office of human subject protectionsf. annual research conference ... time, the office at the gsm in...

UT College of Medicine Chattanooga

Office of Human Subject Protections Standard Operating Procedures

Friedl, Sylvia 10/15/2010

001: Authority and permanent position(s) ......................................................................................................... 5

I. Purpose ............................................................................................................................................................. 5

II. Scope ................................................................................................................................................................ 5

III. Background ....................................................................................................................................................... 5

IV. Procedures ........................................................................................................................................................ 5 A. The minimum qualifications for a research compliance officer: .................................................................. 5 B. The essential functions and responsibilities of the research compliance officer: ....................................... 6

002: Development and implementation of human subjects research education strategy for investigators and key personnel .............................................................................................................................................. 7

I. Purpose ............................................................................................................................................................. 7

II. Scope ................................................................................................................................................................ 7

III. Background ....................................................................................................................................................... 7

IV. Procedures ........................................................................................................................................................ 7 A. The target audience for clinical research training and education: .............................................................. 7 B. Needs assessment ........................................................................................................................................ 8

003: Providing training for research faculty and key personnel on human subjects protections .................. 9

I. Purpose ............................................................................................................................................................. 9

II. Scope ................................................................................................................................................................ 9

III. Background ....................................................................................................................................................... 9

IV. Procedures ........................................................................................................................................................ 9 A. CITI ............................................................................................................................................................... 9 B. Institutional officials signing FWA .............................................................................................................. 10 C. Research symposium ................................................................................................................................. 10 D. Research week ........................................................................................................................................... 10 E. Coordinator Forum ..................................................................................................................................... 11 F. Annual research conference ...................................................................................................................... 11 G. UTCOMC Research Compliance Website ................................................................................................... 12 H. Other educational activities ....................................................................................................................... 12

004: Conducting continuing review of human subjects research, monitoring compliance with Institutional Review Board‐approved protocols .................................................................................................................... 13

I. Purpose ........................................................................................................................................................... 13

II. Scope .............................................................................................................................................................. 13

III. Background ..................................................................................................................................................... 13

IV. Procedures ...................................................................................................................................................... 13 A. Protocol selection ...................................................................................................................................... 13 B. Review preparation .................................................................................................................................... 14

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C. Preliminary interview ................................................................................................................................. 15 D. Review of investigator consent forms ........................................................................................................ 16 E. Review of research subject records and source documentation ............................................................... 17 F. Review of investigator regulatory files ....................................................................................................... 18 G. Review of electronic research records ....................................................................................................... 18 H. Documentation and dissemination of audit findings ................................................................................. 19 I. Reporting non‐compliance ......................................................................................................................... 20

005: Serving as a resource to clinical faculty, staff, and subjects regarding compliance policies relevant to human subject research .................................................................................................................................... 21

I. Purpose ........................................................................................................................................................... 21

II. Scope .............................................................................................................................................................. 21

III. Background ..................................................................................................................................................... 21

IV. Procedures ...................................................................................................................................................... 21 A. Services offered by the research compliance officer ................................................................................. 21 B. Maintains access to current federal, state, university and local regulations ............................................. 21

006: Serving as a resource to the IRB for protocol review and oversight .................................................... 23

I. Purpose ........................................................................................................................................................... 23

II. Scope .............................................................................................................................................................. 23

III. Background ..................................................................................................................................................... 23

IV. Procedures ...................................................................................................................................................... 23 A. Protocol preliminary review ....................................................................................................................... 23 B. Education and training ............................................................................................................................... 23 C. Protocol review .......................................................................................................................................... 24

007: Developing a human protections network ......................................................................................... 25

I. Purpose ........................................................................................................................................................... 25

II. Scope .............................................................................................................................................................. 25

III. Background ..................................................................................................................................................... 25

IV. Procedures ...................................................................................................................................................... 27 A. Identifying responsible parties ................................................................................................................... 27 B. Network development ............................................................................................................................... 27

Appendix .......................................................................................................................................................... 28

Appendix 1: Proposed UT HSC Human Subject Education Competencies ............................................................... 29

Appendix 2: Sample Coordinator Forum Annual Schedule ..................................................................................... 35

Appendix 3: Sample protocol review notification letter ......................................................................................... 36

Appendix 4: Sample preliminary interview/protocol review form .......................................................................... 37

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Appendix 5: Sample protocol review report ........................................................................................................... 45

Appendix 5: Sample protocol review final letter..................................................................................................... 48

Appendix 6: Sample corrective action plan required letter .................................................................................... 49

Appendix 7: Sample IRB review form ...................................................................................................................... 52

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UT College of Medicine Chattanooga Office of Human Subject Protections Standard Operating Procedures

001: Authority and permanent position(s)

I. Purpose To document the authority and staffing for the UT COMC Office of Human Subject Protections

II. Scope This SOP applies to the research compliance officer

III. Background The Office of Human Subject Protections and Research Compliance was created in 2002 through

a grant from the Department of Health and Human Services’ Office of Human Research Protection (OHRP) to provide oversight for all activities that pertain to the inclusion of humans as research participants. Its mission is to create an environment that fosters the ethical conduct of human subjects research through quality assurance and education. Officers were hired for the Knoxville, Memphis and Chattanooga campuses of the Health Science Center. Since that time, the office at the GSM in Knoxville has become independent of the Memphis OHSP, but the Chattanooga officer continues to report to the HSC Associate Vice‐Chancellor for Research in Memphis.

The UT COMC Office of Human Subject Protections provides centralized administration and

serves as the primary point of contact for research compliance‐related issues. As such, the function of this office is to provide an interface between campus compliance committees and faculty, staff, and students. It fosters and safeguards the institution’s culture of compliance through:

• Continuous education of key study personnel;

• Ongoing review of human subject research

• Maintenance of resources for research staff and study participants;

• Development, implementation, and review of relevant institutional policies.

IV. Procedures

A. The minimum qualifications for a research compliance officer:

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1. Master’s degree in clinical psychology, nursing, education, public health or other related disciplines is required. Work‐related experience will be accepted in lieu of Master’s degree.

2. Three or more years of appropriate training and experience in applied human subject research.

3. General knowledge of federal regulations regarding compliance policies and human subject research. Must have education and training skills. Must have computer literacy. Excellent written, oral and interpersonal communication skills. Ability to interact with principal investigators, co‐investigators, key research personnel, and clinical research‐related health care professionals.

B. The essential functions and responsibilities of the research compliance officer: 1. Development and implementation of human subjects research education

strategy for investigators and key personnel; 2. Providing training for research faculty and key personnel on human subject

protections; 3. Conducting continuing review of human subjects research, monitoring

compliance with Institutional Review Board (IRB)‐approved protocols; 4. Serving as a resource to clinical faculty, staff (research assistants, nurses,

coordinators) and subjects regarding compliance policies relevant to human subject research;

5. Serving as a resource to the IRB for protocol review and oversight; 6. Developing a human protections network that includes the UT system, the

Health Science Center and partner institutions (eg, Erlanger Health System, risk management, ethics committee, HIPAA security).

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002: Development and implementation of human subjects research education strategy for investigators and key personnel

I. Purpose

To document the development and implementation of a research education strategy for UT COMC investigators and key personnel


III. Background

The Office of Human Subject Protections (OHSP) recognizes that a comprehensive education program reduces risk, helps to maintain institutional integrity and protects those individuals who make research possible, the volunteers. Prior to the establishment of the OHSP, education within the UTHSC system was extremely limited, consisting basically of a one‐time requirement that investigator complete and pass an on‐line tutorial (approximately a one‐hour, one‐time commitment). The OHSP plan (see Appendix 1) for education includes:

• Establishment of the type and scope of education and training required for the UT HSC;

• Identification of individuals for whom education and training is required;

• Encouragement of appropriate education and training for all relevant individuals and documentation of completion;

• Establishment of functional liaisons with newly developed and existing resources to enhance compliance related activities.

IV. Procedures

A. The target audience for clinical research training and education:

• Institutional signatory official

• Human protections administrator

• Institutional research administrators

• Grants/contracts staff

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• Institutional compliance officer(s) including OHSP

• IRB chair(s)

• IRB administrators

• IRB membership

• Department chairs

• Principal and co‐investigators

• Research nurses and coordinators

• UT‐related facility employees (e.g., Knoxville Memorial Hospital, Erlanger Health System, outlying clinics, research organizations who are legally part of the system)

• Residents, medical students

• Human subjects and their families, legally authorized representatives

• Community

• Other human research protection committees (Radiation Safety, Biohazardous agement, HIPAA, etc). Materials, Risk Man

B. Needs assessment

A major challenge in improving human subject protections is teaching healthcare professionals ways of relating to subjects that will assure adherence to the Belmont principles: autonomy, beneficence and justice. The research compliance officer will provide ongoing assessment through:

1. Conducting and participating in surveys and interaction with research faculty, residents and staff;

2. Gathering information and data from regular inspection and monitoring of IRB‐approved clinical trials;

3. Participating in and sponsoring continuing‐education accredited programs that include evaluations and documentation of resulting changes in practice;

4. Participation in research‐related activities within the UTCOMC and Erlanger, including: IRB meetings, SRC activities, ethics committee meetings, regularly scheduled training programs (e.g., annual research symposium, research week)

5. Monitoring changes in policies and guidances including review of accredited programs such as the online IRB Forum, SOCRA, PRIMR, the DHHS OHRP website, FDA alerts, Medicare alerts, etc.

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003: Providing training for research faculty and key personnel on human subjects protections

I. Purpose

To document training in human subject protections that is implemented through the OHSP


III. Background

The Office of Human Subject Protections (OHSP) has created educational offerings that are unique to each of the three HSC campuses. The one comprehensive training program that is required of all faculty, staff, residents, and medical students who are involved in research is the Collaborative IRB Training Initiative (CITI). It was founded in March 2000 as a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a web‐based training program in human research subject protections. It is used by many centers around the country and has become the standard of training for academic research institutions. Additional programs are tailored to meet the needs of the UT COMC community, as outlined below.

IV. ocedur s Pr e

A. CITI

1. Documentation of completion is required before an investigator can submit a project to the Institutional Review Board. The OHSP officer serves as the CITI administrator and can monitor the learners’ certifications as well as the curriculum. The IRB administrator also has CITI administrative privileges.

2. To register onto the program the learner requires a UT username and password. Once registered, a list of required and optional tutorials is provided. Successful completion of the program is registered automatically by the CITI system.

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3. Training is updated every three years. CITI automatically notifies the learner by email of the need to update his/her certification.

4. Instructions for registering for the course are available on the UTCOMC website, Compliance pages. on both the IRB and Research

B. Institutional officials signing FWA

1. Officials signing the federal wide assurance through the DHHS Office for Human Research Protections are required to have knowledge of the federal regulatory structure. This is provided through the OHRP website.

2. IO’s are also requ

C. Research symposium

ired to complete CITI training, including updates as appropriate.

1. The UTCOMC sponsors an annual conference to provide the “nuts and boots” regarding research methods and to encourage and engage community academic investigators in the development of research as well as promoting the ethical conduct of research. Faculty, residents, fellow and medical students are encouraged to attend, and the Dean requires that all residents and fellow attend the conference at least once during their training.

2. The research compliance officer is part of the planning committee for this event. Other members of the planning committee include the Graduate Medical Education (GME), the GME administrator, the COMC associate dean for academic affairs, and the Continuing Medical Education (CME) director, and the UTCOMC Director of Research. Curriculum regarding compliance issues can be included as plenary or break‐out sessions, depending on the subject matter and audience.

3. There are limited funds available for this program through GME .

4. The progra

D. Research week

m is accredited through the UTCOM CME office.

1. The annual research week is a multidisciplinary event to highlight and recognize research and scholarly activity. The week culminates with a judging of posters and oral presentations.

2. The research compliance officer is part of the planning committee for this event. Other members of the committee include the Graduate Medical Education (GME), the GME administrator, the COMC associate dean for academic affairs, and the

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Continuing Medical Education (CME) director, and the UTCOMC Director of Research.

3. The research compliance officer oversees the ongoing education and training for residents and medical students who are submitting research for review, including completion of CITI, IRB review (either for exemption or Board approval), HIPAA training, and appropriate informed consent of participants.

4. Funding for the judges, awards, and dinner are available through GME.

5. Forms for submission and judging criteria are available on the UTCOMC website. The schedule of deadlines and events are on the website and included in the UT

newsletter. COMmunicator

E. Coordinator Forum

1. The Research Coordinator Forum is a monthly “brown‐bag lunch” series that is open to all research nurses, coordinators, and key personnel involved with and interested in research (including Erlanger and community researchers).

2. The research compliance officer is the director of this forum and is responsible for curriculum (with the Dean’s approval), selection of speakers, and securing a location.

3. The forum is approved for continuing education units through the University of Tennessee at Chattanooga continuing education department. There is no charge for attendance, but there has been a $10 per certification request per attendee fee requested from the continuing education department. (Certification can be for multiple forums.)

4. The schedule is posted on the UTCOMC website, in the UT COMmunicator gh directed email announcements (see Appendix 2). newsletter, and throu

F. Annual research conference

1. An annual research compliance conference has been offered for the UTCOMC community since 2004. It is a half to full day offering on current issues in compliance, e.g. conflict of interest, informed consent, vulnerable subjects.

2. The research compliance officer is the director of this forum and is responsible for the content (with the Dean’s approval), selection of speakers, and securing location and funding.

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3. The conference is offered without charge to promote the University’s intent to protect human subjects. Support has also been received from the Graduate Medical Education program and Erlanger Health System.

4. The conference is approved for accre

G. UTCOMC Research Compliance Website

ditation through the UTCOM CME office.

1. The research compliance officer is responsible for maintenance and content for the Research Compliance website, housed under the UTCOMC site.

2. The website contains information and links to resources regarding education/training, guidance and resources, and policies (federal, state, university and local).

H. Other educational activities

1. The research compliance officer is responsible for disseminating information to the research community as needed. This may include presentations at department/program meetings (rounds), at IRB meetings, at SRC meetings, or in consultation with principal investigators and their staff.

2. Research updates can be provided through the UTCOMmunicator newsletter. An ongoing column, Note to PI, is an established mechanism for reaching the faculty and other key personnel.

3. The research compliance officers from all three campuses will share information and meet as deemed necessary by the Associate Vice‐Chancellor for Research in Memphis.

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004: Conducting continuing review of human subjects research, monitoring compliance with Institutional Review Boardapproved protocols

I. Purpose

To document the process for monitoring UTCOMC human subject research


III. Background

The University of Tennessee Institutional Review Board (IRB) is mandated by Federal Policy 45 CFR 46 to provide ongoing oversight of protocols that have been approved. Specifically the policy reads, “An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.” The research compliance officer, at the direction of the UTCOMC IRB, reviews research studies to confirm compliance with issues such as appropriate screening and enrollment numbers, inclusion/exclusion criteria, informed consent, protection of participants’ privacy, and appropriate IRB reporting. This can also provide an opportunity for continuing education with the principal investigator and key personnel. In addition, the research compliance officer also serves as a resource for the IRB, providing support for timely submission of IRB documentation, appropriate level of IRB review, and current knowledge of federal, state, university and local policy and guidance.

IV. Procedures

A. Protocol selection

1. The research compliance officer is responsible for selecting protocols at random for review. They may be selected from full board, expedited or exempt studies.

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2. The IRB may request that the research compliance officer review any protocol, either for cause (with a specific concern identified) or as follow up to an known infraction.

B. Review preparation

1. After a protocol is identified for review, a written notification will be sent to the principal investigator by the research compliance officer. A research coordinator, if identifiable, may also receive a copy of the notice. (See Appendix 3, Sample Letter)

2. For investigators with an email address, the notice may be sent electronically in addition to hard‐copy.

3. Information documented during a protocol review (not all may apply)

• IRB process o Dates of approval relative to initiation of research activities o Dates of modification approval relative to implementation o Lapse of approval o Progress reports

• Consent process and documentation o Correct version of consent form document o Signed and dates by subject and person obtaining consent o Presence of extemporaneous modifications o Correct emergency contact information o Narrative documentation of informed consent process o Placement of consent document in electronic medical record

• Records regarding subjects o Documentation of all points of eligibility criteria o Documentation of all study activities o Documentation of follow up activities o Copies of source documenting in research records o Reporting of adverse events to appropriate regulatory offices o Documentation of terms of subject termination from study o Review of data collection tools/procedures

• Test article accountability o Proper storage of test article o Review of inventory records (dispensing and retrieval) o Review of return or disposal records

• Documentation o Regulatory files/records

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o IRB files/records o Sponsor correspondence o Monitor visits

4. Prior to the review, the principal investigator will be contacted to make arrangement for the visit. With the investigator’s permission, arrangements can be made through the research coordinator or other designated research staff. The initial contact should take place within one week of the receipt of the written notification.

5. If the investigator is unable to comply within the one week frame, the IRB chair will be notified of problems in scheduling the audit in a timely manner. Unless the IRB Chair directs otherwise, the audit date will be set at the first agreeable date between the investigator and the research compliance officer.

6. Prior to conducting the review, the research compliance officer will obtain and review the research protocol file maintained in the IRB office to document:

a. Dates of initial protocol review and approval by the IRB

b. Nature and dates of any modifications to the IRB approved protocol, e.g. changes in entrance criteria, study procedures, drug/device administration (if applicable)

c. Dates of approval granted by the IRB

d. Lapse of approval

This information will create a protocol timeline, which will be used as reference during the course of the review. Any inconsistencies noted between protocol submissions will be documented and included in the review report. See

ple Preliminary Interview/Protocol Audit Form. Appendix 4, Sam

C. Preliminary interview

1. A preliminary interview is held prior to the conduct of an investigator site review with a member or members of the respective research staff. This interview is performed to identify the names of individual(s) responsible for various protocol related activities, such as:

• IRB submission

• Recruitment measures/advertising

• Screening

• Informed consent

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• Randomization

• Physical exam

• Blood drawn (if applicable)

• Questionnaires

• Record keeping

• Storage of records

• Drug accountability

• Data security

• Data analysis

• Data monitoring

• Staff education

2. During the interview, information may also obtained regarding:

• Number of subjects screened and enrolled into the study

• Number of sites involved, if the study is multi‐center

• Occurrence of adverse events

• Occurrence of site monitoring visit(s)

• Adherence to data and safety monitoring plans

• Difficulties in consent

• Difficulties in subject recruitmen

D. Review of investigator consent forms

t or in study conduct.

1. Informed consent documents will be reviewed for the presence of the following documentation:

• The signature of the subject or the subject’s legally authorized representative (LAR)

• The signature of the investigator

• Dates written adjacent to each signature in the hand of the signatory

• Narrative documentation in the case history regarding the informed consent process

2. Additional items to be assessed during the review include (but are not limited to):

• Presence of the IRB approval date of the informed consent document along with the expiration date

• Utilization of the correct version of the IRB approved consent form for each subject (or if appropriate, a specified selection of forms)

• Consistency between the type and frequency of side effects listed in the informed consent document to those that actually occur

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• Presence of any extemporaneous modifications to the informed consent document

• Determination that informed consent was obtained prior to the initiation of any research‐related procedures

E. Review of research subject records and source documentation

1. The research compliance officer’s review of the research records of human subjects enrolled into the research study will:

a. Evaluate the investigator’s raw data file in terms of organization, condition, completeness, and legibility.

b. Determine whether there is adequate documentation to assure that all audited subjected did exist and were alive and available for the duration of their stated participation in the study.

c. Compare the investigator’s research participant records (i.e. the case report form(s)/data collection tool(s)) with the source documentation to verify the accuracy of the participant’s records relative to the source documents.

d. Determine whether each record contains:

i. Observations, information, and data on the condition of the subject at the time of entry into the study;

ii. Observations and data on the condition of the subject throughout participation in the study as well as at study closure;

iii. Records of exposure of the subject to the test article, if applicable.

2. Review of the research subject’s records will also assess if:

a. Inclusion/exclusion criteria were met as stated in the IRB‐approved protocol.

b. Screening, study and follow‐up procedures were carried out as written in the IRB‐approved protocol.

c. Adverse events occurred and were reported in accordance with IRB and sponsor requirements.

3. The research compliance officer will evaluate whether the procedures performed on the research subject were described in the IRB approved protocol

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and consent document and if there were any modifications to the study eir approval by the IRB. protocol implemented prior to th

F. Review of investigator regulatory files

The research compliance officer will review the regulatory files maintained by the investigator to confirm appropriate contents including, but not limited to:

• Protocol

• Informed consent

• IRB correspondence

• Sponsor correspondence

• Sponsor monitoring log/reports

• Serious and unexpected adverse events

• Data and safety monitoring reports

• Drug/device accountability

• Laboratory certification

• Range of normal values

• Investigator’s CV

• Training certifications

• Signature list

• Final study report

• FDA correspondence (i.e., for investigator‐sponsored INDs and IDEs)

• Investigator’s brochure

• Form FDA 1572

• Form FDA 1571

G. Review of electronic research records

For research that involves the use of electronic records, the research compliance officer will ascertain the following information:

• Who was responsible for the software/hardware installation and training?

• Who has access to the computer and is it password‐protected?

• Were there any record‐keeping problems experienced during the course of the study?

• What is the source of the data entered into the computer, e.g., direct, case report form, office record, other?

• Who enters data and when?

• How are changes made to previously entered data?

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• How are data submitted to the sponsor (i.e., modem, network, fax, hard disk, electronic transfer, mail, messenger)?

• If the sponsor discovers an error, omissions, etc., in the data received, what contacts are made with the investigator? How are corrections implemented, and how are they documented?

• Does the investigator retain a copy of the electronic data?

H. Documentation and dissemination of audit findings

1. The research compliance officer will prepare a written report for each investigator and for distribution to the appropriate parties. The report will include (but not be limited to):

a. The IRB number and title of the study b. The name of the principal investigator c. The date of the review d. The name of the compliance officer e. A brief summary of the study f. A summary of the pre‐audit interview g. A summary addressing IRB correspondence h. The extent of the review (number of records reviewed) i. A summary of findings

j. Recommendations shall be made for each of the summaries as indicated. If necessary, the investigator shall be requested to provide written clarification or outline a plan of corrective procedures.

2. A draft of the audit report shall be reviewed with the IRB Chair, or if appropriate

the full board. Comments and recommendations of the IRB will be incorporated into the final version.

3. A copy of the report shall be sent to the:

• Principal investigator

• Study coordinator

• IRB for inclusion in the IRB binder/record

• Department chair when appropriate. 4. The principal investigator is expected to respond within the timeframe indicated in

the letter. If there are extenuating circumstances, the principal investigator may request an extension of the response due date.

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5. All communications regarding modifications to the protocol and consent form as a result of the audit will be coordinated by the IRB.

6. All communications regarding the audit process, i.e., the principal investigator’s

response to review findings, will be coordinated by the research compliance officer. 7. When the review process is complete, a copy of the audit summary are related,

pertinent correspondence will be placed in the respective IRB protocol file by the IRB administrator or the research compliance officer.

I. Reporting non‐compliance

1. The research compliance officer will report the following findings to the IRB chair as soon as possible after they are identified:

• Evidence of a serious adverse event or unexpected adverse event of moderate or greater severity that appears to be associated with the research intervention and was not reported to the IRB.

• Evidence of the performance of research procedures of greater than minimal risk not previously approved by the IRB.

• No documentation or evidence of informed consent for subject(s) enrolled in research activities of greater than minimal risk.

• Evidence that research subjects audited did not meet the eligibility criteria as written in the IRB approved protocol.

• Deviation from IRB approved experimental procedures observed in the majority of the research subjects audited.

• IRB‐approved follow‐up procedures not performed on the majority of the research subjects audited.

2. The report may initially be a verbal report. However the findings will also be

documented and submitted via the “Significant adverse event report” (Form E). 3. In the event that the review results in information that must be reported to a

governmental oversight office (i.e., FDA or OHRP), all communications will be reviewed by the UT COMC Dean and the chair of the IRB prior to mailing.

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005: Serving as a resource to clinical faculty, staff, and subjects regarding compliance policies relevant to human subject research

I. Purpose

To define the service of providing resources relevant to human subject research


III. Background

The Office of Human Subject Protections (OHSP) provides centralized administration and serves as the primary point of contact for research compliance related issues.

IV. Procedures

A. Services offered by the research compliance officer 1. Consultation during protocol preparation;

2. Pre‐review of protocols, consent forms, and other compliance‐related documents; identifies where modifications need to be made; and assists responsible parties in making those modifications before approval is sought from appropriate compliance entities;

3. Prepares documents necessary to maintain accreditations and assurances, if already obtained, and secures needed assurances and accreditations when needed.

4. Facilitates conflict resolution of compliance related issues. 5. Offers and coordinates research compliance related education and training. 6. Conducts monitoring to ensure that approved procedures, agreements, and

arrangements are being conducted appropriately.

B. Maintains access to current federal, state, university and local regulations

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The research compliance officer is expected to, as much as is possible, maintain current knowledge of federal, state, university and local policies regarding human subjects research. Sources of policy include (but are not limited to):

• Office for Human Research Protections (OHRP)

• Food and Drug Administration (FDA)

• Good Clinical Practice Guidance

• International Code of Harmonization

• Health Insurance Portability and Accountability Act (HIPAA)

• Centers for Medicare and Medicaid Services (CMS)

• Institutes of Medicine Reports

• University of Tennessee Faculty, Medical Resident, and Student Handbooks

• University of Tennessee Policies

1. Policies that are most commonly used can be linked from the UT COMC research compliance website.

2. Notification of relevant changes may require reporting in the UT COMmunicator newsletter, letters to faculty and/or staff, email notification, and/or special educational events. The research compliance officer can coordinate these events through the Dean’s Office (Continuing Medical Education, Graduate Medical Education, Institutional Review Board, Scientific Review Committee)

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006: Serving as a resource to the IRB for protocol review and oversight

I. Purpose

To describe the service of the research compliance officer to the Institutional Review Board (IRB)


III. Background

The UT COMC research compliance officer is an ex officio member of the IRB. As such, the compliance officer does is not allowed to propose or second motions or to vote.

IV. ocePr dures

A. Protocol preliminary review

1. The IRB administrator delivers a binder that contains all new/proposed protocols as well as reports of adverse events, continuing review, and study closures to the research compliance officer approximately one week prior to the meeting. See Appendix 7: Sample IRB review form.

2. The research compliance officer will review the new protocols for:

• Content

• Adequate language in the informed consent

• Possible conflicts of interest or commitment

• Appropriate IRB level of review (full board, expedited, exempt)

3. The research compliance officer will review the balance of the agenda items for:

• Appropriate timing of continuing review (<365 days from previous review)

• Timeliness of adverse/significant event reports

• Appropriate leve

B. Education and training

l of IRB review (full board, expedited, or exempt)

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1. All IRB members are required to complete CITI training (see SOP 003)

2. The research compliance officer may update the Board on new issues of federal, state, local or university guidance and policy as they arise.

3. The research compliance officer informs IRB members regarding Nuts and Bolts Research Symposium, the annual research compliance conference, relevant grand rounds, and Erlanger Ethics Quarterly presentations and encourages their

ion/attendance. participat

C. Protocol review

1. The IRB may refer for‐cause issues to be reviewed by the compliance officer as noted during a meeting.

2. The IRB may refer follow‐up of enrollment or other concerns to the compliance officer as noted during a meeting.

3. The compliance officer may report issues discovered during study review to the IRB, or may answer questions regarding a Review Report Draft (see SOP 004.H.1)

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007: Developing a human protections network

I. Purpose

To describe the implementation of a network that includes the UT system, the Health Science Center, and partner institutions


III. Background

The Institute of Medicine lists the following as necessary conditions for a sound protection program1:

• Accountability—to assure the quality and performance of the protection program;

• Adequate resources—to assure that sufficiently robust protection activities are in place;

• Ethics education programs—to provide research personnel and oversight committees with the knowledge necessary to carry out their obligation to conduct or oversee ethically sound research; and

• Transparency—to ensure open communication and interaction with the local community, research participants, investigators, and other stakeholders in the research enterprise.

The research compliance officer is charged with the coordination of protection functions which requires the ability to create a network among the many parties involved in the research process.

1 Responsible Research: A Systems Approach to Protecting Research Participants, The National Academic Press, 2003, p 52.

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I Pr dures

A. Identifying responsible parties

V. oce

The UTCOMC research enterprise involves a wide range of participants. These include (but are not limited to):

• The research participant

• The research participant’s family

• The principal investigator

• Other key research personnel

• The chair of the department or program who has approved the study

• The Scientific Review Committee

• The Institutional Review Board

• The UT grants and contracts office

• The UT legal department

• The UT administrative offices (both in Memphis and Chattanooga)

• The Erlanger Health System legal department

• The Erlanger compliance office

• Erlanger risk management

• The Erlanger Billing/Coding/Admissions Departments

• The Erlanger Ethics Committee

• The NCI Institutional Review Board

• Private practice physicians whose research is at least partially done at Erlanger Hospital

• The UTCOMC Conflict of Interest committee

• The University o

B. Network development

f Tennessee at Chattanooga IRB

The research compliance officer can develop a network among these entities through educational offerings, by tracking issues that arise through protocol reviews, attendance in departmental/program rounds and other institutional events. Each officer will bring unique skills to the position, but the ultimate goal is the same: providing a safe environment in which clinical trials may be successfully implemented.

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Appendix

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Appendix 1: Proposed UT HSC Human Subject Education Competencies2

Target Audience Competencies Required

Implementation Strategy

Materials available Update required

Institutional Signatory Official Human Protections Administrator

Knowledge of the federal regulatory structure FWA Federal regulations Definition of function & of each component of human research protection program (HRPP) Overview of program accreditation process and specific knowledge of accreditation standards at level of the institution Continuing education on evolving issues of human subject participation protections

Mandatory OHRP tutorial Mandatory UT tutorial Individualized professional development including leadership, team building, regional/national conferences on protecting human subjects

Currently required for FWA Currently UT tutorial is available, OHSP recommending change to more comprehensive tutorial (CITI)

Every 3 yrs Every 3 yrs

Institutional research administrators & Grants/Contracts staff

Knowledge necessary to create an environment that promotes the responsible conduct of research

Mandatory UT tutorial Individualized professional development including federal regulations, team building, regional

Currently available (see above)

Every 3 yrs

2 Competencies from Responsible Research, A Systems Approach to Protection Research Participants, IOM, 2003)

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FWA Federal regulations

& national conferences on protecting human subjects

Institutional compliance officers including OHSP

Knowledge of federal regulatory structure FWA Overview of federal regs Understanding of certification process for IRB professionals and investigators Definition & function of each component of human subject protection program Overview of institutional accreditation process Continuing ed on evolving issues

Mandatory UT tutorial Individualized professional development including federal regulations, leadership, team building, regional/national conferences on protecting human subjects, ethics, auditing and oversight, handling difficult situations, managing conflict of interest, research misconduct investigations OHSP Institutional Self Assessment NCQA/JCAHO AAHRPP Membership in appropriate organizations (PRIMR, ARENA, SOCRA

Currently available (see above) Materials available on line or by purchase Requires institutional support

Every 3 yrs OHSP Self Assessment to be initiated in 2004-2005 Ongoing

IRB Chair IRB administrator IRB Members

FWA IRB policies and procedures Investigator’s Manual UT Tutorial HIPAA Tutorial OHRP Module (chair)

Currently up to date; confirm that correct copy is at all sites Site specific needs, some are more current than others Available in Chattanooga, ?other sites Mandatory Mandatory Mandatory for FWA

Written copy, Website OHSP office Written copy IRB Website Written copy IRB Website Currently available (see above) HIPAA Compliance staff Currently available

Every 3 yrs Annual review Update with to P&P Every 3 yrs Annual update Every 3 yrs

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Knowledge of OHSP Website, Hotline Continuing ed on evolving issues Good Clinical Practice Guidelines Ongoing education at IRB meeting New member orientation

Details on OHSP brochure Individualized professional development including leadership, team building, dealing with difficult people, regional/national conferences on protecting human subjects (eg ARENA, PRIMR, SoCRA) Currently available Currently in practice Orientation times vary at different campuses, need to identify

Currently available Currently available on limited basis IRB, OHRP, FDA websites Handouts at meetings, review of IRB 101 program, newsletters, internal OHSP protocol audits OHSP needs to create packet of information for distribution, brochure is currently available. Should include P&P, areas of responsibility, current events, and UT Human Subjects Tutorial (or CITI when available)

Ongoing distribution Ongoing Ongoing Ongoing Varies at different campuses

Department Chairs

Overview of federal reg structure FWA Knowledge of professional codes of research ethics Knowledge of review process for scientific merit

UT Tutorial Written copy, IRB website

Currently available but not mandatory (see above) Currently available

Every 3 yrs Every 3 yrs Ongoing

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Knowledge of program accreditation standards (when appropriate) Ability to perform (or designate) first scientific review of protocols

Principal & co-investigators

Knowledge of federal regulations for funded research FWA IRB Policies and Procedures Investigators Manual OHSP Website, Hotline HIPAA Good Clinical Practice Guidelines

Mandatory UT tutorial Advised in Faculty Handbook and orientation OHSP education through departmental rounds, distribution of OHSP brochure UT Tutorial Currently available

Currently available (see above) Available on IRB website and hard copy Internal OHSP protocol audits Brochure currently available HIPAA compliance staff IRB, OHSP, FDA websites

Every 3 yrs Ongoing Ongoing Annual update Ongoing

Research nurses and coordinators

Knowledge of federal regulations for funded research FWA IRB Policies and Procedures Investigators Manual OHSP Website, Hotline

Mandatory UT tutorial Advised in Faculty Handbook and orientation OHSP education through departmental rounds, distribution of OHSP brochure

Currently available (see above) Available on IRB website and hard copy Brochure currently available

Every 3 yrs Ongoing Ongoing

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HIPAA Good Clinical Practice Guidelines Current issues, best practices, local policies

UT Tutorial Currently available OHSP sponsored nursing & coordinator forum OHSP internal protocol audits

HIPAA compliance staff IRB, OHSP, FDA websites Currently operational at all three campuses Currently operational at all three campuses

Annual update Ongoing Monthly

UT-Related (Hybrid) Facility Employees

FWA IRB Policies & Procedures Overview of federal regs OHSP Website and hotline HIPAA

Currently available Reviewed at time protocols are submitted Mandatory UT Tutorial OHSP Brochure distribution UT HIPAA tutorial

IRB & OHSP websites IRB website and printed copy UT currently available (see above) Currently available HIPAA compliance staff (orientation)

Ongoing Every 3 yrs or orientation Ongoing Annual update

Residents, medical students

FWA IRB Policies & Procedures Overview of federal regs OHSP Website and hotline HIPAA Good Clinical Practice Guidelines UT Policies and Procedures

Currently available Reviewed at time protocols are submitted Mandatory UT Tutorial OHSP Brochure distribution UT HIPAA tutorial Currently available Orientation

IRB & OHSP websites IRB website and printed copy UT currently available (see above) Currently available HIPAA compliance staff IRB, OHSP, FDA Websites Education through faculty interaction Faculty Handbook

Research orientation Annually reviewed Orientation, every 3 yrs Annual update Ongoing Ongoing

Newly hired FWA Should be in Faculty Presented by OHSP Orientation

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faculty/staff Knowledge of IRB & HIPAA

Handbook and UT HSC website

or other UT staff personnel at orientation

Human Subjects, Families, Community

Institutional commitment to the protection of human subjects Knowledge of IRB, OHSP, hotline

Bill of Patient’s Rights OHSP Brochure IRB Website Informed Consent

Need to check and see what each hospital distributes at admission Currently distributed as appropriate

Community development and outreach future goal

Other Human Research Protection Program committees

UT needs to develop a strategy to promote a cohesive working relationship throughout HSC

Suggestions: Research roundtable with periodic meetings by campus or by HSC general meeting to coordinate efforts HRPP Directory

Should include existing programs (eg IRB, Radiation Safety, Biohazardous Materials, Conflict of Interest Committee, HIPAA, Ethics Committees, Risk Management, Grants/Contracts Office

Human Research Protection Program Reference Library

Repository for all documents relating to human subject protections

Should include current literature, UT policies, Faculty Handbook, IRB Policies and Procedures, HIPAA, List of website references, newsletters, etc.

OHSP Office Ongoing

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Appendix 2: Sample Coordinator Forum Annual Schedule

Research Coordinators and Nurses Forum

Research Compliance 2009-2010

CEU credit available

UT COMC Conference Room Fourth Tuesdays, 12 Noon

September 11, 2009 Clinical Research: Nuts & Bolts UTC Student Center http://utcomchatt.org/docs/2009Nuts_Bolts_Brochure.pdf

February 23, 2010 Cultural Guideposts to Patient Care and Consent Elizabeth Appling, MBA

October 27, 2009 Team Building Exercise— Sim-Man Victor Kolade, MD

Thursday, February 25, 2010 Research Symposium Probasco Auditorium Contact Sylvia Friedl for details

November 24, 2009 Research Budgets to be Thankful For Christy Westmoreland

March 23, 2010 IHI—Patient Safety and Research Catherine Payne, MD

December 22, 2009 No program this month

April 27, 2010 Nanotechnology & Grant Overview Riddhi Doshi, MBBH, MPH

January 26, 2010 The Stroke Center: Research overview and tour Pat Jolley, RN, T. Devlin, MD

May 25, 2010 IRB and Contracting Update Stacey Hendricks, CIM

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http://utcomchatt.org/docs/2009Nuts_Bolts_Brochure.pdf

http://utcomchatt.org/docs/2009Nuts_Bolts_Brochure.pdf

Appendix 3: Sample protocol review notification letter

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Appendix 4: Sample preliminary interview/protocol review form

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Appendix 5: Sample protocol review report

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Appendix 5: Sample protocol review final letter

48

Appendix 6: Sample corrective action plan required letter

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Appendix 7: Sample IRB review form

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office of human subject protectionsf. annual research conference ... time, the office at the gsm in...

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