Frequently Asked Questions

What is Research?

“Research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The regulations further clarify that “activities which meet this definition constitute research whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” 45 CFR 46.102(d)

How do I know if my project involves human subjects?

“Human subjects” is defined as living individuals about whom an investigator (whether professional, faculty, staff, or student) conducting research obtains

1. data through intervention or interaction with the individual, or
2. identifiable private information.”

45 CFR 46.102(f)

When am I required to submit a research project involving human participants to the IRB?

All research projects that will involve human participants must be submitted for review and approval before beginning the study. This also includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.

How long does a IRB review take?

The review varies depending on the research project. Please refer to the summary table under the Submission Requirements webpage

Who reviews my application?

The IRB reviewer depends on the type of review required.

The IRB Chair and/or an experienced member of the IRB reviews research studies that are eligible for exemption or expedited review.

For studies that require full committee review, a primary and a secondary reviewer are assigned to review the research study. A majority of the full committee (that is, a quorum) must be present at a convened meeting of the IRB in order to vote to approve or require modifications to a research study that is not exempt or eligible for expedited review.

What are the main concerns of the IRB while reviewing a research project?

The main concerns of the IRB while reviewing a research project are, but not limited to:

• Are the risks to the research subjects minimized?
• Does the study promise an acceptable risk/benefit ratio?
• Is the selection of subjects equitable? Are there appropriate justifications for the inclusion/exclusion criteria?
• How and from where will the subjects be recruited?
• Do the consent forms contain the required elements?
• Will informed consent be documented appropriately?
• Is adequate subject safety secured?
• Are there adequate provisions in place to protect subjects’ privacy and confidentiality?
• Are the routine/standard and the research procedures to be performed on subjects for the purposes of the study clearly identified?
• Are subjects informed of what is standard and what is research-related?
• Does the research plan make adequate provision for monitoring the data to ensure the safety of subjects?
• Is the purpose of the study clear and acceptable?
• Is compensation paid to subjects appropriate?
• Is there a placebo/no treatment control? If so, is the use of the placebo appropriate and does it put subjects at risk?
• Is a justification for the use of vulnerable groups provided? Does the study include additional safeguards to protect the rights and welfare of these groups?

Who is considered part of a vulnerable population?

Children, pregnant women, fetuses and neonates, the mentally disabled, individuals with diminished autonomy, prisoners, students and employees, elderly, economically disadvantaged and educationally disadvantaged.

Who needs to be listed on the protocol application?

All researchers or individuals that will have some kind of contact with the subject or with the subject’s identifiable information as follows:

• Participate in the recruitment and/or selection of participants
• Participate in the informed consent process
• Perform research related procedures
• Collect or report subject’s identifiable information (such as interviews, surveys, questionnaires, etc)
• Have access to subject’s identifiable information

What is meant by “exempt” protocol?

Under certain circumstances, human participant research activities may be granted exempt status. There are certain categories of activities that are considered research, but can be declared exempt from further review by the IRB. These categories are listed under the federal regulations, 45CFR46 101(b), and are detailed in the Protocol Exempt Application. Under exempt status, the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB review and oversight. Exempt status does not however affect the ethical obligations to subjects as detailed in the Belmont Report. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

How do I confirm that my project is exempt from IRB review?

There are certain categories of activities that are considered research, but can be declared exempt from further review by the IRB. These categories are listed under the federal regulations, 45CFR46 101(b), and are detailed in the Protocol Exempt Application. If you believe that your research project might fit one of the exempt categories, complete the Protocol Exempt Application and submit to the IRB. The IRB administrators and chairman will confirm determination and not the researcher.

I will be collaborating with another institution. Do I need to submit to the LAU IRB and the other institution?

If you are a member of the LAU faculty or staff, or an LAU student, and you are the person responsible for the conduct of the study (PI), you must get the approval from the LAU IRB to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary.

Do I need IRB approval if my work will be conducted off campus?

All research proposals that will involve research with human subjects and will be conducted by anyone affiliated with LAU/ LAUMC–RH must be submitted to the IRB for review and approval/exemption. This requirement applies regardless of the site of the research activity.

My research involves only reviewing medical records; do I need IRB approval?

Yes, if the project meets the criteria for research with human subjects as defined above. If the review is limited to existing data, and identifiers will not be recorded, the project may qualify for exemption under category 4 (D). If prospective data collection is involved, and/or identifiers will be recorded, the protocol may be eligible for expedited review. In either case, the determination must be made by qualified IRB personnel.

My research involves administering surveys/questionnaires; do I need IRB approval? Even if I am only interviewing a few people?

Yes. Any activity conducted by an individual who is affiliated with the Lebanese American University / LAUMC–RH or conducted at LAU / LAUMC–RH that involves research on human subjects (as defined above) must be prospectively reviewed by the IRB, including those studies involving only a few subjects.

Depending upon the types of data collected, the project may be eligible for exemption or expedited review. In addition, the IRB may require additional safeguards for vulnerable populations involved in this type of research.

Do I need IRB approval to put a survey online?

Yes. Computer and internet-based research protocols must ensure voluntary participation. They address the same level of risk such as violation of privacy, legal risks, and psychosocial stress and require the same level of protection as any other types of research involving human subjects. All studies, including those using computer and internet technologies, must

• Ensure that the procedures fulfill the principles of voluntary participation and informed consent,
• Maintain the confidentiality of information obtained from or about human subjects, and
• Adequately address possible risks to subjects including psychosocial stress.

What is a continuing review?

Except for studies determined exempt from IRB oversight, all research project are required to undergo continuing review at least annually or as determined by the IRB at initial review based on the level of risk.

What do I need to do if I want to change or amend my research project?

Any changes or amendments to the protocol or any of the study documents must be submitted to the IRB for review prior to implementation.

Why is human subject training required and who must be trained?

Anyone who is listed as:

• An Investigator or “key personnel” on the IRB application
• A person obtaining informed consent,
• A contact person in the informed consent document,
• A contact person on recruitment materials for research,
• A person obtaining / reviewing individually identifiable health information
• A person conducting surveys, interviews, questionnaires, etc

Furthermore, all members of the Institutional Review Board and staff must complete the human subject training

Does the training requirement apply to students conducting interviews?

Anyone who has contact with subjects or with confidential study data must satisfy the training requirements.

Is there an expiration date on the human subject training certificate?

Yes there is an expiration date on the Certificate and it is a 3 year validity.