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ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL MODULE 2 Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research.

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Presentation on theme: "ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL MODULE 2 Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research."— Presentation transcript:

1 ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL MODULE 2 Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research Professionals

2 Overall Agenda for Orientation Module 1: September 12, Introduction to Clinical Research, Education, and IRB Module 2: September 19, Study Implementation, Documentation, and GCPs Module 3: September 26, Contracting and Hospital Administrative Elements Module 4: October 3, Clinical Trial Management, Budgeting, Hospital and Research Accounting

3 Overall Agenda for Orientation Module 1: Introduction to Clinical Research, Education, and IRB Module 2: Study Implementation, Documentation, and GCPs Module 3: Contracting, COI, and Hospital Administrative Elements Module 4: Clinical Trial Management, Budgeting, Hospital and Research Accounting

4 STUDY TEAM RESPONSIBILITIES Michelle Duclos, NCRP

5 Principal Investigator Ultimate administrative and fiscal responsibility for the team performance of the study subject to IRB/Institution review and oversight: ◦ The science ◦ The integrity ◦ The business operations Understanding and following the protocol as approved by the IRB is the first and most critical obligation of the investigator in human subjects research

6 Legal Commitments in Drug & Device Research When PI signs FDA form 1572 (for IND studies - Drugs) or "Statement of the Investigator” (for IDE studies - Devices), signing a legally binding document committing themselves to conduct study according to protocol and FDA regulations. Form 1572 is a written agreement (signed) between PI and federal government. PI’s nine responsibilities (or commitments) as stated in FDA regulations are detailed on Form 1572 for Drug Trials.

7 Form FDA 1572 (excerpts) I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the drug. I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others. Additionally, I will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

8 Form FDA 1572 – Oversight of Staff I agree to personally conduct or supervise the described investigation(s). I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments.

9 Should Sub-investigator be listed in Section #6 of FDA 1572? FDA’s regulation at 21 CFR 312.3(b) states “In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Sub- investigator” includes ANY other individual member of the team. Purpose of Section #6 is to capture information about individuals who will assist the investigator and make a direct and significant contribution to the data. See Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBS – FAQs – Statement of Investigator (Form FDA 1572) /ucm pdfhttp://www.fda.gov/downloads/regulatoryinformation/guidances /ucm pdf

10 Should coordinator be listed on FDA 1572? The decision about whether to list a pharmacist or research coordinator on the 1572 is a matter of judgment, dependent upon the contribution that the individual makes to the study. A research pharmacist may prepare test articles and maintain drug accountability for many clinical studies that are ongoing concurrently at an institution. Because the pharmacist would not be making a direct and significant contribution to the data for a particular study, it would not be necessary to list the pharmacist as a subinvestigator in Section #6, but he/she should be listed in the investigator’s study records.  A research coordinator has a greater role in performing critical study functions and making direct and significant contributions to the data. For example, a research coordinator often recruits subjects, collects and evaluates study data, and maintains study records. Therefore, the research coordinator should usually be listed in Section #6 of the Excerpt from FDA Guidance document #33

11 Investigator Obligation at UNC-CH With or Without FDA Involvement Obtain IRB approval before performing the protocol and before performing any changes or additions from what the IRB has approved for the project. Perform the protocol AS APPROVED by the IRB Provide the IRB with accurate and complete information and updates as the information changes Notify the IRB of all unanticipated or serious adverse events involving risk to human subjects Provide all reports required by the IRB on the timeline required by the IRB

12 Clinical Research Coordinator (CRC) What is your title? Social/Clinical Research Assistant Social/Clinical Research Associate Social/Clinical Research Specialist Research Nurse Clinical Nurse Project Manager Research Instructor Others?

13 Primary Responsibility Per UNC OCT, role of the CRC is to “... ensure smooth, accurate progress of the project from the planning stage through study end (and often beyond) by acting as liaison to the investigator, the subject, the institution, and the company or government sponsor 1.” Role has evolved over the years as the clinical research industry has evolved

14 Shared Responsibilities Many PI responsibilities are delegated and become the CRC’s operational responsibility Know what responsibilities belong only to PI and what roles you are capable of performing FDA Guidance Document: Investigator Responsibilities – protecting the rights, safety, and welfare of study subjects egulatoryInformation/Guidances/UCM pdf

15 FDA Final Guidance Guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR (i)) Guidance and information sheets represent the Agency’s current guidance and EXPECTATIONS on good clinical practice and conduct of clinical trials. Goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. Guidance intended to clarify for investigators and sponsors FDAs expectation concerning the investigator’s responsibility. 1.To supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties, and 2.To protect the rights, safety, and welfare of study subjects

16 General CRC Responsibilities Protocol Evaluation Subject availability Personnel requirement Equipment & facility availability Develop timelines Propose & negotiate alternatives to improve implementation

17 General Responsibilities Administrative Interact with IRB, lab staff, clinic staff, pharmacy, nursing homes, assist living, churches, community centers, etc Prepare IRB documents including ICF Prepare Study Budget Assure all documentation is maintained Interact with Sponsor Interact with PIs and sub-investigators Coordinate and participate in monitoring visits with sponsor Complete CRFs and submit to sponsor Resolve data queries Facilitate inspections/audits Document study progress

18 General CRC Responsibilities Study Subjects Recruit study subjects Assess subjects for eligibility Discuss study with subject Obtain informed consent Schedule subject visits/assessments Assure all study tests and visits are done at appropriate time intervals

19 General CRC Responsibilities Study Subjects Evaluate study subjects at appropriate intervals Assess laboratory data and clinical signs for potential adverse events Adverse Events (AEs) Assist PI with gathering information to help PI determine classification, and causality Observe and document AEs Act on PI’s recommendation Maintain follow-up until reconciliation Communication with sponsor

20 General CRC Responsibilities Study Subjects Provide information for treatment and reactions Administer or dispense investigational agent, as outlined in the protocol, under the investigator’s supervision Investigational Drug Accountability Order, store, dispense, retrieve, log Randomization codes Unblinding procedures Promote subject compliance by providing patient support and education Prepare lab specimens; ship biological samples and radiologic films Arrange for study subject compensation Comply with FDA regulations for conducting clinical trials

21 STUDY IMPLEMENTATION Michelle Duclos, NCRP

22 Protocol Implementation

23 Research Site – Study start up meeting, documentation of training of all individuals listed on delegation log Notification to providers, nurses, clinic staff, and other team members of upcoming research protocol Pre-identification of potential subjects – Once IRB approval received, contacting potential subjects regarding participation in research protocol Development of a recruitment plan Organization of study materials Creation of source documents

24 Protocol Implementation Organization of study materials Regulatory binder IRB binder Correspondence binder Protocol binder Investigator brochure binder IVRS information Supply Order forms Investigational Drug Study Manual

25 Is this how your office looks? Patient Research Charts

26 Protocol Implementation Creation of source documents Helpful hints: review your study visit schedule review the Case Report Forms or eCRFs to ensure you collect all information that will be documented on CRF Develop standard forms for department that can be used across studies. Examples Physical Exam form Medical history form General Research Record or SOAP note Documentation of Informed Consent Template

27 Depending on study development of a study start up checklist may be helpful

28 Recruitment A recruitment plan should be developed as soon as you have begun work on the protocol, whether investigator initiated, industry sponsored, or NIH (IRB approval of all recruitment materials is required) Advertising campaign TV, Radio, Print, Website Dear Doctor Letters –fax or local providers, recommend follow-up with a meeting if you want practice to help Direct to Patient from databases Posters, Pamphlets, Mailings (letters, post cards) Determine if Carolina Data Warehouse can be utilized Develop a phone screen/script as necessary for phone calls Social networking opportunities Community events (fairs, flea markets, senior centers) Develop a UNC mass Communicate internally with departmental doctors for referrals, develop a system in department for identification of potential subjects Communicate with NC TraCS

29 GOOD CLINICAL PRACTICES & STUDY DOCUMENTATION Marie Rape, RN, BSN NC TraCS Institute

30 Good Clinical Practice GCP defined as “…international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.” E6 Good Clinical Practice: Consolidated Guidance

31 1996: In an attempt to provide consistency among clinical trials, US, European Union, and Japan established a unified standard, called the International Conference on Harmonisation’s “Good Clinical Practice: Consolidated Guideline,” (ICH-GCP). Objective of “guidance is to provide a unified standard to facilitate mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.” E6 Good Clinical Practice: Consolidated Guidance recognized by industry sponsors as the gold standard for conduct of ethically and scientifically sound human subject research. From the Introduction of Guidance for Industry, E6 Good Clinical Practice

32 Topics Covered in ICH GCP Describes: Qualification of an investigator Education and training of study staff Delegation of study-related tasks Requirement for IRB review Compliance with the protocol Responsibility for investigational product accountability Informed consent Safety reporting Trial management & record keeping Data quality and integrity, quality control Essential documents for a trial

33 Why is Adherence to GCP Important? Main tenets of GCP: research involves good science, is verifiable, monitored, well-documented, and study complies with the highest ethical standards. Adherence to GCPs: Protect the rights and well-being of human subjects Ensure accuracy and credibility of the data and reported results Ensure conduct of the trial is in compliance with: the protocol/amendment(s) currently approved by the IRB applicable regulatory requirements institutional policies all applicable rules and regulations

34 Who Should Adhere to GCP? The general concept of GCP is essential for any research study involving human subjects. Whether conducting research involving a new drug or device, a behavioral intervention, or an interview/survey, Good Clinical Practice (GCP) provides investigators and study teams with the tools to protect human subjects and collect quality data. Following the ICH-GCP is one of the best ways to substantiate the quality of any research study and its resulting data.

35 Documentation Once a scientifically valid research idea has been proposed and approved, the key to successful implementation of the study lies in the documentation. “If you didn’t document it, it didn’t happen.” Validity of research data rests in the documentation Resources, such as checklists and templates assist investigators & study staff in implementing, and documenting that they followed GCP and the protocol.

36 FDA Regulations Require Investigator to Maintain Study Files For FDA Drug studies (21 CFR ) prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the (drug) investigation on each individual administered the investigational drug or employed as a control in the investigation case histories include the case report forms and supporting data (source documents). For FDA Device Studies (21 CFR ) Maintain accurate, complete, and current records relating to participation in (device) investigation

37 Source Documents Source Documents: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. International Conference on Harmonization E6 The first place something is recorded is considered the source document for that clinical trial activity A “trail for the trial”: Source documents should create a “trail” so that anyone can verify and follow what happened throughout a clinical trial and where the data came from (an audit trail)

38 Types of Source Documents Medical history Hospital records Clinic & office charts Progress notes Lab notes Memoranda Meeting minutes Notes to file Phone records Subject diaries Questionnaires Subject files or records Drug dispensing records Recorded data from automated instruments (DynaMap, ECG, EEG, ) X-rays, scans, MRIs

39 Example of a source document? Subject ABC 3/1/06

40 Case Report Forms (CRFs) CRFs are paper or electronic documents/forms designed to record all information required by the study protocol for a participant (provided by Sponsors). All information entered on CRF must be supported by source documents If data recorded directly on CRF, there should be an entry in subject's medical record or subject file that records date information was obtained, how and by whom. CRFs may be used as a source document IF data elements are newly created and not transcribed from other sources. FDA opinion that copies of CRF used as a source document are not a replacement for original source documentation.

41 Important Events to Document The Consent Process (more than just signed consent form) Documentation of subject eligibility (inclusion/exclusion criteria) Study randomization, study drug adherence or non-adherence Completion of all protocol-required tests, procedures Missed visits, subject contacts, procedures, or examinations Protocol deviations & violations (notifications to IRB / sponsor and corrective actions) All subject contact – either via phone or in person (include date/time and reason for contact) Unanticipated problems or adverse effects and relationship to study intervention, severity, action taken and reporting to IRB Subject termination (withdraw of consent, lost to follow up, PI removal)

42 Templates Improve Source Documentation Some research data collected on Hospital based forms as part of medical care: Vital signs on clinic record sheet Medication administration on MAR for inpatients, Laboratory tests History and physical exam Other research data only collected by study staff and not maintained in Medical Record or on any other form. Use of templates to document research data helps study team collect required data and have a place to record it. Other data can be written on progress notes.

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44 I / E Criteria Checklists Good practice for study teams to incorporate an eligibility checklist into each subject’s study record so that study staff can document on a form how each of the inclusion and exclusion criteria have been met. Create a template that is study specific, listing all the inclusion and exclusion criteria for the study and check off that subject meets each and every criteria Documentation of Eligibility Important! Keep supporting documentation that demonstrates that subject meets criteria (e.g., colonoscopy results to demonstrate normal colon)

45 Sample Inclusion/Exclusion Criteria Checklist

46 Signature by PI that Subject is Eligible If the responses to all the inclusion criteria are YES and all the exclusion criteria are NO, the subject is eligible to participate in the trial. Is the subject eligible to participate in the trial?YESNO If NO, discontinue the subject and complete the study termination form. If YES, I have reviewed the inclusion and exclusion criteria and have determined that the subject is eligible for participation in the trial. Investigator ___________________________ Date ___________

47 Eligibility Criteria IRB approval of protocol includes approval of inclusion & exclusion criteria as written. These eligibility criteria are NOT guidelines, but are requirements that must be followed. The “inclusion/exclusion criteria” define the study population, and ensure the safety and the integrity of the data Investigator may wish to enroll a subject who does not precisely fit the eligibility criteria PI must obtain IRB approval for the change in eligibility criteria May make an exception for a single subject (not change criteria in protocol) After the amendment or exception is approved by IRB, the subject can be then be enrolled

48 Enrollment Note Template 1. Subject has met inclusion criteria. 2. Subject has no exclusion criteria. 3. Informed consent was obtained prior to any study procedures being performed. 4. Subject was provided with an explanation of study procedures, risks, benefits, and alternatives, was given the opportunity to ask questions, and agrees to participate. 5. Subject was given a copy of the signed consent form. 6. Contact information of research staff given to subject. 7. Other: Additional information: Study IRB #:Principal Investigator: Subject Name: ___________________ID#: ___________ Investigator’s Signature ____________________ Date ________ Yes No

49 Note to File Template From Office of Clinical Trials

50 Template for Progress Notes or PE PROGRESS NOTES IRB # Study Title: Subject ID#: ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ ___________________________________________________________ __________________________________________________________ Signature______________Date __________

51 Telephone Contact Log Date/Time Incoming/ Outgoing Message/ Conversation Comment Incoming Outgoing Message Conversation Incoming Outgoing Message Conversation Incoming Outgoing Message Conversation Incoming Outgoing Message Conversation Incoming Outgoing Message Conversation Incoming Outgoing Message Conversation Study ID __________ Subject ID __________

52 Helpful Hints for Source Documentation Mistakes and mishaps occur, visits, contacts and tests may be missed, subject might not tell you about an adverse event or problem until much later Describe in source documents when you learn of study- relevant information and actions taken when you became aware of information. This demonstrates due diligence. Lost to follow-up subjects: Often begins as a missed subject visit or contact. Document missed visits and actions /attempts to follow up. Document final action taken - certified letter, receipt as signed or undeliverable, notice to sponsor and IRB that no further contact will be attempted, record closed

53 ALCOA* for Data Quality  Attributable: is it obvious who wrote it?  Legible: can it be read?  Contemporaneous: is the information current and in the correct time frame?  Original: is it a copy; has it been altered?  Accurate: are conflicting data recorded elsewhere? *Stan W. Woolen, 1999 DIA Meeting

54 Maintaining Regulatory Files Essential Documents for conduct of Clinical Trial should be maintained together in a Regulatory Binder Purpose of Regulatory Binder: Organize essential documents Allows research team to reference information Allows easy access to documents by monitor, auditor, IRB, FDA, OHRP Principal Investigator ultimately responsible for maintenance of Regulatory Files, but task often delegated to other member of research team

55 Regulatory Binder (Essential Documents) Signature logs (DOA and monitoring log) Screening/enrollment logs Protocol and amendments Investigator’s Brochure Sponsor correspondence Training 1572, Conflict of Interest, CV’s, Licenses, Financial Disclosures IRB membership, FWA IRB approvals and correspondence AE log, SAEs IND Safety Reports Local Laboratory CLIA/CAP, normal values, Lab Dir. CV Temperature Logs Subject ID Code List

56 Delegation of Responsibility Log Study Personnel Printed Name Title Study Personnel Role (e.g. PI, Investigator, Coordinator, Pharmacist, etc.) Responsibilities* (List all letters that apply) Signature of Study Personnel Initials of Study Personnel Obligation PI Signature & Date (To acknowledge roles & responsibilities) IRB Approved Start Date End Date Note: The PI is ultimately responsible for all aspects of the study. Study IRB#:_____________________ Study Title:____________________________________________________________________________________________ _____ Principal Investigator: ____________________________Coordinator: _____________________ *Record staff responsibilities using the following codes, list all that apply: A) Subject Recruitment E) Administers Study MedicationsI) Packs/ships samples B) Obtains Informed ConsentF) Drug, Biologic, or Device AccountabilityJ) Other: ___________________ C) Performs Study Assessments G) Data Management K) Other: ___________________ D) Assesses Subject for Adverse EventsH) Regulatory Reporting/Paperwork/Maintenance

57 Monitoring Log From Office of Clinical Trials

58 Patient Name Telephone Pre-Screen Date Potentially Eligible ? Screenin g Visit Date Study ID NumberConsented/ Enrolled ?Eligibility * Staff Initials Yes No Yes No  Screen Failure, Reason: Date:  Eligible Yes No Yes No  Screen Failure, Reason: Date:  Eligible Yes No Yes No  Screen Failure, Reason: Date:  Eligible Yes No Yes No  Screen Failure, Reason: Date:  Eligible Yes No Yes No  Screen Failure, Reason: Date:  Eligible Screening and Enrollment Log

59 Protocol Deviation Log From

60 Adverse Event Tracking Log Principal Investigator:HRC Protocol #: Study Title: # Subject ID Date of Event Date PI Aware Description of EventSerious Non- seriousExpected Unexpect ed Severity Scale (CTCA E) Relate dness Date Reported to IRB, if applicabl e Date of IRB ReviewOther

61 Documentation of AEs and UPs Keep log of AEs, SAEs, Unanticipated Problems Track adverse events from time consent is signed, until resolution of any serious events - even after the study period ends. Be consistent with terminology and descriptions. Use a severity scale in evaluating adverse events (CTCAE scale or mild, moderate, severe scale) and document according to scale Decisions regarding AE reporting and management are the responsibility of the PI so keep them in the loop and encourage documentation. The PI has the final decision on causality, severity and relationship of adverse events

62 Templates Available for Documentation (NCRP or NC TraCS) Delegation of Authority (Responsibility) Log Protocol Modification Tracking Adverse Event (UP) Tracking Protocol Violation Log Memo to File Progress Note Template Screening and Enrollment Log Telephone Log Investigational Drug or Device Accountability Consent Process Documentation

63 INFORMED CONSENT PROCESS Claudia Christy, NCRP & NC TraCS Institute

64 Informed Consent Process Both a DOCUMENT and a PROCESS

65 Objectives Review regulatory requirements for Informed Consent Review the Informed Consent Process Review documentation of the Informed Consent Process Review additional required forms for the Informed Consent Process

66 History Historical Nuremberg Code Declaration of Helsinki Belmont Report b_09_02_Belmont%20Report.pdf 4178b_09_02_Belmont%20Report.pdf Code of Federal Regulations (21CFR50 or 45CFR46) ICH GCP 1996

67 Informed Consent ICH Guidelines for Good Clinical Practice (ICH E6) Defines Informed Consent: “A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is a documented by means of a written, signed, and dated informed consent form”

68 8 Basic elements of Informed Consent Consent 45 CFR a & 21 CFR Study involves research, purposes, expected duration, procedures and which procedures are experimental Risk and discomfort Benefits Alternative procedures, available therapies Confidentiality Explanation or more than minimal risk Contact numbers for questions Voluntary, refusal, may discontinue any time Plus Clinical Trials Database if it is a qualifying study and other additional elements

69 Informed Consent: the Document Use sponsor template provided with the protocol or create using IRB templates, personalize for research site 8 th grade reading level (lay language) Don’t cut and paste from protocol, too technical Form should be written in 2 nd person – “You are being asked to take part in a research study.” Avoid pages and pages of pure text – Overwhelming and intimidating Schedule of Events

70 Informed Consent: the Process Consent obtained directly from subject or legally authorized representative BEFORE research begins Before any procedure related to trial is conducted - even just taking a blood pressure Consent Process involves Giving subject adequate information concerning study Providing adequate opportunity for subject to consider all options, responding to subject’s questions Ensuring subject has comprehended this information Obtaining subjects voluntary agreement to participate Giving a copy of consent form to subject, keep original for study files

71 Informed Consent: the Process....ONGOING PROCESS Re-confirm consent periodically during the study Continue to provide information as the subject and situation requires A new, IRB approved, informed consent form must be signed every time the risk changes Don’t need to re-consent at each annual renewal UNLESS changes to the protocol require re-consent

72 Assessing Comprehension The fact that a subject signed a consent form does not mean he/she understood what was being agreed to or truly gave their voluntary consent. Ask open ended questions: What is the study about? What will you need to do in the study? What are the possible risks in the study? How long will the study last? Ask subject to tell you how they would describe to a family member the study and their participation Document answers to demonstrate that informed consent was obtained

73 Documentation of Informed Consent Review signed consent documents: ensure signatures of subject and person obtaining consent, printed names, date accurate Document process of obtaining informed consent in source document and/or medical record Write narrative note of consent process: explain that subject was given the consent form and opportunity to read it; the research protocol was reviewed with subject who was given the opportunity to ask questions, and that all questions were answered; the consent form was signed before any study procedures were performed, and that a copy of the signed consent form was given to the subject. Suggest including time written consent obtained especially if study procedures performed same day

74 Additional Forms for ICP HIPAA authorization Storage of samples SSN Form – signed by subject giving permission to collect SSN for payment Assent (pediatrics) & parental permission Translated consent documents & interpreters Short form – used to document consent and witness for blind, illiterate, non-English speaking subjects

75 Health Insurance Portability and Accountability Act – “HIPAA” HIPAA is a federal law aimed at protecting health information by establishing standards for the use and disclosure of individually identifiable health information (known as Protected Health Information or PHI) created or received by a health care entity. PHI is any information about health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of a patient’s medical record or payment history. When a covered entity discloses any PHI, it must make a reasonable effort to disclose only the minimum necessary information required to achieve its purpose.

76 HIPAA and Research HIPAA requires either a patient authorization or a waiver of the authorization requirement for use of identifiable health information (PHI) for research. IRB makes determination. Most research requires a signed HIPAA Authorization form if accessing a subject’s PHI from medical record. See IRB consent form templates. IRB may waive authorization requirement for retrospective chart reviews reviews preparatory to research "de-identified" data set a limited waiver of HIPAA authorization may be granted by IRB to identify potential subjects for recruitment University provides online HIPAA training for new employees and requires annual renewal training,

77 UNC HCS HD-974 Request for Access to Protected Health Information for Research Purposes Information security form that covers UNCH under HIPAA to document disclosures of PHI Form required for every study that needs access to UNC medical record (WebCIS) to obtain information for research (recruitment, review of eligibility, study follow-up) Send form to UNC Hospital Medical Information Management (MIM) along with IRB approval letter, fax to Send updated form to MIM at time of annual renewal Forms are NOT part of IRB application and should not be submitted to IRB (IRB application does refer to requirement)

78 Questions?

79 PLEASE VISIT FOR A COPY OF THIS PRESENTATION & ADDITIONAL HELPFUL INFORMATION TRACS.UNC.EDU / RESEARCH CENTRAL


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