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Frequently Asked Questions (FAQs)

Below are FAQs for researchers at William & 玛丽. If you have questions that are not covered, please feel free to reach out to using one of the contact methods listed at the top of the "Contact Us" page.

General Information

Displays FAQs about research at W&M.

(1) What are the three research committees?

  • Research protocols that involve human participants are required to be submitted to the IRB (Institutional Review Board) using the SPARCS product/module “Human Ethics.” The federal oversight body is the Office of Human Research Protections,
  • Research protocols that involve animals are required to be submitted to the IACUC (Institutional Animal Care and Use Committee) using the SPARCS product/module “Animal Oversight.” The federal oversight body is the Office of Laboratory Animal Welfare,
  • Research protocols that involve biohazards or other hazardous materials are required to be submitted to the IBC (Institutional Biosafety Committee) using the SPARCS product/module “Hazard Safety.” The federal oversight body is the National Institute of Health.

(2) How are research protocols processed?

  • Research protocols are submitted using SPARCS, Sponsored Programs and Research Compliance System. Protocols must be approved by the respective research board before research can commence.
  • Depending on your research, you will submit it using one of the following modules or “products.”
    1. Human Ethics (IRB)
    2. Animal Oversight (IACUC)
    3. Hazard Safety (IBC)
  • To learn how to submit a protocol using SPARCS, you can review user documentation posted on the SPARCS William & 玛丽 website.
SPARCS Info Page

(3) What trainings are required?

  1. CITI Training Courses
    • All required CITI courses must be completed before research can commence
    • Courses research personnel should take are outlined at the following website:
About CITI Training
  1. SPARCS Training
    • Review documentation and training videos to understand how to submit a protocol.
SPARCS Info Page

(4) What are the official laws and regulations that guide research?

(5) Where can I go to find more information?

You can visit William & 玛丽’s Research Compliance page and our SPARCS website to learn more information about how research is processed at the University along with resources from the federal oversight bodies.

Animal Oversight, IACUC

FAQs about the IACUC

(1) How many weeks does the committee need to review my protocol?

Please allow for four (4) weeks for committee review of the protocol before the anticipated review/expiration date. Often, revisions are required and this will take additional time for the approval process.

(2) Are PURELY observational studies required to be submitted for review?

If you are conducting a research protocol that is just observation of animals (no interaction) in their natural environment, this type of project is not required to be submitted to the IACUC. For example, this could include a study in which you and a team of investigators are observing turtles in a pond, but you have no interaction with the animals.
  • Per OLAW:
    • “If the activity is expected to alter or influence the activities of the animals, then further IACUC protocol review and approval is required.”  (https://olaw.nih.gov/sites/default/files/laban51_07_0722.pdf)
    • Studies may be exempt if "purely observational field studies that the IACUC determines are unlikely to alter or influence the biology, behavior or ecology of the study animals or other species. As recommended by the Guide for the Care and Use of Laboratory Animals (Guide), studies with the potential to impact the health or safety of personnel or the animal’s environment may need IACUC oversight, even if described as purely observational or behavioral." (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-119.html)

(3) What is the approval period for my teaching and/or research protocol?

Research and teaching protocols are now valid for 3 years. Continuing (annual) and De Novo (triennial) reviews must be completed for all protocols. If you have completed the protocol, please make sure to “expire” the protocol upon its Continuing or De Novo review date.

(4) I need to report an event of noncompliance/deviation from my approved protocol. How can I do this?

If during your research project you have an incident of noncompliance, protocol deviation, or adverse event, please make sure to report this to the Research Compliance office within 72 hours of discovery. Reports can be submitted by visiting the IACUC W&M webpage

(5) My protocol requires oversight by the IACUC and IBC. What should I do?

Protocols that fall under the research purview of the IACUC and IBC must be submitted using the separate modules/products in SPARCS. While each committee requires a separate protocol form to be submitted, there is a crossover between Hazard Safety (IBC) and Animal Oversight (IACUC). Please watch this short clip to learn how the two platforms are connected

Note – To access the video, you will need to be logged into your W&M email account.

(6) Do students have to be listed on protocol?

Any personnel (student, faculty, staff) who will be involved in the animal care/use and/or the collection of data must be listed as research personnel within the protocol form. These personnel must also have complete the appropriate CITI training modules prior to their work on the project beginning.

(7) Can I request an administrative extension without submitting a protocol?

No. A protocol must be in process in order for an extension for the protocol to be granted. The IACUC is the only authority that can review and approve protocols. The Institutional Official (IO) cannot provide an extension.

The renewal must be received within 30 days of the protocol expiring. During this time, animals CANNOT be used until the protocol is approved.

To obtain an extension, the PI must first submit a renewal via SPARCS. Conditional approval can only be granted by the Chair contingent on "receipt of a very specific and minor administration modification or clarification" (OLAW FAQs). Formal approval will be given within 30 days of receipt of protocol submission.

Human Ethics, IRB

FAQs about the IRB

(1) How many weeks does the committee need to review my protocol?

Similar to the IACUC, the committee requests that all submissions (whether renewal or initial) be submitted 4 weeks prior to the anticipated start date or expiration date of your study. The review will not always take 4 weeks to complete, but we want to make sure the reviewers have enough time to process the review. If you have a tight deadline, please notify the Research Compliance office.

(2) I'm just analyzing the data I collected. Does my protocol need to stay open/be renewed?

Active protocols must be maintained if the data being analyzed can identify the participants in any way. You may submit a "renewal" of your protocol in the SPARCS system. Protocols analyzing de-identified or coded data (with the link destroyed) can be submitted for closure. Learn more about submission types.

(3) My protocol was previously approved in the compliance.wm.edu system, but it has expired. How do I do renew my protocol?

Protocols from the “legacy” system (compliance.wm.edu) were NOT transferred over to SPARCS. To renew your study, you will need to submit the protocol via SPARCS by using the "+new study" feature since the protocol is technically "new" to SPARCS. You can copy over the text from the existing protocol in the compliance.wm.edu to the relevant sections of the SPARCS protocol form along with any attachments you included in the original submission. The SPARCS form does have additional questions that were not included on the compliance.wm.edu form.

In the submission, you can include that this is a renewal of a previously approved project; the explanation can be included in the "Supplemental Comments and Attachments" section. In that section, you can also note if you're making any changes since from the previously approved protocol. You also can include a PDF of the previously approved protocol for yours and the reviewers' reference.

(4) What are the available personnel roles in the system?

Under the “W&M Study Personnel” section, you have the option to add a principal investigator, student investigator, primary contact, co-PI, and all other W&M study personnel.

Explanation of user roles and rights in the SPARCS system.

Role

Abilities in System

Certify?

Principal Investigator
  • Editing Rights
  • Can create additional submissions
  • Included in all study communications
  • Only 1 can be listed

Must certify all submission types

Student Investigator(s)
(must have their advisor listed as the PI)
  • ·Editing Rights
  • Can create additional submissions
  • Included in all study communications
  • More than one can be listed

Must certify initial, modification, and incident submissions

Primary Contact
(can be different from the PI; can be a student)
  •  Editing Rights
  • Can create additional submissions
  • Included in all study communications
  • Only 1 can be listed

Only required to certify submissions if they’re the PI, Student Investigator, or Co-PI

Co-PI(s)
  • Editing Rights
  • Can create additional submissions
  • Included in all study communications
  • More than one can be listed

Must certify initial, modification, and incident submissions

All other W&M Study Personnel
  • Editing Rights
  • Included in all study communications
  • No limit on number that can be listed

Not required to certify submission

(5) Exempt, Expedited, or Full Board. How do I determine which review type and category my study falls under?

In the “Getting Started” section of your submission, you will be asked to self-determine which level of review and subsequent category to applies to your protocol. There are three levels of review: exempt, expedited, and full committee review

Explanation of Exempt categories

Exempt (minimal risk; no expiration date but requires annual “check ins”)

  • Category 1: Normal educational practices in established educational settings
    1. The research won’t adversely impact the students’ opportunities to learn
  • Category 2: Educational tests, surveys, interviews, or observation of public behavior
    1. Surveys and interview procedures CANNOT be used with children. Only observations of public behavior.
    2. The research must meet ONE of the following criteria:
      • The identity of the human subjects cannot readily be ascertained,
      • Disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation
        • If you are collecting information about illicit substance use, then your study WOULD put participants at risk and must either meet point (i) or (iii)
      • The identity of the human subjects can readily be ascertained AND an IRB conducts a limited IRB review
        (cannot be used with children)
        • When appropriate, there are adequate provisions to protect the privacy of subjects AND to maintain the confidentiality of data. (as referenced at 46.111(a)(7))
  • Category 3: Benign behavioral interventions and data collection through written or verbal responses (includes recordings if the adults agree prospectively)
    1. Benign = brief, harmless/not physically invasive, and won’t cause embarrassment or offense to the participants.
    2. Deception can be used BUT:
      • Participants must be informed they will be deceived and AGREE to the deception.
      • Participants must also be “debriefed’ at the end of the study and informed how they were deceived
    3. Cannot be used when research includes children
    4. The research must meet ONE of the following criteria:
      • the identity of the human subjects cannot readily be ascertained,
      • disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation
        • If you are collecting information about illicit substance use, then your study WOULD put participants at risk and must either meet point (i) or (iii)
      • the identity of the human subjects can readily be ascertained AND an IRB conducts a limited IRB review
  • Category 4: Secondary research use of biospecimens or information for which informed consent is not required
    1. The research must meet one of the following criteria:
      • The identifiable private information or identifiable biospecimens are publicly available, or
      • Information, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, AND the investigator will not re-identify subjects, or
      • Researcher’s use of identifiable health information is when HIPAA applies for purposes of "health care operations" or "research" or for "public health activities and purposes “, (ONLY for INFORMATION, NOT BIOSPECIMENS)
      • Research is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities and federal privacy regulations will apply
  • Category 5: Evaluation of public benefit and service programs (only can be conducted or funded by the federal government)
  • Category 6: Taste and food quality evaluation & customer acceptance studies
Explanation of expedited categories

Expedited (minimal risk; 1-year expiration date and requires annual renewal)

  • Category 1: Clinical studies of drugs and medical devices only when certain conditions are met.
    1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
    2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
  • Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture when certain conditions are met
    1. from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
    2. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
  • Category 3: Prospective collection of biological specimens for research purposes by noninvasive means
  • Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves
  • Category 5: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)
  • Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
  • Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
    1. This category is often confused with Exempt Category 2.
    2. Would not apply if identification of the subjects would pout them at risk of criminal or civil liability or damage their financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal
  • Category 8: Continuing review of research previously approved by the convened IRB as follows:
    1. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
    2. where no subjects have been enrolled and no additional risks have been identified; or
    3. where the remaining research activities are limited to data analysis.
  • Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Explanation of full board review

Full Board

  • All studies not eligible for exempt or expedited review
  • Deemed to involve more than minimal risk OR for which a wider range of expertise is required for review.
  • Required for most research activities involving vulnerable subject populations including, but not limited to: children (<18) prisoners and cognitively impaired/psychiatric patients.
  • Use of FDA or other medical devices not approved for marketing. (i.e. not covered under expedited category 1 or 4)
  • Required for most studies involving active deception.
Resources:

(6) I am using an IAA where W&M is the relying institution. How do I enter my protocol?

In the first section, “Type of Review,” you will select “Request to Rely on External IRB.” Once that is selected, additional sections will appear. Please visit W&M’s information page about “IRB Authorization Agreements (IAAs)” to learn more about additional requirements.

(7) I want to make a small change to a "participant-facing" document (e.g. consent, survey, etc.) that has already been approved . Do I have to submit the change to the IRB?

If you are changing anything that is "participant-facing" (i.e. Consents, surveys, etc.), then that has to go in front of the IRB for approval. You are able to continue work under the previously approved procedures, but you wouldn't be able to implement the new procedures until the protocol has been approved.

(8) Can I request an administrative extension without submitting a protocol?

No. The IRB is the only authority that can extend the expiration period of a study. The IO cannot extend research beyond the expiration date of the study for expedited and full board studies. Exempt studies do not require ongoing approval/monitoring by the IRB so they are not subject to expiration dates. If PIs with expedited and full board studies consistently do not follow the renewal/expiration dates for their study, they can be reported to the IRB for continuing noncompliance (see OHRP presentation). IOs have the authority to suspend or terminate approval of research if it is determined necessary.  

(9) Do I need to attach my training certificates to the submission? What do I do if My CITI training isn't loading into SPARCS?

You do not need to atttach CITI certificates of W&M faculty, staff, or students. CITI certificates should be attached for any non-W&M research personnel.

If your training is not automatically syncing into SPARCS, please contact researchcompliance@wm.edu to let us know that the trainings are not loading into your account. You can still submit the protocol without the trainings appearing.HE CITI Trainings View

(10) My project is an Oral History. Does it require IRB oversight?

It depends. William & 玛丽 does not allow researchers to "self-exempt" from the IRB review. If you do not submit your study to the IRB, and it is determined later that your project does meet the definition of "human subject research (HSR)," IRB approval cannot be retroactively sought.

The study being an "oral history" doesn't automatically mean that the project is not subject to IRB review; the determination depends on the aims of the project and how the research is conducted. Any study could be determined to fall under the review of the IRB if it meets the definition of "research"  and involves "human subjects" as defined by the OHRP. Please reach out to the Research Compliance office with any questions about your study. 

(11) My project is a secondary analysis of de-identified, publicly available data. What do I need to do?

William & 玛丽 does not allow researchers to "self-exempt" from the IRB review. Studies using de-identified, publicly available data most likely does not meet the federal definition of "human subject research (HSR)." Submitting the project via SPARCS will allow the committee to provide the researcher with a letter that states your study does not meet the requirements for IRB review.

(12) I am collaborating with another researcher who is not associated with William & 玛丽. What do I need to do?

For exempt projects, each institution should complete their own review of the IRB submission. However, for expedited and full board studies, it is permitted for an IRB Institutional Agreement to be signed that states that one institution will rely on the other institution's review of the research. Instructions on how this can be done can be found here. 

If you are collaborating with someone who is not affiliated with W&M AND their organization doesn't have an IRB, you can complete an Individual Investigator Agreement (IIA). Instructions on how this can be done can be found here. 

Reminder: All research personnel are required to complete the CITI courses. To sign a non-affiliated W&M researcher up for CITI courses, please follow the instructions on our CITI page. Non-affiliated users will use their own institutional email or provide a personal email address when registering for CITI. If your collaborator has already completed CITI training at their home institution, the certificates of completion can be attached to the protocol submission, and the PI does not need to complete W&M's CITI course requirements.

Hazard Safety, IBC

FAQs about the IBC

(1) What is the approval period for my teaching and/or research protocol?

Similar to the IACUC, research and teaching protocols are now valid for 3 years. Continuing (annual) and De Novo (triennial) reviews must be completed for all protocols. If you have completed the protocol, please make sure to “expire” the protocol upon its Continuing or De Novo review date.

(2) I'm asked to select which "NIH Guidelines" section is applicable to my research. What is meant by that?

Research overseen by the IBC falls under one of the categories listed under Section III of the NIH Guidlines. After reading the sections, if you are still unsure, please reach out to the Research Compliance office.

(3) Who needs to be listed as personnel on my protocol?

Anyone who is handling biohazardous agents must be listed on the protocols and also be trained to work in the lab, At this time, training is completed via CITI. The PI should instruct all their lab personnel on specific procedures applicable to their work/lab environment.

(4) Can I request an administrative extension without submitting a protocol?

No. Similar to the IACUC, the IBC maintains the authority to approve studies. Approval must be sought prior to the study's expiration date. Once the expiration date passes, the work on the research protocol must stop until approval has been given by the IBC.

(5) I need to report an event of noncompliance/deviation from my approved protocol. How can I do this?

If during your research project you have an incident of noncompliance, protocol deviation, or adverse event, please make sure to report this to the Research Compliance office within 72 hours of discovery. Reports can be submitted by via Incident Report Form