Frequently Asked Questions

Frequently Asked Questions

QUESTION

ANSWER

What constitutes research involving human subjects/participants?

According to Federal guidelines (45CFR46, 102(d)), research is defined as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

How do I know if the Institutional Review Board (IRB) should review my research?

Any research involving human participants that is conducted by a Pace University faculty member, staff member, or student, and meets the federal definition of research, must be reviewed by the IRB. Any individual who wishes to use any of the faculty, staff or students of Pace University as participants in their research must have his/her research reviewed by the IRB.

How do I know if the Institutional Review Board (IRB) should review student research assignments and/or class projects that involve human participants?

Only research that meets the Federal definition of research should be reviewed by the IRB. Normally, course work that is not intended to generate knowledge does not need to be reviewed by the IRB. Individuals who question whether their assignments constitute research may consult with the IRB.

What is considered exempt research?

Exempt research involves no risk to participants. Examples are: 1) research conducted in established educational settings involving normal educational practices; 2) research involving the use of educational tests (if anonymity can be assured); 3) research involving survey or interview procedures (if confidentiality can be assured); 4) research involving observation of public behavior; and 5) research involving the collection or study of existing data, documents, records, etc. There are exceptions within some of these examples, so investigators are urged to review more detailed Federal guidelines. If you have questions about whether or not your research is exempt, contact the IRB Co-Chairs.

What is considered expedited research?

Expedited research involves minimal risk. A signed consent form is required and the investigator keeps signed consent forms. Examples include: clinical studies; noninvasive data collected using standard clinical procedures; use of data collected for non-research purposes; research on individual or group characteristics or behavior; voice, video, digital or imaging studies for research. There are exceptions within some of these examples, so investigators are urged to review more detailed Federal guidelines. Expedited studies will be reviewed by two committee members.

What does informed consent mean?

The purpose of informed consent is to protect participants from harm and to assure privacy and confidentiality. Informed consent is the means by which investigators advise research participants of the nature of the research as well as procedures, benefits and risks, and gain written consent for their participation. Some research, for example, certain questionnaires, does not require the completion of informed consent forms. Review Federal guidelines for more information.

What is assent?

Even though parents and guardians must constent for their child to join a study, children should have a part in making a decision to join a study, if they are capable of doing so. When a child is asked to have a part in the decision, this is called "assent". Investigators should follow Federal regulations, namely 45CFR 46 Subpart D and FDA guidance on assent of children for enrolling minors (generally children under age 18) in research. Investigators should obtain parental permission, and the assent of the minor when appropriate. Information should be appropriate for the developmental age of the child.

What do I need to prepare for submission of my research to the IRB?

Guidelines for completing the proposal summary may be found on the IRB website.

What will the reviewers be looking for when they read my proposal?

The IRB reviews each proposal to assure that participants are selected fairly and protected from harm. Protection includes freedom from physical and psychological harm and assurance that the research is firmly grounded in the literature and has been well thought out (has scientific merit) so that the use of the participant’s time is well spent.

How is the IRB structured at Pace University?

Pace University has a centralized IRB that functions within the Office of Sponsored Research and Economic Development. Professor Brian Evans  and Professor Lin Drury are Co-Chairs of the IRB and Beatrice Moy is the IRB Coordinator.

Where do I submit the completed forms for IRB submission?

The completed proposal should be submitted to the IRB Coordinator, Beatrice Moy at 163 William St (bmoy@pace.edu), in hard copy per the established Guidelines.

Who will review my proposal?

The IRB Coordinator assigns each proposal to the IRB Chairperson and one other IRB member to review proposals. If the proposal is deemed exempt or expedited, the ruling is recorded and the investigator is advised of the ruling. If it is determined that there is more than minimal risk, the proposal is subjected to full review by the IRB.

How long will the review take?

The review process usually takes 8 -10 weeks if a proposal is exempt or expedited. A full review can take up to 3 months, so an investigator who is uncertain as to whether or not there is more than minimal risk should leave sufficient time to have the proposal reviewed.

Under what circumstances would my proposal need to be revised?

When there are questions about data collection procedures (including participant selection and informed consent) that may have potential risk to human participants (subjects) revisions to the proposal may be needed.

What happens if revisions are needed?

If revisions are needed, the IRB Chairperson will contact the investigator with specific revisions needed to assure protection of human participants. Once the revisions are made, the Chairperson (if expedited review) or full committee (if full review) will rule on the revised proposal. The Chairperson will notify the investigator of the outcome. (Study Revision Form)

How long is the approval for?

The approval for full and expedited proposals is for one calendar year, generally commencing on our about the investigator’s declared date to start data collection.

What do I do if the research continues beyond a year?

If the research continues, without change, the researcher may request an extension for an additional year. Extensions may be requested on an annual basis. If there is a change of any kind in the research, the proposal must be re-reviewed by the IRB. (Renewal Form)

What is the optimum time for submitting a proposal?

Proposals should be submitted as soon as complete information is available to address all sections of the proposal form and before starting data collection

Should I submit a research proposal before or after seeking external funding?

In some instances, IRB approval must be obtained before a proposal is submitted for external funding. In other instances, IRB approval may be sought while a proposal is being reviewed for external funding. The researcher should determine the funding source’s requirements for IRB approval.

Should I submit a research proposal before or after seeking internal funding?

It is highly advisable to obtain IRB approval prior to seeking Pace University funding for your research. A researcher who intends to use human participants in his or her research may not begin collecting data until IRB approval is obtained.

Where can I get help with any questions I may have?

There are three ways to have your questions answered:

1) checking this website and its various links

2) contacting the IRB Coordinator (bmoy@pace.edu)

3) contacting the IRB Co-Chairs  (bevans@pace.edu) and/or (ldrury@pace.edu)

Revised October 6, 2003