SCHOOL-BASED CURRICULUM RESEARCH
An investigator proposes to evaluate the effectiveness of a new type of curriculum that uses Hispanic and African folk tales to teach grammar in a public high school serving black and Hispanic youth from an economically depressed neighborhood. The investigator developed the curriculum in collaboration with teachers at the school. Curriculum evaluations will be conducted every 3 months utilizing standardized English grammar tests and a standardized test of self-esteem. Test scores of students taking the new curriculum will be compared to the test scores of students in the same school taught the traditional grammar curriculum. The investigator proposes that under federal guidelines CFR Title 45 Part 46 Protection of Human Subjects, the research is eligible for exemption from IRB review.
1. What factors must the IRB chair take into account in considering her proposal?
2. Is the research "Institutionally sponsored"?
3. Does the research "involve risk to human subjects?"
4. Does the research involve "more than minimal risk?"
5. Isthe research restricted to the evaluation of instructional strategies?
6. Are these research activities eligible for expedited review?
7. How would the IRB determine whether the anticipated risks were reasonable with relation to anticipated benefits?
8. How would the IRB determine whether the selection of subjects was equitable?
9. How would the IRB determine whether the student privacy and confidentiality were adequately protected?
10. Should informed consent/parental permission be required for students to participate in either the "experimental" or standard grammar
11. What suggestions if any would the IRB Report of Action to the investigator include?
TREATMENT OF ANXIETY IN CHRONICALLY ILL ELDERS
An investigator proposes to study the effectiveness of a new visual imaging treatment for impoverished, Hispanic elderly residents with chronic illness who have been diagnosed with anxiety disorder, and who, due to their illness cannot take standard anti-anxiety medications. For these patients, the out-patient clinic of a local city hospital has been offering a cognitive therapy technique that was found to be effective in a national multi-site study on anxiety treatments in healthy adults. The investigator argues that many Hispanic chronically ill older adults suffering from anxiety do not stay in cognitive therapy long enough for it to be effective because it is time-consuming and because patients are often not fluent enough in English to benefit from the treatment. Individual case reports from clinicians around the country who have begun to use the new visual imaging technique with younger adults, report that symptoms of anxiety are dramatically reduced in one to two sessions. Participants will be recruited through hospital staff when they come to the clinic for either physical or mental health services. The experimental and standard treatments will be conducted by hospital staff trained by the investigator. The investigator proposes to compare patient retention and effectiveness of the new treatment to an out-patient control group receiving the standard cognitive therapy.
What factors should the IRB consider when evaluating whether it is ethically justified to assign subjects to either the treatment or control condition?
1. Is the scientific design adequate to determine if the treatment is effective?
2. Does an empirically validated standard treatment already exist for this population?
3. Does the length of the study or the severity of the disorder/problem under investigation place either the treatment or control group subject at greater than minimal risk?
4. Does the investigator serve a dual role that may pose a conflict of interest?
5. Are those selected to implement the interventions competent to do so?
6. Are the criteria for which community members will be included or excluded for study participation scientifically and clinically appropriate?
7. What are the risks and remedies to insuring that subject recruitment is not coercive?
8. What are the special risks, benefits, and conditions associated with RCT research for which prospective participants must be informed? Are prospective participants adequately informed about random assignment and that one of the possible consequences of participation is that the group to which they are assigned will turn out to have received the less effective intervention? Does the participant understand thedifference between treatment and research?
9. What steps should the investigator take to insure that participants comprehend the informed consent material?
10. Does the protocol provide for adequate monitoring of subjects for adverse reactions? Are provisions made for early termination? What monitoring conditions have been put into effect to protect the safety of treatment and control group subjects. Have criteria for clinical risk and removal of subject from study beendefined?
11. How will conflicts regarding subject termination in a project among service providers, subjects, guardians, or scientists be resolved?
12. Are referrals available for subjects who refuse to participate or who are removed from protocol?
13. Are criteria needed for when the study should be stopped or modified?
14. Is any socially sensitive information taken that might place a subject at social risk?
15. What procedures are necessary to protect participant confidentiality and privacy?
16. Will subjects be adequately debriefed?
17. If beneficial effect is demonstrated, does the control group have access to the experimental treatment?
PREVENTION OF PROBLEM BEHAVIORS ASSOCIATED WITH TRAUMATIC LOSS
A group of researchers from severalprofessional schools in the university propose to deliver a multi-service intervention they developed to children and adolescents living in an impoverished high crime district who have suffered traumatic loss of a sibling as a result of gang violence. The intervention is aimed at preventing emotional, school, and behavioral problems associated with such trauma in youngsters not currently receiving social services. The 6-week intervention would be held at a local law clinic and consist of weekly support group sessions, assessment of social and legal services needs, and appropriate referrals conducted by doctoral students under the supervision of the faculty investigators. Participants would be recruited through newspaper announcements; flyers distributed in schools, churches, and community settings; and a community liaison. Half the participants would receive the intervention and half would be assigned to a no-treatment control group. The effectiveness of the treatment would be measured by psychological assessments, school reports, and police reports collected prior to and following the 6-week study.
Consider how each question would be viewed from the perspective of the investigator, the participant and his or her guardian(s), community members, treatment staff, and the IRB.
1. Has the investigator provided sufficient scientific or clinical background to support the potential efficacy of the new treatment?
2. Does an empirically validated standard treatment already exist for this population?
3. Does the length of the study or the severity of the disorder/problem under investigation place either the treatment or control group subject at greater risk?
4. Is the investigator able to demonstrate that the scientific design can determine if the treatment is effective?
5. What are the potential risks of not conducting this study?
6. Does the investigator serve a dual role that may pose a conflict of interest?
7. Are those selected to implement the interventions competent to do so?
8. Has the investigator selected scientifically and clinically appropriate criteria to equitably select which community members will be included or excluded for study participation?
9. Does the protocol provide for adequate monitoring of and referral for subjects with adverse reactions to either the treatment or control condition?
10. What are potential risks and what procedures are necessary to protect participant confidentiality and privacy?
11. If a beneficial effect is demonstrated, does the control group have access to the experimental treatment?
12. What forms of dissemination of research results could benefit or stigmatize the community?
PREVENTION PROGRAMS FOR SIBLINGS OF ASIAN YOUTH SLAIN IN GANG
University scientists propose to evaluate a school-based mental health prevention program for 12–15 year old male youth who have lost a sibling to gang violence. The school serves a poor, high crime district, of mostly Southeast Asian immigrants and their children. The State initiated the program following an increase in gang violence and neighborhood crime.
Participants are identified through police records of the sibling death and school referrals. Previous research indicates these youth are at high risk for depression, anti-social disorders, and criminal activity.
In the first year, youth attend a weekly support group focusing on trauma and anti-social behaviors. These sessions continue on a monthly basis in year 2. Youth also receive bi-yearly assessments of social and legal services needs and provided appropriate referrals.
To evaluate the efficacy of the program, the investigators recommend random assignment to either the treatment or a no-treatment control group. Participants in the control group would not receive any intervention or evaluation of social or legal service needs. However, they would be provided appropriate referral information on the basis of yearly assessments.
The effectiveness of the treatment compared to the control condition would be measured by yearly psychological assessments, school reports, and police reports.
Consider each issue from the perspective of the Investigator, IRB, Adolescents, Family Members, and Community Members.
1. Does the study length or severity of the disorder/problem place either the treatment or control group subjects at greater risk? How is this determined?
2. Is assignment to treatment and control conditions equitable?
3. Can the scientific design determine if the treatment is effective?
4. What are the individual, social, and scientific benefits of this study?
5. Does the protocol provide for adequate monitoring of and referral for subjects with adverse reactions to either the treatment or control condition?
6. What are potentialrisks and procedures necessary to protect participantconfidentiality?
7. What forms of dissemination of research results could benefit or stigmatize the community.
8. What unique ethical issues are raised by the ethnic/cultural background of the participants?
9. Are risks outweighed by potential benefits? What are the potential risks of not conducting this study?
DEVELOPMENTAL DIFFERENCES IN THE PSYCHOLOGICAL SEQUELAE OF RAPE TRAUMA
Researchers propose to study developmental differences in the psychological sequelae of rape traumato improve rape crises intervention services for minors at a local hospital. Participants will be 10–17 year old females admitted to the rape treatment clinic within 24 hours of a sexual attack.
A brief clinical interview would be conducted at the initial admission followed by a battery of psychological assessments one week later during aregularly scheduled medical follow-up visit.
In their human subjects application to the IRB, the researchers request a waiver of parental permission requirements for females aged 15–17 on the basis that state law allows the waiver of parental permission for medical treatment of sexually related disorders for this age group, that obtaining parental permission may not be possible during this 24 hour period if parents are not present or cannot be contacted, and that obtaining parental permission may violate the teenager's right to privacy and not be in her best interest.
For each question, consider the perspective of the Investigator, the IRB, the Parent, the Teenager, the Hospital Administrators, the Clinical Staff, and the Community.
1. What factors would determine whether a waiver of parental consent for older teenagers is or is not ethically justified?
2. What are the potential risks and benefits of this research for the individual participant and her community?
3. What are state laws and hospital policy regarding consent for emergency treatment of minor rape victims?
4. What special characteristics of the prospective participants and their community need to be considered (e.g., would differences in ethnic/cultural background or socioeconomic status influence ethical-decision making in this case)?
5. What additional protections would be required if a waiver of parental permission was granted for adolescents 15–17 years of age?
6. What measures should be taken to insure that consent of the adolescents and parental permission if required is informed, rational, and voluntary?
7. Does the investigator need to re-obtain consent during the second visit?
FACTORS INFLUENCING ADOLESCENT ALCOHOL BELIEFS AND BEHAVIORS
An investigator proposes to explore the influence of family, peers, and ethnic background on adolescents' beliefs about the effect of alcohol and their drinking practices. 6th and 8th graders from diverse ethnic and socioeconomic backgrounds will be asked to fill out written questionnaires containing questions on their drinking behavior, beliefs about alcohol and its effects, peer group and family drinking behavior. The students will take the questionnaire again when they are in 7th and 9th grades respectively.
Guardians will be informed by mail about the study purpose and procedures. They will also be told that the participation of their child in the project is completely voluntary. A stamped postcard will be included for parents to sign and return if they do not want their child to participate in the study. Students will also be informed that their participation is voluntary and that they may refuse to participate, discontinue participation at any point, or refuse to answer specific questions.
For each question, consider the perspective of the Investigator, the IRB, the Parent, the Teenager, the School, and the Community.
1. Have federal requirements for parental permission been met?
2. Do recruitment procedures ensure that participation is voluntary? Why or why not? If not, what procedures should be used?
3. What information needs to be provided to insure that consent is fully informed?
a) How should the purpose and nature of the research be described?
b) What potential risks need to be identified in the consent form?
c) What confidentiality procedures need to be described?
d) How should the investigator describe the potential benefits of the study?
e) How should the voluntary nature of the study be described?
4. Would the teen assent form differ from the parental permission form?
5. What population characteristics need to be considered to ensure that consent is rational?
6. Does the investigator need to re-obtain permission and assent during the second year wave of testing?
THE EFFECT OF EARLY INTERVENTION ON YOUTH VIOLENCE
In 1992, the National Institutes of Health sought to address the sharp escalation in violence among urban youth by sponsoring research to examine possible biological predispositions to violence and the effect of administrating psychopharmacological medications to children with Attention Deficit Hyperactivity Disorder that might prevent the development of violent behaviors associated with adolescent conduct disorders.
Many African Americans felt this federal initiative raised the specter or research with genocidal intent similar to how membersof their community viewed the Public Health Service supported infamous "Tuskegee Study." A storm of protest ultimately led to the cancellation of a NIH planned conference on genetic factors in crime.
What factors might haveled some to believe the NIH "Violence Initiative" was a product of institutional racism?
What factors might have led some to believe the NIH "Violence Initiative" was a product of institutionalracism?
Why was the reaction of the African American community to this research unanticipated?
Can the potential risks to individuals and ethnic communities be justified by the potential benefits of these studies?
Are there scientific and ethical procedures that can insure that such studies meet standards set by the principle of justice?
MATERNAL HISTORY OF ABUSE AND MALTREATED CHILDREN IN CHILD WELFARE AGENCIES
A state agency sends out a directive to all local child welfare agencies under its auspices to participate in data collection procedures to determine the history of child abuse experienced by mothers of maltreated children. The state agency considered the study a "needs assessment" to improve the statewide parent management training program in which mothers of maltreated children in welfare were required to participate.
A research team at one of the state universities was contracted to study this question usinginformation collected as part of the agencies' standard maternal interview. The interview includes questions about the mother's personal history with physical and sexual abuse, current sexual practices, and use of illegal substances. The research team leader citing CFR 46.101 (b) (4), requests that the IRB consider this research exempt from review because it draws upon existing data.
For each question, consider the perspective of the Investigator, the IRB, the Mothers, the State, the Agency Staff, and the Community.
1. Will the research use solely existing data?
2. Are the data publicly available?
3. Will the identity of the participants be available to the investigator?
4. Will others who read a report of the study be able to link subjects directly or indirectly to identifiers?
5. Is the research restricted to the needs assessment question?
6. Must the mothers have consented to this specific use of their interviews for it to be used for research purposes?
7. What are the potential risks and benefits of this study?
A study proposes to examine informal group formation and dissolution of alienated marginalized inner-city adult males in a Bronx park that is a popular hang out for drug users and dealers. In the first phase of the study the investigator plans to "hang out" in the park for a period of 2 months, taking extensive written notes on the timing and manner in which "social" groups are formed each day and the stability and variability of group membership and composition over time. The second part of the investigation requires participant observation. Based upon knowledge gained from his preliminary observations the ethnographer will attempt to informally join some of the social gatherings to acquire additional information on verbal and non-verbal social cues that are used to establish group membership and hierarchy. At no time will the investigator record the names of individuals or any physically identifying information. The investigator plans to disclose his investigatory role to the individuals he observes upon completion of data collection.
EVALUATING AN OUTPATIENT PROGRAM THERAPY INTERVENTION FOR SUICIDAL ADULTS
Researchers wanted to study the effect of a time limited group therapy outpatient interventionfor suicidal adults. Over the course of 2 weeks, patients would participate daily in intensive (8 hours/day) experiential-affective group work (focusing on issues precipitating the suicidal incident) and psycho-educational groups (covering stress management, impulse control, goal setting) with homework assignments. Groups would be run by masters' level psychologists. These group leaders would be supervised by the PI, a clinical psychologist with a specialization in suicide. Patients would return home each evening and on the weekends. Efforts would be made to limit the inpatient treatment to 3 days of those experimental treatment participants requiring acute hospitalization for stabilization purposes.
The experimental treatment would be compared to a treatment as usual (TAU) condition in which patients typically receive 7 days of inpatient care followed by a combination of outpatient group and individual treatment for time periods dependent upon the patient's needs. Control participants would receive a variety of treatments depending upon the practitioner's orientation and specific hospital from which he or she was referred.
Prospective participants, referred on the basis of suicidal risk factors, would be sent to the study by treatment staff of various city-run public emergency rooms and clinics. Treatment staff would be instructed to exclude individuals with substance abuse and psychotic or personality disorders. Those patients who agreed to be in the study would be randomly assigned to the treatment or control group and given a 1 day battery of standardized psychological tests on suicidal ideation and behaviors, life stress, depression,and family andindividual psychiatric history. Follow-up assessments would be completed at 1, 6, and 12 months following completion of treatment. During the follow-up period participants would be asked to refrain from seeking psychological services from professionals unaffiliated with the research study.
Consider how each question would be viewed from the perspective of the Investigator, the Participant and his or her Family, Community Members, Treatment Staff, and the IRB.
1. What type of information would the investigator have to provide his/her IRB to demonstrate that the treatment and the control conditions were ethically justified?
2. What would be sufficient scientific or clinical background to support the potential efficacy of the new treatment?
3. How can one determine whether the experimental treatment or Treatment as Usual (TAU) control group is being deprived of an effective treatment?
4. What characteristics of the participant population need to be considered in evaluating clinical equipoise for this study?
5. Is the investigator able to demonstrate that the scientific design can determine if the treatment is effective?
6. What are the potential risks of not conducting this study?
7. How would the IRB determine whether the design met other ethical standards?
8. Does the investigator serve a dual role that may pose a conflict of interest?
9. Are those selected to implement the interventions competent to do so?
10. Is the selection of the subject population fair and equitable?
11. How might recruitment and follow-up procedures effect the risk-benefit calculus for this study?
12. How will the investigator determine whether the prospective participant is competent to give informed consent or if guardian consent should be sought?
13. Does the protocol provide for adequate monitoring of and referral for subjects with adverse reactions to either the treatment or control condition?
14. What are potential risks and what procedures are necessary to protect participant confidentiality and privacy?
15. If a beneficial effect is demonstrated, does the control group have access to the experimental treatment?
16. What forms of dissemination of research results could benefit or stigmatize the population?
RATE OF CHANGE OF SERIAL B-HUMAN CHORIONIC GONADOTROPIN VALUES AS A PREDICTOR OF ECTOPIC PREGNANCY
Investigators want to study the predictive value of the rate of change of serial B - human chorionic gonadotropin (hCG) values in patients with symptoms suggestive of ectopic pregnancy, but who have indeterminate transvaginal ultrasound findings.
Each year approximately 300 patients are admitted with suspected ectopic pregnancy, with 10% eventually diagnosed with the disorder. Measurement of serial B-hCG values and ultrasound readings are standard practice for suspected ectopic pregnancy in the Emergency Medicine Department.
To have a sample size sufficient to answer the research question, investigators propose studying the archival records of patients admitted for suspected ectopic pregnancy during the previous year and patients admitted for this suspected disorder during the coming year.
1. Under what conditions if any, is this research exempt from IRB review?
ASSESSING THE PREVALENCE OF HEPATITIS B AND C IN ASSAULT VICTIMS: AIDS/HIV-RELATED RESEARCH
Emergency Department physicians propose to study the prevalence of Hepatitis B and C in patients admitted with injuries from assaults with knives and other sharp objects. As part of the research protocol the investigators need to know the HIV seriostatus of the patients.
Some prospective participants with minor injuries who do not want a police record of the assault may not want to participate in the study out of fear that in the future law enforcement will gain access to their records.
For each question, consider whether theissue would be viewed differently from the perspective of the Investigator, the Patient, the Patient's Partner, the IRB, the Hospital Administrators, the Clinical Staff, and the Community.
1. What steps can investigators take to protect participant confidentiality?
2. Some of the prospective participants will not have previously been tested for HIV and may not want to participate in the research out of fear they will learn they are HIV positive. Can the investigators offer patients the "right not to know?"
3. Some prospective participants found to be HIV positive will have sexual partners who are unaware of their HIV status. What are the investigators' obligations to the patient and the patient's partner?
EVALUATING ADVANCED CARDIAC LIFE SUPPORT FOR CARDIAC ARREST: EMERGENCY RESEARCH CONSENT WAIVER
Physicians wish to study the effect of exogenous epinephrine to improve the efficacy of advanced cardiac life support as therapy for cardiac arrest. Optimal therapy would require the immediate enrollment of patients admitted to the ER with severe cardiac arrest. In some cases, the patients' condition would preclude him or her from being able to consent to participate in the trial.
For each question, consider whether the issue would be viewed differently from the perspective of the Investigator, the Patient, the Patient's Family, the IRB, the Hospital Administrators, the Clinical Staff, and the Community.
1. Under what conditions, if any, can the requirement for informed consent be waived for individuals whose condition precludes prospective consent for this research?
2. What procedures need to be followed if prospective consent was waived for some participants in this research?