IRB Frequently Asked Questions (FAQs)

Find the answers to many of your IRB questions.


General IRB Questions

1. How do I know if my project needs to be reviewed?

The IRB at UWF reviews all educational, training or research activities involving human subjects, at any UWF campus or by any UWF faculty, staff or student.

Research: a systematic investigation designed to develop or contribute to generalizable knowledge.

Human subject involvement: means a living individual about whom an investigator conducting research obtains: (a) data through intervention or interaction with the individual, or (b) identifiable private information.

For help in determining if your project requires IRB review, use these decision charts. If you are still confused, call the Research Integrity Coordinator at 850-857-6378 or email irb@uwf.edu.

2. What are some examples of projects that do not require IRB review?

Projects that do not meet the criteria for research do not require IRB review. For example:

  1. Survey procedures only for internal purposes (program evaluation) such that results will not be published nor presented in a public setting (e.g. at conferences or professional meetings)
  2. Gathering of information from a person to assess suitability for and/or supplement a public program, publication, or cultural performance

 

In addition, projects that do not meet the criteria for human subject involvement do not require IRB review. For example,

  1. Interviews used to provide quotes or illustrative statements (i.e. journalism)
  2. Gathering of information from a person to clarify the history of a particular item in a museum collection
3. Do I need IRB approval to conduct ethnographic interviews?

Yes. UWF guidelines for ethnographic interviews follow the guidelines adopted by the American Anthropological Association (AAA). The AAA Statement on Ethnography and Institutional Review Boards was adopted in 2004 and advises ethnographic researchers to seek help from IRBs so that the welfare of human participants can be protected.

The AAA explains that ethnographic research should require IRB approval as it involves human participants and is research. While this type of research studies human behavior in the participant's natural environment, and not in clinical laboratories, ethnographic researchers should also consider potential harms to participants and take precautions to minimize these risks.

Thus, ethnographic researchers at UWF must submit project proposals to the IRB for approval prior to initiating an ethnography project and must obtain informed consent from all participants prior to beginning the interview process.

4. Do I need IRB approval to conduct a class-related project?

◦Are you the student? Talk to your professor! If you are enrolled in a research design and/or research methods courses, your professor may require you to complete a research project as a part of your regular coursework. By assigning this task, you will experience the use of research methods first hand. In these cases, the UWF IRB allows for the professor teaching the course to act as the party responsible for the protection of human research participants. The professor leading your class, therefore, should conduct a review of your and your classmates' research protocols to ensure that all human research participation protections have been included.

Note: All research projects involving human participants that are completed as a part of a directed study, thesis, or dissertation project require IRB approval. In these cases, the student research proposals should be submitted to the IRB employing the usual application process.

◦Are you the professor? You may submit one comprehensive IRB application for your classroom-assigned project instead of having each student complete a separate application for IRB review. As a part of the comprehensive application, you must complete the mandatory training for researchers and submit an IRB proposal using the standard form. For instructions on how to complete an IRB application for a classroom-related activity, all professors are encouraged to read the IRBs Instructor Guidelines for Screening Course-Related Student Research Proposals (PDF).

*Note: Data collected for a class project may not be used for publication or presentation, unless the project was reviewed and approved by the IRB prior to recruitment and data collection. Should there be any possibility of or intent to publish, present, or otherwise disseminate research data or findings outside the course in the future an application must be submitted for review and approval by the IRB prior to the start of recruitment and data collection.

5. Do I need IRB approval to conduct a quality improvement (QI) activity?

Projects that do not meet the criteria for research do not require IRB review. While the QI activity will most likely be conducted in a systematic manner, the results of the activity are not likely to be used to increase general knowledge.

Thus, if your QI activity is designed to discover methods to improve your organization's/department's processes or outcomes and you do not plan on sharing the results outside of your organization/department, IRB approval is not needed.

Note: If you think that you might wish to share the information outside of the organization/department at a later date, you may consider submitting an application to the UWF IRB. IRB approval is required for you to be able to present or the results of your QI activity outside of the group you examined.



Application Process Questions

1. Can students or employees serve as research subjects?

Students and employees are often recruited to serve as research participants. While UWF does not prohibit the involvement of its students or employees, you should take precautions to avoid use of coercion and/or undue influence during the recruitment process.

For example, a professor proposes to include his or her own students in a research project. Students who are contacted and asked to participate may feel that their refusal to participate could affect their course grade. Even if this is not true, any perception of undue influence must be avoided. As such, researchers should avoid using their own students or employees in their research.

Note: Researchers affiliated with the School of Psychological and Behavioral Sciences (SPBS) proposing to recruit students for participation in their research project should consider use of the SPBS Psychology Research Pool. Find more information about the SPBS Research Pool.

2. Can participants be paid?

Research subjects may receive incentives or compensation for their participation. If you choose to compensate your research participants, you must clearly describe this compensation in your IRB application. In addition, your informed consent form should explicitly outline any compensation the participant may receive. Note: Compensation should not be described as a benefit of the study. It is important for the IRB to review proposed payments to participants as high levels of compensation could coerce participants into accepting research-related risks that they would normally not accept.

Important ideas regarding compensation for research participation:
a.Payments should not encourage participants to participate or continue to participate against their better judgment. When deciding upon the level of compensation you will provide to your research participants, you must remember that the amount paid to participants must correspond to the "burdens of participation". The "burden of participation" assumed by a participant may be estimated by the amount of time that participant has given to the study.

b.Participants who withdraw from a study prior to the completion of the project should still receive partial compensation. Choosing to withhold compensation to the end of the study constitutes coercion on behalf of the researcher by compelling the participant to continue participation despite any feelings about early withdraw.

c.UWF policy prohibits cash payments to participants as compensation for research participation. Should you wish to provide compensation to your participants, you may choose to offer gift certificates, gift cards, or store vouchers. You must contact UWF Financial Services (850-474-3051) if you plan to provide these kinds of participant incentives.

d.Florida statutes consider the offering of participation in a drawing or raffle as compensation for participation in research to be a game of chance. As such, the use of drawings/raffles as incentives for research participation is prohibited by state law unless even non-participants are allowed to enter the drawing or raffle. For more details, contact the Research Integrity Coordinator at 850-857-6378.

 

3. My research and data collection will primarily take place away from the UWF campus. Do I need to have any special approvals to conduct research off-campus?

As a UWF researcher, you may propose to conduct research at a local public school, a community center, a nursing home and assisted living center, or within a local organization.

The UWF IRB requires that you obtain approval from the appropriate personnel in order to conduct research at an off-campus site. The appropriate personnel (e.g. director of a nursing home or community center) must provide a letter to the IRB that indicates that you have permission to conduct your proposed research at their site. The IRB will not approve an off-site project without evidence of the sites' approval.

If you are proposing to conduct research in a local public school, you must have written approval from the district's Superintendent of Schools. A copy of this approval letter must be submitted to the IRB.

4. What is the difference between privacy and confidentiality?

Privacy refers to persons and the right of an individual to control who has access to him/herself. In contrast, confidentiality refers to the data collected and the agreement between the researcher and the participant in regards to how the data will be stored and shared.

5. How can a researcher protect the privacy of participants?

When designing the research protocol, a researcher should consider how, when, and where, and what kind of interactions will take place. For example, the researchers should consider:

◦Methods used to identify and contact potential participants (recruitment)
◦The setting in which the participant will interact with the researcher (i.e., participants may not wish to complete an interview in a place where others can overhear their responses.)
◦The methods used to obtain information about participants
◦The nature of the information to be obtained

6. How can I maintain confidentiality of my research data?

In ensuring that you have adequately planned to protect your participants, the IRB will examine the steps you will take to maintain their confidentiality. The IRB application asks you to describe, in detail, how data will be secured to safeguard confidentiality.

Some of the common methods used by researchers include:

◦Using codes instead of names to identify different participants
◦Using anonymous surveys
◦Shredding the face sheets of survey instruments should they contain names or addresses
◦Destroying video and/or audio-recordings as soon as interview has been transcribed
◦Limiting the access to identifiable data to one or two people
◦Storing all hard copies of records in locked cabinets in locked offices

Computer security has become an important part of maintaining confidentiality as most data is now stored electronically. Researchers should restrict the storage of research data to secure drives. If the data is of a sensitive nature or when data may be linked to specific individuals, it may be necessary to store the data on an encrypted drive. Finally, identifiable data should not be shared via email or through any other unencrypted electronic means.

NOTE: Certain types of research projects encompassing interviews with specific individuals may seem to be exempt from confidentiality rules (i.e. ethnography). Researchers leading these projects, however, should ensure that the interviewee is aware that his or her identifiable information will be shared. If the participant does not consent to this sharing of personal information, the researcher must work to maintain the confidentiality of that participant.

7. Who should be listed on the consent form as the contact to answer questions?

The federal regulations outlining human research participant's protection have established 8 minimum topics that must be addressed in an informed consent form. One topic that you must address is whom the participants may contact if they have questions. Specifically, you are required to include contact of information for the individual who is capable of answering questions about (a) the research project; (b) the participant's rights as research participants; and (c) research-related injuries.

In most cases, you will need to include contact information from multiple individuals in order to meet these federal requirements. For example: you may include your information so that questions concerning the research and research procedures can be addressed and add the contact information of the Research Integrity Coordinator to ensure questions about an individual's rights and the reporting of concerns are adequately handled.

The following contact information must be included when referencing the UWF IRB in your informed consent form:

Christi Boddiford
Research Integrity Coordinator
Research and Sponsored Programs
850-857-6378
irb@uwf.edu

8. Do HIPAA rules apply to my project?

The Health Information Portability and Accountability Act (HIPAA) establishes the rights of an individual to maintain privacy of his or her own personal health information. HIPAA rules apply to health care providers and any other health-related organization. Your research would only be subject to HIPAA regulations if you are collecting identifiable health information from a covered entity.
a.Is UWF a covered entity?

Certain departments within UWF may be considered covered entities under HIPAA because their databases may contain personal health information belonging to UWF faculty, staff, and/or students. These departments include, but may not be limited to:
◾Allied Health Sciences;
◾Environmental Health and Safety;
◾Student Health Services;
◾Benefits Section with Human Resources; and
◾University Archives.

b.What are examples of other covered entities?

Your research may take place at an external organization that meets the definition of a covered entity. Hospitals, nursing homes, health clinics, physician's offices, and health insurance companies are all examples of covered entities. If you are unsure about whether the organization at which you plan to conduct research is a covered entity, contact the Research Integrity Coordinator (850-857-6378, irb@uwf.edu).

Thus, if you are collecting identifiable health information from one of the above UWF departments or external organizations, your research will be subject HIPAA. As such, participants must agree to your use of their PHI by signing a HIPAA authorization form in addition to the informed consent form.

 



IRB Review Process Questions

1. What are the categories of review conducted by the IRB?

Based on federal regulations and recommendations, an IRB may conduct several levels of review based the characteristics of the proposed participant population and on the severity and/or likelihood of risks to participants. For example, the IRB conducts more comprehensive reviews a research application that chooses to study children or a research application that involves places the participant at great risk of physical or social harm.

There are three levels of review conducted by the IRB - exempt review, expedited review, and full board review.

Even if you believe your project qualifies for exempt review or if someone tells you that your project will be exempt, you must still submit an application to the IRB. An exempt project is not exempt from any review; rather, it is only exempt from the complex level of reviews other types of research must undergo. You must still obtain an approval from the IRB in order to begin work on an "exempt" research project.

2. What types of research qualify for an exempt review? What is involved in an exempt review?

If a research project presents no more than minimal risk to participants and belongs to one of categories of exempt research (PDF), it may qualify for an exempt review. Applications qualifying for exempt review can be approved after review by a single member of the IRB.

3. What types of research qualify for an expedited review? What is involved in an expedited review?

If a research project presents no more than minimal risk to participants and belongs to one of categories of expedited research (PDF), it may qualify for an expedited review.

Qualifying for an expedited review does not mean that the review of your application will be completed quicker than usual. Expedited review refers to a level of IRB review that involves fewer people than the full board review. However, this process may still take up to two weeks.

4. What is minimal risk?

Projects are classified as minimal risk when they probability or magnitude of harm or discomfort are not greater than those ordinarily encounter in daily life or during the course of routine examinations or tests.

When trying to consider whether a project classified as a minimum risk project, the researcher must consider physical risks, emotional/psychological risks, financial risks, risks to employability, risk of stigma and more.

5. What types of research require full board review? What is involved in a full board review?

Typically, applications reviewed by the Full Board present more than minimal risk to the participants, deal with sensitive information, or involve the participation of vulnerable populations. During the review, the members of the IRB vote on whether to approve the application. In order for an application to be approved, a majority of the members in attendance (i.e. a quorum of members) must vote for approval.

6. If my project requires full board review, will I be asked to attend an IRB meeting?

If your research proposal requires full board review, you will be invited to attend the IRB meeting. However, you are not required to attend the meeting.

Your presence is requested at the IRB meeting so that you will be available to answer any questions brought forth by members of the IRB. Should you chose not to attend the meeting, any questions or concerns of the committee will be forwarded to you upon the meeting's close. At that time, you will be allowed to respond.

Thus, by attending the meeting and working with the IRB on the date of your full board review, you may limit any delay in the approval process that may occur as information is exchanged back and forth post-meeting.

7. When should I submit my proposal for review?

All research proposals should be submitted to the IRB at least four weeks before the researcher intends to begin the project. This provides ample time for the IRB to review the application, for you to make modifications to the application based on reviewer comments, if necessary, and for you to obtain the IRB approval notice.

IRB approval cannot be retroactively applied to previous dates. Therefore, be careful when laying out your research timeline. You may not conduct any data collection or interaction with human participants until you have received IRB approval.



Post-Approval Questions - Project Initiation, Continuation and Conclusion

1. How do I know when my IRB application has been approved? When can I start my research?

You will be notified by the IRB via email when your research project has been approved. Once you have received this notification letter, you may begin your research. Be sure to keep a copy of this approval letter for your records.

2. How long will my IRB approval last?

IRB approval of applications approved under expedited or full board review lasts for one year. The notification letter you receive from the IRB stating your approval to conduct research will contain the expiration date for your approval. After this date, you are no longer allowed to add more participants, contact current participants, or gather more data.

3. How can I continue my research project for more than one year?

You must request an extension for your project should you wish to continue your research past the IRB approval expiration date. This includes continuing the project for additional data collection or to continue with analysis of identifiable data. (If the only remaining project activities are the analysis of de-identified data, you do not need to submit a request for an extension.)

To request an extension, you must complete a continuing review form (PDF) to provide an update regarding the status of your project and certify that you are conducting your research by following the protocol approved by the IRB. A continuing review request must be approved by the IRB before the original expiration date in order to continue the project.

Once the IRB-approval end date has been reached, you must stop all data collection. If you still need to collect additional data, you will be required to submit a new application to the IRB and you cannot start collecting that additional data until you receive IRB approval for the new application.

Therefore, the IRB recommends that requests for extensions be submitted to Research and Sponsored Programs one month before the expiration date. To help you keep track of your project's IRB-approval end date, you will receive an email from the IRB approximately 30-60 days before your project's expiration date reminding you that your expiration date is near.

4. I've completed my study and data analysis, what should I do?

As the primary investigator, you are responsible for submitting a final report to the IRB. The final report lets the IRB know that your research is complete, that the research was conducted using the IRB-approved protocol, and that all adverse events were promptly reported. Please compose a document (maximum one page) that answers the final report questions (PDF).

On your expiration date, you will receive notification that your project's IRB approval has expired and all data collection must cease. The email notification will also prompt you to complete your final report and submit the report to the IRB.

5. Can I make changes to my materials or procedures once approved?

Once the IRB has reviewed a project, the project must be conducted as approved. Any proposed changes in participant population, recruitment plans, research procedures, study instruments, study sites, revisions to the consent/assent forms, or major research personnel must be approved by the IRB.

To request approval for modifications to an IRB-approved protocol, you must complete a project modification form (Word) and submit the completed form to the IRB for review. Should the IRB approve your proposed changes, you will be notified via email. Only after that time may the changes you proposed be enacted.

6. What are the steps for reporting unanticipated problems or adverse events?

The occurrence of an adverse events and/or unanticipated problems during your research project that involves risks to subjects or others MUST be reported to the IRB. Examples of adverse events and unanticipated problems include:

◦Unexpected illness or injury to a participant that was related to participation in the activity
◦Failure to obtain informed consent/assent for a participant
◦Breach in confidentiality

To report an adverse event or unanticipated problem, complete the adverse event reporting form (Word) found on the IRB website. Be sure to detail the facts surrounding the event, what steps were taken to address the problem, whether the problem is likely to happen again, and how you will prevent the problem from recurring.

Upon submission of the complete reporting form, the IRB will review the event and decide upon the best course of action. In the case of severe or frequent adverse events or problems, the IRB has the power to suspend a research project to ensure the safety of all participants.

7. What should I do with all my research materials after my study is complete?

Federal regulations require that all documents related to the subject's participation in your research be maintained for three years after your project is complete. This includes the consent forms that each participated signed. All documents should be stored in a secure location until three years after the study is concluded.



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