hrpp 201 case studies

HRPP 201 Case Studies

Kevin L. Nellis, M.S., M.T. (A.S.C.P.)

Program Analyst,

Program for Research Integrity Development and Education (PRIDE)

March 28, 2011

Reminders From HRPP 101

• Key questions

• Key terms for making determinations

• Waiver of informed consent

• Waiver of documentation of informed consent

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Key QuestionsAsk in the Following Order

Answer questions in proper sequence when determining whether an activity is research, human subjects research, exempt, or can be expedited

1. Is this project research?

2. If so, does it involve human subjects?

3. If so, is it exempt?

4. If it is not exempt, is it eligible for expedited review?

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Key Terms

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

• A systematic investigation is a project that is planned in advance and that uses data collection and analysis to answer a question

• Generalizable knowledge is information that expands scientific understanding or the knowledge base of a scholarly field of study

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Key Terms

• Human subject means a living individual about whom an investigator conducting research obtains

• Data through intervention or interaction with the individual, or

• Identifiable private information

• Private information must be individually identifiable to constitute research involving human subjects (identity of the subject is or may readily be ascertained by the investigator or associated with the information)

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If it is human subjects research, is it exempt?

Research activities in which the only involvement of human subjects will be in one or more of the categories outlined in 38 CFR 16.101(b) may be exempt from the provisions of the Common Rule (Title 38 CFR part 16)

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Can Human Subjects Research be Reviewed by an Expedited process?

1. Must fit one or more of the expedited review categories, and be no more than minimal risk

-OR-

2. Minor changes in previously IRB approved research during the period for which the approval is authorized

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Criteria for Waiver of Informed Consent in Minimal Risk Research

• Research involves no more than minimal risk to the subjects

• Waiver or alteration will not adversely affect the rights and welfare of the subjects

• Research could not practicably be carried out without the waiver or alteration; and

• Whenever appropriate, the subjects are provided with additional pertinent information after participation

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Criteria for Waiver of Documentation of Informed Consent

• The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

• That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context

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THE DEVIL IS ALWAYS IN THE DETAILS

• Overlooking or changing one detail of the protocol could change the determination…

• From research to human subjects research

• From exempt to requiring expedited IRB review

• From expedited IRB review to requiring convened IRB review

• Understand the difference between waiving informed consent and waiving documentation of informed consent

• All details of the project must be taken into consideration before these determinations can be made

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Consider All the Risks

• Risks to human subjects must be minimized

• Risks to subjects must be reasonable in relation to

• Anticipated benefits (outcome or advantage)

• Importance of the knowledge that is expected as a result of the research

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Group Exercise

• Get handouts from your package

• Categories and criteria handout

• Group activity handout

• Each table is assigned a case to review and present (first table to raise hands gets the easy case)

• If time permits at your table, review the rest of the cases and record your answers on the sheet

• Select a spokesperson at your table to report out results of case

• An answer sheet will be provided at the end of the exercise – no need to take notes

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Validation of Survey Data Collected in VA Operations

• The Old Glory VA Medical Center conducts a two part study:

• Part A:

• For internal quality assurance, they review existing data on employee satisfaction and patient satisfaction surveys

• Data from both are from anonymous surveys done as a VA operation activity

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• Part B:

• For validation purposes, they conduct a new survey with employees; however they do not collect identifiable data

• The study team plans to publish results with generalizabilty beyond the VA

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• Is Part A of the project research? No

Reason: Part A is a VA operations activity

• Is Part B of the project research? Yes

Reason: Part B is both systematic and generalizable

• If so, does it involve human subjects? Yes

If yes, who are the subjects? The employees in Part B

Reason: The survey is a research interaction

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• If so, is it exempt? Yes

If yes, exemption Category #: 2

Reason:

• Research involves survey procedures

• Information obtained is recorded in such a manner that human subjects can be identified

• If it is not exempt, is it eligible for expedited review? N/A

If yes, expedited Category #: N/A

Reason: N/A

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Evaluation of Education Materials for Self-Management of Diabetic Veterans

• The Red, White, and Blue VAMC wants to compare the effectiveness of educational tools used to teach diabetic Veterans to self-managed their glucose levels

• They randomize diabetic Veterans to either watch an educational video at the VA or read a 20 page educational booklet in their home

• A study team uses interview procedures to test the comprehension of each patient after each intervention

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• The study team records the names of the patient as well as their answers on a data form

• They plan to conduct follow-up surveys after one year to determine which tool works best

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• Is this project research? Yes

Reason: The activity is both systematic and generalizable


If yes, who are the subjects? Diabetic Veterans

Reason: There is both interaction and collection of individually private identifiable data

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• If so, is it exempt? No (only part of the project meets exemption category #1)

• If yes, exemption Category #: N/A

• Reason: • The VAMC and the patient’s home are commonly accepted

educational settings for these activities and they are researching the effectiveness of education instructional strategies, which qualifies for exemption #1, but the entire research is not exempt.

• The survey activity does not meet the criteria for exemption category #2, because any disclosure of the Veterans’ identifiable responses might place subjects at risk

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• If it is not exempt, is it eligible for expedited review? Yes

If yes, expedited Category #: 7

Reason: The non-exempt portion of the project qualifies for research on individual or group characteristics employing a survey method

• Does the investigator need to obtain informed consent? Yes

Reason: It is practicable to obtain informed consent

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• Must the investigator document informed consent? No

Reason: The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context

• What other issue(s) may be considered?

• Providing an information sheet to the subjects if documentation of informed consent is waived

• Ensure privacy, confidentiality, and data security

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Continuing Review of a Study: Prevalence of Seizure Disorders in Vietnam Veterans • Since 1985, Dr. ABC has been collecting identifiable

healthcare data from Vietnam Veterans to determine the prevalence of seizure disorders

• The study was determined by a convened IRB to involve no greater than minimal risks

• The research is permanently closed to the enrollment of new subjects

• All subjects have completed all research-related interventions

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• The project is up for continuing review, with an expiration date of December 31, 2011

• Dr. ABC submits the continuing review documents to the IRB on December 1st, 2011.

• The only remaining research activity is data analysis

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Continuing Review of a Study: Prevalence of Seizure Disorders in Vietnam Veterans

• Should this study be closed? No

The study is still active (data analysis)




If yes, who are the subjects? Vietnam Veterans

Reason: Study involves collection of individually private identifiable data

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• If so, is it exempt? No

If yes, exemption Category #: N/A

Reason: The study collects prospective (ongoing) data

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If yes, expedited Category #: 8

Reason:

• The research is permanently closed to the enrollment of new subjects

• All subjects have completed all research-related interventions

• The remaining research activity is limited to data analysis

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Continuing Review of a Study: Prevalence of Seizure Disorders in Vietnam Veterans• If the IRB approves the continuing review of the study on

December 12, 2011, what date does the renewed project expire?

December 12, 2012 or December 31, 2012 (30 day rule), depending on IRB policy

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Research Involving the Study of a Drug Under an Investigational New Drug (IND) Application• A VA Immunologist noticed that a few of his diabetic

asthma patients show remarkable improvement in their breathing capacity with they are prescribed drug XYZ for their treatment of weight loss and hypertension

• He designs a study to determine if drug XYZ improve symptoms of moderate to severe asthma in obese Veterans

• The FDA determines that an IND is needed

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Research Involving the Study of a Drug Under an Investigational New Drug (IND) Application• The subjects will be randomized to get drug XYZ or a

placebo, while remaining on all of their current medications, for a period of 27 weeks

• The new drug is known to cause kidney and liver failure in a few patients, which is disclosed in the informed consent

• The VA Immunologist will only monitor medical records, pulmonary function, asthma symptom, and measure quality of life with questionnaires

• All data points are linked to the subjects identity

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Research Involving the Study of a Drug Under an Investigational New Drug (IND) Application• Is this project research? Yes



If yes, who are the subjects? Obese Veterans

Reason: The study includes interactions, interventions, and collection of individually identifiable private information

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Research Involving the Study of a Drug Under an Investigational New Drug (IND) Application• If so, is it exempt? No


Reason: Does not meet criteria for any exemption

• If it is not exempt, is it eligible for expedited review? No

If yes, expedited Category #: N/A

Reason: Does not meet criteria for expedited review

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Research Involving the Study of a Drug Under an Investigational New Drug (IND) Application• If Is this project greater than minimal risk? Yes


Reason:

• It is practicable to obtain informed consent

• The study is greater than minimal risk

• Can the investigator provide an information sheet in lieu of documenting informed consent? No

• Reason: Does not meet criteria for waiving documentation of informed consent

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Research Involving the Study of a Drug Under an Investigational New Drug (IND) Application• What else might the IRB require to reduce risks in these

subjects?

• Monitoring of kidney and liver function throughout the duration of the study

• Require a DSMB

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Case Study #5

• A VA Oncologist wants to study the genetic epidemiology and susceptibility of cancer and obesity in Veterans

• The study will involve

• A behavioral questionnaire administered every 2 years

• Collection of buccal swab or blood sample (2ml) for genetic analysis

• Weighing the patient every time the patient is seen in clinic

• Pulling data from the electronic medical record for the life of the patient

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Case Study #5

• The IRB determines that the investigator has appropriate protections in place to protect privacy and confidentiality

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Case Study #5




If yes, who are the subjects? Veterans

Reason: The study includes interactions, interventions, and collection of individually identifiable private information

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Case Study #5

• If so, is it exempt? No


Reason: Does not meet criteria for any exemption


If yes, expedited Category #: 2, 3, 4, 5, and 7

Reason: • Category 2: Blood sample (2ml)

• Category 3: Buccal swab sample

• Category 4: Weighing the subject

• Category 5: Collecting medical records data

• Category 7: Behavioral questionnaire

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Case Study #5

• Is this project greater than minimal risk? No

NOTE: IRB may be concerned with genetic tests but risks are minimized with appropriate protections


Reason: It is practicable to obtain informed consent

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Case Study #5

• Can the investigator provide an information sheet in lieu of documenting informed consent? Yes

Reason: IRB may waive documentation under 117(c)(2) if the IRB determines the study is no greater than minimal risk and written consent is not normally required for procedures outside of the research context

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Survey About Sexuality and Illegal Drug Use

• Dr. Im A. Researcher wants to study gay and lesbian Veterans who were victims of bullying, harassment and discrimination while on active duty in the military

• The research involves a survey that will query the Veterans about sexuality and illegal drug use (names of the Veterans are recorded on each survey)

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If yes, who are the subjects? Veterans

Reason: The survey is an interaction

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Survey About Sexuality and Illegal Drug Use• If so, is it exempt? No


Reason:

• Subjects can be identified

• Disclosure or responses outside the research could reasonably place the subjects at risk (e.g., legal, social)

• Is this project greater than minimal risk?

• It depends

• There is not enough data provided to make a determination

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If yes, expedited Category #: 7 (only if IRB determines risk is no greater than minimal risk, otherwise it must be reviewed by the convened IRB)

Reason: Research employs the use of a survey

• Does the investigator need to obtain informed consent? YES

Reason: It is practicable to obtain informed consent (even if the IRB determines that study is not greater than minimal risk)

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• Can the investigator provide an information sheet in lieu of documenting informed consent? It depends

Reason:

• IRB may waive documentation under 117(c)(2) if the IRB determines the research is minimal risk and involves procedures not normally requiring written consent

• Note: IRB cannot waive documentation under 117(c)(1) because Dr. Researcher has records that link the subject and the research

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• What might the IRB require to minimize risks?

• Require that counseling be available to subjects, if needed

• Removing the name of subjects from survey (could be coded) or require anonymous surveys with no links of subjects to any data, if not needed

• Recommend changes in design so that documentation of informed consent can be waived

• Require a Certificate of Confidentiality

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