Frequently Asked Questions (FAQ)

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

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 and Penn State regulations require that ALL research (a systematic investigation) soliciting information be submitted for review.

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?

Investigators should contact the Office for Research Protections whenever collaborative research is occurring. Separate applications may be necessary, or an IRB Authorization Agreement may be reached with the other institution.

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Before/During the Review Process...

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

Exemption proposals require:

• 1 copy of the Exemption Determination Form
• 1 copy of the Informed Consent Form
• 1 copy of all measures (e.g., surveys, interview outlines, etc.)
• 1 copy of any supporting documentation such as letters of agreement, letters from electricians, etc. (if applicable)
• 1 copy of advertisements, flyers, posters, etc. (if applicable)
• 1 copy of the grant proposal (if applicable)

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)
• 2 copies of the grant proposal (if applicable)

Full Review proposals require:

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

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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 of the proposed change(s). Please use the appropriate modification form for the level of review. 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 his or her 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, 201 Kern Graduate Building. 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 a significant adverse event to ORP and the IRBs within 5 working business days. Mild/Moderate events are reported at the time of continuing review.

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.

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Questions About Informed Consent

Participants must be provided with a copy of the approved consent document, regardless if signed or implied consent is used. For phone interviews, phone surveys, or verbal consent, a copy may not necessarily need to be provided. For online surveys, participants should be informed that they can print the consent form for their records.

1. What does "informed consent" mean?

Being fully informed is a basic requirement in all research with human participants. Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies.

2. What types of informed consent exist?

Three types of informed consent exist: (1) signed informed consent; (2) waiver of documentation of informed consent and (3) waiver of informed consent.

3. What is signed informed consent?

Used most commonly, signed informed consent allows prospective participants to document their agreement to take part in research activities by signing and dating the consent document.

4. What is a "waiver of documentation" of informed consent?

A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form.

There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:

• The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation) OR
• The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews)

PLEASE NOTE: The IRB will take in consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.

5. What is "implied" consent?

By completing a research task (e.g., completion of a questionnaire, interview, survey, etc.), the individual has provided consent to participate in the research. This is an example of a waiver of documentation of informed consent. Before granting a waiver, the IRB may require the researcher to provide the participants with a written summary or an information sheet about the research, including: (1) purpose of research; (2) time involved; (3) assessment of minimal risk; (4) statement regarding benefit to participants; (5) contact for questions about the research; and (6) contact for questions about rights as a research participant.

For example, you wish to mail out a survey. The survey does not ask for any identifiable information. The cover letter accompanying the survey could be written in such a manner as to serve as the "implied" informed consent form. The letter would need to contain a statement indicating that completion and return of the survey implies consent to participate in the research.

6. What is a "waiver" of informed consent?

A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided:

• The research involves no more than minimal risk
• The waiver of informed consent will not adversely affect the rights and welfare of the subjects
• It is not practicable to conduct the research without the waiver or alteration
• Whenever appropriate, participants will be provided with additional pertinent information after their participation

Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, or studies of existing pathology specimens, ethnographic research and studies that require deception or passive (opt-out) consent.

PLEASE NOTE: The IRB will take in consideration the risks and potential harms involved in the research and consent process before granting a waiver of informed consent.

7. Are there any sample consent forms or consent form templates available for review?

For sample informed consent forms and/or templates for both 'signed' and 'implied' consent, see http://www.research.psu.edu/orp/areas/humans/samples/index.asp

8. How is the consent process handled for Internet-Based research?

For anonymous Internet-based surveys, it is sometimes appropriate to use implied informed consent. Participants would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.

Other Internet-based surveys include "I agree" or "I do not agree" buttons on the website for participants to click their choice of whether or not they consent to participate.

If, for study design, the researcher needs to keep track of who participated or the IRB determines that some sort of documented consent is required, instead of "signed" informed consent, the researcher may email the consent form to participants who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email. This process may be appropriate for data collected via email, chatrooms, online interviews, etc.

NOTE: Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is in question. A statement indicating the limits to confidentiality is typically required. The following statement may be used: "Confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties."

For additional information on internet based research, see IRB Guideline X -"Guidelines for Computer- and Internet-Based Research Involving Human Participants."

9. What are the basic elements of informed consent?

See http://www.research.psu.edu/orp/areas/humans/samples/index.asp

10. Are there additional informed consent requirements for the use of children and other special populations as participants in research?

For additional information on obtaining consent from parents and assent from minors, see IRB Guideline I - "Parental Consent and Minor Assent."

11. Are there any elements needed in the consent form when the research protocol uses audio- and/or video-taping?

Yes, Pennsylvania state law stipulates that consent must be provided before audio-and/or video-taping is used. If you are planning to use audio- and/ video-taping, please include a section in the consent form for the participant to give permission to be audio- and/or video-taped. Check boxes work well. Information related to the use (who), storage (where), and destruction method and date (when applicable) should also be included in the consent form. If more than one participant is being taped, all involved individuals must agree before the video tape can be used.

For additional information on using audio- and/or video-taping, see IRB Guideline XI - "Research Involving Audio, Video or Digital Recordings of Research Participants."

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