11 Dec

IRB SOP Update for December 11, 2012

Jonathan | December 11th, 2012

Our office would like to keep you informed of any changes made to the IRB Standard Operating Procedures as policies and guidelines progress. Today, we published a new, December 2012 version of our SOPs at http://oric.research.wvu.edu/r/download/148564. The following is a list of sections that were changed in this version and a synopsis of what was changed for each:

3.3.2, category 4
Added reference to see 3.3.6 for clarification of exemption category 4 determination.

3.3.6 (added as a section)
Added additional criteria for collection of data from medical records to be exempt: (1) Data must exist at the time of application and (2) the data must be recorded without codes or links to patient identifiers (e.g., medical record number).

3.14, paragraph 1
For a disapproval, termination, or suspension, the notification must also now be copied to the respective department chair.

5.4, number 10
Specifies language that must be added to informed consent documents for clinical trials.

5.11
The heading for this section has changed from Waiver of Informed Consent to Waiver of Informed Consent for Planned Emergency Research.

5.12 (added as a section)
Specifies procedure for protocol amendments without consent form changes.

5.13 (added as a section)
Specifies procedure for protocol amendments with consent form changes.

6.7.2.1
Corrected reference to informed consent from section 5.8 to section 5.9.

7.4.3.6
Deleted the sentence that read “At the time of review, the IRB will determine if written consent from participants for use of the HUD is necessary.”

8.2.1, number 10
Added the statement that “Protocol violations must be reported within thirty (30) days of the PI being made aware of the violation.”

9.4, paragraph 1
Added the statement for exceptions or deviations that “These reports must be filed with the ORIC within thirty (30) days of the PI being made aware of the violation”

10.2, paragraph 2
Added the statement that “The identity of any entity bringing a complaint, concern, and/or allegation of non-compliance to the attention of the ORIC shall be kept confidential to the greatest extent possible.”

2 Oct

ORIC Newsline - Fall 2012 (Text)

Jonathan | October 2nd, 2012

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

Update on the New System, WVU+kc

The WVU+kc electronic research administration system will become available to faculty and staff on a rolling basis for the submission of new exempt human research (IRB) protocols (e.g., surveys, interviews, medical reviews, questionnaires). WVU+kc is being implemented to replace the BRAAN2 submission system and all exempt protocols will be required to be submitted through the new system in the near future.

Training is required to access WVU+kc and sessions will be offered by the Office of Research Integrity and Compliance (ORIC). Training sessions will be held on Mondays and Tuesdays from 1 to 3 p.m. in Room 209 of the Chestnut Ridge Research Building. To sign up for a training date, please click here. Search under Keyword (near the top right), and type in “wvu+kc,” then press enter. You will want to click on the training date you prefer, then click register at the top right of the screen.

ORIC will provide PCs for the training sessions, but if you are a Mac user and would prefer to bring your own laptop to training, that is acceptable as long as it has wireless internet capabilities.
If for some reason you cannot register with the WVU Calendar, please contact the ORIC by emailing Kimberly Yoney at Kimberly.Yoney@mail.wvu.edu. Due to limited seating at each session (a 15 person maximum), it is suggested that you register early to be able to attend the session you desire. When you arrive, parking passes for parking lot 85 will be posted on the front door of the building.

If you are working on a research team, at least one person from the team must attend a training session in order to provide guidance to the rest of the team on how to use the system. If you cannot attend training on one of the days listed, contact the ORIC in order to discuss other training options available.

The WVU+kc system will be available for the submission of new not human subject research (NHSR) submissions and new exempt protocols only. Higher level reviews that involve greater risk to the participants, such as expedited and full board protocols, should continue to be submitted through BRAAN2 until further notice.

If you are interested in learning more about the WVU+kc system, visit the project website at kuali.wvu.edu. Additional training documents are available online including short videos and downloadable handouts. For updates regarding future training dates and future protocol submission dates, sign up for the ORIC listserv or follow the WVU+kc project on Facebook, G+, or Twitter.

Three Year Expiration of Exemptions

Please note that, in the WVU+kc system, exemptions will expire after 3 years of activity. If you would like to continue your study past 3 years, you will need to submit another exemption. There will be no continuing review process for exemptions.

Changes for Medical Records Research

Research studies involving the collection of data from medical records may qualify as exempt from review under category 4 provided that the following two criteria are met:

1. The data must exist at the time of the exemption application. Studies wishing to collect data from the medical records of patients who have NOT YET BEEN SEEN clinically would not qualify for exemption.
2. The data must be recorded without codes or links to patient identifiers (i.e. the medical record number (MRN)). For example, researchers often obtain a list of MRNs patients with a specific condition being studied that they then use to locate medical records for the purposes of data collection. As long as no code or link is assigned to each patient that would allow linkage of the collected data and the specific medical record, this type of research may qualify for exemption. However, researchers wishing to assign such a link to enable revisiting of the medical record would need to apply for expedited approval. A HIPPA waiver application should be submitted for both review types (exempt an expedited), and a consent form waiver will need to be submitted for medical records research not qualifying as exempt category 4.

New Post-Approval Guide Available

The ORIC has created a post-approval guide for use by researchers who have already had their research approved by the IRB. This guide covers several specific areas of interest for principal investigators and their research team, including:
• Principal Investigator (PI) Responsibilities and Delgation of Authority
• Recordkeeping
o Security/HIPAA
• Training Personnel
• Amendments
• Adverse Events, Protocol Deviations, and Violations
• Renewal/Continuation Submissions
• Informed Consent
• Study Closure and Document Retention
This guide is available at http://oric.research.wvu.edu/r/download/141149.

Responsible Conduct of Research

More Information Available on our Website

Our website has recently been updated to include more extensive information about the Responsible Conduct of Research (RCR). A more robust explanation of the program is now available, including a streamlined section on Education & Training and policy requirements. Head over to http://oric.research.wvu.edu/rcr_train to take a look.

Why is the Responsible Conduct of Research Important?

Over the last decade, research compliance and the responsible conduct of research have received increasing attention and responsive action from the scientific community. The broad forces behind that heightened consideration are the increasing potential rewards that can be garnered from innovation and the changing scale of research. The more specific driving factors are an increase in regulatory requirements, the influence of publicized compliance breakdowns at institutions of higher education, and heightened scrutiny from the media, advocacy groups and government. An added element is the idealistic desire of many scientists to attain a high ethical standard while practicing what many perceive as humanity’s best hope for advancement to a more supportive and fulfilling existence, namely the scientific enterprise. The practical side of all this reflection and action can be summarized in a line from the recent National Academies publication Integrity in Scientific Research: “The public will support science only if it can trust the scientists and institutions that conduct research.”

However, trust has to be thought of in its broadest sense and not just applicable to the individual research practitioner. Research institutions will only flourish when those who support them and ultimately make use of their product, i.e., the public, have high regard for their ways and means. Many academic institutions such as WVU have internalized this insight and have expanded their responsible conduct of research (RCR) training programs concomitantly to meet the needs of a more demanding and competitive era. The National Institutes of Health (NIH) have had an RCR education and training requirement in place for their training grants for nearly two decades, and WVU has offered courses to meet that requirement. The new initiatives are in response to recent federal requirements but are in keeping with the University’s avowed commitment to academic integrity as specified in its Academic Integrity Committee Policy to be found at the following web address:
http://www.wvu.edu/~lawfac/mmcdiarmid/aic/Final%20RIC%20Policy%20WVU%205-9-11.pdf
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

Some Important Points IACUC Reviewers Look for in an Animal Care and Use Protocol

In order to approve proposed use of animals for research or teaching or proposed changes in ongoing research projects or instruction involving animals, the IACUC must review those components related to the care and use of animals and ensure that the proposed activities are in accordance with Public Health Service Policy, Animal Welfare Regulations, and the applicable U.S. Government Principles.

The Guide for the Care and Use of Laboratory Animals gives very specific topics that should be considered in the preparation of an animal use protocol and its review by the IACUC. Listed below are some of the “must” statements that the committee is specifically looking for an answer to. The sections in the WVU Animal Care and Use Protocol form that these “must” statements pertain to are listed in italics.

1. LAY SUMMARY (section 7)
a. There must be a clear rationale and purpose of the proposed use of animals.
b. There must be a statement of benefit (i.e., benefit to society, benefit to animal health, benefit to the advancement of science).

The IACUC is obliged to weigh the objectives of the study against potential animal welfare concerns.

2. EXPERIMENTAL DESIGN (section 8.A)
a. There must be a clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee.
b. The above must be done for each group of animals in the study.

A flow chart can often add clarity and use of one is strongly encouraged.

3. JUSTIFICATION OF NUMBERS (section 8.B)
a. The number of animals used for each study must be justified.
b. Whenever possible, the number of animals and the experimental group sizes should be justified statistically (e.g., provision of a power analysis).

4. CATEGORY “E” (Appendix G)
a. Humane endpoints must be described and justified.
b. There must be justification regarding why a less invasive or less painful procedure cannot be used to achieve the study objectives.

5. HUMANE ENDPOINTS (Appendix A, items 5 & 6; Appendix B, item 4; Appendix F, item 4)
a. The criteria and process for timely intervention, removal of animals from a study or euthanasia if painful or stressful outcomes are anticipated must be clearly stated.

6. MONITORING OF ANIMALS (Appendix A, items 4 & 5; Appendix B, item 3)
a. There must be a clear description of how often animals will be monitored after a potentially painful/distressful procedure.
b. There must be a clear statement regarding what personnel will be looking for to determine pain/distress in an animal during this monitoring.

7. EUTHANASIA (section 9)
a. Even if the endpoint of the study is NOT death, a method of euthanasia must be indicated to account for the unlikely event that an animal needs to be euthanized.
b. A secondary method of euthanasia to ensure death must be included.

8. PERSONNEL TRAINING AND QUALIFICATIONS (section 3 & 4)
a. Personnel who will be involved with activities involving animals must be adequately trained with regard to the specific procedures they will be responsible for.
b. Training and qualifications must be specific to the species being proposed.

The roles and responsibilities for all personnel listed on the protocol, including the PI, must be included.

9. SURGICAL PROCEDURES (Appendix A)
a. Appropriate anesthesia, analgesia, or sedation must be used at the appropriate doses for each species.
b. A description of the specific surgical procedure must be included.

Reference to the Rodent Surgery and Post-Operative Care WVU IACUC Policy must be included if the general surgical procedures described in that policy will be followed. If anything in that policy cannot be followed, justification and a clear description must be included.
d. Post-procedural care and observation must be clearly stated with inclusion of postsurgical assessment forms.

Biological Safety

Biological Safety

The new West Virginia University Exposure Control Plan has been posted to our website. You can find the plan at http://oric.research.wvu.edu/r/download/137908. Please note that this plan applies to non-hospital personnel only. When you download the policy, you can tailor it to the specific needs of your laboratory.

The WVU Sharps Policy is available at http://oric.research.wvu.edu/r/download/133854.

As part of the Bloodborne Pathogen (BBP) training, trainees will now also be required to sign a form indicating that they have or have not received the Hepatitis B vaccination.

The information regarding lab location and principal investigator or lab contact name is now being captures to develop a biosafety level 1 (BSL1) and biosafety level 2 (BSL2) database.

Conflict of Interest in Research

Changes in Regulations

As many of you may be aware, new requirements regarding conflicts of interest in research (COIR) funded by the Public Health Service were enacted into law last summer. Detailed information can be found at the DHHS website. These regulations will become effective on August 24, 2012. These are the first revisions to the regulations since 1995 and will require changes in the existing WVU guidelines and procedures regarding conflict of interest in research, including the introduction of newly required components, such as mandatory training and investigator reporting.

The Office of Research Integrity and Compliance (ORIC) has worked hard to try to minimize the burden the new regulations will place on our researchers. However, there will be some changes that will require advanced planning by our PI’s. The new regulations are extensive but the most important changes to the WVU Guidelines and procedures include these requirements:

• Disclosure: For each proposed research activity, regardless of funding source, all PI’s and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of current or proposed research, (including collaborators, consultants, and students) must complete a Disclosure of Interest in Research (DOIR) Form before final approval can be given.

• Training: All investigators must complete the Collaborative Institutional Training Initiative (CITI) training modules on COIR before engaging in any research activity; training must be completed every four years thereafter. The course can be completed by going to http://www.citiprogram.org and following the instructions located at http://oric.research.wvu.edu/r/download/120167. The ORIC will check to insure completion of the training and testing. (Note: The CITI COIR course is different from the CITI IRB course and will require about 15 minutes to complete.)

• Travel: Investigators receiving PHS funding (including NIH) must disclose the occurrence of all reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities, within 30 days of such travel. This policy does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Other Announcements

Schedule of Upcoming ORIC Presentations

To access the ORIC calendar of upcoming events and presentations, please click here. Search under Keyword (near the top right), and type in “research integrity,” then press enter. You will want to click on the event you would like to find more information about. If the event requires registration, you will need to click register at the top right of the screen.

The ORIC, Now on Facebook

The ORIC now has a presence on Facebook at http://www.facebook.com/pages/West-Virginia-University-Office-of-Research-Integrity-Compliance-ORIC/299775123444843.

Please “like” the WVU ORIC Facebook page so you can receive regular and immediate updates on policies, WVU+kc, new developments, and more.

30 May

ORIC Newsline - Spring 2012 (Text)

Unknown | May 30th, 2012

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

Update on the New System, WVU+kc

As you may be aware, the Office of Research Integrity and Compliance (ORIC) has announced the first release of the WVU+kc electronic research administration system for the submission of IRB documents. The system is immediately available for the submission of Not Human Subject Research (NHSR) documents only. NHSR documents apply only to those projects that may need to be submitted to the IRB and may potentially involve human subjects and/or human-related data.

Training on the use of the new electronic system is required to gain access. Please note that this training is not the standard CITI ethics training; this is a separate, short training course (taking perhaps 10-15 minutes) designed exclusively for use of the new system. The training can be completed on your own through the online videos, through 1-on-1 remote training, or by scheduling a 1-on-1 session with the ORIC. Specific instructions for completing the training and requesting access can be found on the WVU+kc website at http://kuali.wvu.edu/wp-content/uploads/QRG12-NHSR-Submission-Training.pdf. Access to the system must be requested via an online form after reviewing all applicable training videos and downloadable handouts.

For more information about the WVU+kc system, visit the project website at http://kuali.wvu.edu. For updates regarding training and future protocol submission release dates, sign up for the ORIC listserv or follow the project on Facebook, G+, or Twitter.”

For all other IRB submissions, to include exempt, expedited, and full board studies, please continue to submit using BRAAN 2 at http://ecomp.wvu.edu. Please do not hold your submissions for the full release of WVU+kc

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.

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

Laboratory Inspections

Laboratory inspections and annual reviews are an important part of the continuing review process for Animal Care and Use protocols. However, because of new areas of emphasis in the 8th Edition of the Guide for the Care and Use of Laboratory Animals, the WVU Animal Care and Use Committee (IACUC) will be making some changes in these two areas.

The federal regulations state that all Animal Care and Use protocols must be reviewed on an annual basis for continuing approval. Therefore, beginning in June 2012, all Principal Investigators who have animal protocols will receive a form titled “Self Report Form and Protocol Renewal Application” which must be completed for each protocol and returned to the Animal Compliance and Training Officer. This form asks questions specific to the Animal Care and Use protocol and will be reviewed by one or more IACUC members. The purpose of this form is to determine if anything needs to change, be added, be removed, etc. If you would prefer to discuss the questions on the form with an IACUC member or the Animal Compliance and Training Officer in person, the phone number of the IACUC office is at the top of the form and a face to face meeting can be arranged. Please be sure to answer all of the questions on this form thoroughly to ensure an accurate review can be accomplished and that all protocol information is up to date.

The second change is with regards to laboratory inspections. Federal regulations require that the IACUC inspect all animal holding and procedure areas at least once every 6 months. Therefore, Animal Care and Use protocols that involve animals being moved from their general holding room (e.g., vivarium) to other areas (e.g., laboratories), for any reason, will require inspection of those procedure areas for continuing approval of the protocol. An IACUC member will contact you to set up these inspections a month or two before they are due to be completed.
In addition to these laboratory inspections every 6 months, we will soon be starting a Post-Approval Monitoring (PAM) program. These PAM sessions will be a more in depth and thorough review of Animal Care and Use protocols and the procedure areas. They will also typically involve observation of one or more procedures listed in your protocol. This program is being established to satisfy the requirement that ensures all personnel listed on Animal Care and Use protocols are properly trained in the procedures that they are responsible for. Post-Approval Monitoring is designed to create an open dialog between animal users and various members of the Animal Care and Use staff (e.g., IACUC members, veterinary staff, compliance staff) to identify potential problems and establish a solution before problems become significant.

As always, please feel free to call anytime with any questions that you may have!

Biological Safety and Export Control

Biological Safety

The WVU OLAR Animal care personnel attended the training on the awareness of working in animal facility housing the Lab animals infected with the Respiratory Syncytial virus.

The WVU Exposure Control Plan (ECP) will be posted at the ORIC Biosafety website under the title of ‘Bloodborne Pathogen Standard’. The ECP document is a part of the (Bloodborne Pathogen) BBP Training. The Lab Supervisors must make sure that the ECP in their labs is available to all their Lab employees.

The trainees completing the BBP Training will have to sign the Hepatitis B Vaccination acceptance or declination form which is also a part of the BBP training. The form will be posted online at the ORIC, Biosafety BBP website.
The WVU Sharps Policy is about to be posted at the WVU ORIC Biosafety website. All lab personnel are required to refer to the WVU Sharps Policy regarding appropriate use & disposal of sharps.

The contact personnel are being assigned to oversee the Biohazard disposal at various colleges of the WVU Downtown campus as a part of the WVU Biohazard waste management program.

The CITI Biosafety training assignment list has been finalized. Completing the Biosafety training required by the WVU Institutional Biosafety Committee (IBC) is mandatory prior to receiving the IBC Approval letters for the approved IBC protocols. Also, submitting any information to the WVU Biosafety Officer as required by the WVU IBC is mandatory prior to receiving the IBC Approval letters for the approved IBC protocols.

The development of the required policies, guidelines & documents for the WVU Biosafety program is ongoing.

Export Control

The WVU ORIC is implementing a process in place to abide by the Export Control Regulations by The WVU Faculty & Staff who travel overseas. The WVU Faculty 7 Staff traveling overseas will be required to sign off on the WVU Academic travel information form & submit the form to the WVU Export Control Officer. If necessary, a second step requiring an in-depth review of the overseas travel will be conducted by the WVU Export Control Officer. The Academic Travel document has been modified & is undergoing review. The updated forms will be posted at the ORIC Export Control, Academic Travel website.

The I-129 questionnaire for deemed export verification has been modified. The 2 questionnaires have been merged into 1 questionnaire to make it convenient for the users. After the review process, the form will be posted at the WVU ORIC Export Control, I-129 Certification website. The CITI training on Export Control for WVU Staff & Faculty is being reviewed prior to its implementation.

Conflict of Interest in Research

As many of you may be aware, new requirements regarding conflicts of interest in research (COIR) funded by the Public Health Service were enacted into law last summer (http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf). These regulations will become effective on August 24, 2012. These are the first revisions to the regulations since 1995 and will require changes in our existing policies and procedures regarding conflict of interest in research, as well as the introduction of newly required components, such as mandatory training and reporting.
In order to comply with these new federal regulations, a number of changes and improvements to our COI system have been or are in the process of taking place. For example, the CITI COI training is currently being developed and a web-accessible travel reporting instrument is under construction. WVU policies on Conflict of interest in Research have been substantially updated, reviewed, and upon final approval, will go into effect in late August, 2012.

The new regulations are extensive but the most important changes to our policies and procedures include:

• The institution, not the faculty member, must determine whether a faculty member’s outside interests overlap with/are related to their institutional responsibilities and if so, if they are related to their research/scholarship responsibilities (and specifically to PHS funded research). If that is the case the institution must determine whether an financial conflict of interest (FCOI) exists, rather than allowing the faculty member to make this determination.
• For each proposed research activity, regardless of funding source, all PI’s and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of current or proposed research, (including collaborators, consultants, and students) must complete a Disclosure of Interest in Research (DOIR) Form before final approval can be given.
• All investigators must complete CITI training on COI before engaging in any PHS-funded research; training must be completed every four years thereafter.
• Almost all travel reimbursements must be reported.
• The threshold at which a personal financial relationship or interest is deemed significant will be decreased from $10,000 in the current policy to $5,000 in the 2012 revision. If that financial relationship or interest is related to a faculty member’s institutional responsibilities and it is determined to have the potential to have a direct and significant effect on the research, or the research on the financial interest, then an FCOI (Financial Conflict of Interest) exists.
• When a FCOI exists, institutions must assure the NIH that they have managed the FCOI related to a specific PHS funded project before an award can be accepted for that project and any monies spent. This assurance needs to be updated annually and as new FCOIs occur.
• The amount of information that must be reported to the NIH if a FCOI exists is significantly increased.
• Institutions must make readily accessible to the public, certain information concerning FCOIs that overlap with PHS funded awards.
• If noncompliance with regulations is found, a series of significant review procedures are required to take place.

We have worked hard to try to minimize the burden the new regulations will place on our researchers. However, there will be some changes that will require advanced planning by our PI’s. We will provide updated information on new WVU COIR requirements throughout the summer.

Other Notifications

The Availability of the ORIC Responsibility Matrix

The ORIC website is now host to the ORIC responsibility matrix. The WVU research integrity and compliance matrix is a comprehensive easy-to-use source of information about the policies, education and training programs, forms, processes and leads on accessing ORIC services and can be located at http://oric.research.wvu.edu/responsibility-matrix.

This matrix was developed to facilitate the responsible conduct of research at WVU by providing its investigators with a single point of access for policy information, education & training programs, forms & submission processes, and more related to research integrity and compliance.

The ORIC, Now on Facebook

The ORIC now has a presence on Facebook at http://www.facebook.com/pages/West-Virginia-University-Office-of-Research-Integrity-Compliance-ORIC/299775123444843.

Please “like” the WVU ORIC Facebook page so you can receive regular and immediate updates on policies, WVU+kc, new developments, and more.

More News on WVU+kc

More information about the new WVU+kc electronic administration system can be found at http://wvutoday.wvu.edu/n/2012/05/24/kill-the-paperwork-wvu-goes-online-with-simpler-electronic-system-to-facilitate-the-work-of-faculty-researchers.

16 May

Electronic Research Administration

Unknown | May 16th, 2012

The Office of Research Integrity and Compliance is pleased to announce the first release of the WVU+kc electronic research administration system for the submission of IRB documents. WVU+kc is now immediately available for the submission of new Not Human Subject Research (NHSR) protocols only. Training is required in order to access the system and can be completed independently or through remote 1-on-1 sessions with the Office of Research and Integrity Compliance. Specific instructions for completing training and requesting access can be found on the WVU+kc website at http://kuali.wvu.edu/wp-content/uploads/QRG12-NHSR-Submission-Training.pdf.


For more information about the WVU+kc system, visit the project website at http://kuali.wvu.edu. For updates regarding training and future protocol submission release dates, sign up for the ORIC listserv or follow the project on Facebook, G+, or Twitter.

27 Jan

ORIC Newsline - Winter 2012 (Text)

Jonathan | January 27th, 2012

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.

26 Jan

Problem Reporting: EthicsPoint Available

Jonathan | January 26th, 2012

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.

1 Nov

ORIC Newsline - Fall 2011 (Text)

Jonathan | November 1st, 2011

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.

26 Aug

IRB - Policy Update: Incidental Findings

Jonathan | August 26th, 2011

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.

14 Jul

ORIC Newsline - Summer 2011 (Text)

Jonathan | July 14th, 2011

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).

29 Jun

Policy Update: Tissue Banking Policy

Jonathan | June 29th, 2011

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.”