Protocol due dates apply only to applications requiring Full Board review. Expedited and Exempt reviews are conducted on an on-going basis.
Fall 2024
November 1, 2024 (Protocols due by October 25)
Spring 2025
TBD
The Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects. The IRB is responsible for reviewing all research involving human subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision about whether or not to participate.
The IRB reviews and monitors human subjects research that fits the definitions of research and human subject as defined by the Code of Federal Regulations. Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102 (l)). The IRB considers data gathering activities not to be within its scope of review if the data is used for non-research purposes, such as institutional evaluation, and/or if it will not result in presentation or publication. Such activities, including but not limited to course evaluations or alumni surveys, are not typically within the scope of the IRB review. A human subject is defined by Federal Regulations as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” (45 CFR 46.102(e)(1)).
Engaging in human subject research without IRB approval has serious ethical implications and violates federal policies. Students, faculty, and staff are required to submit IRB applications before embarking on any data collection. Even pilot studies should be approved by the IRB.
Ramifications for Faculty and Staff
Ramifications for Students
There are three levels of IRB Review (full board, expedited, and determining if exempt from IRB oversight), determined by the nature of the protocol, level of potential risk to human subjects, and the subject population. The determination of level of review applicable to a particular study is made by the IRB. Regardless of the kind of review, all applications use the same submission form.
Only research involving no more than minimal risk to subjects may be considered for expedited review. An expedited review is conducted by an individual reviewer or a few reviewers, rather than going to the full board.
Federal guidelines provide categories for expedited review. Examples of categories include:
Research with very minimal risk to human subjects and that meets one of the categories of exemption as defined by 45 CFR 46 may be exempted from full board review. Although the project does not require full board approval, the IRB chair or designee must certify the exemption before the research study begins. If the risks to human subjects appear questionable or the project does not fit into the federally defined categories for exemption, then the study must undergo either full or expedited review. Some research may qualify for an exemption if a limited IRB review is conducted. Limited review is conducted by an IRB member to ensure that appropriate privacy and confidentiality protections are in place. An exemption is granted by the IRB upon initial review of the application. Since this constitutes a review, protocols that are deemed exempt are effectively “exempt from continuing review.”
To request review of your proposed research project by the IRB, complete the Request for Review of Research Involving Human Subjects form, Informed Consent form, and other documents as related to your research. The signed and approved PDF of the protocol, including all attachments, must be submitted to Michele Smith, Grants and Sponsored Research Development, by the submission deadlines published above in order to be considered at that meeting if Full Board review is required. Protocols received after the submission deadline will be reviewed at the next scheduled meeting. Protocols that may qualify for an exemption or that qualify for review under the expedited process are reviewed on an on-going basis.
Submit a Request for Review of Research Involving Human Subjects form. Forms are available on the GSRD Forms webpage. Instructions accompany the application. Save a copy of your form in case revisions are needed. For projects that will require full board review, submit materials by the deadline indicated on the IRB website.
GSRD will assign the protocol an IRB number that should be used on all correspondence relating to the study. The IRB will determine the level of review required for each study. The IRB will conduct its review, and take one of the following actions:
Approval of Research: Research may proceed upon receipt of written IRB approval memo.
Exemption: The study has been found exempt from IRB oversight and research may proceed upon receipt of written IRB exemption memo.
Revisions or Clarifications Requested: It is common for the IRB to request some changes to the protocol prior to approval/exemption. Researchers will receive a memo detailing revisions required. For minor changes, revisions will be reviewed under the expedited review process. Substantive changes may require full board review at the next scheduled meeting.
Disapproval: At a full board meeting, the IRB may determine that the research cannot be conducted as proposed. A disapproval memo will be sent to the researchers, and research may not proceed.
Expedited or exempt reviews typically take 7 business days. Response times may be delayed at mid-semester and other peak times.
Studies requiring full board review are scheduled for the next IRB meeting as noted on the IRB webpage. Correspondence from the IRB is sent to researchers within one week of full board review.
Researchers have some influence on the length of time between protocol submission and final approval. Well-prepared applications result in fewer requests for revisions. Rapid response by researchers to requests for revisions speeds the approval process.
You may begin your research.
Once the study begins, researchers are responsible to report any adverse events that may occur. An adverse event is an undesirable and unintended, though not always unanticipated, injury or physical/emotional consequence to a study participant. Unanticipated problems, developments within the research activity that suggest a potential for increased risks to human subjects, must also be reported to the IRB. Use the Adverse Event Report form on the Forms webpage.
Once a study is approved/exempted, modifications may be submitted. Use the Request for Modification of Previously Approved or Exempt Protocol form from the Forms webpage to describe the changes requested. Instructions are included on the form. Include revised surveys, informed consent documents, recruitment materials, and other documentation as needed. All changes must be approved by the IRB prior to implementation. Modification review is generally conducted via the expedited process but may require full board review depending on the revisions requested. Submission of a modification request does not change the review date for approved protocols.
Scholarly and Journalistic Activities: For purposes of this part, the following activities are deemed not to be research: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected (45 CFR 46.102 (l)(1).
Datasets: Public and/or published datasets not subject to Human Subjects Review include those that are accessible without restriction (e.g., password not needed*) and containing no readily identifiable, individual information. Examples include:
Program Evaluation: Program Evaluation is the inquiry into past, present, and potential programs to understand or clarify their need, working process or impact. There are three major categories of program evaluation: Needs assessments (formative evaluations) establish whether or not a program is feasible or necessary; process evaluations determine whether or not a program's implementation is congruous with its conception; impact evaluations (summative or outcome evaluations) ascertain whether or not a program meets its goals. Generally, program evaluations not requiring human subjects review involve data internally collected and analyzed for the normal course of business. These evaluations' goals range from simple descriptive statistics to qualitative information, and examples include program enrollment data, constituent demographics, and outcome analyses. Therefore, irrespective of human subject involvement, these program evaluations remain internal and thus do not contribute to generalizable knowledge. However, if a program evaluation is research and uses human subjects, then it requires approval. Program evaluations that lead to publishing results in scholarly journals or making presentations outside your institution likely require approval. The assumption being that publishing/disseminating the findings generalizes the data. Moreover, evaluations connected to groups' or individuals' outcomes and affecting the development or implementation of other programs similar in nature, are generalizable human subjects research and require human subjects review. Furthermore, an evaluation impacting upon the replication of other programs or services and the population at large or public policy, should be reviewed and monitored.
Examples of research that might be exempt include:
A study evaluating the effectiveness of a commonly accepted reading curriculum. Researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
A study involving interviews with college students (age 18 and older) about their plans after graduation. The answers to questions asked would present no risks to subjects if divulged outside the research.
An anonymous survey regarding workplace satisfaction.
A study that involves asking subjects to solve puzzles while listening to various types of music. Study procedures take less than 2 hours.
Research that involves greater than 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 encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Research with vulnerable populations. Certain research activities are not eligible for exempt status because additional protection has been required by federal regulations for vulnerable populations. Specifically, the following do not qualify for exempt status: (1) survey or interview of children; (2) observation of the public behavior of children when investigators interact with the children; (3) interactions with children; and (4) research involving prisoners except for research aimed at involving a broader subject population that only incidentally includes prisoners.
For project approved under full board review, federal regulations require continuing review within one year of the original approval. Near the end of the approval period, researchers will receive a Request for Status Report. If research is continuing, submit the Status of IRB Approved Project form from the Forms webpage.
Projects that are reviewed under the expedited review process do not require annual continuing review but must report if research is ongoing or not. Projects reviewed under the expedited process are not assigned an expiration date unless a justification for continuing renewal exists. This will be determined by the IRB.
Projects that the IRB determines to be exempt from further review do not require renewal.
Yes, the IRB requires that participants in research give their consent to take part in the study. The standard expectation is that participants will sign a document containing all the elements of informed consent. This document gives potential subjects a clear and complete description of the study, allowing him/her to judge whether or not to participate. The informed consent document should provide easily understandable information in an amount appropriate to the level of risk of participating.
A signed informed consent document may be waived in some circumstances, such as an online survey, but participants must still give their informed consent to take part in the research.
Yes, Winthrop uses several standard informed consent templates. These are located on the Forms webpage.
These templates include all of the information that is required in an informed consent form:
A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
A description of any reasonably foreseeable risks or discomforts to the subject;
A description of any benefits to the subject or to others that may be reasonably expected from the research;
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
A statement describing the extent, if any, to which confidentiality of the records identifying the subject will be maintained;
For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
An explanation of whom to contact for answers to pertinent questions about the research
and research subject’s rights, and whom to contact in the event of a research related
injury to the subject, if relevant. Typically, questions concerning a research project
should be referred to the Principal Investigator for that project, whereas questions
concerning the rights of human subjects
should be referred to Grants and Sponsored Research Development.
A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
If the research involves the collection of identifiable private information or identifiable biospecimens, one of the following statements must be included:
Researchers should take great care when obtaining informed consent from individuals who do not speak English or whose understanding of the language is limited.
Researchers should be fluent in the subject’s language or an interpreter should be available during the consent process and throughout the subject’s participation as needed.
Consent forms should be prepared in the language understandable to potential subjects.
See Guidelines on International Research and Research with Non-English Speaking Participants (PDF - 460 KB) for additional information.
While standard procedure is that the informed consent of research participants should be documented through a written and signed consent form, the requirement for a written, signed consent form may be waived by the IRB if:
Waiving the requirement for a signed, written consent form does not waive the requirement that subjects be informed of the nature of the research, and that their consent (or permission of their legal representatives, when appropriate) be obtained. In cases where a written consent is not used, the researcher should provide the subject with a statement or cover letter of the research that includes all relevant elements of informed consent.
Assent is basically the same as consent yet involves minor children (under age 18) who are not authorized to give legally valid informed consent because of their age. Assent is written in child friendly language and describes the research participation, risks, benefits, and other elements of consent. Assent does not waive the requirement for informed consent to be obtained from a parent or legal guardian.
All members of the research team, including the primary investigator, co-researchers, research assistants, and/or faculty advisors must complete CITI Human Subject training before submitting a protocol for IRB review.
Instructions to create a CITI account and additional information about CITI can be found here. Users with an account can log into the CITI Training Site.
45CFR46: Protection of Human Subjects
Belmont Report
Human Subject Regulations- Decision Charts
