understanding our hrpp and your role in the accreditation process

Understanding Our HRPP and Your Role in the Accreditation Process

Understanding Our HRPP and Your Role in the Accreditation Process

IntroductionIntroductionEugene Oddone, MD, Vice Dean for

ResearchEugene Oddone, MD, Vice Dean for

Research

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What is AAHRPP?What is AAHRPP?

Association for the Accreditation of Human Research Protection Programs

Gold standard for Human Research Protections programs is participation in a voluntary accreditation process.

Independent, non-profit accrediting body that incorporates a voluntary, peer-driven, educational model to ensure that Duke’s Human Research Protection Program (HRPP) meets rigorous standards for quality and protection

Association for the Accreditation of Human Research Protection Programs

Gold standard for Human Research Protections programs is participation in a voluntary accreditation process.

Independent, non-profit accrediting body that incorporates a voluntary, peer-driven, educational model to ensure that Duke’s Human Research Protection Program (HRPP) meets rigorous standards for quality and protection

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Why is Duke Seeking Accreditation?

Why is Duke Seeking Accreditation?

The accreditation process allows us to take a comprehensive look at our HRPP in order to identify and address any weaknesses and build upon our strengths.

It helps to ensure: The highest possible standards & protections An assurance of quality Improved efficiency & effectiveness A competitive edge Government recognition Public trust & confidence

The accreditation process allows us to take a comprehensive look at our HRPP in order to identify and address any weaknesses and build upon our strengths.

It helps to ensure: The highest possible standards & protections An assurance of quality Improved efficiency & effectiveness A competitive edge Government recognition Public trust & confidence

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What is My Role in the Process?

What is My Role in the Process?

Investigators and their study teams are an important component of an HRPP

Prepare for the site visit:Familiarize yourself with Duke’s HRPPReview Duke’s policiesKnow what resources are available to assist

you If identified as a contact on the consent

form, you may be called to determine if you are prepared to answer questions & if you respond in a reasonable amount of time.

Investigators and their study teams are an important component of an HRPP

Prepare for the site visit:Familiarize yourself with Duke’s HRPPReview Duke’s policiesKnow what resources are available to assist

you If identified as a contact on the consent

form, you may be called to determine if you are prepared to answer questions & if you respond in a reasonable amount of time.

Overview of AAHRPP Accreditation

Overview of AAHRPP Accreditation

Wesley Byerly, PharmD, Associate Dean, Research Support Services

Wesley Byerly, PharmD, Associate Dean, Research Support Services

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Your Clinical Research Environment

Your Clinical Research Environment

Your Human SubjectsYour Human Subjects

Good Clinical Practice: Regulations, Guidance, Policies & SOPs

Duke HRPP

Site Based Research

Institutional (Duke) Policy

Human Research Protection Programs (HRPP)

• AAHRPP• Research

Administration

Offices

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Good Clinical Practice (GCP)Good Clinical Practice (GCP)

“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible” ICH HARMONISED TRIPARTITE GUIDELINE , GUIDELINE FOR GOOD CLINICAL PRACTICE , E6

(http://www.ich.org/LOB/media/MEDIA482.pdf)

“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible” ICH HARMONISED TRIPARTITE GUIDELINE , GUIDELINE FOR GOOD CLINICAL PRACTICE , E6

(http://www.ich.org/LOB/media/MEDIA482.pdf)

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Good Clinical PracticeGood Clinical Practice

Detailed directions

Professional Expectations of Practice

Standards of Care

Suggested ways to comply Guidances

Mandatory requirements Regulations

Prescribes obligations Laws

Protect SubjectsGoal

Standard Operating Procedures

ICH Guidelines

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Which Regulationsdo you Follow?

Which Regulationsdo you Follow?

Department Health and Human Services (HHS)

45 CFR 46, “Common Rule” The Federal Policy for the protection of human subjects and is codified by a number of federal agencies.45 CFR subpart B: Protection for Pregnant Women, Human Fetuses & Neonates45 CFR subpart C: Protection for Prisoners45 CFR subpart D: Protection for Children

Federally FundedFederally FundedFDA RegulatedFDA Regulated

21 Code of Federal Regulations (CFR) Code of Federal Regulations (CFR)21 CFR Parts 50: Human Subject Protection CFR Parts 50: Human Subject Protection21 CFR PART 54: Financial Disclosure CFR PART 54: Financial Disclosure21 CFR 56: Institutional Review Boards CFR 56: Institutional Review Boards21 CFR 312: Investigational New Drug CFR 312: Investigational New Drug ApplicationApplication21 CFR 803,812: Devices CFR 803,812: Devices

• Health Insurance Portability and Accountability Act (HIPAA) – Office of Civil Rights

• National Coverage Decision (NCD) –Office of Inspector General (OIG)• VA Policies & Procedures

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An integrated process where all the various components of an organization involved in the conduct of human research work together to protect the rights and welfare of participants

An integrated process where all the various components of an organization involved in the conduct of human research work together to protect the rights and welfare of participants

Human Research Protections Program (HRPP)

Human Research Protections Program (HRPP)

The HRPP is not an office.The HRPP is the collective effort of all who participate in the Conduct, Review, Approval and Facilitation of Clinical Research at Duke.

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Goals of an HRPPGoals of an HRPP

Improve the systems that protect the rights and welfare of individuals who participate in research

Communicate to the public the strength of an organization's commitment to the protection of human research participants

Improve the overall quality of research by consistently applying high standards and practices, raising the global benchmark for human research protection

Improve the systems that protect the rights and welfare of individuals who participate in research

Communicate to the public the strength of an organization's commitment to the protection of human research participants

Improve the overall quality of research by consistently applying high standards and practices, raising the global benchmark for human research protection

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ConductWhere?• Duke University Hospital• Durham Regional Hospital• Duke Raleigh HospitalBy Whom?• Investigators and Study

Teams Review and Oversight• Site-Based Research Units (SBRs)• Institutional Review Board (IRB) and

Subcommittees• Clinical Research Support Office

(CRSO)• Clinical Trials Quality Assurance

(CTQA)• Privacy Office• Research Integrity Office• Information Security Office

Sponsorship and Finance• Office of Research Administration (ORA)• Office of Corporate Research and

Collaboration (OCRC)• Office of Sponsored Programs (OSP)• PRMO Clinical Trials Billing Office• Research Costing & Compliance (RCC)

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Association for the Accreditation of Human

Research Protection Programs (AAHRPP)

Association for the Accreditation of Human

Research Protection Programs (AAHRPP)

Step 2A team of experts reviews the materials and sends report of changes to be made by institution to meet accreditation standards

Step 2A team of experts reviews the materials and sends report of changes to be made by institution to meet accreditation standards

Step 1Institution prepares and submits application with detailed policies, procedures, tools

Step 1Institution prepares and submits application with detailed policies, procedures, tools

Step 3 (Currently at this step)Institution makes changes, AAHRPP schedules Site Visit to look at institution's HRPP performance with respect to accreditation standards

Step 3 (Currently at this step)Institution makes changes, AAHRPP schedules Site Visit to look at institution's HRPP performance with respect to accreditation standards

Step 5AAHRPP’s Council on Accreditation reviews the application, Site Visit Report and institution’s response and determines site’s accreditation status

Step 5AAHRPP’s Council on Accreditation reviews the application, Site Visit Report and institution’s response and determines site’s accreditation status

Step 4 Step 4 Site Visit occurs: A report is received in 30 days Site Visit occurs: A report is received in 30 days and there is a response periodand there is a response period

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AAHRPP Accreditation Domains

(What will be reviewed)

AAHRPP Accreditation Domains

(What will be reviewed) Organization The entity that assumes responsibility for the Human

Research Protection Program and applies for accreditation

Research Review Unit Refers to the arrangements that the Organization has made for an independent review of ethical and scientific aspects of each research protocol involving human participants

Investigator Includes the various arrangements that the Organization has made for assuring that individuals who plan to conduct research — whether as a principal investigator, co- investigator, or other member of a research team — understand and fulfill their responsibilities

Sponsored Research Includes the Organization’s arrangements for structuring its relationships with those who fund or initiate research external to the Organization, such as federal agencies, foundations, individual donors, and corporations

Participant Outreach Refers to the arrangements the Organization has made for understanding the social, psychological, and physical needs and concerns of research participants and their communities

Organization The entity that assumes responsibility for the Human Research Protection Program and applies for accreditation

Research Review Unit Refers to the arrangements that the Organization has made for an independent review of ethical and scientific aspects of each research protocol involving human participants

Investigator Includes the various arrangements that the Organization has made for assuring that individuals who plan to conduct research — whether as a principal investigator, co- investigator, or other member of a research team — understand and fulfill their responsibilities

Sponsored Research Includes the Organization’s arrangements for structuring its relationships with those who fund or initiate research external to the Organization, such as federal agencies, foundations, individual donors, and corporations

Participant Outreach Refers to the arrangements the Organization has made for understanding the social, psychological, and physical needs and concerns of research participants and their communities

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What Happens During the Site Visit?

What Happens During the Site Visit?

Twelve study team groups will be interviewed as representatives of our research community

The interviews will last 45 minutes Groups will be either PI groups or coordinator groups Investigators will meet separately with the site visitors

from the coordinators The CRSO will meet with these representatives of our

study teams to assist them in preparing for the visit Site visitors will ask questions regarding our training

resources, practices, procedures and processes

For more information on the site visit, go to the CRSO’s webpage on AAHRPP:

http://crso.som.duke.edu/modules/crso_home/index.php?id=6

Twelve study team groups will be interviewed as representatives of our research community

The interviews will last 45 minutes Groups will be either PI groups or coordinator groups Investigators will meet separately with the site visitors

from the coordinators The CRSO will meet with these representatives of our

study teams to assist them in preparing for the visit Site visitors will ask questions regarding our training

resources, practices, procedures and processes

For more information on the site visit, go to the CRSO’s webpage on AAHRPP:

http://crso.som.duke.edu/modules/crso_home/index.php?id=6

Duke’s HRPPDuke’s HRPPJennifer Holcomb, Director of Operations,

CRSOJennifer Holcomb, Director of Operations,

CRSO

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Research Administration Offices

Research Administration Offices

CRSO Clinical Research Support Office IRB Institutional Review Board RIO Research Integrity Office OCRC Office of Corporate Research Collaboration ORA Office of Research Administration OSP Office of Sponsored Programs PRMO Patient Revenue Management

Organization CTBO Clinical Trials Billing Office IDS Investigational Drug Service CTQA Clinical Trials Quality Assurance DUHS Compliance Duke University Health System

Compliance

CRSO Clinical Research Support Office IRB Institutional Review Board RIO Research Integrity Office OCRC Office of Corporate Research Collaboration ORA Office of Research Administration OSP Office of Sponsored Programs PRMO Patient Revenue Management

Organization CTBO Clinical Trials Billing Office IDS Investigational Drug Service CTQA Clinical Trials Quality Assurance DUHS Compliance Duke University Health System

Compliance

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Site-Based Research Units

(SBRs)Site-Based Research Units

(SBRs)

3

Unit Business Manager

Department Chair

CRSOFaculty Advisory Board

CRCsResearch Staff

SBR Medical Director

PIs

Financial Manager

Lead CRCs

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What Role do SBRs and Study Teams Play in our HRPP?

What Role do SBRs and Study Teams Play in our HRPP?

Policies, practices and procedures at the institutional (Duke), Site-Based Research Unit (SBR) and Study Team levels respectively, must be followed and reviewed, evaluated and revised regularly

Communication between the Study Team and Research Administration is essential to Compliance with Regulations and Institutional Policies

Policies, practices and procedures at the institutional (Duke), Site-Based Research Unit (SBR) and Study Team levels respectively, must be followed and reviewed, evaluated and revised regularly

Communication between the Study Team and Research Administration is essential to Compliance with Regulations and Institutional Policies

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SBR FunctionsSBR Functions

Responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of the projects conducted in their groups

Provide day-to-day management of site-based research activities including: Feasibility assessment of potential studies Study selection decisions Personnel management (hiring/supervision) of

non-faculty research staff Protocol-specific training and study execution Financial management

Responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of the projects conducted in their groups

Provide day-to-day management of site-based research activities including: Feasibility assessment of potential studies Study selection decisions Personnel management (hiring/supervision) of

non-faculty research staff Protocol-specific training and study execution Financial management

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In addition to regulatory and DUHS requirements, Investigators are responsible for:

Identifying and proposing studies Participating in the development of the Schedule of

Events, budget, and billing grid Participating in negotiation with sponsors Following SBR Standard Operation Procedures (SOPs) The academic productivity of research Compliance with Duke HRPP training requirements -

new on-line training modules taking effect Jan. 1, 2009

In addition to regulatory and DUHS requirements, Investigators are responsible for:

Identifying and proposing studies Participating in the development of the Schedule of

Events, budget, and billing grid Participating in negotiation with sponsors Following SBR Standard Operation Procedures (SOPs) The academic productivity of research Compliance with Duke HRPP training requirements -

new on-line training modules taking effect Jan. 1, 2009

Site Based ResearchInvestigator Responsibilities

Site Based ResearchInvestigator Responsibilities

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Study Conduct and Management

Study Conduct and Management

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Source Data (Documentation) All information in original records and certified copies of original records…” (ICH GCP 1.51) Includes

Clinical findings Observations Other study activities

Necessary for: The reconstruction and evaluation of the study Confirmation of subject existence and observations Substantiation of study data integrity

Source Document: A record which contains ORIGINAL source data (e.g. Medical records, Lab reports, X-rays, ECGs, Intake/ Screening forms, Telephone contact records, faxes, e-mails, Subject diaries, Informed consent forms, CRFS)

Source Data (Documentation) All information in original records and certified copies of original records…” (ICH GCP 1.51) Includes

Clinical findings Observations Other study activities

Necessary for: The reconstruction and evaluation of the study Confirmation of subject existence and observations Substantiation of study data integrity

Source Document: A record which contains ORIGINAL source data (e.g. Medical records, Lab reports, X-rays, ECGs, Intake/ Screening forms, Telephone contact records, faxes, e-mails, Subject diaries, Informed consent forms, CRFS)

Managing Approved Studies:Documentation – What & Why


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Note/Memo to File Used to clarify missing or inaccurate data or

procedures. Store memo in the appropriate regulatory binder and

with the source documentation. Not a panacea for all things that have gone wrong.

Document problem –Not enough. Document problem -> document corrective action identified

for preventing recurrence -> institute corrective action Examples:

An assessment is missed or completed out of sequence Are unable to obtain a blood sample at a visit A subject failed to initial one page of a consent document If an original document is destroyed and only a copy remains A subject is lost to follow-up A subject is dropped from the study

Note/Memo to File Used to clarify missing or inaccurate data or

procedures. Store memo in the appropriate regulatory binder and

with the source documentation. Not a panacea for all things that have gone wrong.

Document problem –Not enough. Document problem -> document corrective action identified

for preventing recurrence -> institute corrective action Examples:

An assessment is missed or completed out of sequence Are unable to obtain a blood sample at a visit A subject failed to initial one page of a consent document If an original document is destroyed and only a copy remains A subject is lost to follow-up A subject is dropped from the study



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Drugs/Biologics: 2 years following the date of market application approval, market application non-approval or discontinuation of the investigation (21 CFR 312.62[c])

Devices: For a period of 2 years after the latter of the following investigation termination/completion date , or date that records no longer required to support premarket approval application (21 CFR 812.140[d])

FYI - ICH Guidelines: 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. (ICH GCP (E6), 4.9.5)

Drugs/Biologics: 2 years following the date of market application approval, market application non-approval or discontinuation of the investigation (21 CFR 312.62[c])

Devices: For a period of 2 years after the latter of the following investigation termination/completion date , or date that records no longer required to support premarket approval application (21 CFR 812.140[d])

FYI - ICH Guidelines: 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. (ICH GCP (E6), 4.9.5)

Managing Approved Studies:Record Retention – Quick Takes

Managing Approved Studies:Record Retention – Quick Takes

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Study Conduct & Subject Protection

Study Conduct & Subject Protection

How do Privacy and Confidentiality Differ?

Privacy is about protecting the personConfidentiality is about protecting the

private information (DATA) you have access to

How do Privacy and Confidentiality Differ?

Privacy is about protecting the personConfidentiality is about protecting the

private information (DATA) you have access to

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Do not “cold contact” subjects When designing the recruitment process,

remember that the study must be introduced by healthcare personnel known to the potential subject. If the subject indicates interest in the study, then research personnel may approach the subject to discuss the study further.

Ensure interviews are convened in a private setting If others are present, ensure that their presence is

appropriateConsider how the subject might like to be

treated given their age, ethnicity, or gender

Do not “cold contact” subjects When designing the recruitment process,

remember that the study must be introduced by healthcare personnel known to the potential subject. If the subject indicates interest in the study, then research personnel may approach the subject to discuss the study further.

Ensure interviews are convened in a private setting If others are present, ensure that their presence is

appropriateConsider how the subject might like to be

treated given their age, ethnicity, or gender

Study Conduct & Subject Protection:

How do I Maintain the Privacy of my Subjects?


How do I Maintain the Privacy of my Subjects?

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Refers to the protections that you provide for private information

Expectation that data will not be divulged except in ways previously agreed upon

It's about DATA verbal written electronic

Refers to the protections that you provide for private information

Expectation that data will not be divulged except in ways previously agreed upon

It's about DATA verbal written electronic


Protecting Confidentiality



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Does your subject have an expectation that information provided will be kept confidential?

How do you identify potential subjects? What data are you collecting?

Is the information you are recording of a personal nature?

Are you recording information about a third party?

How are the data going to be stored? Who is going to have access to the data?

Does your subject have an expectation that information provided will be kept confidential?

How do you identify potential subjects? What data are you collecting?

Is the information you are recording of a personal nature?

Are you recording information about a third party?

How are the data going to be stored? Who is going to have access to the data?





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There are tools to protect it both inside and outside of Duke

HIPAA: Set of tools (and rules) for maintaining confidentiality now and after disclosure (commonly referred to as the “Privacy Rule”)

Certificate of Confidentiality: Allows you to keep the data away from outsiders; even from a court order (Applies to any research, not just NIH funded)

There are tools to protect it both inside and outside of Duke

HIPAA: Set of tools (and rules) for maintaining confidentiality now and after disclosure (commonly referred to as the “Privacy Rule”)

Certificate of Confidentiality: Allows you to keep the data away from outsiders; even from a court order (Applies to any research, not just NIH funded)

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How is equitable selection operationalized?

Who has first contact with prospective participants?

When is it appropriate to approach a family member or friend first?

Is it acceptable to leave a consent with the medical provider to pass on?

How is first contact made?

How is equitable selection operationalized?

Who has first contact with prospective participants?

When is it appropriate to approach a family member or friend first?

Is it acceptable to leave a consent with the medical provider to pass on?

How is first contact made?


Recruitment – The Foundation ofInformed Consent


Recruitment – The Foundation ofInformed Consent

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Study Conduct & Subject Protection: Do You Have

Informed Consent?

Study Conduct & Subject Protection: Do You Have

Informed Consent?

When does Informed consent begin…end?

What do you assess to determine the individual's capability to provide legally effective informed consent?

What criteria should be in place to ensure you have informed consent?

When does Informed consent begin…end?

What do you assess to determine the individual's capability to provide legally effective informed consent?

What criteria should be in place to ensure you have informed consent?

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*Indications of potentially diminished capacity are: A diagnosis of dementia or cognitive impairment Presenting for an evaluation of dementia A report, in medical records or from a family member or person well

acquainted with the subject, that the subject has symptoms of cognitive impairment or dementia

An abnormal degree of confusion, forgetfulness, or difficulties in communication that is observed in the course of interacting with the subject

Psychotic symptoms, bizarre or abnormal behavior exhibited by the subject

For research that may involve subjects with diminished capacity to make an informed decision, you need to inform the IRB of:

What special protections will you ensure are in place? Who will assess for decisional capacity? When will this occur? Under what circumstances will reassessment occur? What provisions will be made to obtain the consent of the research

subject if the period of diminished capacity is temporary?

*UC Davis Alzheimer's Disease Center

*Indications of potentially diminished capacity are: A diagnosis of dementia or cognitive impairment Presenting for an evaluation of dementia A report, in medical records or from a family member or person well

acquainted with the subject, that the subject has symptoms of cognitive impairment or dementia

An abnormal degree of confusion, forgetfulness, or difficulties in communication that is observed in the course of interacting with the subject

Psychotic symptoms, bizarre or abnormal behavior exhibited by the subject

For research that may involve subjects with diminished capacity to make an informed decision, you need to inform the IRB of:

What special protections will you ensure are in place? Who will assess for decisional capacity? When will this occur? Under what circumstances will reassessment occur? What provisions will be made to obtain the consent of the research

subject if the period of diminished capacity is temporary?

*UC Davis Alzheimer's Disease Center


Diminished Capacity/Cognitive Impairment



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Considerations for the Informed Consent Process Determining extent of cognitive impairment

Will the individual have enough information to make an informed decision?

Will the individual be able to make a decision? Will the individual understand the consequences of the

decision? Will the individual be able to communicate the decision?

Will the subject need a legally authorized representative to act on behalf of the subject?

Will assent be sought? Circumstances under which the subject’s failure to assent

can be overridden by the subject’s legally authorized representative

Periodic reassessment of the subject’s cognition – will it be necessary? If yes, when it will occur, and by whom?

Will the subject will be asked to consent for continued study participation if the subject’s decisional capacity improves, and if not, why not?

Considerations for the Informed Consent Process Determining extent of cognitive impairment

Will the individual have enough information to make an informed decision?

Will the individual be able to make a decision? Will the individual understand the consequences of the

decision? Will the individual be able to communicate the decision?

Will the subject need a legally authorized representative to act on behalf of the subject?

Will assent be sought? Circumstances under which the subject’s failure to assent

can be overridden by the subject’s legally authorized representative

Periodic reassessment of the subject’s cognition – will it be necessary? If yes, when it will occur, and by whom?

Will the subject will be asked to consent for continued study participation if the subject’s decisional capacity improves, and if not, why not?

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1. Court-approved guardian2. Health care agent3. Spouse4. Adult son and/or daughter5. Parent6. Adult brother and/or sister7. Uncle and/or aunt8. Other adult kin

1. Court-approved guardian2. Health care agent3. Spouse4. Adult son and/or daughter5. Parent6. Adult brother and/or sister7. Uncle and/or aunt8. Other adult kin


N.C. Order of Authority for Serving as a Legally Authorized Representative

(LAR)


N.C. Order of Authority for Serving as a Legally Authorized Representative

(LAR)

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Subjects with Diminished Capacity/Cognitive Impairment – IRB does not have specific policies regarding assent for this population

Children In NC residents under 18 years of age are considered

minors in unless they are "emancipated" by court order In determining whether children are capable of assenting,

the IRB will take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate

Age related IRB consent requirements > 6 years of age should be involved in the decision to

participate in a research project ≥ 12 years of age must sign assent after the parent or legal

guardian has given consent (for exceptions consult IRB manual)

Subjects with Diminished Capacity/Cognitive Impairment – IRB does not have specific policies regarding assent for this population

Children In NC residents under 18 years of age are considered

minors in unless they are "emancipated" by court order In determining whether children are capable of assenting,

the IRB will take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate

Age related IRB consent requirements > 6 years of age should be involved in the decision to

participate in a research project ≥ 12 years of age must sign assent after the parent or legal

guardian has given consent (for exceptions consult IRB manual)


Assent – Diminished Capacity & Children


Assent – Diminished Capacity & Children

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Document that the Subject was given a (signed) copy of the ICF in the case history

If subject is a patient, DUHS requires a copy of the consent form in the subject’s DUHS medical record (JCAHO requirement)

Best Practice: Document the consent process in the case history & the

medical record Include:

IRB approval obtained prior to subject consenting How subject was informed (read consent, discussion, Q&A, video) Who participated in the consent process and how (investigator,

study coordinator, legal authorized representative, family, etc.) How subject’s understanding of the information was assessed Disposition of the signed consent form (original and copies) Special or unusual circumstances (e.g. Illiterate subject –how did

you ensure the subject was informed and that your process met regulatory requirements?)

Document that the Subject was given a (signed) copy of the ICF in the case history

If subject is a patient, DUHS requires a copy of the consent form in the subject’s DUHS medical record (JCAHO requirement)

Best Practice: Document the consent process in the case history & the

medical record Include:

IRB approval obtained prior to subject consenting How subject was informed (read consent, discussion, Q&A, video) Who participated in the consent process and how (investigator,

study coordinator, legal authorized representative, family, etc.) How subject’s understanding of the information was assessed Disposition of the signed consent form (original and copies) Special or unusual circumstances (e.g. Illiterate subject –how did

you ensure the subject was informed and that your process met regulatory requirements?)


Documenting Informed Consent


Documenting Informed Consent

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Study Conduct & Subject Protection: Unanticipated

Problems vs. Adverse Events

Study Conduct & Subject Protection: Unanticipated

Problems vs. Adverse Events

• Most adverse events are not unanticipated problems• Unanticipated problems include other incidents, experiences,

and outcomes not considered adverse events

Adverse Events Unanticipated

Problems

SAE’s

Unanticipated Problems (including

SAE’s and AE’s) involving new or

increased risk

Require prompt reporting to the IRB, and sponsor, if applicable, and the FDA, if

applicable.

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Study Conduct & Subject Protection: Medical Devices, Adverse Events and Effects

Study Conduct & Subject Protection: Medical Devices, Adverse Events and Effects

UnreasonableRisk

Serious &Unanticipated

Device RelatedAdverse Effect

Record & Document21 CFR 812.140(a)(3)(ii)

Report to sponsor & IRB within 10 days 812.150(a)(1)

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(Sponsor Obligation)

Investigator Reporting Requirements

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Types of Departures Deviation – Unintentional Violation – Intentional

Departures must be reported when the following are impacted: Rights, welfare or safety of subject Integrity of the research data Subject’s willingness to continue study

Forms to use “Notification of Protocol Deviation/Violation” If departure is both unanticipated and meets above

criteria, the “Notification of a Problem or Event requiring Prompt reporting to the IRB as a New or Increased Risk” must also be submitted to IRB

Types of Departures Deviation – Unintentional Violation – Intentional

Departures must be reported when the following are impacted: Rights, welfare or safety of subject Integrity of the research data Subject’s willingness to continue study

Forms to use “Notification of Protocol Deviation/Violation” If departure is both unanticipated and meets above

criteria, the “Notification of a Problem or Event requiring Prompt reporting to the IRB as a New or Increased Risk” must also be submitted to IRB

Managing Approved Studies: Protocol Departures, a.k.a.

“Noncompliance”

Managing Approved Studies: Protocol Departures, a.k.a.

“Noncompliance”

understanding our hrpp and your role in the accreditation process

Documents

protection of human

research slide

human subject protection

accreditation process

clinical research environment

protection association

human services hhs

cfr subpart c