The West Virginia University Office of Research Integrity & Compliance (ORIC)

ORIC is committed to helping faculty, staff, and students comply with all applicable federal, state, and institutional requirements and policies. Research integrity and compliance areas covered by this office include human research protections, animal welfare, biosafety, conflict of interest in research, export control and the responsible conduct of research. The ORIC Newsline online newsletter has the goal of keeping the WVU research community informed and up-to-date on policies and procedures, guidelines, educational programs, regulatory changes, and monitoring and accountability in these areas.

Human Research Protections

The Transition from BRAAN to Kuali-Coeus (KC)

Our office has received numerous questions recently about the transition from BRAAN to KC. Primarily, researchers are asking if they should wait to submit their protocols via KC rather than BRAAN. Please do not wait to submit your IRB document since BRAAN will still operate in parallel with KC for at least one year after KC launches (tentatively scheduled for the Spring semester). This will allow you to maintain full access to your documents in BRAAN if you submit shortly before the launch of KC. In short, waiting for KC to launch in order to submit your IRB document will not provide any added benefits.

Training for KC

Research Office Information Technology (ROIT) will begin implementing several training programs prior to the release of the KC system. These training programs include Internet-based video training, a KC test-drive portal (https://testdrive.kc.kuali.org/kc-ptd/portal.jsp), one-on-one training, and group training sessions. Anyone planning to work with Kuali should familiarize themselves as much as possible with the system for their own benefit.

The WVU community is encouraged to follow the status of this project and provide feedback. Please ‘Like’ us on Facebook at WVU Kuali Coeus (KC) for weekly updates. Also we encourage the WVU IRB investigators to sign up for the WVU Office of Research Integrity and Compliance (ORIC) IRB listserv on the ORIC website at http://oric.research.wvu.edu/ . For further information please contact us at ResearchIT@mail.wvu.edu or 3-5967 in the Research Office Information Technology department.

Responsible Conduct of Research

Adoption of New University-wide Policy

West Virginia University administration has adopted a new Responsible Conduct of Research (RCR) Education Policy for all new incoming graduate students, postdoctoral fellows, and faculty members. This new policy will go into effect on August 16, 2012. Therefore, all new graduate students, postdoctoral fellows, and faculty hires must take the CITI RCR course and receive a passing grade of 80% or better within 30 days of the beginning of their tenure at WVU.

The Office of Research Integrity and Compliance (ORIC) will publish a training list derived from the CITI website database of those who have taken the training. This list will be published daily on the ORIC website (http://oric.research.wvu.edu) in the “Training Lists” section. Each department (preferably utilizing a full-time staff person or office administrator) will then be responsible for ensuring that each incoming graduate student, postdoctoral fellow, and faculty member in the department has completed the most applicable RCR online courses via CITI by using the daily list.

Training checks should be done on all incoming faculty and graduate students at the beginning of each semester (Fall, Spring, and Summer). Furthermore, training checks should be done whenever a new faculty member or graduate student arrives at the University during any semester on any non-regular date. If any faculty member or graduate student remains out of compliance for more than 30 calendar days, then he or she must be reported as being in non-compliance to the ORIC. The ORIC will then take any necessary action. Audits will be conducted by the ORIC on random departments within the University every 30 days to ensure that departments are fulfilling their responsibility for conducting appropriate training checks.

For questions, concerns, and inquiries please contact Jonathan Young by e-mail at Jonathan.Young@mail.wvu.edu or by phone at (304) 293-1119.

Animal Care and Use

Pain, Distress, and Refinement in Animal Research

The WVU IACUC is responsible for evaluating all procedures being done on animals for research, teaching or testing at WVU. One component of this evaluation is the potential for pain or distress during the course of the proposed study. If there is pain or distress that may occur during the study, the committee must perform a harm/benefit analysis that assesses the severity and duration of that pain. If pain or distress will occur that cannot be alleviated, scientific justification must be provided. It is up to the IACUC to determine the appropriateness of the scientific justification. For example, there should be more than the unsupported statement that analgesics might interfere with the purpose of the study. Finally, if pain is likely to occur, the protocol must describe criteria for early removal from the study.

Pain and distress in animals
Pain as an outcome of procedures that are carried out on animals must be minimized. It is the responsibility of the investigator to predict and prevent pain in their animal subjects whenever possible. If it is not known whether pain may occur, often a pilot study is required to gauge the potential for pain during the proposed procedures, and ways of alleviating any resulting pain must be planned.

Refinement
Refinement is the third of the “Three R’s” of alternatives and was first introduced in the 1959 book by William Russell and Rex Burch, The Principles of Humane Experimental Technique. Refinement is defined as “techniques that minimize any pain or distress the animals may experience” and covers anything that serves to reduce the animals’ pain and distress or to enhance their well-being.

Examples of minimizing pain and distress
• Giving an animal appropriate medication for pain;
• Using techniques that are less invasive to the animal; or
• Offering animals appropriate toys to play with.

Searching for alternatives to painful or distressful procedures
Things to consider before beginning your search:
• Note the objectives and endpoints of the study;
• Note the drugs or compounds used in the procedures:
• Note the methods or procedures using animals that may cause pain or distress;
• Note potential alternative procedures that you know of; and
• Select the databases that are appropriate for the area of study, keeping in mind the type of protocol (research, teaching, testing, etc.).
Once you have considered these issues, develop a conceptual search strategy using the keywords and concepts that you noted above. Be sure that your search strategy is flexible, dependent both on the topic and on the database selected.
If too many records are retrieved, additional relevant terms may make the results fewer and more useful; if too little is retrieved, fewer terms and a more conceptual approach may identify the relevant material. As a rule of thumb, a well done search should retrieve 10-50 hits.

Summarizing the findings from your search
Once you have completed your search for alternatives to painful or distressful procedures, an explanation must be provided detailing what alternative-related information you found. In this explanation, you must indicate how you are integrating those alternative methods, procedures, or models into your protocol, as well as why you are not using others.
Please note that this information is relevant to sections 11.B.1 and 11.B.2 on the WVU IACUC Protocol Application for the Use of Animals.

Biological Safety and Export Control

Biological Safety

Currently, the ORIC is developing a full WVU Biosafety Manual in order to better serve researchers who conduct studies using biological material. This manual is also being developed in the hope that federal, state, and University regulations be more fully and thoroughly understood.

Our office is also working on the development of the WVU Sharps Policy and the WVU Exposure Control Plan. Biosafety registration documents and the CITI Biosafety training requirements will also be undergoing changes.

The Biosafety website will soon be refurbished so that forms, guidance, and regulations are better organized for easier researcher access.

Export Control

The Export Control website will soon be refurbished so that forms, guidance, and regulations are better organized for easier researcher access.

Conflict of Interest in Research

Any University investigator/key personnel engaged in a research study, regardless of the source of funding, who wishes to be eligible to engage in a particular research program shall have an ongoing duty to complete and file annually (by June 30th of each year) the WVU Disclosure of Interest in Research (DOIR) Form. This form was previously entitled “Conflict of Interest in Research Certification Form.” Federal regulations require the University to manage any potential conflicts of interest through an appropriate management process which is initiated and generally resolved through disclosure. If any questions arise as to who must complete and file a DOIR, or whether the DOIR is up to date please contact our office.

New federal regulations regarding the disclosures made on the WVU Disclosure of Interest in Research (DOIR) Form and the WVU Supplemental Disclosure Form will go into effect in July 2012. Currently amounts over $10,000 earned through employment, consulting, or financial or significant relationships, including ownership, outside of an individual’s University activities need to be disclosed. With the new regulations, amounts earned over $5,000 for payments for services and/or equity interests earned through employment, consulting, or financial or significant relationships, including ownership, outside of an individual’s University activities will need to be disclosed on the DOIR and Supplemental Forms. An equity interest of 5% or more will still need to be disclosed for interests in publicly traded entities. With the new regulations, any equity interest in non-publicly traded entities will also need to be disclosed.
The ORIC would also like to announce that Conflict of Interest will become a working part of the Kuali Coeus electronic system in late 2012.

If there are any questions regarding anyone who needs to complete and submit a DOIR Form, whether or not a DOIR is currently on file, or any other questions regarding the WVU Policy, please feel free to contact Joy Edwards (304-293-5475) or Dr. Daniel Vasgird, ORIC Director (304-293-6094).

For more information, please visit http://oric.research.wvu.edu/conint.

Other Notifications

The Availability of EthicsPoint Reporting

We would like to remind the WVU community that the University has an anonymous system for reporting possible violations of the University’s policies.

WVU has joined with EthicsPoint to establish a website to report possible violations at https://secure.ethicspoint.com/domain/media/en/gui/14303/index.html. There is also a toll-free hotline: 866-413-1955.

Reporting via the website can be done in one of three categories:
• Accounting and Financial Matters, which focuses on accounting or disclosure issues, fraud, theft or other financial issues
• Research, which covers issues related to compliance requirements of research grants
• Information Technology, which involves issues relating to misuse of technology resources and data privacy/integrity
WVU holds itself to the highest ethical standards and encourages employees, whenever possible, to discuss concerns with their supervisors or appropriate University personnel in such units as Internal Audit, Human Resources or the General Counsel’s Office.

The University will not take retaliatory actions against employees or constituents who make good faith reports about potential misconduct. The EthicsPoint reporting system is a confidential alternative for reporting issues.

We would like to remind the WVU community that the University has an anonymous system for reporting possible violations of the University’s policies.

WVU has joined with EthicsPoint to establish a website to report possible violations at https://secure.ethicspoint.com/domain/media/en/gui/14303/index.html. There is also a toll-free hotline: 866-413-1955.

Reporting via the website can be done in one of three categories:
• Accounting and Financial Matters, which focuses on accounting or disclosure issues, fraud, theft or other financial issues
• Research, which covers issues related to compliance requirements of research grants
• Information Technology, which involves issues relating to misuse of technology resources and data privacy/integrity

WVU holds itself to the highest ethical standards and encourages employees, whenever possible, to discuss concerns with their supervisors or appropriate University personnel in such units as Internal Audit, Human Resources or the General Counsel’s Office.

The University will not take retaliatory actions against employees or constituents who make good faith reports about potential misconduct. The EthicsPoint reporting system is a confidential alternative for reporting issues.

The West Virginia University Office of Research Integrity & Compliance (ORIC)

ORIC is committed to helping faculty, staff, and students comply with all applicable federal, state, and institutional requirements and policies. Research integrity and compliance areas covered by this office include human research protections, animal welfare, biosafety, conflict of interest in research, export control and the responsible conduct of research. The ORIC Newsline online newsletter has the goal of keeping the WVU research community informed and up-to-date on policies and procedures, guidelines, educational programs, regulatory changes, and monitoring and accountability in these areas.

Human Research Protections

Kuali Coeus (KC)

Having difficulty completing IRB protocols? Want to avoid BRAAN freeze? We do too. Coming soon you will be able to use Kuali Coeus (KC).

The KC project is using the latest web technology, in combination with an MIT product known as Coeus, to build a comprehensive system to manage the complexities of research administration. The WVU Research Office and OIT are working together to replace the current electronic system known as BRAAN with a new KC IRB module. This new system will be put into place January 2012. Investigators will continue to be able to create and manage IRB protocols; however, the KC IRB will be a stable and user friendly system. The KC IRB system will operate in parallel with BRAAN for one year as protocols are manually transferred by the investigators to the new system through the new protocol and renewal application process. BRAAN will eventually become an archive system for historical data only.

The WVU community is encouraged to follow the status of this project and provide feedback. Please ‘Like’ us on Facebook at WVU Kuali Coeus (KC) for weekly updates. Also we encourage the WVU IRB investigators to sign up for the WVU Office of Research Integrity and Compliance (ORIC) IRB listserv on the ORIC website at http://oric.research.wvu.edu/ . For further information please contact us at ResearchIT@mail.wvu.edu or 3-5967 in the Research Office. Information Technology department.

Responsible Conduct of Research

Please remember that both NIH and NSF now have Responsible Conduct of Research (RCR) training requirements. Monitoring for compliance with these RCR training requirements has now been fully implemented by ORIC..

Our office monitors each NSF or NIH award, when applicable, for compliance with RCR regulations. In the event an award is not in compliance with federal and WVU RCR standards, both the PI and relevant others will be notified that immediate follow-up is required to bring the grant into compliance.

Note that failure to comply with federal and University regulations may result in the suspension of research funding for that particular project.

In order to facilitate understanding of the specific requirements for each applicable award and whether the award does indeed fall into a category for compliance monitoring, our office has posted the Responsible Conduct of Research Requirements Sheet online.

For questions, concerns, and inquiries please contact Jonathan Young by e-mail at Jonathan.Young@mail.wvu.edu or by phone at (304) 293-1119.

Animal Care and Use

ACUC Announces Changes!

There have been some important changes that animal users need to know!

• The due date for amendments and protocols is the 15th of the month.
• There is a new animal care and use protocol form.
o Are you renewing a protocol or submitting a new protocol? Go to http://oric.research.wvu.edu/animal/protocolsub for instructions as well as the new form and appendices to the new form
o Are you amending a protocol that is currently approved in the old form?
 Make changes in this old form.
 Highlight these changes.
 Include a summary addressing the reason for the amendment and brief synopsis of the changes.
o Save a tree?we don’t require hard copies of your protocol! Submit your protocol via email to ACUC@mail.wvu.edu or mhollander@mail.wvu.edu.
o Signed signature pages should be mailed to Robin Anderson, PO Box 6845.
• Veterinary pre-reviews will be done before your protocol goes to the committee. Protocols WILL NOT be submitted to the committee until the veterinary review is addressed.
• New IACUC polices, standard operating procedures and guidelines are being posted every month! Find all of them at http://oric.research.wvu.edu/animal/guidlines
• Dr. Michael Perone, a Professor in the Department of Psychology, is now serving as the Chairperson for the IACUC.

Biosafety

OLAR ABSL2 Biosafety SOPs have been finalized and are being posted at the ORIC website under the title ‘Animal Biosafety’.

A memorandum of Understanding of the Authority & Scope of the Institutional Biosafety Committee has been drafted pending review by the Vice President for Research, Dr. Curt Peterson.

WVU’s Exposure Control Plan for Non Healthcare Personnel is being developed as a part of the OSHA Bloodborne Pathogen Training.

The list of WVU Biosafety CITI Training modules has been finalized, and the
ORIC Export Control & Biosafety websites are being updated.

Please visit http://oric.research.wvu.edu/biosafety for more information.

Export Control

On September 21, 2011, a meeting was held for an update on the WVU Export control program. Dr. Smitha Moter presented the current structure of the WVU Export control program.

Many principal investigators, graduate students or research fellows, and even undergraduates travel internationally to attend various academic projects. The academic traveler’s failure to comply with U.S. export control laws can have grave consequences. WVU personnel scheduled for international travel for an academic purpose must fill out the Academic Travel Forms posted at the ORIC website.

Guidelines regarding encryption software as related to academic travel and U.S Export control regulations have been posted at the ORIC website.

For more information, please visit http://oric.research.wvu.edu/export_control.

Conflict of Interest in Research

New Federal regulations regarding the disclosures made on the WVU Disclosure of Interest in Research (DOIR) Form and the WVU Supplemental Disclosure Form will go into effect in July 2012. Currently, amounts over $10,000 earned through employment, consulting, or financial or significant relationships, including ownership, outside of an individual’s University activities need to be disclosed. With the new regulations, amounts earned over $5,000 for payments for services and/or equity interests earned through employment, consulting, or financial or significant relationships, including ownership, outside of an individual’s University activities will need to be disclosed on the DOIR and Supplemental Forms. An equity interest of 5% or more will still need to be disclosed for interests in publicly traded entities. With the new regulations, any equity interest in non-publicly traded entities will also need to be disclosed.
If there are any questions regarding who needs to complete and submit a DOIR Form, whether or not a DOIR is currently on file, or any other questions regarding the WVU Policy, please feel free to contact Devin Goudy (304-293-5475) or Dr. Daniel Vasgird, ORIC Director (304-293-6094).

For more information, please visit http://oric.research.wvu.edu/conint.

As of the 26th of August, 2011, the WVU Human Research Protection Program Standard Operating Procedures have been updated to include a section pertaining to incidental medical findings (IFs). Please refer to the WVU HRP SOPs at http://oric.research.wvu.edu/r/download/104456. The new section is listed as section 3.7.12.

The West Virginia University Office of Research Integrity & Compliance (ORIC)

ORIC is committed to helping faculty, staff, and students comply with all applicable federal, state, and institutional requirements and policies. Research integrity and compliance areas covered by this office include human research protections, animal welfare, biosafety, conflict of interest in research, export control and the responsible conduct of research. The ORIC Newsline online newsletter has the goal of keeping the WVU research community informed and up-to-date on policies and procedures, guidelines, educational programs, regulatory changes, and monitoring and accountability in these areas.

Human Research Protections

Deception Policy Added

The IRB Standard Operating Procedures have been updated to reflect a new policy on deception involving human subjects. The deception policy can be found by downloading the SOPs and navigating to the newly added section 3.7.10.

Tissue Banking Policy Updated

The IRB Standard Operating Procedures have been updated to reflect a new policy on tissue banking involving human subjects. The tissue banking policy can be found by downloading the SOPs and navigating to the newly added section 3.7.11. The tissue banking form has also been updated.

Responsible Conduct of Research

Researchers and administrators at the world famous St. Jude Children’s Research Hospital heard West Virginia University’s Dr. Daniel Vasgird, director of the Office of Research Integrity and Compliance, speak on the critical need for research institutions to nurture high levels of public trust and concomitant respect for their product as part of an overall research enterprise.
The objectives of the Danny Thomas Lectures Series are to: educate and inform the St. Jude basic science and clinical faculty of the latest cutting edge research and therapies in biomedical sciences and bring to St. Jude information from a range of experts that promotes continued excellence in patient care, research and administration.
“Integrity and responsibility are words with profound implications, especially for those who participate in the global community of science,” Vasgird told the St. Jude audience. “Research as a profession generally flourishes when the public that supports it and ultimately makes use of its products has high regard for its ways and means.”
Vasgird’s St. Jude appearance traced the evolution of techniques related to the responsible conduct of research of the last half century and stressed the need to emphasize compliance with rules for integrity in order to ensure the continued public trust in institutional research results.

For questions, concerns, and inquiries about WVU’s RCR requirements, please contact Jonathan Young by e-mail at Jonathan.Young@mail.wvu.edu or by phone at
(304) 293-1119.

Animal Care and Use

Submitting an Amendment to IACUC Protocols

When submitting an amendment to your IACUC protocol, please follow these steps:

1. Use the most current version of your approved IACUC protocol. If you are not sure of which version is the most current, please feel free to contact us and we would be happy to send it to you.
2. Incorporate the changes you plan for your amendment into the body of your most current approved protocol and highlight these changes. If previous highlights are present, please remove these.
3. If you are removing something from the body of the approved protocol as a part of your amendment, use a single line to cross out the text being removed and highlight these changes as well.
4. In addition to incorporating the changes for the amendment directly into your protocol form, PLEASE submit a BRIEF statement that MUST include 1) an explanation of the changes and why these changes are being requested, 2) the number of animals being added/removed (if applicable), 3) the protocol number, and 4) the PI name. This summary statement may be supplied in the body of your email used to send your attached and revised protocol to the ACUC office.
5. Submit the highlighted version along with the summary statement to mhollander@mail.wvu.edu or ACUC@mail.wvu.edu. Remember to include the protocol number.
   

h4. Biosafety

A University-wide Biosafety manual is currently being developed. Please check the ORIC website at http://oric.research.wvu.edu for updates or continue to read future versions of this newsletter. The exposure control document is also currently being updated.

Export Control

The Deemed Export Control Policy for WVU principal investigators has been developed and will be posted to the ORIC website at a future date. The Export Control Officer, Dr. Moter is responsible for assessing and communicating the requirements of U.S. export controls on WVU research activities. She serves as the primary point of contact on export control issues, both internally and with outside government agencies. Dr. Moter can be reached at Vijayasmitha.Moter@mail.wvu.edu.

Conflict of Interest in Research

The Office of Research Integrity and Compliance (ORIC) has recently informed all Deans and Department Chairs within the University about the importance of the WVU Disclosure of Interest in Research (DOIR) Form. This form was previously entitled “Conflict of Interest in Research Certification Form”.

All WVU faculty members, whether currently involved with research or not, should complete and submit this form annually (by June 30th of each year) to the ORIC. It is especially important that any University investigator/key personnel engaged in a research study, regardless of the source of funding, who wishes to be eligible to engage in a particular research program, submit the DOIR Form.

In addition to faculty and staff, any WVU student, graduate or undergraduate, also participating in research through the University should also annually submit a DOIR Form.

Federal regulations require the University to manage any potential conflicts of interest through an appropriate management process which is initiated and generally resolved through this disclosure. Along with federal regulations requiring disclosure, it is also required by the WVU Policy on Conflicts of Interest in Research. Both the WVU Policy on Conflicts of Interest in Research and the WVU Disclosure of Interest in Research Form can be found at the following link: http://oric.research.wvu.edu/conint.

If there are any questions regarding who needs to complete and submit a DOIR Form, whether or not a DOIR is currently on file, or any other questions regarding the WVU Policy, please feel free to contact Devin Goudy (304-293-5475) or Dr. Daniel Vasgird, ORIC Director (304-293-6094).

The IRB Standard Operating Procedures have been updated to reflect a new policy on tissue banking involving human subjects. The tissue banking policy can be found by downloading the SOPs at http://oric.research.wvu.edu/r/download/97048 and navigating to section 3.7.11. The tissue banking form has also been updated. The new policy reads:

“WVU Specimen Bank Policy: May 16, 2011

1.0 Introduction

For purposes of this policy, the term, “tissue” includes any cell tissue, fluid, or excreta from which measures of normal or pathologic human physiologic function can be obtained. The term, “tissue” includes, but is not limited to pathological specimens, diagnostic specimens, hair and nail clippings, deciduous and permanent teeth, dental plaque and calculus, sweat, uncannulated saliva, placenta removed at delivery, amniotic fluid, cerebrospinal fluid, genetic material, urine, blood and other bodily fluids. First trimester fetal tissue may include additional guidelines.

2.0 Policy

Research using human tissue can be conducted, using the normal established guidelines for IRB review, as long as all tissue collected is either used for the purposes of the study described or discarded. If any tissue collected as part of an approved protocol, normal operating room procedure, or from a non-university affiliated institution will be banked for future research investigations at West Virginia University or its affiliates, the investigator must first register the tissue bank and then conform to the guidelines set forth in this policy for tissue banking. The policy is not directed at tissue banks that exist for other than research purposes, e.g., quality improvement or state reporting.

Registration

Individuals intending to create an on-site database or tissue bank utilizing clinical health information or authorized tissue specimens must complete and submit to the IRB office an “Application to Establish an On-site WVU Tissue Bank for Research or Database Development Involving Specimens Stored with or without Clinical Health Information” to register with the WVU Office of Integrity and Research Compliance. The form can be found on the IRB Forms & Samples page at http://oric.research.wvu.edu/human_subjects_research_and_the_irb/irb_forms_samples, and is listed as the Tissue Bank Development Form. Review and formal approval for the On-site WVU Tissue Bank application will be given by the ORIC Director and one of the IRB Chairs or Vice-Chairs. Once approved the form should be submitted as part of an IRB application.

Individuals intending to create an on-site database or tissue bank utilizing clinical health information or authorized tissue specimens from decedents must still register the bank with the IRB utilizing the aforementioned form. It is expected that proper informed consent from family members to have the decedent’s tissue stored will be obtained and submitted with the registration application. 3.0 Approval of Tissue Banking Protocols

3.1 Placement: Collection and placement of human tissue into a bank for research purposes can occur after completion and approval of an IRB protocol application. To establish an on-site Tissue Bank the approved Tissue Bank Development Form must be attached to the IRB protocol application. Human tissue, accompanied by a copy of an approved consent agreement signed by the donor, can be placed into an approved tissue bank for unspecified research purposes. Human tissue can be deposited as part of an IRB approved protocol: (1) following standard operating or delivery room procedures, (2) following standard diagnostic and treatment procedures (e.g., dental extraction, collection of bodily fluids), and (3) from a non-affiliated institution that conforms to comparable standards for the protection of human subjects. An approved protocol is needed if human tissue is to be placed into a bank as part of an approved protocol for unspecified research purposes other than that outlined in that protocol, a separate consent form obtaining approval of the donor must be obtained.

a) Surgical Consent Form. If human tissue obtained through standard operating or delivery room (non-research) procedures is to be placed into a bank for potential research purposes, a separate consent form obtaining approval of the donor must be obtained in addition to the standard operating room consent form.

b) Non-Surgical Consent Form. If tissue obtained for purposes of standard medical or dental diagnostic and treatment (non-research) procedures is to be placed into a bank for potential research purposes, a separate consent form must be approved by the IRB for this purpose. For example, if a blood sample is obtained for standard clinical diagnostic purposes and then discarded without identifiers, no consent is required, unless the blood is analyzed as part of a research project prior to being discarded, in which case a standard approved consent form is required. If the remaining blood or components of blood from a standard clinical diagnostic test are banked for potential research use, a signed approved consent is required. Additionally, if the bank is on-site then the bank must be registered with the WVU Office of Research Integrity and Compliance.

c) Tissue Acquired from a Nonaffiliated Institution. If identifiable human tissue is acquired from an institution, laboratory, or company not affiliated with West Virginia University for the purpose of tissue banking for research, the tissue must be accompanied by an approved consent agreement signed by the tissue donor. The approved consent agreement must contain comparable language to the approved WVU tissue banking language, providing assurance that the tissue can be used without additional consent as long as donor confidentiality is maintained, that tissue can be used with subject identification with additional consent, and that financial considerations regarding the cost and potential financial advantage to institutions are enumerated. If CORE (Center for Organ Recovery and Education) is involved, their consent form may be substituted.

3.2 Removal: Removal of human tissue from a bank for research purposes.
Human tissue can be removed from an approved tissue bank for research purposes with an approved protocol using the normal established guidelines for NHSR (Not Human Subjects Research), exempt, expedited, or quorum review. All researchers must apply singly for an IRB approval for each individual research project utilizing tissue from a Tissue Bank.

a) NHSR. If human tissue is totally de-identified (stripped of all 18 Protected Health Information Identifers) so that the researcher cannot trace the tissue back to the donor, then it is not human subjects’ research (NHSR). The researcher must submit an NHSR application to the IRB for acknowledgement

b) Exempt Research. If identifiable human tissue is removed from a bank for research purposes, but the researcher records the data without identifiers, the project qualifies as “exempt research.”

c) Expedited or Quorum Review. If identifiable human tissue is removed from a bank for research purposes and information is provided to the investigator in such a manner that human subjects can be or are identified, and the researcher uses the identifiers, the research project must follow the procedures for Expedited Review or Quorum Review.

d) Tissue Sent to a Nonaffiliated Institution. If identifiable human tissue is removed from an approved bank at West Virginia University and sent to an institution, laboratory, or company not affiliated with West Virginia University for purposes of research, the investigator must conform to the IRB Guidelines for the Protection of Human Subjects by obtaining approval through an approved protocol from their institution.

4.0 Approval of Tissue Banking

4.1 Policy: All research conducted on banked human tissue at West Virginia University must be obtained from an IRB-approved tissue bank.

4.2 Requirements: Requirements for IRB-Approved Tissue Banking.

a. All WVU Tissue Banks must have biosafety approval from the Institutional Biosafety Committee (IBC) before the IRB will approve the protocol.

b. Storage of tissue must be conducted in a manner conforming to the appropriate care and handling of biological specimens as outlined through the IBC Guidelines.

Disposal of tissue must be conducted in a manner conforming to the appropriate care and handling of biological specimens as outlined through the IBC Guidelines.

d. This identification number assigned by the tissue bank will be the only method of linking the specimen, the Specimen Record, and the Donor Record. The Donor Record and the Specimen Record will be housed in separate files.
• The Specimen Record. The Specimen Record includes demographic and medical information from the patient’s medical or research record which does not identify the patient. Variables like age (< 90), medical diagnosis, and laboratory values can be included in the Specimen Record. Variables like date of birth, hospital record number, or phone number cannot be included in the Specimen Record.

• The Donor Record. Any information identifying the donor, including a copy of the approved consent agreement signed by the donor, shall be kept in the Donor Record.

e. Deposits of banked specimens must conform to the IRB-approved guidelines for conducting research on human tissue. All specimens in a tissue bank must be accompanied by a copy of the consent agreement signed by the donor.

f. Removal of banked specimens or portions of banked specimens must conform to the IRB guidelines for conducting research on human tissue. No tissue can be removed for research purposes without an approved IRB research protocol or IRB acknowledgement of a protocol involving de-identified samples.

g. All tissue deposited and/or removed from a tissue bank must be logged using a Tissue Bank Log which will include date and time of deposit or removal, specimen number, the approved IRB protocol number, name(s) of investigators making the deposit or removal, and name of the tissue bank personnel responsible for completing the transaction.

4.3 Monitoring of IRB-Approved Tissue Banking: The IRB has the authority to suspend or terminate any or all research being conducted through a tissue bank that is not in compliance with IRB Guidelines. Tissue banks are subject to periodic audits.

5.0 Pre-Existing Specimens

5.1 Policy: The IRB acknowledges that there may be specimens that were collected prior to the development and enforcement of the approved policy for conducting research on human tissue, and that records accompanying these specimens may not be in compliance with these IRB Guidelines. Whenever possible, it is the duty of the tissue bank to bring records from pre-existing specimens into compliance with IRB Guidelines (e.g., obtaining copies of consent forms to accompany specimens, separating the Specimen Record from the Donor Record, completing a Tissue Bank Development Form to register an on-site Tissue Bank).
5.2 Grandfather Clause: All tissue deposited or removed from a tissue bank after 1 January 2011 must conform to the IRB Guidelines for Tissue Banking. Any tissue banked after 1 January 2011 must conform to the IRB Guidelines for removal of tissue from a tissue bank. As it may be impractical to obtain consent for many specimens deposited before 1 January 2011, the tissue bank will not be required to demonstrate evidence of informed consent for specimens collected prior to this date.”

The IRB Standard Operating Procedures have been updated to reflect a new policy on deception involving human subjects. The deception policy can be found by downloading the SOPs at http://oric.research.wvu.edu/r/download/97048 and navigating to section 3.7.10. The new policy reads:

“3.7.10 Deception

Definition: Deception occurs as the result of investigators providing false or incomplete information to participants.

The IRB accepts the need for certain types of behavioral and social science studies to employ strategies that include deception. Employment of such strategies must, however, be justified. In general, deception is not acceptable if, in the judgment of the IRB, the participant may have declined to participate had they been informed of the true purpose of the research. Studies that use deception as part of their experimental design must meet all the requirements of 45 CFR §46.116(d), described below, and include a post-study debriefing, unless an exception is granted by the IRB. If such an exception is requested, this will require full board review.
In the event that a study includes the use of deception, the investigator must:

• Provide a justification for the deception (i.e., why the study could not be
conducted without deception);
• Describe the manner of deception (e.g., the participants are not informed of the
true intent of the study) and/or how the deception will take place (e.g., a
confederate will simulate an accident);
• Note whether the deception results in any increased risk to participants (e.g.,
confederates engage in a staged altercation , which could result in emotional
upset) or may affect subject’s willingness to participate in research;
• Describe how any additional risks would be minimized; and
• Offer the participant the option to withdraw their data from the study in the debriefing script.”

As part of the new campus-wide implementation of the synchronization of all WVU user IDs into one ID being performed by the Office of Information Technology (OIT), some of you may notice that you are no longer to access your protocols in BRAAN under your new ID. If this is the case, you will need to contact Jonathan Young at 304-293-1119 or Jonathan.Young@mail.wvu.edu.

Please provide your old and new usernames to us and your old username will be reactivated for a period of one month, after which time it will again expire. You will be able to access your protocols and you must then create an amendment for each of them that you are PI on and contact the PI to create an amendment on each protocol you are a research team member on. In the amendment, you must indicate that your username has changed and then delete yourself from the protocol under your old username and add yourself under your new username. Instructions to do so can be found at How To Update Your User ID Using an Amendment .

NOTE: This notice only applies to those people whose BRAAN usernames are affected by the OIT campus-wide synchronization. If your user ID is not changing, you will not be affected.

Thank You!

For those who review any IRB protocol associated with the Department of The Navy (this includes IRB staff, IRB Chairs, IRB Vice-chairs, and all IRB members), you must now complete the “DON-Supported Extramural Performers” training course via CITI. To do so, you must first affiliate with the Department of The Navy using your current (or a new) CITI account. You can find the detailed instructions on how to affiliate with the DoN and add the course by downloading and opening the PDF file entitled CITI - DoN Extramural Directions . This file has been provided to us by the Department of The Navy.


If you have any specific questions regarding this training, please contact Jonathan Young at 304-293-1119 / Jonathan.Young@mail.wvu.edu or Lilo Ast at 304-293-7555 / Lilo.Ast@mail.wvu.edu.

PDF version available at http://oric.research.wvu.edu/r/download/90225



1. Human Research Protections (HRP): Please remember that any upcoming audits of a protocol, conducted either by your sponsor or the FDA must be reported to the ORIC and the Internal Audit Office. A representative from these offices will need to attend the exit interview held by the auditing team.

   Consider Summer IRB Submission

   For any researcher that is planning to conduct a research project that will involve human research subjects, the summer season is an excellent time to submit your project for IRB review.

   The fall semester is always the busiest semester with new students and faculty arriving at the University. With this in mind, we encourage you to call our office at (304) 293-7073 if you need any guidance for your study or call (304) 293-1119 to begin the process of creating your protocol for approval for any future study.
   



2. Responsible Conduct of Research (RCR): Complete monitoring for compliance with the Responsible Conduct of Research (RCR) training requirements has now been fully implemented.
   
   Our office is now monitoring each NSF or NIH award, when applicable, for non-compliance. In the event an award is not in compliance with federal and WVU standards, the person who is listed as principle investigator on the award will receive an e-mail informing them of the specific requirements applicable to their study and who on that study is non-compliant. Each researcher who is non-compliant will also receive a letter of notice. Moreover, when a new researcher is added to a grant and falls under the purview of the RCR regulations, that researcher must also remain in compliance.
   
   Remaining in a non-compliant state may result in the suspension of funding for that grant.
   
   In order to facilitate understanding of the specific requirements for each applicable award and whether the award does indeed fall into a category for compliance monitoring, our office has posted the Responsible Conduct of Research Requirements Sheet online.
   
   For questions, concerns, and inquiries please contact Jonathan Young by e-mail at Jonathan.Young@mail.wvu.edu or by phone at
   (304) 293-1119.
   


3. Animal Care and Use (ACU): Post Approval Monitoring for Animal Protocols:

   Post Approval Monitoring (PAM) is a new program that will begin in June or July. The purpose of this new program is to fulfill the federal requirement to assure that the actual animal activities being conducted are consistent with the approved protocol. This will be a scheduled visit and an opportunity to ask questions regarding the Animal Care Program at WVU. The visits will be conducted by various people involved with the Animal Care Program and are designed to ensure that the quality of animal research and care at WVU remains at the highest level.

   We encourage all PIs with an Animal Care and Use Protocol to review their protocols and ensure that what is being done in practice matches what has been approved by the Animal Care and Use Committee. If discrepancies are found, we highly suggest that you amend your protocol accordingly. We now have a great way to track amendments so please do not hesitate to submit as many amendments as are needed. We are always available to answer questions and assist you, so please feel free to contact the Animal Compliance Officer at any time.
   



4. Conflict of Interest in Research (COIR): Any University investigator/key personnel engaged in a research study, regardless of the source of funding, who wishes to be eligible to engage in a particular research program shall have an ongoing duty to complete and file annually (by June 30th of each year) the WVU Disclosure of Interest in Research (DOIR) Form. This form was previously entitled “Conflict of Interest in Research Certification Form.”

   Federal regulations require the University to manage any potential conflicts of interest through an appropriate management process which is initiated and generally resolved through disclosure. If any questions arise as to who must complete and file a DOIR, or whether the DOIR is up to date please contact our office at (304) 293-5475.
   

5. Biosafety: The Instituitional Biosafety meeting is scheduled on the second Monday of every month. The Principal Investigators have been requested to submit their IBC Protocol Registration Document to the ORIC on the Last Monday of each month to aid in the Protocol review process.
   
   Lab Inspections & the completion of necessary Training will become mandatory prior to the approval of IBC Protocols. Biosafety Guidelines for WVU will be implemented. Other upcoming changes would be the IBC Protocol approval duration & the content of IBC registration documents. If needed the Biosafety training topics will be added on to the existing Biosafety training modules.
   


6. Export Control: Deemed Export Control Policy awareness will be created by circulating the Policy to the Principal Investigators all over the West Virginia University campus. The implementation of the Export Control Training and auditing will follow.
   
   The Export Control Officer, Dr. Rayadurg is responsible for assessing and communicating the requirements of U.S. export controls on WVU research activities. She serves as the primary point of contact on export control issues, both internally and with outside government agencies.