Who Needs To Apply?
All human subjects research connected with members of the Smith College community (either as researchers or study participants) must be reviewed and approved by the IRB prior to the initiation of the project.
The Smith College IRB defines research as a systematic investigation designed to develop or contribute to generalizable knowledge.
A human subject is a living individual about whom you obtain:
- data through intervention or interaction, including surveys and interviews, and/or
- identifiable private information in a form associable with that individual
Who Does Not Need to Apply?
For help with determining if IRB review is required for your project, please use the Pre-Proposal Diagnostic Survey in the Mentor IRB system. This should be used if you are at all unsure if your project requires IRB review or not.
Examples of projects that do not fit the IRB’s definition of human subjects research:
- Classroom projects—see our Classroom Projects Policy for guidance.
- Quality Improvement/Program Evaluation activities designed to measure the effectiveness of a program, curriculum, or assessment. The purpose is not to generalize to the larger community and results will not be compared with other assessments.
- 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.
- Oral History - IRB review is not required if you are conducting an oral history project focused on an individual and you are not planning to use your findings to generalize about a community or group of people. Refer to the Oral History Association's Best Practices and Statement on Ethics.
- Interviewing Experts - If you are asking experts solely about their professional work experience and professional opinions, you do not need to submit an IRB proposal. This applies only if you are not asking them any questions about their personal lives or opinions.
- Repository Research/Tissue Banking
- If you want to use samples or data that have already been collected and have no way to link the samples or data back to the individual (and you will make no effort to re-identify the data), then you do not need IRB review.
- Databases/Secondary analysis of de-identified data
- If you are conducting a secondary analysis using publicly available data and you will not be merging the data sets in such a way that individuals might be identified OR supplementing the public data with potentially identifiable data, then your study does not require IRB review.
- If you plan to obtain data that were collected by someone else and do not contain any names, phone numbers, emails, ID numbers, or other information that could be used to identify the participant, you do not need IRB review for your secondary analysis. If you have any way to access a code to re-identify the data, you need IRB review before conducting the secondary analysis.
The Application Process
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. New researchers are encouraged to make an appointment to meet with the IRB Coordinator, Sherry Wingfield and she will help advise you on the approval process, required documents, best practices, and more.
Training for IRB Researchers
The CITI training for IRB researchers is meant to introduce researchers to the ideas and principles of ethical research involving human participants and the IRB process.
To access the courses, follow this link to the CITI program website and the following directions.
Step 1: Register as a user affiliated with Smith College.
- Click “Register” on home page, then select your organization affiliation (Smith College) and enter your personal information to create your account.
- Note: You are not required to purchase CE credits, select “No” when asked that question unless you need it for another purpose.
- When asked what course you plan to take – “Basic Human Subjects – Social & Behavioral Focus”
- If you previously set up a CITI account with a different institution, log in to your existing account and change your institutional affiliation to Smith College.
Step 2: Add the appropriate course to your account.
- If the “CITI Course Enrollment Procedure” page appears, skip to step 3 below.
- If the page does not appear automatically, go to "Courses" - "Learner Tools for Smith College" and select "Add a Course.”
Step 3: Answer questions to help CITI select the appropriate course for your account.
- Review the page that appears, then click on "Continue to Question 1 at this time."
- Question 1 - Since your research involves human subjects, choose "All Researchers."
- Question 2 - Leave this section blank (unless you are conducting research with animals for a different course/project).
- Question 3 - choose "Not at this time"(unless you are conducting research that is funded by NSF).
- Question 4 - choose "No."
- Click “Submit.”
Step 4: Complete the required IRB Researchers - Basic Course that is listed on your CITI home page.
- Complete all 7 required modules (readings and quizzes with 3-5 multiple choice questions).
- Achieve an average score of at least 75% on all quizzes. You can repeat the quizzes for each module if necessary.
- The time commitment varies widely depending on your familiarity with these topics, but it typically takes 2-3 hours to complete.
- You can save your progress and complete the training over several days if necessary.
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 as staff or students who meet any of the following criteria:
- Enroll individuals in studies
- 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 noninvasive (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 (faculty advisers)
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 the IRB office. All CITI accounts are also linked to Smith College Mentor IRB accounts. As such, it is not necessary to submit this report with your IRB application.
For investigators from other institutions:
Anyone who has registered and completed a CITI Program Training Course for research involving human subjects at their home institution may download their Completion Report from their own institution and submit it to the Smith IRB to meet the training requirement.
- Go to: about.citiprogram.org/en/homepage/
- Log in by entering your user name and password.
- Go to either "My Courses" or "My Records" and select “View-Print-Share” in the Completion Record Column for the course.
- Download the appropriate Completion Record and upload it to Mentor IRB with your IRB proposal.
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.
Online IRB Submission
The Smith College IRB is now using the Mentor IRB system.
Setting up your account
- The first time Smith College faculty members, staff, or students use Mentor IRB, they will need to activate their account by following the instructions on the first screen of the Mentor IRB website and entering their Smith single sign-on account username and email address.
- If you do not have a Smith College account, send an email to the IRB coordinator requesting a Mentor IRB account. You will receive an email from the IRB coordinator with your username for Mentor.
Pre-proposal survey (optional)
You have the option to start the IRB review process in Mentor by taking the pre-proposal survey. This will help determine if your project is "not subject to IRB review", or if it requires an exempt, expedited, or full IRB review. Answering these questions is helpful to some investigators, but you have the option to skip this step if you are ready to submit your IRB proposal.
The Mentor IRB proposal surveys will guide you through the proposal submission process. You will fill out a basic proposal survey to set up the new IRB project record in your account, then you will be asked to answer supplemental questions to give the IRB enough information to complete the review process.
- Your research proposal must indicate that adequate provisions will be made for the protection of the rights and welfare of prospective research participants, 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. Please answer every question, doing so in 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, which can be found on the Forms & Templates page. Upload your customized informed consent document(s) to your IRB proposal through the Mentor IRB system prior to submitting your proposal for review.
Messages & Notifications from Mentor IRB
- IRB emails and reminders will be sent with "IRB Smith firstname.lastname@example.org" in the header details.
- If you use a priority inbox and the Mentor emails are being sorted to a place you don't regularly check, flag them as important by opening a message, clicking the three dot 'more' icon in the message toolbar and selecting 'mark as important'. Subsequent messages from Mentor should then be marked important.
Preliminary Feedback & Revision Requests
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.
Types of IRB Review
The review status depends on the anticipated level of risk to participants and is determined by the IRB chair. 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 is listed below.
5-7 business days
Federal regulations limit the categories of research that qualify for exemption.
7-14 business days
Research that falls into certain categories and that meets conditions of minimal risk may qualify for expedited review status.
15-30 business days (depends on proximity of submission to meeting date)
Research that targets vulnerable subjects or involves more than minimal risk to participants must be reviewed by the full committee. The full committee meets monthly during the academic year. The meeting schedule and submission deadlines are listed on the home page.
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 writing. After 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.
If you wish to conduct a research study at Smith College that has been approved by another institution (primary IRB), you will be required to submit your protocol and all related materials and documents to the Smith IRB, along with the approval letter from the other institution for review. In most cases, the Smith IRB will defer oversight to the primary 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.
Instructions for Submission
To submit a protocol that has already been approved by another institution, log in to your Mentor IRB account. Go to 'My Protocols' and click 'Create New Protocol'. Be sure to select 'Study Approved by Another IRB' as the 'Review Type'.
After You Have Received Approval
Proposals approved under full review must be renewed annually. The Mentor IRB system will notify you when the IRB approval for your proposal is due for renewal.
If you are a primary investigator and will no longer be affiliated with the college when your annual report is due (for example, graduation, end of employment, etc.), you must contact the IRB prior to your departure with alternative contact information for your project.
A protocol deviation is an incident involving noncompliance 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. Submit a protocol deviation report through your Mentor IRB account.
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 in Mentor IRB.
Investigators must store signed consent documents in a way that ensures confidentiality of participants' information. Investigators are required to keep consent forms on file for 3 years following the completion of the research.
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.
Qualtrics is the Smith College licensed software that community members can use for anonymous online surveys.
- Smith students: prior to launching a survey using Qualtrics, you must contact the Office of Institutional Research to request appropriate Qualtrics account access.
- Smith faculty and staff can click to log-in via the Smith portal.
- Non-Smith community members can click for the Qualtrics home page.
Anonymity: When using Qualtrics you must take the appropriate steps to ensure that data is collected with no identifying information attached, making the survey truly anonymous. Read instructions for anonymizing responses on the Qualtrics website.
Verifying Age: Participants must be 18 years or older in order to consent to participate in a study. If they are not 18, a parent or guardian must provide consent. With an anonymous online survey it is impossible for an investigator to know for sure that participants are 18 or older. To increase the likelihood that the participants are 18 or older:
- State in your recruitment that participants must be 18 or older to participate
- Include a statement at the bottom of the "click" consent such as "I verify that I am 18 years old or older."
Informed consent: For a no-risk or low-risk anonymous online survey, it is possible that condensed paragraph format informed consent language may be used along with "click consent." Click consent refers to the participant clicking on an "agree" or "continue" button to indicate their consent to participate after they have read the informed consent language.
- Right to Refuse or Withdraw: Remember that participants always have the right to terminate participation in a survey for any reason. They also have the right to skip any question in the survey (i.e. no question should be "required").
Compensation: If you wish to collect participant contact information in order to offer compensation, to maintain anonymity, you must create a separate Qualtrics form into which participants may enter only their contact information. A link to the separate form should appear at the end of your main survey so that participants do not enter their contact information in the survey, and contact information cannot be connected to their data. (Also see "Payments to Subjects" below).
Certain populations are considered more vulnerable to coercion than others. Research that specifically targets vulnerable populations requires additional protections that must be described in the protocol. The following is a list of some—but not all—potentially vulnerable populations (see below for specific precautions to be taken for these groups):
- decisionally impaired individuals
- educationally disadvantaged individuals
- economically disadvantaged individuals
Participants in these categories need not be excluded from research; rather, researchers must make a special effort to ensure that potential participants are given every opportunity to exercise free choice in consenting to participate in a research project. For some participants, this will include requesting informed consent from a parent or legally authorized representative as well as assent from the potential participant.
Children/Minors (under 18 years old)
Please review the Research with Children page for more information.
A prisoner is defined by federal regulations as any individual involuntarily confined or detained in a penal institution. This definition includes individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, as well as individuals being held prior to arraignment, trial or sentencing. Research involving prisoners must have as its goal either a direct benefit to the individual subject or seek an understanding of issues and conditions specific to prisoners.
Decisionally Impaired Individuals
Decisionally impaired individuals are those who have a diminished capacity for decision-making and who may be unable to fully understand the risks of research. Research may only involve decisionally impaired individuals if it offers a direct benefit to the individual subject or to the subject's class or condition. If the subjects are not capable of giving consent for themselves, it must be obtained from their legally authorized representative. In that case assent from the subject must also be obtained.
Educationally Disadvantaged Individuals
Investigators must use recruitment and consent language that can be easily understood by potential participants, which may involve modifying consent forms language.
Economically Disadvantaged Individuals
Economically disadvantaged subjects may be easily persuaded to participate in research if the economic compensation is so great that it would result in the subject ignoring or disregarding the research risks because of the income generated by the study. In such cases investigators should be careful to set economic compensation at a meaningful level that compensates the subject for their time, but it not so great that it becomes coercive. It is also important in such cases that the risks to the subjects be made clear to the subjects.
It is sometimes appropriate to offer payment to subjects as compensation for their time and to cover expenses incurred by their participation. However, it is not appropriate to offer payment that is so high that it would encourage an individual to ignore or disregard the research risks. Excessive compensation, whether in the form of money or in-kind payments, is coercive and will not be allowed.
Smith College Policy on Payments to Employees and Students - Gifts to employees and students from college funds are generally not allowed. However, the Controller has agreed that research investigators may request an exemption to this policy. To request an exemption, email the Controller with your request and the following information:
- the amount of compensation per participant
- the method of payment
- the letter of IRB approval for the study
- a description of the receipts that will be retained.
Following approval, the Controller's Office will assist in cash payments, or you may use your P-card to purchase gift certificates or cards. Please include the approval email, the IRB letter, and other supporting documentation with your Expense Report on Smart Data.
You may maintain the confidentiality of participants but must retain the participant list in a secure location for IRS purposes.
Materials aimed at recruiting participants for studies should include a clear description of the purpose of the study and what the person would be expected to do if they choose to participate. In general, your recruitment statement should include:
- Names and contact information of the researcher(s)
- The researcher's affiliation with Smith College
- Purpose of the research
- General eligibility criteria (i.e., the reason you are recruiting that particular person)
- Brief description of what the person will be asked to do (i.e. fill out a 10 min survey or participate in a 1 hour interview)
- Accurate and honest description of risks, benefits, and/or compensation involved in the study without coercion to participate.
Advertisements should not make extravagant claims, use attention-getting techniques, nor pressure readers to participate.
Federal regulations prohibit the use of deceptive techniques that place subjects at greater than minimal risk.
Explanation and Justification for Deception
In studies involving deception, the IRB requires that the investigator: (a) acknowledge to the IRB that they are deceiving (not fully informing participants) (b) provide justification to the IRB for the deception (e.g., fully informing the participant would destroy the psychological effect under investigation) (c) argue that it would be difficult to do the study without the deception, and (d) persuade the IRB that participants are unlikely to be upset upon learning the true purpose of the study.
The following statement, or some similar statement, must appear in every consent form/information sheet for studies involving deception:
- Some research designs require that the full intent of the study not be explained prior to participation. Although we have described the general nature of the tasks that you will be asked to perform, the full intent of the study will not be explained to you until after the completion of the study. At that time, we will provide you with a full debriefing which will include an explanation of the hypothesis that was tested and other relevant background information pertaining to the study. You will also be given an opportunity to ask any questions you have about the hypothesis and the procedures used in the study.
Participants should be debriefed after the research procedures are completed. The debriefing should include a detailed description of the ways in which deception was used. The investigator is responsible for ensuring that the subject leaves the research setting with an accurate understanding of the deception. The debriefing process, including any written materials, should be explained to the IRB as a part of submitted protocols.
Debriefing statements can serve an educational function for anyone participating in a research study. Writing a paragraph that talks about the study hypothesis and theory can serve to generate goodwill with research participants and, particularly with student participants, serve an important educational purpose.
Debriefing statements are not required by the IRB except in instances where deception is used or if the study addresses topics that may provoke strong emotions in research participants (e.g., personal trauma, stigmatized social identities, mental health symptoms, microaggressions). If your study addresses upsetting topics, you must provide a list of relevant resources in the debriefing statement. It is not appropriate for the researcher to offer mental health services to participants.
Association Ethics Codes
Useful Information & Links
- Crisis Resources from the Schacht Center for Health & Wellness
- Research involving biospecimens - contact Margaret Rakas, Lab Safety & Compliance Director
- Smith Sponsored Research Office
- Office for Human Research Protections (OHRP)