Frequently Asked Questions
- Is my project considered research involving human subjects?
- What if I am planning a study involving human subjects and do not believe it meets these criteria or am not sure if it meets these criteria?
- What if my study is not exempt?
- I teach a course in which my students engage in instruction-related research involving human subjects. Do all of these projects need IRB approval?
- Why do I need approval from the IRB for my research involving human subjects? I am an experienced researcher and I have never had to do this before.
- When does the IRB meet?
- How long does a full IRB review take?
- What training do researchers need?
- May I advertise to recruit participants for my study? May I recruit participants for my study before IRB approval?
- Is there a time limit on IRB approval?
- What if I want to change something in my study after the IRB has reviewed it?
- What is an adverse event and what do I need to do if one occurs during my study?
- I am working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to submit the protocol with the Xavier University IRB?
- What is informed consent and when is it needed?
- What is Assent and when is it needed?
- My research involves private health information. What do I need to know?
- Can I use research assistants on my study, and if so, what does the IRB need to know about them?
- Can I use online data storage sites (e.g., Dropbox), and if so, what do I need to do to protect the security of my data?
- Why does the IRB need details about my data analysis and study planning? What does that have to do with appropriate treatment of human subjects?
- Since you ask about data analysis, if I decide to do additional analyses, does that mean I need to submit a Modification Request Form to the IRB to get the new analyses approved?
- What kind of timeline should I plan on, when I submit a study for Full-Board Review?
The Code of Federal Regulations Title 45 Part 46 Protection of Human Subjects (45CFR46) provides definitions for research and human subjects:
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The concept of generalizability is usually applied to quantitative research, but in this sense also applies to qualitative research because of the expectation to contribute to knowledge.
- Human Subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
- See examples of research activities as applied to the federal definition of human subject research.
In order to determine if your project is Human Subjects Research, please submit the following form (Determining Research) to the IRB office to render that determination and allow us to provide documentation for your records.
What if I am planning a study involving human subjects and do not believe it meets these criteria or am not sure if it meets these criteria?
It is the responsibility of the IRB, not the researcher, to determine whether a study involving human subjects is considered research subject to the federal policy. If the research is not subject to the federal policy, it is determined to be exempt from review, but the study must be submitted to the IRB (IRB Submission Form) in order for the official determination to be made. The IRB Submission Form includes a section to aid researchers in determining if the project may qualify for exemption. The submission, review, and approval process for exempt research is generally fairly simple and does not require a meeting of the IRB since only one or two IRB members review the submission. (Use the Course Certification Form rather than the IRB Submission Form for courses incorporating course required student-conducted survey research that involves neither sensitive topic areas nor minor subjects. See below.
Research that is not exempt is reviewed under one of two categories (or levels) of review, expedited review or full board review according to the policies of 45CFR46. The expedited review process is used for certain kinds of research involving no more than minimal risk or for review of minor changes to already approved research. Minimal risk is defined in the regulations as the probability and magnitude of physical and psychological harm that is normally encountered in the daily lives, or in the routine medical, dental or psychological examination of healthy persons. The expedited level of review does not require a meeting of the board but is subject to the same requirements for human subjects protection as studies requiring full board review. Research that does not meet criteria for either exemption or expedited review must undergo full board review which requires a meeting of the IRB. While the expedited review only requires review by two or three members of the board, the same requirements for human subject protection apply as apply to protocols requiring full board review. See the Types of IRB Review and Approval section in the IRB Policies and Procedures Manual for more information.
I teach a course in which my students engage in instruction-related research involving human subjects. Do all of these projects need IRB approval?
You must submit a Course Certification Form every two (2) years. If more than one instructor teaches the course, each instructor must submit a form. The submission of this form will certify to the IRB that the instructor is fully cognizant of the policies of Xavier University with respect to the protection of human subjects in research and will exercise reasonable and customary instruction supervision in an attempt to ensure that all student research projects will be conducted in compliance with these guidelines. Student-conducted studies which fall under the category of full board review must be submitted to the IRB even if the course is certified. All human subject research studies conducted to satisfy master?s thesis or doctoral dissertation requirements must be submitted to the IRB.
Why do I need approval from the IRB for my research involving human subjects? I am an experienced researcher and I have never had to do this before.
The IRB policies and procedures apply to all research conducted by faculty, staff or students at Xavier University, regardless of experience and even if no federal funding is sought for the study. The federal government has mandated protection for human subjects in research since the mid-1970's as a recommendation of the Belmont Commission, whose function was to articulate the ethical principles of conducting research with human subjects. The principles of respect, beneficence and justice were published in the Belmont Report and adherence to these principles must be documented in each study conducted under the auspices of any agency receiving federal funds. The federal Office of Human Subjects Protections (OHRP) is the oversight agency for institutional review boards (IRB's) located in universities, hospitals and other agencies in which research is conducted. Although much discretion is left to the institution regarding the functioning of the IRB, the federal rules and regulations (45CFR46) mandate that certain protections must be verified by the IRB before data can be collected. Failure to comply places the institution at risk for the loss of federal funding and at risk for lawsuits by research subjects based upon ethical violations. In recent years, the OHRP has gradually begun holding universities accountable for ensuring compliance and federal funding has been halted in some institutions. As a result, Xavier University has developed policies and procedures designed to ensure compliance with the federal regulations. The IRB policies and procedures apply to all research conducted by faculty, staff or students at Xavier University, regardless of experience and even if no federal funding is sought for the study. As a result, Xavier University has developed policies and procedures designed to ensure compliance with the federal regulations.
The IRB will meet on a monthly basis during the academic year. A meeting may be cancelled at the discretion of the IRB chair if no full protocols are to be reviewed. Deadlines will be announced on the IRB web site.
Researchers should submit their protocols at least one working week prior to the next scheduled IRB meeting in order to be considered for the agenda, and it is encouraged to submit the protocol at least two weeks prior to the meeting. Protocols received after the deadline will normally be delayed until the next scheduled meeting. The IRB chair will inform researchers within five (5) business days after the scheduled meeting the results of the IRB review of the protocols. (Exempt and expedited research will generally be reviewed without a meeting, but the researcher should still allow ten (10) business days for review.)
All researchers and instructors of instruction-related student research must complete the NIH training program and attach a copy of the NIH training certificate with the protocol. This free, web-based two-hour tutorial, designed for those involved in conducting research involving human participants, presents information about the rights and welfare of human participants in research.
May I advertise to recruit participants for my study? May I recruit participants for my study before IRB approval?
Advertisements and consent forms must be approved by the IRB so these cannot be used until IRB approval is received. Under no circumstances may data be collected without IRB approval.
Studies determined to be exempt from review are not subject to IRB oversight, so a time limit is not applicable. Studies approved in the expedited or full board review categories are generally approved for one calendar year. If the IRB determines that special risks apply, approval may be granted for less than one year. At the end of the approval period (or upon completion of the study if completion precedes the approval expiration date), you must submit a Progress Report.
If a modification to any approved study is planned, the modification must be approved by the IRB prior to implementation of the modification. Submit the Modification Request Form to initiate the review and approval process.
Injury to subjects, breaches of confidentiality and unapproved deviations from the protocol are examples of adverse events that must be reported to the IRB and the research halted if necessary. The researcher must immediately report such events to the IRB and submit the Adverse Event Report.
I am working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to submit the protocol with the Xavier University IRB?
Yes. The federal guidelines are meant to be a starting place from which institutions should develop their own policies and procedures regarding the use of human subjects in research. Since the XU IRB would not know if another institution?s policy is compatible with ours, the XU IRB will conduct its own review of the project. If available, the researcher should submit the other institution?s IRB approval to the XU IRB.
In almost all cases, consent must be obtained from the research participants or their legally authorized representatives (parents or guardians) before participation in research begins.
The informed consent process is a basic ethical obligation for researchers. It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to the questions the subject may have and ensuring that the subject or the legal representative understands the information. In addition, the process includes obtaining the subject?s voluntary agreement to participate in the research, typically indicated by the subject?s signature on the written consent document. After the subject?s signature is obtained, the informational process should continue as required by the situation or the subject, both during and after the study.
For exempt research involving anonymous minimal risk survey data collection , the consent process may be as simple as having consenting participants read a document that includes the elements of informed consent and a statement advising them that completion of the survey indicates their consent.
Because children have not yet attained legal age, the parent or legal guardian is asked to give permission for participation whenever a child is asked to take part in research. Federal regulations require, however, that children be asked to provide assent, or agreement to participate in the research, whenever they are capable of doing so. Age, maturity and psychological state need to be taken into account when determining whether to ask for assent.
Out of respect for developing persons, it is important to involve children in the decision-making process whenever possible. Though they may not be able to give legal consent, they have the ability to assent or to dissent. It is important to keep in mind that a child?s failure to object to participation should not automatically be construed as assent. Assent implies the affirmative agreement of the children.
The HIPAA Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as Protected Health Information (PHI). See the Other Protections for Human Subjects in Research section of the IRB Policies and Procedures Manual.
The IRB needs to be made aware of anyone who will be interacting with participants and their qualifications to do so in order to ensure that the rights and safety of the participants will be adequately protected. As such, the use of research assistants has to be communicated to the IRB, and documentation on their having completed NIH training, as well as any study-specific training needed to adequately protect participants, must be provided. When possible, information about research assistant recruitment and status (i.e., graduate vs. undergraduate) should be provided.
Can I use online data storage sites (e.g., Dropbox), and if so, what do I need to do to protect the security of my data?
Researchers are responsible for protecting the privacy and confidentiality of their study- related data, whether it is in tangible (e.g. interview transcripts) or electronic format. Regardless of format, all data must be securely stored so that only those who are authorized to do so can access the information. Storing data online is acceptable as long as measures are taken to ensure that its security is protected. Please click here for more information regarding online data storage.
Why does the IRB need details about my data analysis and study planning? What does that have to do with appropriate treatment of human subjects?
There are two main reasons the IRB is concerned with these kinds of details. The first is to ensure that your project meets the definition of “research” that governs IRB functioning, which includes that the study must be “systematic.” Our attention to these details is part of making sure that your study actually qualifies for IRB review. The second reason is much more critical. As the level of risk increases, it is incumbent on the IRB to ensure that the study being proposed is conducted in a fashion that is rigorous enough to provide scientifically meaningful results. Studies which pose heightened risk to participants but which do not demonstrate a rigorous approach to data collection, data analysis, or any other aspect of study planning, are problematic because they make it unlikely that the project will contribute to generalizable knowledge (another key facet of the Code of Federal Regulations definition of “research”). If the IRB determines that the project creates a risk for participants greater than the project’s likely benefits to the larger community, the IRB has no choice but to disapprove the project. This is the core of human research protection. Please note that disapproving a study is not something our IRB (or any IRB) does lightly, and we will attempt to give researchers every opportunity to provide clarifications and updates to their methodology before a final vote to disapprove is made.
Since you ask about data analysis, if I decide to do additional analyses, does that mean I need to submit a Modification Request Form to the IRB to get the new analyses approved?
If you are doing additional analyses to clarify findings in an IRB-approved study, no. The IRB needs to be notified of any modification that substantively changes your data collection (including addition of new data collection sites, changes in methodology that impact participant experiences, etc.) or increases the level of risk for participants; conducting follow-up analyses on your data set as part of an approved research protocol does neither of these things. If you decide to use the same dataset to address a new research question, however, that new study should be submitted to the IRB using normal procedures. Assuming you have de-identified your data set, such follow-up projects are generally reviewable as Exempt or Expedited studies.
Your study should be submitted a minimum of one week prior to the next scheduled IRB meeting, and AT LEAST ONE MONTH prior to any planned onset of data collection. Because IRB review generally involves at least two submissions to our office (the initial submission and a response to any questions or clarifications we may request), providing yourself a MINIMUM of one month’s lead time prior to planned data collection is vital. Please note that the IRB does not and cannot guarantee that all reviews will be completed within a one-month time window, and that one month is the minimum you should plan on from the time you submit to a Full-Board protocol to our office until approval is granted and you can begin data collection.