IRB Procedures & Guidances

At W&M, the overarching policy guiding the research is the Research with Human Subjects Policy. Researchers must be familiar with the policy prior to submitting IRB protocols.

W&M RESEARCH WITH HUMAN SUBJECTS POLICY

Complete list of Terms referenced in the procedures
Dictionary of Terms Behavioral health-related outcome: This is a change in a person's behavior that directly affects their health and wellness. This is often measured by behavioral assessments, psychological assessments, self-reporting, or observation. This can be a curriculum, a psychological method, a behavioral intervention, the use of a wearable, etc. Benign Behavioral Interventions: Benign behavioral interventions are brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the participants, and the investigator has no reason to think the participants will find the interventions offensive or embarrassing. Benign behavioral interventions can never be a clinical trial. Biomedical health outcome: This is an outcome directly related to the physical body. This can be measured through physical examination, lab testing, images, self-report, or observation. A biomedical outcome is directly related to the physical body and the changes the physical body undergoes because of the intervention being studied Children: Children are defined in the HHS regulations as persons who have not obtained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. 45 CFR 46.402(a). Criteria for Approval:The criteria detailed in 45 CFR 46.111 address qualities of a human subjects research protocol that are eligible for approval. These criteria must be met for all human subjects research where 45 CFR 46 is applied. Clinical Trial A clinical trial is a type of human subject research study. Clinical trials try to answer a research question about health-related outcomes by prospectively assigning human participants to either a control group or one or more interventions to evaluate the effects of the intervention on biomedical or behavioral health-related outcomes. An intervention is the act of interfering with an outcome, course of action, treatment, condition, health-related curriculum, or process in some way. Clinical trials are the primary way that researchers find out if a new treatment, course of action, condition, process, or curriculum (like a new drug, diet, therapy, movement, health curriculum, or medical device) is safe and effective. A health-related outcome is an outcome from the intervention being studied that directly influences a human as related to their physical health, psychological health, or behavior. Deception: Deception refers to providing false information to prospective participants. Exemption: Exemption from the federal regulations governing human subjects research at 45 CFR 46 includes activities in which the only involvement of human participants will be in one or more of the categories detailed in 45 CFR 46.104(d) and Appendix A of this procedure. Research studies that fall into the eligible categories are not required to adhere to the federal regulations governing research with human participants but are required to adhere to any other applicable laws, contractual obligations, and W&M University policies, procedures, and standards. Exemption Determination:A determination made by the W&M IRB regarding a submitted human subjects research protocol. Expedited Review: A list of categories of research that may be reviewed by the IRB through an expedited review procedure. Expedited review procedures are for certain kinds of research involving no more than minimal risk, and minor changes in IRB Full Board approved research. FLEX Exemption: When a study is solely subject to the W&M policy for human subjects’ research and not subject to the federal regulations at 45 CFR 46 governing research with human participants, some research protocols may be reviewed and approved under the W&M special exemption category - “FLEX Exemption,” This review process and determination is designed to provide ethical protections equivalent to those found in 45 CFR 46, while also reducing administrative workload and regulatory excess. Refer to section B of this SOP for details. Funded or Sponsored Research: A sponsored or funded research project has a defined scope of work and a set of objectives supported by external funds. Identifiable Biospecimen: Identifiable biospecimen is a natural sample for which the identity of the participant is or may readily be ascertained by the investigator or associated with the sample data. Identifiable Private Information: Identifiable private information is private data for which the identity of the participant is or may readily be ascertained by the investigator or associated with the information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public. Incomplete Disclosure: Incomplete disclosure is when information about the real purpose or nature of the research is withheld from participants. Informed Consent: The informed consent process involves three key features: (1) disclosing to potential research participants’ information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. Requirements for Informed Consent are detailed in 45 CFR 46.116. Limited Review: A limited review pertains to research in which the primary risks to participants relate to privacy and confidentiality. Research that qualifies for an exemption requiring limited IRB review would have required IRB review and approval either through the expedited review procedure or by a convened IRB review under the pre-2018 Requirements. A limited review is performed by an IRB board member where, as opposed to considering all the criteria for IRB approval, the reviewer must review specific, more limited aspects of a proposed research study related to participant privacy and confidentiality. A determination that there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data must be found. Minimal Risk:Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. More than Minimal Risk: More than minimal risk are situations where the probability and magnitude of harm or discomfort anticipated in the research are greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Not Human Subjects Research: Research activities are considered “Not Human Subjects Research (NHSR)” when they do not meet the definition of “research” or “human subjects” as defined by 45 CFR 46, and the W&M University Policy for completing research with human participants. Pregnant: Pregnancy encompasses the period from implantation until delivery. A person shall be assumed to be pregnant if they exhibit any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. Prisoners: A person who is incarcerated is any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Individuals who are incarcerated if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. People who are incarcerated may be convicted of a crime or may be untried persons who are detained pending judicial action, for example, arraignment or trial. Readily Ascertainable: Readily ascertainable is when the identity of the individual participant can be obtained, discovered, or determined without significant difficulty or effort. Identities of participants are considered “readily ascertainable” when the data are: directly identifiable, linked to a master list that the researcher(s) can access, indirectly identifiable to any member of the research team due to their access, role, or expertise, or identifiable from the content of the data, triangulation of data points, pairing with other data, or sample size A transient health-related outcome is sufficient for a study to be considered a clinical trial if all other elements of the clinical trial definition are met. Subparts: Subparts are sections of 45 CFR 46 with additional information and requirements. In the case of human subjects research regulations, subparts identify some vulnerable populations (pregnant people, fetuses, neonates, those who are incarcerated, and minors) that require additional protections in research. Vulnerable Populations: Vulnerable populations are identified in the human subjects research regulations as pregnant people, fetuses, neonates, those who are incarcerated, minors, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons. The IRB may also require additional protections for any other group not specified in the regulations but determined, by the IRB, to be vulnerable.

List of Procedures & Guidances

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IRB Procedures
This page contains the complete list of IRB Procedures. Topics include: non-compliance, exempt determinations, expedited review, clinical trials, conflicts of interest, IRB membership/meetings, renewals/amendments/transfers/closures, cooperative research, local context reviews, international research, research with vulnerable populations, unanticipated problems/adverse events, FDA-regulated research, participant complaints/concerns, Pilot/Feasibility Work, and consent procedures.
Is it IRB-Regulated Research?
This document provides information regarding the federal definition of research and what it means to complete a “systematic investigation” and “contribute to generalizable knowledge.” This document should clarify issues regarding research and assessment, evaluation, class projects, pilot work, feasibility studies, presentations, and dissemination of data and findings. An activity may be research, but may not meet the criteria for regulated research as defined by the federal regulations governing research with human subjects (45 CFR 46).
Is it Human Subjects Research (HSR) under IRB Regulations?
This document provides information regarding the federal definition of “human subject” and what activities involving humans are regulated by the IRB.
Using or Creating Educational Records for Research
FERPA applies when records are created or used for research, provided they were created while the student was enrolled at an educational institution. In that case, FERPA and IRB regulations apply.
Class Projects that are Not IRB-Regulated Research
If you are an instructor who is assigning a class research project that does not meet the definition for regulated research, please use this document to help guide your students in the development of their projects, including teaching your students what to say when communicating with people involved in their non-IRB-regulated project.
Comparison of Activities: Research versus Evaluation, Assessment, Quality Improvement and Quality Assurance
Determining whether a project requires IRB review depends on whether it constitutes research involving human subjects. The data provided is intended to help determine whether a project requires submission to the IRB as a research project involving human subjects. Many evaluation projects look like research, but do not fall into the regulatory definition of research.
Oral Histories and the W&M IRB
This document serves as guidance for those seeking nuanced information about the scope of the IRB regulations as related to oral history, journalism, biography and historical scholarship.
Roles of Students and Other Personnel on IRB Studies/Submissions
The purpose of this guidance is to explain the roles and responsibilities of both undergraduate and graduate students when submitting protocols to be reviewed by the Institutional Review Board (IRB). This guidance also defines the roles of personnel in SPARCS and who is required to certify submissions.
Recruiting on SONA and Prolific
SONA is a recruiting system used by the Psychological Sciences and Business school to recruit participants for studies in turn for course credit. Prolific helps researchers recruit and manage participants for your online research.
Incomplete Disclosure & Deception
The purpose of this guidance is to address when deception or incomplete disclosure can be used and how to ensure there is appropriate informed consent and a sufficient debriefing process.
IRB Reliance Agreements
Occasionally, protocols require investigators or other institutions to rely on one another to perform an IRB review. Please see this guidance if wanting more information about Individual Investigator Agreements (IIA) or IRB Authorization Agreements (IAA)
IRB & International Research
Research with human participants in countries outside the United States must comply ethical standards. Additional considerations may be required depending on the country of research. Furthermore, attention must be given to the cultural context and local regulations.
Reporting of Deviations and Incidents
Reports of noncompliance or protocol deviations must be submitted to the IRB within 48 hours of discovery. Please see this guidance document on how to submit reports.
Translating Materials for Non-English Speakers
Federal regulations mandate that information given to potential research participants or their representatives be in a language that they can understand. Translation of research documents, thus, is necessary to comply with such regulations in order to effectively engage non-English speaker populations in research and address some of the barriers to participation.
.118 Determination
46.118 Determinations can be granted to satisfy federal sponsor requirements (e.g., Just-In-Time) to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects.
Compensating Research Participants
When compensating human research subjects/participants, there are certain guidelines that need to be followed. "Compensation" includes non-monetary rewards, such as course/extra credit.
Management and Retention of Data
Researchers may refer to this guidance when determining how to handle the collected research data from human subjects, and what steps need to be taken after data collection is complete.
Suicidal Ideation and/or Behavior in Research Protocols
This guidance provides directions for researchers using measures that involve questions related to suicidal ideation. Research shows that asking questions related to suicidal ideation (SI) does not increase suicidal risk; however, research studies or surveys that inquire about SI require additional monitoring of responses to ensure the safety of participants during the study.
IBC and IRB Protocols
Occasionally, researchers will need to submit their research to more than one research committee. This guidance addresses when submitting to the IBC and IRB is required.

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Dictionary of Terms

List of Procedures & Guidances