Animals (Research)

Virginia Tech is committed to providing humane care for and ensuring the well-being of animals used in research and teaching at this university by our faculty, staff, and students. This commitment is guided by the ethical principles described in the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" and in applicable federal regulations, guidelines, and policies, including, but not limited to the federal Animal Welfare Act, the "Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals", and the ILAR/NRC "Guide for the Care and Use of Laboratory Animals". For operational purposes, as required by federal law, this commitment is vested in the Institutional Animal Care and Use Committee (IACUC) which operates under an Animal Welfare Assurance on file with the Office for Laboratory Animal Welfare (OLAW) within the U. S. Department of Health and Human Services (DHHS).

All research involving vertebrate animal species (excluding human subjects), regardless of funding source, is under the purview of the Virginia Tech IACUC. Animals cannot be obtained or used without prior protocol review and approval by the IACUC.

1. Determine whether your project requires an IACUC protocol. If you are unsure, please contact: IACUC@vt.edu
   The following uses and categories of animals do not require IACUC approval:
   
   1. Invertebrate species (however, not their vertebrate hosts, will require an IACUC protocol.)
   2. Client-owned animals (companion animals/pets, livestock, horses, fish, avian species) that are presented to the CVM Veterinary Teaching Hospital for clinical and surgical care.
   Note: The VT IACUC is willing to review animal activities utilizing the above species or client-owned animal research if the intended target journal requires an IACUC approval number for publication.
   
2. If your proposed activity requires IACUC approval, the approval must be obtained prior acquiring and/or using any vertebrate species (living or dead) or their primary tissues.
3. Please read the following carefully when calculating the start date of the proposed research activity: IACUC processing takes a minimum of 2 weeks, assuming the PI is available to answer any questions that arise, and may take longer if the protocol is held over to full committee review at a convened meeting. Please plan accordingly.
4. Determine the Principal Investigator (PI) - A graduate student, resident or laboratory technician may be a Co-PI but a faculty member must be PI and must send in the submission.
5. Complete the following training for the PI and all others listed on the protocol.
   1. IACUC Core Training (must be renewed every three years)
   2. Virginia Tech-specific IACUC (must be renewed every three years)
   3. Training on the Virginia Tech Occupational Health and Safety Program must be completed initially and repeated if the animal species changes.
   4. Other training as determined by the Attending Veterinarian, Animal Care Supervisors and Research Faculty.
6. All employees working with animals must complete the Health Surveillance Questionnaire initially and on an annual basis. Following submission of the Health Surveillance Questionnaire and Environmental, Health and Safety Services review of your work-related exposures, you will be offered access to medical services appropriate for those exposures. Note that certain immunizations may take several weeks to provide adequate protection; therefore, please request services in a timely manner.
7. Create a submission package by completing all of following forms. All forms must be submitted by email to IACUC unless otherwise designated.
   1. Animal Use Protocol Review
   2. Appendices (as Relevant to Proposed Project)
      1. Appendix A: Housing and Husbandry
      2. Appendix B: Ante-mortem Specimen Collection
      3. Appendix C: Test Substance Administration
      4. Appendix D: Surgical Procedures
      5. Appendix E: Antibody Production
      6. Appendix F: Stress Studies
      7. Appendix G: Tumor Induction and Management
      8. Appendix H: Field Studies and Wild Caught Animals
   3. Certification of Compliance Assurance? this is no longer downloadable and will be sent to you shortly after the IACUC office has received your submission. It must be printed and signed by the PI (faculty member who is Lab or Course Leader) and mailed to:
   
   IACUC Office
   Office of Research Compliance
   2000 Kraft Drive, Suite 2000 (0497)
   Blacksburg, VA 24060
   
8. Researchers must submit their protocols in a timely manner to allow adequate time for review of their protocol prior to the desired start date of their research activity. New protocol submissions that are replacing expiring protocols must be submitted sufficiently in advance of the expiration date of the expiring protocol to ensure continuity of availability of animal use.
   
   There is no longer a monthly deadline for most protocol submissions because protocols are now reviewed on weekly basis via electronic distribution to the IACUC Membership. However, Category E and similar protocols ARE required to be reviewed at a convened meeting of the IACUC, per Virginia Tech's IACUC Policy. If you know your submission will have to be reviewed at a convened meeting, please allow at least 4-6 weeks for review.
   
   The Institutional Animal Care and Use Committee typically meets monthly on the third Thursday of the month. Category E protocols and significant amendments and applicable review forms that have been designated by the membership to be reviewed at a convened meeting of the IACUC must be pre-reviewed in advance of the meeting. Thus, the IACUC Administration Office should receive Category E protocols that require review at a convened meeting at least 10 working days (two weeks) before the scheduled meeting. Category E protocols that must be reviewed at a convened meeting for which they are not adequately pre-reviewed will be held over for review at the next month's meeting. Please plan accordingly.
9. Within 48-72 hours after initial receipt, the protocol goes through an administrative pre-review. The protocol then undergoes Veterinary pre-review and this step also takes up to an additional 48-72 hours. If you are contacted with questions during either pre-reviews, please respond as soon as possible to avoid delays.
10. After the pre-reviews are complete, the protocol is passed to the full committee via email for preliminary review and determination of the type of review to be performed on the protocol.
    Most protocols are routed by the committee to be approved via Designated Member Review (DMR). The following could happen:
    1. Held and required minor modifications from the PI.
       1. Satisfactory modifications- protocol is reviewed by the Designated Member Reviewer.
       2. Unsatisfactory modifications- protocol is tabled to a convened meeting.
    2. Reviewed by the Designated Member
       1. Approved- PI notified and provided Approval Letter via email. A protocol is approved for 3 yrs.
       2. Tabled to Convened Meeting
    3. Held and bound to a convened meeting. The meetings are usually held on the third Thursday of each month. *All category E protocols must be reviewed at a convened meeting.
       1. Approved- PI provided Approval Letter in PDF format via email. A protocol is approved for 3 yrs.
       2. Requires modifications prior consideration for approval
       3. Disapproved- PI notified via email with explanation
       4. Tabled to the next meeting for further discussion
11. Work with the IACUC to facilitate your protocol's review until you receive your approval letter. You may then begin to order animals via the proper channels in your department or with the Vivarium you will be working with.
12. Save a copy of the approval letter and retain a printed copy of your protocol in your laboratory or office. It is a contract between you, the IACUC and the federal government.

Modifications or Amendments to Your Protocol

If you need to modify your protocol, you are permitted up to three amendments before a new protocol will be required to be submitted. The exception is that additions or deletions of personnel, except the PI, do not count against the three-amendment limit. Please note that the IACUC reserves the right to require a new submission in the event of changes that significantly alter the original protocol, even before a protocol has reached it's three amendment limit.

1. Complete an amendment form
2. Submit it to IACUC
   1. Modifications are considered Administrative, Minor or Significant. Examples are below but please see the amendment form for further detail.
      • - Administrative changes (i.e., change of funding source, change of title) will be reviewed by IACUC administrator.
      • - Minor modifications (i.e., slight changes in animal numbers or sampling) will be reviewed by a veterinary reviewer who is a Committee member.
      • - Significant modifications (i.e., procedure changes, more than slight changes of animal numbers) will have to be reviewed by the full Committee, usually via the DMR process. NOTE: All category E must be reviewed at a convened meeting. The meetings are typically held the third Thursday of each month.

Annual Reviews

1. Annually, usually in the Fall, you will be queried for Annual Continuing Review information so that the IACUC may review the current status of your IACUC protocol.

Protocol Expiration

1. Protocols expire three years on the day before their approval date. Courtesy expiration notices are sent 6-8 wks prior to expiration but PI's are expected to be aware of their protocols' expiration dates to avoid possible interruptions in animal activity and to avoid potential compliance issues or reportable incidents.

For More Information, Please Visit the IACUC Homepage

Animals (Teaching)

Virginia Tech is committed to providing humane care for and ensuring the well-being of animals used in research and teaching at this university by our faculty, staff, and students. This commitment is guided by the ethical principles described in the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" and in applicable federal regulations, guidelines, and policies, including, but not limited to the federal Animal Welfare Act, the "Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals", and the ILAR/NRC "Guide for the Care and Use of Laboratory Animals". For operational purposes, as required by federal law, this commitment is vested in the Institutional Animal Care and Use Committee (IACUC) which operates under an Animal Welfare Assurance on file with the Office for Laboratory Animal Welfare (OLAW) within the U. S. Department of Health and Human Services (DHHS).

All teaching uses as well as any research involving vertebrate animal species (excluding human subjects), regardless of funding source, are under the purview of the Virginia Tech IACUC. Animals cannot be obtained or used without prior protocol review and approval by the IACUC.

1. Determine whether your project requires an IACUC protocol. If you are unsure, please contact: IACUC@vt.edu
   The following uses and categories of animals are exempt and do not require IACUC approval:
   1. Invertebrate species (however, their vertebrate hosts, if applicable, will require an IACUC protocol.)
   2. Client-owned animals (companion animals/pets, livestock, horses, fish, avian species) that are presented to the CVM Veterinary Teaching Hospital for clinical and surgical care.
2. If your proposed activity requires IACUC approval, the approval must be obtained prior to acquiring and/or using any vertebrate species (living or dead) or their primary tissues.
   Please read the following carefully when calculating the start date of the course or lab: IACUC processing takes a minimum of 2 weeks, assuming the PI is available to answer any questions that arise, and may take longer if the protocol is held over to full committee review at a convened meeting. Please plan accordingly.
3. Determine the Lab Leader (PI) - A student assistant may be a Co-PI but a faculty member must send in the submission.
4. Complete the following Training for Lab Teacher and any assistants working with animals and thus included on the protocol.
   1. IACUC Core Training (must be renewed every three years)
   2. Virginia Tech-specific IACUC Training (must be renewed every three years)
   3. Training on the Virginia Tech Occupational Health and Safety Program must be completed initially and repeated if the animal species or organism changes.
   4. Other training as determined by the Attending Veterinarian, Animal Care Supervisors and Research Faculty.
5. All employees working with animals must complete the Health Surveillance Questionnaire initially and on an annual basis. Following submission of the Health Surveillance Questionnaire and Environmental, Health and Safety Services review of your work-related exposures, you will be offered access to medical services appropriate for those exposures. Note that certain immunizations may take several weeks to provide adequate protection; therefore, please request services in a timely manner.
6. Create a submission package by completing all of following forms: All forms must be submitted by email to IACUC unless otherwise designated.
   1. Animal Use Protocol Review
   2. Appendices (As Relevant to Proposed Project)
      1. Appendix A: Housing and Husbandry
      2. Appendix B: Ante-mortem Specimen Collection
      3. Appendix C: Test Substance Administration
      4. Appendix D: Surgical Procedures
      5. Appendix E: Antibody Production
      6. Appendix F: Stress Studies
      7. Appendix G: Tumor Induction and Management
      8. Appendix H: Field Studies and Wild Caught Animals
   3. A copy of the course or lab syllabus with detailed animal use procedures
   4. Certification of Compliance Assurance- this is no longer downloadable and will be sent to you shortly after the IACUC office has received your submission. It must be printed and by the PI (faculty member who is Lab or Course Leader) and mailed to:
      IACUC
      Office of Research Compliance
      2000 Kraft Drive, Suite 2000 (0497)
      Blacksburg, VA 24060
7. Instructors and researchers must submit their protocols in a timely manner to allow adequate time for review of their protocol prior to the desired start date of the lab or course. New protocol submissions that are replacing expiring protocols must be submitted sufficiently in advance of the expiration date of the expiring protocol to ensure continuity of availability of animal use.
   
   There is no longer a monthly deadline for most protocol submissions because protocols are now reviewed on weekly basis via electronic distribution to the IACUC Membership. However, Category E and similar protocols ARE required to be reviewed at a convened meeting of the IACUC, per Virginia Tech's IACUC Policy. If you know your submission will have to be reviewed at a convened meeting, please allow at least 4-6 weeks for review.
   
   The Institutional Animal Care and Use Committee typically meets monthly on the third Thursday of the month. Category E teaching and research protocols, significant amendments and applicable review forms must be pre-reviewed in advance of the meeting. Thus, protocols that require review at a convened meeting should be received by the IACUC Administration Office at least 10 working days (two weeks) before the scheduled meeting. Protocols that must be reviewed at a convened meeting for which they are not adequately pre-reviewed will be held over for review at the next month's meeting. Please plan accordingly.
8. Within 48-72 hours after initial receipt, the protocol goes through an administrative pre-review. The protocol then undergoes Veterinary pre-review and this step also takes up to an additional 48-72 hours. If you are contacted with questions during either pre-reviews, please respond as soon as possible to avoid delays.
9. After the pre-reviews are complete, the protocol is passed to the full committee via email for preliminary review and determination of the type of review to be performed on the protocol. Most protocols are routed by the committee to be approved via Designated Member Review (DMR). The following could happen:

1. Held and required minor modifications from the PI.
   1. Satisfactory modifications- protocol is reviewed by the Designated Member Reviewer.
   2. Unsatisfactory modifications- protocol is tabled to a convened meeting.
2. Reviewed by the Designated Member
   1. Approved- PI notified and provided Approval Letter via email. A protocol is approved for 3 yrs.
   2. Tabled to Convened Meeting
3. Held and bound to a convened meeting. The meetings are usually held on the third Thursday of each month.
   All category E protocols must be reviewed at a convened meeting.
   1. Approved- PI provided Approval Letter in PDF format via email. A protocol is approved for 3 yrs.
   2. Requires modifications prior consideration for approval
   3. Disapproved- PI notified via email with explanation
   4. Tabled to the next meeting for further discussion

10. Work with the IACUC to facilitate your protocol's review until you receive your approval letter. You may then begin to order animals via the proper channels in your department or with the Vivarium you will be working with.
11. Save a copy of the approval letter and retain a printed copy of your protocol in your classroom or office. It is a contract between you, the IACUC and the federal government.

Modifications or Amendments to Your Protocol

1. If you need to modify your protocol, you are permitted up to three amendments before a new protocol needs to be submitted. The exception is that additions or deletions of any personnel, except the PI, do not count against the three-amendment limit. Please note that the IACUC reserves the right to require a new submission in the event of changes that significantly alter the original protocol, even before a protocol has reached it's three amendment limit.
   1. Complete an amendment form
   2. Submit to IACUC
   3. Modifications are considered Administrative, Minor or Significant. Examples are below but please see the amendment form for further detail.
      • - Administrative changes (i.e., change of funding source, change of title) will be reviewed by IACUC administrator.
      • - Minor modifications (i.e., slight changes in animal numbers or sampling) will be reviewed by a veterinary reviewer who is a Committee member.
      • - Significant modifications (i.e., procedure changes, more than slight changes of animal numbers) will have to be reviewed by the full Committee, usually via the DMR process. NOTE: All category E must be reviewed at a convened meeting. The meetings are typically held the third Thursday of each month.

Annual Reviews

1. Annually, usually in the Fall, you will be queried for Annual Continuing Review information so that the IACUC may review the current status of your IACUC protocol.

Protocol Expiration

1. Protocols expire three years on the day before their approval date. Courtesy expiration notices are sent 6-8 wks prior to expiration but Lab Leaders and Course Leaders are expected to be aware of their protocols' expiration dates to avoid possible interruptions in animal activity and to avoid potential compliance issues or reportable incidents.

Biohazards and "Select" Biological Agents

The Environmental, Health and Safety Services is charged with regulating and approving protocols that involve biohazards and Select Biological Agents.

Biohazards

Biohazardous materials used in research and teaching, including:

• - biological agents known to, or suspected to, cause disease in humans
• - toxins of biological origin that may cause death or severe incapacitation at relatively low exposure level
• - human, non-human primate, and mammalian blood, blood products, and unfixed tissue
• - animal/plant pathogens and products, specific genetically engineered organisms requiring a USDA APHIS permit for transportation or use and veterinary biologics requiring a permit for research, evaluation, or transportation
• - select agents and toxins which includes specific agents, toxins, and related genetic material determined by HHS and USDA to pose a severe threat to human health, animal health/products, or to plant health/products

Please visit the EHSS' Biohazard Program for guidelines and necessary forms.

1. All employees working with biohazardous or select agents must complete the Health Surveillance Questionnaire initially and on an annual basis. Following submission of the Health Surveillance Questionnaire and Environmental, Health and Safety Services review of your work-related exposures, you will be offered access to medical services appropriate for those exposures. Note that certain immunizations may take several weeks to provide adequate protection; therefore, please request services in a timely manner.

"Select" Agents

Please visit the EHSS' Select Agent and Toxin Program for guidelines and necessary forms.

Bloodborne Pathogens Program

The Bloodborne Pathogens Program (BBP) outlines safety policies for the protection of Virginia Tech employees who have a potential for occupational exposure to bloodborne pathogens, such as Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV), and Hepatitis C Virus (HCV), among others. Departments must develop work practices and procedures, assure 'at risk' employees are provided access to training and vaccinations prior to hazard exposure, provide necessary personal protective equipment, and provide on-going oversight to assure compliance is being maintained. Researchers using human cell lines or other human material would need to comply with OSHA's BBP standard.

For more information, see the Bloodborne Pathogens Program.

Electrical Safety Program

The use of extension cords is permitted for temporary use only, and shall not be used in place of permanent building wiring. For more information on permitted extension cord and temporary power uses, click here.

Research involving electrical systems operating at 50 volts or more to ground must comply with Virginia Tech's Electrical Safety Program.

Environmental Regulatory Compliance

Compliance with environmental regulations is central to university operations. EHSS maintains oversight responsibility for all university compliance activities. The university's environmental engineer is primarily responsible for compliance with all air, water, and groundwater pollution control regulations.

This program applies to all individuals in the university community.

1. Please visit Environmental Compliance Oversight Information for a listing of programs and required procedures.

Export Administration Regulations (EAR)

Office of Export and Secure Research Compliance

The primary focus of the Export Administration Regulations (EAR) is to control the export of dual-use technologies i.e., items that are used, or have the potential to be used, for military as well as non-military purposes if such export could adversely affect the national interests of the United States.

1. Determine if your research is subject to EAR Ear Decision Tree
2. If subject to EAR, learn how to create a Technology Control Plan

For more information about EAR, please go to the Office of Export and Secure Research Compliance webpage or see our Frequently Asked Questions (FAQs)

Other Useful Links:

• General EAR Information and Regulations Summary
• Export Administration Regulations Database
• United States Export Administration Regulations

Hazardous Chemicals

The Hazardous Chemical Management Program provides information and guidelines to manage and reduce personnel exposure to hazardous chemicals and materials. If your work involves the use of chemicals in a laboratory, you must develop Laboratory Specific Documentation as specified in the Hazardous Chemical Management Program. If your work involves the use of chemicals outside of a laboratory environment, you must develop a site specific Hazard Communication Plan.

1. Visit EHSS' website for criterion
2. Read the following Hazardous Chemical Management program for requirements and necessary forms

Electronic Waste (Dead Batteries, Computer Monitors)

Computer monitors contain toxic elements (including lead and cadmium) that may be harmful to the environment when improperly disposed of. Batteries may also contain mercury, lead and cadmium. As a result, EPA regulations prohibit the disposal of nonworking computers monitors in a landfill for institutions such as Virginia Tech.

Virginia Tech's Environmental, Health and Safety Services will pick up and properly recycle your nonworking computer monitors and spent batteries. There is no cost to your department for this service. Just complete the form linked below. The expected pick-up date of the monitors or batteries should be within one to two weeks of submitting the form.

1. Please visit the Battery and Computer Monitor Pickup Form for a listing required procedures and forms

Chemical and Radiological Waste

Virginia Tech's Environmental, Health and Safety Services will pick up and properly dispose of all chemical and radiological waste generated on campus, and coordinates the disposal of chemical waste generated off-site. The EHSS website provides guidance on chemical waste disposal procedures, radiological waste disposal procedures, and access to an on-line pick-up request form.

Regulated Medical Waste

The regulated medical waste provisions apply to to anyone who is working with human tissues, blood or items contaminated with human blood. It also applies to any lab working with potentially infections substances, including cultures and plates, pipettes, needles, intentionally infected lab animals and their bedding.

Any area that is generating regulated medical waste is required to properly package this waste per federal and state regulations. EHSS must be contacted for disposal immediately upon packaging the waste to ensure timely disposal. All disposal and packaging materials are supplied to the university community free of charge.

1. Please visit the Regulated Medical Waste Program for a listing required procedures and forms

Disposal of Other Regulated Wastes

The Hazardous Waste Disposal Program oversees the collection, handling, and disposal of chemicals and hazardous materials from over 1,300 laboratories located on Virginia Tech's main campus, Virginia Tech's Physical Plant, and all agricultural research and extension centers. This program ensures compliance with all federal, state, and local regulations, which govern the handling, storing, and disposing of hazardous waste. The program also manages the recycling of batteries, mercury, oil, photo fixer and the disposal of light ballasts, and fluorescent tubes.

1. Please visit EHSS Waste Removal for a listing of programs and required procedures for a listing of programs and required procedures or contact Environmental, Health and Safety Services at (540) 231-2982 for assistance.

If you have any questions about how to dispose of hazardous waste, please call our office at (540) 231-2982.

Humans

For More Information: Visited the IRB Homepage

Virginia Tech is committed to protecting the rights of and ensuring the safety of human subjects participating in research conducted by faculty, staff and students of the University. This commitment is guided by the ethical principles described in the "Belmont Report" and in applicable federal regulations. For operational purposes, as required by federal law, this commitment is vested in the Institutional Review Board for Research Involving Human Subjects (the IRB) which operates under a Federal wide Assurance (FWA) on file with the Office for Human Research Protection (OHRP) within the U.S. Department of Health and Human Services (DHHS)

1. Determine if IRB approval is required.
2. Please plan accordingly if you require the release of OSP funds before you are able to put together a complete IRB application. Apply for interim approval.
3. Determine the primary investigator (PI)- A student may be a co-PI but a faculty must make the submission.
4. Complete Human Subject Protections trainings for all investigators. Please see the following link for the Available Training Opportunities
5. Create a submission package by completing all of following forms.
   1. Research Protocol (doc) (Note: submit in place of the previously required internal review application)
   2. Consent document (Note: not required for exempt studies)
6. Instructions for Developing your Consent Form
   1. Involving minors- Include proposed Parental Permission form & Child Assent form. Learn more.
7. Needing to request a waiver for this requirement? Learn more.
   1. Bio-sketch or CV for all investigators.
   2. Documentation of completion of human subject protections training for all investigators (Note: if training completed through the IRB online tutorial or Virginia Tech's human subjects class (instructed by Dr. David Moore), submission of a certificate is not required). Available Training Opportunities.
   3. For federally funded research, if available at the time of submission, submit the OSP proposal with the IRB application. Learn more.
8. Submit forms to departmental reviewer if required by department. Not Sure?
9. Have all Investigators listed on this project and Departmental Reviewer (if required) review the submission. All requested revisions must be implemented into the application AND copy all the investigators to the submission.
10. Email items A-F under #6 to IRB
    1. Provide all required documents as attachments in ONE e-mail. Do not break items into separate e-mails unless necessary.
    2. If part of your submission (e.g., questionnaire) cannot be submitted electronically, follow these steps:
    3. Electronically submit all documents that can be sent electronically
    4. Within the submission e-mail, inform the IRB of any missing documents
    5. The submission will not be reviewed until all documents have been received.
11. Send the department reviewer's signature if required via email, fax or mail:

IRB
Fax #: (540) 231- 0959
Office of Research Compliance
2000 Kraft Drive, Suite 2000 (0497)
Blacksburg, VA 24060
Attn: IRB

12. The review process
    1. Exempt and Expedited review
    2. Assuming no major problems/deficiencies in the submission, IRB Chair or designee will generally review the submission within 10-14 days after receipt of the submission package
    3. If there are problems or deficiencies, the IRB administrator will contact the investigators with specific requests to resolve those deficiencies or problems. Please respond back as soon as possible to avoid further delays. In order to prevent unnecessary delays, provide sufficient detail in your IRB submission and submit all required documents.
    4. Full Board Review (all studies that do not qualify for exempt or expedited status)
13. Full Board meets once a month (typically the second Monday of each month) to review and make decisions on submissions.
14. The IRB Chair will contact you within a 7-10 days after the meeting with the Board's decision and may request action on your part.
15. After review by the full IRB, the protocol will be:
    1. Approved as submitted; OR
       1. When approved, researchers receive an approval letter via email. Retain this official approval letter. The Graduate Department will request a copy of this IRB approval letter before graduation. The email will include the IRB approved consent form(s) in PDF format. The protocol is valid for ONE year.
    2. Contingently approved with stipulations for non-substantive changes (conditions that must be met before final approval is granted); OR
    3. Tabled / deferred, pending receipt of additional information or major revisions; OR
    4. Not approved.

Modifications or Amendments to Your Protocol

1. Any changes (change of personnel, survey questions etc) to the approved protocol, the researcher must submit the following to IRB
   1. Request for Amendment Form
   2. Clean copy of the modified form(s).
2. If researchers wish to continue research past the initial year, the following must be submitted it IRB:
   1. Request for Continuing Review needs to be submitted to IRB
   2. The most recent IRB-approved consent form templates(s) [unless previously waived by the IRB], including assent & permission forms (if applicable)
   3. Unless the protocol is originally approved as expedited also email a copy of the current "i.e. incorporating amendments," research protocol/initial review application

Data Security

Disclaimer: This is intended to provide a general guidelines overview and does not constitute the final word on data security. If an individual is unsure, please contact Virginia Tech Information Technology Security or visit their website.

1. Computer Security
   1. Use a strong password. (Learn More)
   2. Use an anti-virus software. (Learn More)
   3. Use a firewall
      • - Windows
      • - MAC
   4. Apply all software updates regularly
      • - For Macs
      • - For Windows
      • For Linux
2. Using Flash Drives and Other Media:
   
   1. Scan the flash drives for viruses when the flash drive has been moved from one computer to the next. More malicious software is targeting flash drives and other media.
   2. Encryption and locking files
      • - Be wary of storing data on flash drives because they are easily lost. A lost flash drive is a breach of confidentiality in human research.
      • - Vendor Tools
3. When Choosing a Software:
   
   1. Review the following Acceptable Use Guidelines below or click on the following pdf
      • - use resources only for authorized purposes.
      • - protect your user id and system from unauthorized use. You are responsible for all activities on your user id or that originate from your system.
      • - access only information that is your own, that is publicly available, or to which you have been given authorized access.
      • - use only legal versions of copyrighted software in compliance with vendor license requirements.
      • - be considerate in your use of shared resources. Refrain from monopolizing systems, overloading networks with excessive data, degrading services, or wasting computer time, connect time, disk space, printer paper, manuals, or other resources.
   2. Research the company carefully and not just their website. Malicious individuals can fake security certificates and make false promises.
      • - It is the researcher's responsibility. If you are unsure, contact VT IT Security at www.security.vt.edu
   3. Read the following pdf generated by the United States Computer Emergency Readiness Team: pdf
   4. Make sure the site you are using will have SSL (https://)
      1. Anything that goes over a web address beginning with http:// can be seen by any third party. SSL is an encryption that makes it harder for a third party to view data in transit over the internet.
      2. In determining whether SSL is properly enabled on an active online survey researchers must ensure that when a research participant visits the online survey the following occur:
         1. The URL begins with https:// (http:// is inadequate). If, while attempting to access the online survey, a research participant erroneously enters the URL using http:// in place of https://, then he/she is automatically (and without fail) rerouted to the correct (https://) URL.
         2. Security certificate must verify high-level encryption. To check the security certificate, double-click on the padlock or similar symbol (typically found at the bottom right of the browser window).
         3. For picture examples please visit the following IRB page

With Video/Auto Recording

Points to Consider

• - Studies involving the use of video or audio recording of human subjects do not qualify for exempt status.
• - Subjects must be fully aware that they are being video and/or audio recorded and have provided prior consent to be recorded.
• - During the consent process and throughout the research procedures, ensure that subjects are comfortable with the recording and let them know that they are free to stop the recording at any time and have the right to have those records destroyed.

Consent Form Process

1. Consent Document
   1. Procedures Section
      1. Inform subjects that the study will involve audio and/or video recording;
      2. Inform subjects whether or not these recordings are required to participate in the study procedures (if recording is optional, provide a space at the end of the consent document where subjects initial to consent specifically for the audio and/or video recording).
      3. provide a separate space on the consent document that the subjects can initial providing consent specifically for the audio and/or video recording. This is especially important if the recording is optional (i.e., the subject may continue to participate in the study procedures if they do not wish to be audio/video recorded).
   2. Anonymity / Confidentiality Section
   1. How the study will ensure the security of the tapes;
   2. Who will be transcribing the recordings;
   3. Who will have access to the recordings; and
   4. When the tapes will be erased / destroyed.

With Students

1. Reduce Coercion
   1. Possibility that students may volunteer to participate out of a belief that participating will result in receiving better grades, recommendations, employment or out fear of negatively affect relationship with faculty
      1. Solution: require that faculty-investigators advertise for subjects generally (e.g., through notices posted in the school or department) rather than recruit individual students directly.
   2. Requiring participation in research for course credit (or extra credit) is also controversial, though common in the social and behavioral sciences.
      1. As with any research involving a potentially vulnerable subject population, IRBs must pay special attention to the potential for coercion or undue influence and consider ways in which the possibility of exploitation can be reduced or eliminated.
   3. Providing Extra Credit for Participation in Research-Limit the use of extra credit points as a reward for participating; they should be used when the research is closely tied to the course subject matter and they should not raise a student's grade by a whole step (e.g., from a B to an A).
      1. Equal alternatives to receiving extra credit must be provided.
      2. Limit the use of extra credit points as a reward for participating; they should be used when the researcher is closely tied to the course subject matter and they should not raise a student's grade by a whole step (e.g., from a B to an A).
      3. Keep financial rewards commensurate with the risks of participation.
      4. Additional information to provide in your consent document(s) (Compensation Section) if your study involves students and extra credit:
         • - Amount of extra credit given for completion of each study procedure and for completion of the entire study
         • - The impact this extra credit will have on students; grades.
2. Confidentiality- another concern raised by the involvement of students as subjects is confidentiality. As with research involving human subjects generally, the Virginia Tech IRB is aware that research involving the collection of data on sensitive subjects such as mental health, sexual activity, or the use of illicit drugs or alcohol presents risks to subjects of which they should be made aware and from which they should be protected, to the greatest extent possible. The close environment of the university amplifies this problem.
   1. Accessing Student Records
      1. If a research project includes the need to access student records (i.e., SAT or GRE scores, or student GPA), a separate signed consent/permission form must be obtained from the student subject and submitted to the Registrar's office.
3. Potential recruiting of minors. Some freshman college students are under the age of 18.
4. Will study procedures be completed during school time? If so, students not included in the study may view this as unfair. Also, students may feel compelled to participate if it means missing out on regular classes.
   1. If possible, avoid using class time to recruit subjects or complete study instruments.

With Minors

The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. 45CFR46 Subpart D (Additional DHHS Protections for Children Involved as Subjects in Research) applies to all research involving children as subjects.

Minor Assent and Parental Permission

1. Wards of the State
   1. Children who are wards of the State or any other agency, institution, or entity can be included in research approved under CFR 46.406 or 46.407 only if such research is
      1. related to their status as wards; or
      2. conducted in schools, camps, hospitals, institutions, or similar setting in which the majority of children involved as subjects are not wards.
      3. The IRB will require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis.
         • - One individual may serve as advocate for more than one child.
         • - The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

Emancipated Minors

• - Definitions of the emancipated minor include those who are:
  • * self-supporting and/or not living at home
  • * married
  • * pregnant or a parent
  • * in the military; or
  • * declared to be emancipated by a court. Legal emancipation recognizes a special status (eg, independent living) or serious public and/or individual health problems that might not otherwise receive appropriate attention (eg, sexually transmitted disease).
• - Many states give decision-making authority (without the need for parental involvement) to some minors who are otherwise un-emancipated but who have decision-making capacity (mature minors) or who are seeking treatment for certain medical conditions, such as sexually transmitted diseases, pregnancy, and drug or alcohol abuse.
• - The situations in which minors are deemed to be totally or partially emancipated are defined by statute and case law and may vary from state to state.

College Students as Minors

1. Federal regulations define children as persons who have not attained the legal age for consent to treatments or procedures involved in the research. In Virginia, the legal age for consent is 18.
   1. Therefore, unless waived by the IRB, researchers must obtain parental permission and assent for all minors.
   2. IRB supports the inclusion of college students who are minors in research; therefore, for very low risk research (e.g., low risk surveys) will typically waive the requirement for researchers to obtain signed and/or informed parental permission from their parents.
2. The University General Counsel at Virginia Tech has determined that college students under the age of 18 are not Emancipated Minors for purposes of participating as subjects in research. Therefore, any student under 18 years of age enrolled at the university may not be used/participate in a human subjects research project without first obtaining parental permission (unless waived) and the student's assent.

Suspected Child Abuse or Neglect

If you as a researcher ever suspect that a child is in danger due to abuse or neglect, you are obligated to contact the Department of Social Services and report the concern. This is in compliance with the mandatory reporting laws of the state of Virginia.

Determining Minimal Risk

Central to IRBs' consideration of research involving children is the determination of what constitutes minimal risk.

Procedures that usually present no more than minimal risk to a healthy child include:

• - urinalyses
• - obtaining small blood samples
• - EEGs
• - allergy scratch tests
• - minor changes in diet or daily routine
• - the use of standard psychological or educational tests.

Behavioral interventions

Those likely to cause psychological stress and/or anxiety may exceed minimal risk.

Points to consider:

• - Does the research have an identifiable prospect of direct benefit to the individual child participant? Can that benefit be achieved through alternative means?
• - Does the research have an identifiable prospect of risk to the individual child participant? What safeguards are proposed to minimize these risks? When procedures involving greater than minimal risk to children are anticipated, are convincing scientific and ethical justifications given?
• - Is the inclusion of normal volunteers justified?
• - Do studies involving placebo controls place the child at greater risk by withholding from selected subjects potentially therapeutic research drugs or interventions?
• - When possible, have appropriate studies been conducted on animals and adults first? Will older children be enrolled before younger ones?
• - What is the age of majority in the state? Can a child consent to medical care for certain conditions, and, if so, at what age? What legal limits are there on the right of parents to consent on behalf of their children?
• - Is permission of both parents necessary? Under what conditions may one of the parents be considered not reasonably available?
• - Will efforts be made to ensure that parents' permission to involve their children in research studies is free from coercion, exploitation, and/or unrealistic promises?
• - Are mechanisms in place to ensure that children are involved as research subjects in ways that do not undermine their dignity as young persons? Are provisions made that show respect for the developing rights of children, such as: (a) obtaining their assent, and, where appropriate, honoring their dissent; and (b) protecting their need for privacy and the confidentiality of information regarding them?
• - Are there special problems that call for the presence of a monitor or advocate during consent procedures?
• - Are special needs of adolescents such as counseling and confidentiality accounted for in the research design?
• - Are there any special problems such as confidentiality and reporting that might arise in sensitive research about child abuse or sexual practices of teenagers?

With Deception

1. When Deception May be Used
   • - Deception should be employed only when there are no viable alternative procedures. The IRB may find the use of deception acceptable when, and to the extent which, it is unavoidably required by the research to be done, and when the benefits outweigh the risks.
   • - Problems arise when major deception is involved. For example, if an investigator leads a subject to believe that he or she has committed a crime, or has a disease, or has some serious character flaw, then the merit of the investigation must clearly counterbalance the risk to the subject for the research to be approved.
2. How Deception May Be Used
   1. Preliminary Quasi-Consent
      1. Where deception is a necessary part of an experiment, the IRB will generally require that a preliminary quasi-consent be obtained, in which the investigator informs the subject that the experiment cannot be described fully in advance.
      2. Preliminary quasi-consent may be provided verbally or in written form. If in written form, do not call the document a Consent Form for participants cannot fully consent since they do not know the full nature of the research. Instead, you may call the document an Information Sheet.
      3. The research must qualify for an alteration of consent for quasi-consent.
   2. Debriefing
      1. To ameliorate the effects of unavoidable deception, the IRB requires debriefing of the deceived subjects.
      2. After the experiment, the subject should be informed of the deception and its purpose and provide permission for the use of data to be used for the research. It is at this time that participants sign a debriefing form, if appropriate. The researcher should, if possible, review the debriefing form verbally.
      3. The debriefing form must include the following information:
         • - Apology for the use of deception;
         • - Explanation of why it was necessary;
         • - Offer the subjects a chance to ask questions or work through any confusion they might have;
         • - Description of the extent the study can ensure confidentiality of the data gained from the deception;
         • - Inform the subjects that they have the right to have the data obtained from the research destroyed instead of used for data analysis.
      4. The IRB may require that the study have subjects sign the debriefing form to provide written consent for the use of the data during data analysis.
      5. The IRB recognizes that there are rare instances in which no consent can be obtained or debriefing done: e.g., if the researcher pretended to lie unconscious on a sidewalk and noted how many and what sorts of persons stopped, attempted assistance, or simply hurried past; or where debriefing would cause more harm to the subject than the deception itself.
      6. Goals of Debriefing
         • - to repair the breach of informed consent entailed by the deception
         • - to remove any confusions or defuse any tensions that might have been generated by the deception
         • - to make it clear especially to younger subjects that deception is permissible only in exceptional circumstances, and
         • - to repair (as much as possible) the breach of trust that has occurred not only between the investigator and the subject, but (potentially) between all researchers and all subjects.

With Surveys with Sensitive Questions

This type of study may involve more than minimal risk which may necessitate Full Board review. Some studies involving collection of sensitive data may qualify to obtain a Certificate of Confidentiality. Learn more about Certificates of Confidentiality.

Include the additional information in your Risk Section:

1. Be specific regarding potential risks including psychological, social, legal, economic, dignity and physical. Remember the potential of emotional distress while completing these surveys
2. Provide an explanation of the study's efforts to reduce the potential risks.
3. Anonymity / Confidentiality Section:
   1. Provide subject with contact information of professional counselors within the area that he/she may contact
   2. Inform subjects that any expense from the counselor will be incurred by the subject; AND
   3. Inform subjects that if he/she provides responses to the survey that indicate the potential of harm to themselves or others, the researcher is obligated to report to the appropriate authorities;
   4. Provide a thorough explanation of how the study will ensure confidentiality of this sensitive information.

With Colleagues

When studying colleagues or subordinates as research subjects, you must be able to:

1. provide a rationale other than convenience for selecting them
2. show that the recruitment method does not lead colleagues to think they will be compromised by not participating.

Recruitment through bulletin board advertisements or by a third party is preferable to direct recruitment.

With Cognitively Impaired Subjects

Who Are Considered Cognitively Impaired?

Individuals with:

• - Psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders)
• - Organic impairment (e.g., dementia)
• - Cognitive disorder
• - Developmental disorder (e.g., mental retardation)
• - Substance abusers

Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

The predominant ethical concern in research involving cognitively impaired individuals is that their disorders (affecting cognitive or emotional functions) may compromise/diminish their capacity for judgment and understanding of the information presented, and their ability to make a reasoned decision about participation.

As a general rule, all adults, regardless of their diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability that would impair reasoning or judgment. Even those who do have a diagnosed mental disorder may be perfectly able to understand the matter of being a research volunteer, and quite capable of consenting to or refusing participation. Mental disability alone should not disqualify a person from consenting to participate in research; rather, there should be specific evidence of individuals' incapacity to understand and to make a choice before they are deemed unable to consent.

1. Persons formally adjudged incompetent have a court-appointed guardian who must be consulted and consent on their behalf.
   1. Officials of the institution in which incompetent patients reside (even if they are the patient's legal guardians) are not generally considered appropriate, since their supervisory duties may give rise to conflicting interests and loyalties.
   2. Family members or others financially responsible for the patient may also be subject to conflicting interests because of financial pressures, emotional distancing, or other ambivalent feelings common in such circumstances.
2. Obtaining Consent/Witness to Consent
3. When obtaining Informed Consent from a mentally deficient or incompetent person, a witness must be present and must sign the consent document. The witness is verifying that the subject was fully informed and that the subject voluntarily agreed to participate.
4. Consider the Following Concerns If the Prospect Subject is a Voluntary or Involuntarily Resident of an Institution-
   NOTE: Persons who are institutionalized, particularly if disabled, should not be chosen for studies that bear no relation to their situation just because it would be convenient for the researcher.
   • - The eagerness for release may induce an institutionalized person, especially one who is involuntarily confined, to participate in research out of a desire to appear rational and cooperative to those who will make decisions about his or her release. The impact of institutionalization may further compromise their ability to exercise free choice (voluntariness). (These concerns apply both to voluntary patients and those committed involuntarily.)
   • - Should the patient's physician or other health care provider be consulted before any individual is invited to participate in the research?
   • - Is the research likely to interfere with ongoing therapy or regimens?
   • - Is it possible that the request to participate itself might provoke anxiety, stress, or other serious negative responses?
   • - Does the research pertain to mental disabilities so that it is necessary to involve persons who are mentally disabled as subjects?
   • - If the investigator proposes to involve institutionalized individuals, has he or she provided sufficient justification for using that population? Are non-institutionalized subjects appropriate for the research and reasonably available? Does the research pertain to aspects of institutionalization?
   • - Are adequate procedures proposed for evaluating the mental status of prospective subjects to determine whether they are capable of consenting? Are these procedures appropriate both to the subject population and the nature of the proposed research?
   • - Is more than minimal risk involved? If so, is the risk justified by anticipated benefits to the participating subjects and the importance of the knowledge that may reasonably be expected to result?
   • - Is it possible to identify persons authorized to give legally valid consent on behalf of any individuals judged incapable of consenting on their own behalf? Should assent of the prospective subjects also be required? If incapable of giving valid consent, can subjects' objection to participation be overridden? Under what circumstances?
   • - Should an advocate or consent auditor be appointed to ensure that the preferences of potential subjects are elicited and respected? Should someone ensure the continuing agreement of subjects to participate, as the research progresses?
   • - Does the IRB need to include a member knowledgeable about and experienced with the mentally disabled or cognitively impaired?

With Terminally ill Subjects

Severe illness often affects a person's competence, and terminally ill patients may be vulnerable to coercion or undue influence because of a real or perceived belief that participation is necessary to receive continuing care from health professionals or because the receipt of any treatment is perceived as preferable to receiving no treatment.

Two important reasons for concern regarding research involving terminally ill persons are:

1. they tend to be more vulnerable to coercion or undue influence than healthy adult research subjects
2. research involving the terminally ill is likely to present more than minimal risk.

With Elderly or Aged Subjects

It is generally agreed that the elderly are, as a group, heterogeneous and not usually in need of special protections, except in two circumstances:

• - cognitive impairment
• - institutionalization

Under those conditions, the same considerations are applicable as with any other, nonelderly subject in the same circumstances. In the past, persons in nursing homes or other institutions have been selected as subjects because of their easy accessibility. It is now recognized, however, that conditions in institutional settings increase the chances for coercion and undue influence because of the lack of freedom inherent in such situations. Research in these settings should therefore be avoided, unless the involvement of the institutional population is necessary to the conduct of the research.

Points to consider:

1. Does the proposed consent process provide mechanisms for determining the adequacy of prospective subjects' comprehension and recall?
2. How will subjects' competence to consent be determined?
3. Will the research take place in an institutional setting? Has the possibility of coercion and undue influence been sufficiently minimized?

Minorities

The inclusion of minorities in research is important, both to ensure that they receive an equal share of the benefits of research and to ensure that they do not bear a disproportionate burden.

In addition to ensuring adequate appropriate representation of minorities in study populations (and guarding against inappropriate overburdening of minorities), IRBs must ensure that any special vulnerabilities of subjects are accounted for and handled appropriately. To the extent that prospective minority study populations are also economically or educationally disadvantaged, IRBs should safeguard their rights and welfare by making sure that any possible coercion or undue influence is eliminated (e.g., compensation that is not commensurate with the risk, discomfort, or inconvenience involved, or recruiting in institutional settings where voluntary participation might be compromised).

1. Non-English Speaking Subjects
   1. The Consent Form-IRBs must safeguard the consent process (and, indeed, the entire research relationship) to ensure open and free communication between the researcher and the prospective subject.
      1. The role of cultural norms of subjects should also be addressed.
      2. The consent form must be in a language understandable to the subject. Researchers should prepare both English-language and translated consent forms for proposals involving non-English-speaking subjects. An explanation of the translations and the expertise of the translator should be provided for IRB review. The IRB may consult with language experts or require a “back-translation” into English.
2. Witness to Consent
   1. A witness, fluent in both English and the language of the subject, must be present during the consent process and must sign the consent document. The witness is verifying that the subje