or neglect?

Some states mandate anyone aware of cases of abuse report them to the proper authorities. Others only require medical providers and social workers report such cases.

More than the issue of reporting, what ethical responsibilities are incumbent upon the researcher should he discover youth who would likely benefit from medical care, mental health services, treatment for drug and alcohol abuse, and other services?

What should the IRB require of the investigator should he identify youth at imminent risk of suicide, sexual violence or bodily injury or death?

IRB Decision: The IRB asked the investigator to confirm the reporting requirements for the state in which the research was to be conducted and also independently verified the state statutes as well.

The state did have a child protection law that required doctors, social workers and other licensed providers to report suspected cases of child abuse or neglect but the reporting requirements did not apply to the researcher.

This obviated the investigator from obtaining identified information from participants that would be needed to report cases of abuse. It also removed any legal reporting responsibility thereby likely enhancing prospective subjects' comfort with study participation since they could be informed that the investigator was not a mandatory reporter.

The interview questions were highly personal in nature and were intended to elicit information that might include certain kinds of illegal activities such as drug abuse. The research was structured purely as a qualitative and observational approach to improving the understanding of the complex set of issues faced by these homeless adolescents. It thus excluded any interventional component such as encouraging participants to seek help for their mental illness or substance abuse or directly connecting them with programs or services.

While the researcher was prepared to provide participants with publicly available information on how and where to access help for drug and alcohol abuse, housing, and other problems routinely faced by these adolescents, he intended to offer such information only if requested by the participant. The investigator did agree with the IRB of the need to report to the authorities any concerns of risk of imminent harm to participants or to himself.

Given the inclusion of these safeguards, the IRB approved the research.

Respond to Ashley Ashley Anderson

Manage Discussion Entry For this week's discussion I was given option one: Internal Review Board case studies.

After reviewing the case studies

IRB Case: An ethnographic study of homeless adolescents. This case study was presented to the IRB to explore the case of homelessness among youth and interventions available to re-integrate them into society. The study proposed that the researcher "Conduct 30 semi-structured, open-ended interviews which were to be audiotaped" (Associate Director of Research Compliance, 2017).

I believe that the IRB decisions where right in all points proposed. The first decision the IRB had to make was how to obtain informed consents from the individuals participating in the study. They made the choice to use verbal consent which "still contains all elements of written consent; however, the participant is verbally read the elements and verbally agrees to participate" ( Nijhawan, & Janodia, 2013).

Using this method along with providing them with an information sheet I believe was the best option due to the fact that this demographic has little to no parental interaction and it would be difficult to require an informed consent which, "the subject must be 18 years if age and competent to make the decision to participate" ( Nijhawan, & Janodia, 2013).

The next point the IRB had to address was the risk factors and confidentiality for the researcher and the youth participating in the study. Again I believe the IRB evaluated the risks and their decision was made that the researcher assessed the risk and proposed an appropriate plan.

The researches plan was to approach youth only in groups, never to approach anyone who was visibly intoxicated or under the influence and only conducting his research in the public square he was familiar with. This study is asking very sensitive information from the youth participating. "To enhance the likelihood that they will honestly disclose information, a promise of confidentiality may be required" (Hiriscau, Stingelin-Giles, Stadler, Schmeck & Reiter-Theil, 2014).

To provide as much confidentiality and privacy the interviews will be conducted in discreet manner and the audiotapes will be destroyed at the end of the study and no identifiers would be recorded to provide as much privacy as possible.

The final point was one addressing the obligations of the researcher in regards to reporting mental illness, sexual abuse, runaways, risk of suicide, bodily injury, drug abuse or alcohol abuse.

The IRBs decision was that the researcher was not a mandatory reporter but they needed to "report to the authorities any concerns of risk of imminent harm to participants or to himself" (Associate Director of Research Compliance, 2017).

Also upon request the research had information on accessing treatment and help for drug and alcohol abuse.