- What is the Human Subjects Research Office (HSRO)?
- What is an IRB?
- How does the IRB work?
- How do I know if my project needs to be reviewed?
- Someone told me my research is “Exempt” research, does that mean it doesn’t need to be reviewed?
- I need my project reviewed very soon, can I have an Expedited review?
- I know my project needs to be reviewed by the IRB, what do I do first?
- I’m only doing a survey; I don’t need review, do I?
- My research is part of a class; it doesn’t need review, does it?
- I’m not gathering names on the survey, doesn’t that mean its anonymous and doesn’t need to be reviewed?
- My research includes children, I’m confused about the consent process.
- Which branch of the IRB will review my project?
- How long will it take to review my project?
- How do I coordinate IRB review with my grant application?
- I’m mentoring a student who wants to do research, what next?
- How do I know if my activity is Exempt or Expedited?
- What is the Human Subjects Research Office (HSRO)? back to top
The RIT Human Subjects Research Office (HSRO) is part of the Office of the VP for Research. The HSRO reviews all research with human subjects that takes place at RIT, develops relevant institutional policies and procedures for protecting human subjects, approves Exempt research, provides guidance on interpreting the Federal Guidelines relevant to human subjects in research, and offers educational opportunities for researchers.
- What is an IRB? back to top
An Institutional Review Board (IRB) is an administrative body that oversees research with human subjects. Its role is to protect the rights, welfare and safety of the people who take part in research. AT RIT there are two Branches to the IRB; they both contain people from RIT as well people from outside of RIT. Members may be faculty or staff and come from different departments around RIT. Not all members are researchers or scientists; this ensures that multiple perspectives are considered when looking at research activities.
- How does the IRB work? back to top
The members of the IRB meet and review research activities and discuss whether the risks involved outweigh the potential benefits. The Members consult Federal Guidelines to make this determination. Certain conditions must be satisfied before they can approve an activity.
- How do I know if my project needs to be reviewed? back to top
The Federal Policy for the Protection of Human Subjects (Title 45 CFR part 46) outlines two requirements that must be satisfied for a research activity to be considered research with human subjects:
- Human subjects must be involved – these are living individuals about whom an Investigator conducting research obtains (1) data through intervention or interaction with the subject, or (2) identifiable private information
- The activity is a systematic investigation, including research development (pilot testing), testing, and evaluation designed to develop or contribute to generalizable knowledge.
Generalizable knowledge is information which may add to a field of study and allows for application to populations and settings different from where it was collected.
General Attributes of Non-Research Activities (these do notneed IRB review):
- The intent is to identify and control a specific problem or asses and/or improve a program or service
- Benefits are primarily or exclusively for present or future participants or their community
- Knowledge is not expected to extend beyond the scope of the activity
If an assessment or evaluation activity includes any component of research with human subjects than it needs to be reviewed.
- Someone told me my research is “Exempt” research, does that mean it doesn’t need to be reviewed? back to top
No, Exempt means it fits into a specific set of Federally defined categories. These six categories are defined in the regulations and the determination as to whether a research activity fits into a category is made within the HSRO at RIT.
As long as your activity is considered research with human subjects it needs to be submitted to the HSRO. After review, a determination will be made if it is Exempt.
- I need my project reviewed very soon, can I have an Expedited review? back to top
No, Expedited research, like Exempt research, is a specific category in the Federal Regulations. In spite of the name, it is not a speedier review reserved for the last minute. Research activities must fall into one of the eight Federally defined Expedited categories. This kind of research is reviewed by the Chair or an appointed Member of the IRB instead of the entire Board at a convened meeting. This means the review may happen more quickly than if the activity needed to be reviewed by the entire Board, but the same effort and care is taken with an Expedited review as any other.
- I know my project needs to be reviewed, what do I do first? back to top
Fill out and submit the signed Form A and any necessary supporting materials (consent/assent forms, surveys, instruments, abstract, flyers/invitations, etc.) to HSRO, University Services Center, Suite 2400, along with electronic copies to the Human Subjects Research Office email@example.com. Expect about two to three weeks from the time you submit until you receive feedback from an initial review by RIT’s Office of Human Subjects Research (HSRO). This gives the HSRO time to process the submission, enter the materials into the databases, and review the Form A and materials. You may be asked for additional clarification or materials.
- I’m only doing a survey; I don’t need review, do I? back to top
You may if your activity is considered research with human subjects; survey research, even if you think the risk is very low, needs to be reviewed if it fits the definition of research with human subjects.
- My research is part of a class; it doesn’t need review, does it? back to top
It may if your activity is considered research with human subjects; if your research fits that definition then it will need to be reviewed.
The important point to consider is the concept of “generalizable knowledge”. This means that the intent of the research is to add information to your field of study; the results can be applied beyond the subject population to other settings. It doesn’t matter if the results will be published or not, if your research activity is designed with the aim of discovering information that can be applied in other settings it can be considered research.
- I’m not gathering names on the survey, does that mean it’s anonymous and doesn’t need to be reviewed? back to top
Not necessarily. Although there is no regulatory definition in Title 45 CFR Part 46 that defines anonymous, the Federal office that oversees research with human subjects has indicated that for purposes of determining anonymity, if there remains any possible linkage between the person and the data, the spirit, if not the definition of "anonymity" would be violated. In other words, anything that can link the research to an actual human being would probably take it out of the realm of anonymity.
For example, if you are distributing a survey to a class and have people drop the completed survey on a table as they leave, there is a possible linkage. It is known that a specific person has taken the survey (you and everyone else sees him/her leave the completed survey on the table), and depending upon the nature of the survey questions, it may be possible to link that person through their completed survey to the data. The review process determines if the lack of anonymity poses any risk to the subject, and if the level of risk is appropriate to the information that may be discovered.
If a survey fits the definition of research with human subjects then it needs to be submitted to RIT’s Human Subjects Research Office for review.
- My research includes children, I’m confused about the consent process. back to top
Don’t panic, research involving children may require additional consent documents, but the process is straightforward.
Except in certain situations, all research conducted by students, staff and faulty at RIT must involve an informed consent process. This is the foundation of our respect for the rights and welfare of human subjects. The consent process allows an Investigator to inform the potential subject about the research and ensure that the potential subject is aware of all the risks and is joining the study voluntarily.
If you are working with children (individuals under the age of 18) you will need Parental Consent for the child to be involved, and Assent (agreement) from the child to take part. In cases where Parental Consent is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may be waived.
- Parental Consent - Parents need to be informed of the research and have the opportunity to allow or prohibit their child from participating. Parental consent forms follow the structure of a regular consent form, but are directed toward the parent instead of to a research subject.
- Assent - Assent refers to the agreement of a child to participate in a research study. Assent forms should be written at the reading level of the subjects and offer the child the opportunity to decline participation in a study. The assent can be read to or with the child if that helps to ensure complete understanding.
Please see the Consent Toolbox section for more information.
- Which branch of the IRB will review my project? back to top
There are currently two branches of the IRB at RIT; one branch reviews research activities where the research focuses on deaf and/or hard of hearing subject populations, and the other branch reviews research where the subject population is hearing. The determination is made within the HSRO; both branches review research using the same parameters as defined by the Federal Guidelines.
- How long will it take to review my research? back to top
Since the review process is unique to each submission we can’t give an exact answer about how long it will take to review an activity. Generally you can expect a wait of 15 to 20 business days from when we log your project in for review. During that time an initial review will be conducted; that doesn't mean the review will be completed in 15-20 business days. It means we will begin reviewing and discussing your project and hope to have comments to you within 20 business days. These comments may include an approval if your submission was complete and easily reviewed, or they may include a request for more information of clarification.
If your submission will be reviewed by the Chair (Expedited review) it will take another week or two, depending on the Chair’s schedule, and if your submission needs review by the entire Board it may take even longer depending on when the next Board meeting is scheduled.
Make sure to give yourself enough time before you plan to recruit subjects and collect data, some reviews take longer and some times of the year are busier than others.
- How do I coordinate IRB review with my grant application? back to top
Most funding agencies use a concept called "just in time" review; this means that they don’t expect approval until after they award a grant. Researchers should verify the agency’s expectations for review with their project officer at the funding agency or with their Sponsored Research Services Administrator. Keeping in mind that review may take a month or longer, Researchers may want to get started on their application to the IRB in case they are funded.
- I’m mentoring a student who wants to do research, what next? back to top
If you have determined that the research meets the Federal definition of research with human subjects, the first step is for the student to submit the Form A. Faculty Mentors supervising students who are conducting research are responsible for informing students of elements of the RIT policy relevant to the research.
- How do I know if my activity is Exempt or Expedited? back to top
Check the Review Process at RIT Section for more information about how to determine if research is Exempt or Expedited. For research to be considered Exempt or Expedited it needs to fit into a Federally defined category. In both cases, the research is submitted to RIT’s Human Subjects Research Office (HSRO) using a Form A and the determination is made by the HSRO. The Researcher should not feel the burden to determine how their project is categorized; this is the responsibility of the HSRO. Having an idea of the category is only helpful in that it provides information about how the review process will unfold and the expectations of the researcher in terms of continuing review responsibilities.