The following are the essential elements of the IRB process. Please read through and familiarize yourself with these elements before submitting a proposal; it will make the process quicker, easier and more coherent.
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“Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” better known as The Belmont Report, was created by the former United States Department of Health, Education, and Welfare—now known as Health and Human Services (HHS)—and is an important historical document in the field of medical ethics. The report was created on April 18, 1979 and gets its name from the Belmont Conference Center, formerly a part of the Smithsonian Institution and located in Elkridge, Maryland, where the document was drafted.
The Belmont Report explains the unifying ethical principles that form the basis for the National Commission’s topic-specific reports and the regulations that incorporate its recommendations. The three fundamental ethical principles for all human subject are
- respect for persons: protecting the autonomy of all people and treating them with courtesy and respect;
- beneficence: maximizing good outcomes for humanity and research subject, while minimizing or avoiding risks or harm; and
- justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly.
Those principles remain the basis for the HHS human subject protection regulations, and the Institutional Review Board is responsible for upholding them by reviewing all research involving human participants before it begins. A full version of the report can be found here.
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Smith College requires researchers to first complete the Collaborative Institutional Training Initiative (CITI) online training course. On the CITI site you will create a user account affiliated with Smith College, identify your role in the research (i.e. principal investigator or co-investigator); and take the "Basic Human Subjects - Social and Behavioral Focus" course. When asked if you wish to take the 'Responsible Conduct of Research' course, please check, "Not at this time, Thank you." That course is for researchers working on NSF-funded grants only. If you need that course, you will be informed.
The training will guide you through the review of relevant human subject research materials and several quizzes on that material to obtain certification. The CITI training is meant to introduce researchers to the ideas and principles of ethical research involving human participants and the IRB process. Throughout the training, the discussion is focused on federal guidelines for research with human participants. Smith College practice may vary in important ways. For example, federal guidelines tend to focus largely on the contribution of human subjects research to the body of generalizable knowledge, while the College is concerned with the appropriate determination of review status.
Who Needs to Complete CITI Training
All Investigators and key personnel who are engaged in research with living human beings, human tissue samples or identifiable private information, are required to take the CITI Training Program.
Federal guidelines define “Key Personnel” who are “engaged in research” with human subjects are staff or students who meet any of the following criteria:
- enroll individuals
- obtain participants' informed consent by doing more than handing out or collecting forms or telling participants how to get in touch with the Investigators
- intervene or interact with participants by performing invasive (e.g., drawing blood) or non-invasive (e.g., survey) procedures
- collect data directly from or follow-up directly with participants
- collect identifiable private information from participants or have access to information that links participants' names or other identifiers with their data
- act as authoritative representatives for the investigators
Proof of Completion
For Smith students, faculty and staff:
When you complete the CITI course, a copy of your Completion Report will automatically be sent to, and kept on file in, the IRB office. As such, it is not necessary to submit this report with your IRB application, though you should retain a copy for your own records. To do so, select “View Completion Report” at the top or the bottom of your Grade Book and print it for your records.
For investigators from other institutions:
Anyone who has registered and completed a CITI Program Training Course at their home institution may print out their Completion Report from their own institution and submit it to the Smith IRB to meet the training requirement.
- Go to: https://www.citiprogram.org/default.asp
- Log in by entering your user name and password.
- Select Completion Reports.
- It will list your Completion Report(s) by the name of the Learner Group(s) for which you registered. (Biomedical, Social Behavioral, IRB Reference, IRB Member)
- Select the Completion Report(s) and print.
Recertification
Because Federal policy and regulations are evolving and changing with regard to the use of human participants, Smith College IRB requires that researchers be recertified every four years.
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Once you have obtained certification of training, you will need to complete and submit an IRB Research proposal form (Documentation of Review and Approval of Research Project Involving Human Participants).
Your research proposal must indicate that adequate provisions will be made for the protection of the rights and welfare of prospective research participants (including but not limited to the rights to Informed Consent and Confidentiality), and that pertinent policies and regulations will be observed. Your answers to the specific questions on the proposal will allow the IRB to evaluate whether your proposed research fully addresses these concerns.
This proposal form consists of two parts:
(1) the Documentation of Review and Approval of Research Project Involving Human Participants, which provides essential information about your project and the individuals conducting the research, and (2) the Description of Research Project Involving Human Participants, which requests specific information regarding your Research Methods. Each question walks you through various elements of your research method relevant to the IRB review. Please answer every question, doing so in a clear, concise, self-explanatory language so that IRB reviewers, who may not be familiar with your subject area, will readily understand the proposed research.
An important component of the Description of your research plan is the Documentation of Informed Consent. The IRB has created templates to assist in preparing this document. The Participant Consent, Parental Consent, and Participant Assent Templates provide the basic elements of an Informed Consent Document, depending on whether your research will use adults or minors (persons under the age of 18). Sample text for additional elements of the informed document (such as a debriefing form), which may or may not be necessary depending on your particular research, are available in the Informed Consent section of the Forms page.
For more extensive answers to specific questions you may have about writing your proposal, see the Writing A Proposal section.
Note: All student research requires the supervision and signature of a Faculty Adviser prior to submission. The Faculty Adviser's signature on the Research Proposal confirms that they have supervised the composition of the proposal and they approve of the research proposal as submitted.
Submission
Once you have completed these forms, you will submit your proposal to the IRB Committee Chair for review, following the steps listed below:
- Send your complete proposal as an email attachment to irb@smith.edu
- Print the first page of your proposal, complete the required signatures, and send by campus or U.S. mail to Bass Hall, room 302, or fax it to (413)585–3786)
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Once the IRB has received your proposal, the Committee Chair will conduct a preliminary review to determine the review status of your proposal. Review status is usually determined within a few days of proposal submission. The review status will affect you only in that each type of review—Exempt, Expedited, and Full—requires a different amount of time between proposal submission and final approval. For information purposes, the typical length of reviews are listed below.
Exempt Review
2 business days
Federal regulations limit the categories of research that qualify for exemption. “Data obtained in person, or that are coded and linked to name, record number, social security number or other identifiers do not qualify for exempt review status.”
Expedited Review
7 business days
Research that falls into certain categories and that meets conditions of minimal risk may qualify for Expedited Review status.
Full Review
15-20 business days (depends on proximity of submission to meeting date)
Upon initial reading, regardless of the assigned review status, the board will often request additional information or suggest changes to your proposal, before it is formally reviewed. This feedback will improve the proposal and speed the formal review process. As such, the timeliness of your proposal's approval will depend on your prompt response to the board's queries.
After its review, The IRB will notify you of action taken regarding your proposal:
- Approval: the application is complete, the risks to subjects are minimal/minimized, and the procedures are appropriate. The IRB gives approval for the research to be conducted.
- Approval with Contingencies/Stipulations: the application is complete but there are issues/changes that must be addressed before the project can begin. Once a satisfactory response to these contingencies is received and approved by the IRB Chair, the review is complete.
- Deferral: applications that are found to have significant concerns (risk to subjects, unclear procedures, serious omissions, ethical issues, or major contingencies) will be deferred. The researcher will receive a listing of concerns that must be addressed for approval to proceed. The researcher's response will then be reconsidered by the IRB.
- Non-Approval: While an extremely rare occurrence, applications that are found to have risks which outweigh the potential benefits to subjects and/or society will receive a non-approval and the research will not be allowed to be conducted. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. After an in-meeting appeal or the receipt of a written appeal, the IRB will vote again. The second vote of the IRB is final. Institutional administrative officials may not override this decision.
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If you wish to conduct a research study at Smith College that has been approved by another institution (primary IRB), you must also receive approval from the Smith College IRB. The review performed by the primary IRB must meet the human subject protection requirements of the Smith IRB. Approval by the primary IRB does not guarantee approval by the Smith IRB.
Prior to seeking approval from the Smith IRB, see sections 1 and 2 above, and then submit the following to irb@smith.edu or via campus or U.S. mail to Bass Hall, room 302:
You may be asked to provide other documentation, as needed.
While conducting your research, you are responsible for reporting any deviations from the approved protocol and/or adverse events to the IRB. If in the course of conducting your research you need to change the procedures, you are required to submit a Research Project Change of Protocol Form to the IRB for approval. You are required to respond in a timely fashion to the annual renewal notices sent by the IRB to every researcher with an open project. When you have completed your research, you must notify the IRB of the completion of your project. Please keep the IRB abreast of any changes in your contact information while your project remains active.
Annual Review
Proposals approved under Full and Expedited Review must be renewed annually. The IRB will initiate contact with the primary investigator to inquire about the status of the research project. Application forms for Continuing Review are also available for download on this site. If you are a Primary Investigator and will no longer be affiliated with the College at that time (e.g. graduation, end of employment, etc.), you must contact the IRB prior to your departure with alternative contact information for your project.
Deviations from Approved Protocol
A Protocol Deviation is an incident involving non-compliance with the approved proposal, but typically does not have a significant effect on the integrity of the research or on the participants' rights, safety or welfare. As the Primary Investigator (PI), it is your responsibility to report any action taken by a researcher that goes beyond or outside what has been approved by the IRB. You can download a Protocol Deviation Report for this purpose.
Adverse/Unanticipated Events and Findings
During the conduct of your research, you may have findings whose nature, severity and/or frequency are not described in the proposal approved by the IRB. Examples include, but are not limited to, unexpected complications in a subject, missteps in the study procedures or consent documentation, or breaches of confidentiality. Alternatively, you may encounter problems or events that are potentially harmful to either the participants or the researcher. In either case, you must report these facts immediately to the IRB using an Adverse/Unanticipated Events Report.
Changes of Protocol
If at any time you wish to make any change to the research procedures you originally submitted to the IRB, you must submit a Research Project Change of Protocol form. Make sure to fill in the correct information about the project's primary investigator, title and project number. Once these changes have been approved, the IRB will forward a copy of the signed form to you.
Project Completion
When data collection and analysis have been completed, you must report this using a Research Proposal Continuation/Completion Form.
Documentation and Record keeping
Investigators must store signed consent documents in a way that ensures confidentiality of participants' information. Smith College will prepare and maintain documentation of IRB activities. This documentation is kept on file for at least 3 years after completion of the research and includes: copies of all research proposals reviewed, evaluations, approved sample consent documents, progress reports, and reports of injuries to subjects; minutes of IRB meetings; copies of IRB correspondence; a list of IRB members; and copies of policies and guidelines.
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