Frequently Asked Questions (FAQ)

Do I Need to Submit?
Before/During the Review Process
After Submitting the Proposal and Approval is Granted...

Do I Need to Submit?

Q. When am I required to submit a human participants proposal?

All proposed protocols involving the use of human participants being conducted under the auspices of The Pennsylvania State University are to be submitted for review. This includes proposed research involving secondary data and previously collected human fluid and tissue samples.

Q. I am just doing a simple survey, do I need to submit to the IRB?

Yes. The Assurance Penn State has with the Department of Health and Human Services states that all research being conducted under the auspices of this institution will be submitted to the Office for Research Protections which oversees the review and approval process for the IRBs.

Q. I am not collecting any identifying information, do I need to submit for approval?

Yes. Federal regulations require that ALL research (a systematic investigation) soliciting information be submitted for review and approval.

Q. I am not collecting any identifying information, do I still need an Informed Consent Form?

Yes. If the proposed study is truly "anonymous" - no coding for identifiers (e.g., names, social security numbers, drivers license numbers, etc.), an implied Informed Consent Form may be used. That is, all of the elements of consent must be documented for the participant, but the signature line is replaced with a statement informing the participant that completion and return of the survey is considered implied consent. If however, the procedures involve risk or biological sample collections, written consent is usually required.

Q. I am only working with previously collected data, do I need to submit for approval?

Yes. Federal regulations require that the study of existing data, documents, records, pathological specimens, or diagnostic specimens are to be submitted for review and approval. Please refer to the "Use of Secondary Data" section for more detailed information.

Q. I will be collaborating with another institution, do I need to submit to PSU and the other institution?

Yes. Any faculty, staff, or student conducting research or collaborating with another institution while under the auspices of Penn State is required to submit to the IRB at PSU for review and approval. It is also the responsibility of the researcher to contact the collaborating institution regarding its requirements for review and approval of research projects regarding the use of human participants.

Before/During the Review Process

Q. What do I need to submit and how many copies are needed?

Exemption and Expedited proposals require:

2 copies of the Application for the Use of Human Participants
2 copies of the Informed Consent Form
2 copies of all measures (e.g., surveys, interview outlines, etc.)
2 copies of any supporting documentation such as letters of agreement, letters from electricians, etc. (if applicable)
2 copies of advertisements, flyers, posters, etc. (if applicable)
1 copy of the grant proposal (if applicable)

Full Review proposals require:

17 copies the Application for the Use of Human Participants
17 copies of the Informed Consent Form
17 copies of all measures (e.g., surveys, interview outlines, etc.)
17 copies of any supporting documentation such as letters of agreement, letters from electricians, etc. (if applicable)
17 copies of advertisements, flyers, posters, etc. (if applicable)
1 copy of the grant proposal (if applicable)

Q. What is the time period for the review of a proposal?

The estimated review time for exemptions and expedited reviews is three weeks. This time frame may be increased if revisions/changes are requested before the review process can be completed. Protocols requiring full review by the Institutional Review Board are to be submitted to the Office for Research Protections (ORP) by the specified dates noted on the following documents: 2008 Biomedical IRB Meeting List (PDF) | 2008 Social Science IRB Meeting List (PDF). The meeting dates/times are listed on these documents as well. The time frame for approval may be increased if additional information and/or revisions are required by the IRB in order for them to conduct a thorough review prior to issuing an approval.

Q. Who is required to complete the human participants training?

All faculty, students, and staff proposing to use human participants in research under the auspices of The Pennsylvania State University are required to complete the human participants training. Approvals for use of human participants in proposed research projects will be not be granted until this training has been completed and verified by ORP. For additional information on this topic, please see IRB Policy II, "Verification of Training on the Protection of Human Participants".

Q. Where can I obtain the appropriate forms for submission?

Forms are available at ORP, The 330 Building, Suite 205 (865-1775) or they can be downloaded from the ORP Human Participants Web page.

Q. Is advisor and department head signature required on all submission forms?

The department head signature is mandatory. It is strongly recommended that the signature of the advisor be obtained; however, ORP recognizes the time constraints that may prevent adequate time for the review process, if the advisor is not readily available for the investigator to obtain his/her signature.

After Submitting the Proposal and Approval is Granted...

Q. When should a modification to an approved protocol be submitted?

All changes to an approved protocol are to be submitted for review and approval prior to incorporating the change into the research project (e.g., additional surveys/questionnaires, additional participants, a different participant population, a title change, change in principal investigator, change of funding source, increased time for participant participation, etc.).

Q. Does approval of a modification for an approved protocol extend the original approval date?

No. The expiration date of the original approval is not changed by the review and approval of a modification.

Q. What do I have to do if I need to amend my approved protocol?

ORP needs to be informed in writing (letter/memo/email) of the proposed change(s). This information needs to clearly describe the proposed changes/modifications. If applicable, a revised copy of the Informed Consent Form, as well as revised measures (surveys, interview outlines, etc.) are to be submitted for review.

Q. How do I renew my project for continued approval?

It is the responsibility of the researcher to ensure continued approval of their research projects involving human participants. However, if the submitted Human Participants application indicates that approval beyond one year will be required, then approximately one month prior to the approval expiration, ORP will forward a Continuing Progress Report and Review Form to the principal investigator for completion and return to ORP, The 330 Building, Suite 205. Upon receipt of the form, ORP will initiate the review process for continued approval.

Q. In the case of an adverse event, when is the investigator expected to report this occurrence to the ORP and the IRB's?

The researcher is to report the adverse event to ORP and the IRB's within 5 working business days.

Q. Can the IRB temporarily or permanently discontinue a research project as result of an adverse event?

Yes. If an adverse event poses an unexpected risk(s) to the participants, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Dependent on the investigation, the IRB may request changes to a research project or permanently discontinue the research project.

Q. Can the IRB request revisions to the approved protocol and the Informed Consent Form as a result of an adverse event?

Yes. As a result of the IRB's investigation of the adverse event, revisions to the approved protocol and the Informed Consent Form may be requested.

Go to Quiz