RESEARCH COMPLIANCEAgenda

1. No Destruction of local research documents after scanning

2. Training for shipping biological samples/specimens

3. Regulatory Audits4. Investigational Drug changed to “Study

Drug” in CPRS progress note templates: Research Consent & Contact and Research Reconsent

5. Informed Consent & HIPAA Waivers 1

Destruction of Local Research Documents After

ScanningIs an investigator permitted to destroy the original VA Form 10-1086 signed and dated by the subject or the subject’s legally authorized representative after its scanned into CPRS?

 Email communication from Bob Brooks, ORO June 18, 2010 2

Destruction of Local Research Documents After Scanning

“…in concurrence with both ORD and ORO”

NO!   A subject’s original signed and dated informed consent document cannot be destroyed after it has been scanned into the VHA health record. The subjects’ original signed and dated informed consent documents are investigator research records, not clinical records.

3Email communication from Bob Brooks, ORO June 18, 2010

Training for shipping biological samples/specimens

– Initial training required for all research

personnel that ship (SRS & R&D)Training offered:

Mayo Clinic (free) http://www.mayomedicallaboratories.com/education/index.html?type=&topic=&format=&query=transportation&action=Search

Safe-T-Pak (fee) http://www.saftpak.com

NJ DOH (small fee-offsite) https://hazmatonline.phmsa.dot.gov/services/publication_documents/measure_up.pdf

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Regulatory AuditsAll studies approved after 1/1/08 required• Follow the protocol history• Training records

– (CITI, Info. Sec. 201 for R&D)– Inclusion/Exclusion criteria– Documentation of consent

Recommended:regulatory file contain all submitted

and received documents (all committees)5

CPRS Progress Note Template Investigational Drug changed to “Study Drug” in

Research Consent & Contact and Research Reconsent

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Informed Consent & HIPAA Waivers

• Waiver of Consent

• Waiver of Documentation of Consent

• Request for Waiver of HIPAA Authorization

Informed Consent Waivers

What is a waiver of informed consent?

Waiver of Consent Can be granted by the IRB if:

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• The research involves no more than minimal risk to the subjects

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

Waiver of Consent

The research could not practicably

be carried out without the waiver or alteration

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Waiver of Consent

Whenever appropriate, the subjects must be provided with additional pertinent information after participation

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Informed Consent & Documentation of Consent

Waivers • If data is obtained about

individuals without their consent and authorization, it is likely that a waiver is required

• Just obtaining contact information prior to consent is a trigger for a waiver of informed consent and a waiver of HIPAA Authorization

Waiver of Documentation of Consent

Waiver of Documentation of Consent

Criteria for IRB consideration

1. 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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Waiver of Documentation of Consent

Criteria for IRB consideration:

2. That 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

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Waiver Of Documentation Of Consent

Once a study has a waiver of documentation of consent…

…how do the requirements differ from those for studies where a signed consent form is obtained?

See next 2 slides for the answer

Waiver Of Documentation Of Consent

Same:1.Obtain informed consent (disclosure for

informed decision, time to consider, no undue influence or coercion, no exculpatory language, etc.)

2.Include all basic and applicable additional elements of consent

3.Person obtaining consent must be the PI or be formally delegated

4.Progress note must be entered in CPRS

Waiver Of Documentation Of Consent

Progress note must be entered in CPRSThe IRB may consider waiving the

progress note requirement when the research procedures do not require medical record entries

– No inpatient visit– No outpatient visit– No clinical resources– The research intervention would not lead

to physical or psychological adverse events

Waiver Of Documentation Of Consent

Different:1.IRB may require that a written

statement be given to subjects2.No signed consent form3.No witness4.No entry of consent form in CPRS5.No IDMC Screening form6.No HIPAA Authorization – Need HIPAA

Waiver

Request for Waiver of HIPAA Authorization

HIPAA WaiverIRB may waive HIPAA when all 4 items are

met1.No more than minimal risk to privacy

A. Written plan to protect identifiersB. Written plan to destroy identifiers. NOTE: All

research records must be kept (not destroyed) until the release of VA regulations on retention of research records

C. Written assurance that PHI not re-used or disclosed except:

1. As required by law2. For authorized oversight of research3. With specific approval from IRB for other research

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HIPAA Waiver

2. Research cannot practicably be done without waiver

3. Research cannot be done without PHI

4. Uses and disclosures of PHI must be limited to the minimum necessary to achieve the research purpose

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RESEARCH COMPLIANCEConclusion

1.Don’t destroy research records2.Get shipping training if you ship3.If there is a study, it will be audited4.Study drug = the drug being studied

—even if it is FDA approved5. Request a waiver if your study will

obtain information about subjects prior to consent (Consult Privacy Officer or RCOs )

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