Institutional Review Board (IRB) Frequently Asked Questions 

Federal law allows certain categories of research to be exempted. Complete the exemption form and see if your research fits into one or more of these categories. If it does, apply for an exemption. Exemptions are quicker and lasts three years before needing renewal, regular approvals must be renewed every 12 months.

We process exemptions in about two weeks, expedited reviews in about three weeks, and regular reviews take about two months.

When a grant is obtained that calls for developing a survey or instrument and then uses it later. Developmental approval allows you to get your funds and develop the instrument. However, all instruments and consent forms must be approved before collecting data.

Research that cannot be exempted but is minimal risk and does not involve prisoners can usually be approved by expedited review. This means one member of the IRB reviews the proposal and can approve it. All protocols that are submitted and seem to fit this category are sent out for expedited review automatically. You do not have to request it.

We process exemptions in about two weeks, expedited reviews in about three weeks, and regular reviews take about two months.

All LSU faculty, students, and staff who are involved in the design or conduct of research with human subjects. The IRB will not approve any protocol until all certificates are received.

You will need to take the CITI Program on-line course in Human Subjects Research in either Social & Behavioral or Biomedical. Upon expiration, the refresher course will need to be taken. Step by step instructions can be found on the ORED website under CITI IRB Training.

No. We assume they have their own human subjects training course.

Yes. You need IRB approval before collecting any data, and keep your approval letter for when you turn in your thesis/dissertation. Don’t forget the IRB cannot give retroactive approval.

If the project will not lead to generalizable knowledge it is not considered research by the federal standard. However, some instructional development and service program projects may involve a “research” component that falls under the HHS definition of human subject’s research. Please send an inquiry to the IRB office that outlines your prospective project. We will decide if an
application is needed. In the case of research methods courses, you are still strongly encouraged to get IRB approval for class projects so that students have the experience. Please consider if there is a chance that you or your students will ever utilize the data collected in the future for other purposes.

As researchers we are focused on the positive side of our research and don’t see potential dangers. This is why it is important to have the IRB look at what you are doing and help you prevent risks:

• A researcher interested in stopping spouse abuse might not see the danger in interviewing couples about occurrences of spouse abuse.
• There are always risks in exercising, so we must warn participants in exercise studies of the risks in the consent form.
• We have to be very careful not to release sensitive or embarrassing data about individuals. This is why we need a privacy statement in the consent form.
• With the popularity of web based surveys we must take extra precautions that sensitive data cannot be stolen.
• Studies of vulnerable populations like children or prisoners need extra precautions.

No. All projects involving human subjects must receive approval before any work with subjects can begin. Also, it is illegal for the IRB to give retroactive approval.

No. Blanket approvals are not given. For recurring projects such as those done in classes, the PI, should submit an application (most likely an exempt application) containing all the necessary elements. In succeeding semesters, the PI can file a modification that contains the names of the new student investigators, their NIH certificates, consent forms, and any procedures that differ from those originally approved.

It is POSSIBLE that videotaping public behavior, as in ethnographic studies, will not need IRB approval. Investigators should send an email which summarizes the project to the IRB office. Investigators will receive a reply to either confirm there is no need to submit an application or that IRB review will be needed. Generally, if a project will go beyond simple videotaping and include any form of intervention with, or manipulation of, the subjects then IRB review will be needed.

The entire research enterprise depends on honesty, so it is essential that you never fabricate and/or falsify data, nor plagiarize material. These actions violate the National Academy of Science’s standards for research integrity, and could result in dismissal from the University. Furthermore, do no harm to your research subjects. The IRB will help you design your research so that it is as safe as possible.

If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:

• select the right NIH funding opportunity announcement
• write the research strategy and human subjects sections of your application
• comply with appropriate policies and regulations

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form. For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.

Second, take a moment to answer these four questions about your current or proposed research:

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of
trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.

Need help determining whether your study would be considered by NIH to be a clinical trial? See the NIH webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:

• 
  the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
• Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
• updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
• new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
• use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
• expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

Improving the design, efficiency, and transparency of clinical trials is important because it:

• respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
• facilitates design of clinical trials while reducing unnecessary duplication
• promotes broad, timely, and responsible dissemination of research information and results
• fosters responsible stewardship of the public’s investment in biomedical research

NIH developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.

The NIH will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on Dr.
Michael Lauer’s blog.