Any project which involves the collection of data from human subjects needs IRB approval. There are three levels of approval: exempt, expedited, and full.
- Exempt Approval: An exempt proposal is one that does not require full IRB committee review, as it poses no risk to human subjects. The chair of the IRB reviews exempt proposals to determine if they are indeed, exempt from review.
Exempt Review Application [pdf]
- Expedited Approval: Proposals for projects, which involve minimal risk (see above) to human subjects, should be submitted as an expedited review, which involves a review by a few members of the committee.
Expedited Review Application [pdf]
- Full Approval: Proposals for projects, which involve more than minimal risk to human subjects, should be submitted for review by the entire committee for a full review. Normally, full reviews require a presentation to the full committee by the researcher, in order to answer any questions the committee members may have.
Full Review Application [pdf]
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards must be included in the study to protect the rights and welfare of these subjects.
An exempt proposal is one that does not require full IRB committee review, as it poses no risk to human subjects. The chair of the IRB reviews exempt proposals to determine if they are indeed, exempt from review. You can determine the level of review you seek from IRB after you have determined the scope of your project and how data will be collected. Exempt proposals often involve data collection from paper sources, such as charts or a review of the literature. Your faculty advisor can assist you with this determination.
Proposals may be submitted at any time. However, if your proposal requires a full review, it will need to be submitted at least one month before the next regularly scheduled meeting.
The IRB committee needs to know how you will disseminate your research results in order to determine risk to individual human subjects. For example, if you intend to publish the results of your study in a professional journal or other source, then IRB approval often provides reassurance to the readers that the rights of human subjects have been considered in the research process.
The IRB committee meets on a monthly basis throughout the year. Proposals can be submitted at any time for exempt or expedited review; proposals needing full review should be submitted at least one month before the next scheduled IRB committee meeting. See a typical IRB timeline (below) for more information.
Human subjects involved in research at St. John Fisher College have the right to:
- Informed Consent: The right to be fully informed about the nature and purpose of the research in which they are being asked to participate.
- Confidentiality: The right to be guaranteed that data collected from human subjects will be treated in a confidential manner (not be traced back to the subject).
- Non-participation: The right to refuse to participate or withdraw from participation at any time without risk of penalty.
- Minimal Risk: The right to be kept safe from physical, educational, psychological, professional, personal, or emotional harm as a result of participation.
Examples of potential harm include receiving less than the standard service or treatment, psychological distress, concern about a reduction in grade, fear of loss of job, being deceived about the study purpose, etc.
You need to know what your rights are as a participant (see above). You also need to be fully informed about the purpose of the experiment, and any potential risks that the experiment may present. You also have the right to receive the results of the study once the researcher has finished analyzing the data. Finally, you need to know where to go for help if you feel any of your rights have been violated. The IRB is here to protect your rights, and to assist you in addressing violations.
It is helpful if you develop a timeline with your faculty advisor in order to plan and organize the sequence of tasks required by your research project. IRB approval is required before data is gathered from human subjects, so it is helpful to plot out when data will be collected and plan accordingly. A typical timeline might be arranged in the following sequence:
- Meet with faculty advisor to focus project.
- Develop proposal for faculty review.
- Begin literature review.
- Submit proposal to IRB.
- Receive IRB approval.
- Collect data.
- Analyze data.
- Write results.
The timing and details of these events will vary in accordance with the size of the project and the department criteria.
One of the most frequent problems is a poorly constructed proposal that does not supply information about the type of data being gathered, the role of the human subjects, or the use of the data. Secondly, some proposals are submitted without consent forms or a letter of introduction to the subject to inform them of their role in the project. See the Proposal Checklist to determine whether you have included all the necessary information in your proposal.
Each department should identify exemplar proposals to demonstrate the essentials of a well-written proposal. Faculty advisors can review copies of successful proposals in the Center for Academic Advising and Support Services, and can then assist you in putting together a successful proposal. The IRB has developed a one-page guideline sheet and checklist to assist students/faculty in creating a proposal for review.
IRB approval is necessary whenever conducting research with human subjects, even if the information is publicly available. However, online research raises many new ethical questions and dilemmas that researchers and IRBs have not previously faced. Although more information will be coming out soon about ethical guidelines for online data collection, there are some summaries, commentaries, and early versions of guidelines available at:
Any research involving children as research subjects must formally address the intent to obtain child assent in the consent form section of the proposal application. This is in addition to obtaining informed consent from the parent.
Script for Assent
Child who is verbal: Prior to initiation of a session, the experimenter will describe the task the child will be asked to complete in language the child will understand. The experimenter will then ask the child who is verbal if s/he wishes to participate in the task. For example, in research involving a questionnaire with children the experimenter could say something like the following: “I am going to be asking you questions about different things you learn in school. I want you to answer the questions as best as you can. I won’t be giving you a grade for your answers, I just want to help your teacher figure out the best way to teach kids. You don’t have to answer any question you don’t want to and if you want to stop at any time just say, 'I want to stop now please.' If you don’t know the answer to a question it’s okay just to say I don’t know. Would you like to begin now with the questions or would you rather go back to your classroom?” If the child’s response is affirmative, the experimenter will assume that assent has been given and the task will begin as scheduled. If the child’s response is negative, the experimenter will assume that assent has not been given and the task will not begin.
Child who is nonverbal: Prior to the initiation of the session, the experimenter will ask the child who is nonverbal child if s/he wishes to participate in the task by using both verbalizations and gestures. If the child does not resist initiation of the task or does not overtly object to the task (i.e., try to escape from situation or display behaviors suggestive of displeasure with the task such as hitting, biting, slapping), the experimenter will assume that assent has been given and the task will begin as scheduled. If, however, the child resists initiation of the task and/or displays behaviors indicative of displeasure (as indicated above), the experimenter will assume that assent has not been given and the task will not begin.
Forms are available on our documents and forms page. Once they are filled out, return them to the Center for Academic Advising and Support Services. The IRB committee meets once a month to review full proposals, and to receive reports on expedited and exempt proposals.
Call the chair of the IRB, or one of the committee members. We’ll be glad to help you.