FAQs (Frequently Asked Questions)
Getting
Started & Completing the Forms
Q.
What exactly qualifies as human subjects research (and thus requires IRB
approval)?
Q.
Can I share my IRB protocol approval with colleagues working on similar
projects?
Q.
Do students' academic research projects require IRB approval?
Q. I am using archived information for my
research. Do I still need to submit an
IRB application?
Q.
When should I submit my proposal?
Q.
What is required for off-campus research?
Q.
Who can consent on behalf of a subject for participation in a research study?
Q.
Can I recruit students for my research from my own class?
Q. I
received Exempt approval for my study. Do I still need to submit a continuation
every year?
Q. I
received a "Suspension Notice." What does this mean?
Q. I
received a "Termination Notice." What does this mean?
Q.
What is the difference between closure and termination?
Q.
...I carried out my research without IRB approval?
Q.
Where can I read more on the regulations governing human subject research?
Q.
What happens when a non-research activity becomes research?
A. Any systematic investigation that is designed to develop or contribute to generalizable knowledge, and which involves living humans about whom an investigator obtains information through intervention or interaction or obtains identifiable private information, qualifies as human subjects research. Please see our webpage "What is human subjects research?"
A. In order to conduct human subjects research at
1. "Application for IRB Review (exempt, non-exempt, & expedited),"
2. Your consent form (if needed) should be written using the consent form template (remember to check the web page for information regarding informed consent, and assent of minors),
3. "Faculty Supervisor Signature on IRB Application." **Make sure that all the forms that require a signature have been signed. We require the application to be reviewed and signed by your faculty supervisor if you are a student before being submitted to the IRB.
A. No. There are three categories of review, Exempt, Expedited and Full Board. Depending on the risk/benefit ratio of the study you plan to do, one of these three levels of review will be assigned. There are six categories that fall under the Exempt Review and nine categories under Expedited. A complete listing of these categories may be found in the Research Categories for IRB Review section on our web page.
**You can only apply for one type of review. Your study cannot be both Exempt and Expedited.
A. No. The use of audio and video equipment is not allowed in Exempt studies. You may qualify for Expedited review if your study meets the criteria outlined in 45 CRF 46.110.
A. No. The IRB approves protocols with the understanding that only the investigators named in the protocol application will conduct the work. If your colleagues would like to work on your research project, you may modify your existing protocol to add them as co-investigators by submitting an Amendment application along with the changes you want to make. Otherwise, they must apply for their own IRB protocol approvals.
A. If human subjects are involved, yes. Student research that involves human subjects requires approval by the IRB prior to initiation. Please note: student researchers are required to obtain a faculty sponsor for each research project.
A. Yes. Even though most archival data is Exempt, you cannot make that determination. Only the IRB can certify research as Exempt. Therefore, you must complete and submit an IRB application.
A. You should complete and submit your proposal as soon as you define your research. This allows the IRB time to review it. By submitting it that far in advance, it will also give you time to make any changes that the IRB requests in a timely manner and still meet your start date. The IRB meets formally only one time per month. Expedited or Exempt approval may be given before the formal meeting, but actual letters of approval will not be sent until after the formal meeting. For a Full Board review, your proposal should be submitted by the agenda deadline, prior to the monthly meeting.
A. Research that is physically conducted on private property (schools, hospitals, community agencies, NGOs, businesses) requires documented approval from that site (site letter). All research conductied within schools requires district approval.
Consent & Recruitment
A. Yes. All research involving interaction with human subjects (including collection of specimens) requires informed consent regardless of who the subjects are. In some cases, written informed consent may be waived.
A. If an adult subject is unable to consent on his/her own behalf due to medical
incapacity, the subject's legally authorized representative (a court appointed
conservator or guardian, an attorney-in-fact pursuant to a durable power of
attorney) may consent on his/her behalf. Family members (also called
"next-of-kin") who do not meet the definition of legally authorized
representative may not provide consent for a related adult to be enrolled in
research. If there is no legally authorized representative, and the adult
subject cannot consent, the subject may not become a human subject in an
experiment unless the federal requirements for waiver of consent have been met.
If a child is unable to consent on his/her own behalf due to medical
incapacity, a parent or legal guardian may provide consent for research. (Note:
enrollment of children as subjects requires consent by the parent or legal
guardian as well as assent by the child. In
A. We prefer that you do not use students from your own class because it is difficult to avoid giving the perception to your students that they have an obligation to participate. In other words, there is a potential for a conflict of interest. However, it can be done if recruitment is done in such a way that there is no hint of undue influence. The students should not be made to feel pressured to participate, and if they refuse, their refusal should not influence their grades for the course. Alternatives to research participation should be listed in the consent form, such as an alternate assignment.
After You Submit Your Proposal
A. Federal regulations require that the IRB communicate directly with the Primary Investigator regarding protocol-related issues. Accordingly, all correspondence from (or on behalf of) the Primary Investigator must be submitted to the IRB with the Primary Investigator's signature. The IRB may return any protocol-related correspondence that is received without evidence of the Primary Investigator's approval.
A. Yes. The IRB chair will send you a letter asking if the study is continuing without change approximately one year after approval. If that is the case, sign and return the letter and you can continue your study. Failure to respond in a timely manner will result in your study being "suspended." The study will be kept on suspension status for 30 days after which it will be "terminated. "
A. A "Suspension Notice" is sent out to the Primary Investigator when their study has expired and the investigator has failed to submit a continuation. During the period of suspension, the investigator is prohibited from collecting further data and from recruiting more participants. The investigator should submit a continuation as soon as possible.
A. A "Termination Notice" means that your study has lapsed its expiration date by 30 days and the IRB has now terminated it. Further research is prohibited. You will need to resubmit a new protocol for review. You may also have received a "Termination Notice" even if you submitted a closure after receiving your "Suspension Notice." You cannot close a study once it has been suspended.
A. A study is terminated when it has lapsed its expiration date by 30 days. This is an automatic action taken by the IRB. A closure is an action taken by the PI to end the study. The closure can be submitted at any point prior to the suspension of the study. Once a study is suspended it cannot be closed.
A. "Any systematic investigation that is designed to develop or contribute to generalizable knowledge, and which involves living humans about whom an investigator obtains information through intervention or interaction or obtains identifiable private information about living humans, qualifies as human subjects research. " While some researchers may argue some cyber chat rooms are "public" space, we still have an ethical and moral responsibility to the protection of human subjects. A study that will use existing data, whether public or private must still get human subjects approval. We will post more information and ethical guidelines regarding internet research as they are developed.
A. Wrong. While your job duties may allow you full access to their records, you are not allowed to use information contained in their records or to gather information from them as a researcher without prior IRB approval and the consent of the subject. As a researcher you are still required to submit an IRB application along with the supporting documents for review prior to beginning your study.
A. If the information being gathered is not going to be published and will be used only to improve the services offered by your department, then you do not need IRB approval.
A. If you are conducting human subject research without IRB approval, you
are in violation of Federal Regulations and subject to non-compliance reporting
both to the university officials as well as OHRP in
A. You can find a lot of information governing human subject research at the following sites:
45
NIH: http://www.nih.gov/
Office of Human Research Protections: http://ohrp.osophs.dhhs.gov/
FDA Title 2 I, Part 50: http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html
FDA Title 21, Part 56: http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr56_00.html
FDA Information Sheets: http://www.fda.gov/ohrt/irbs/default.htm
A. Research using data collected for non-research purposes requires IRB to determine if the research:
Is exempt because it already exists, and the sources are publicly available or the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants;
May be reviewed using the expedited procedure if risks are minimal;
Requires full IRB review if data are identifiable and risks cannot be minimized