Have a Question You'd Like to Ask?
General Questions about the UCR Office of Research Integrity (ORI)
What are the functions of the Office of Research Integrity?
The Office of Research Integrity provides broad oversight, resources and education for integrity and compliance issues relating to the conduct of research at the University of California, Riverside. More detailed information can be found on our UCR ORI Website.Where is the Office of Research Integrity located?
We are located on the 2nd floor of the University Office Building (between the Fawcett Laboratory building and the University Laboratory building), across the street from Batchelor Hall on Eucalyptus Street (off West Campus Drive).
Who is the Office of Research Integrity staff?
The ORI staff consists of:
Bill Schmechel, the Director of Office of Research Integrity
Monica Wicker, Senior IRB/COIC Analyst
Patricia Steen, Senior IACUC/IBC Analyst
Joanne Hsu, Compliance Analyst
How do I contact the ORI staff?
Email is usually the best way to contact the ORI staff.
For IRB (human subjects) information, please email IRB@UCR.EDU
For IACUC (lab animal) information, please use IACUC@UCR.EDU
For IBC (rDNA and biohazards) information, please use IBC@UCR.EDU
To contact us by phone, please call (951) 827-5535, and for fax, please use (951) 827-4483.
General Questions about the UCR Institutional Review Board
What is the mission of the Institutional Review Board (IRB)?
The research community has a responsibility to ensure that the treatment of human participants in research meets the highest ethical standards. If the proposed research activity involves human participants and may contribute, through publication, presentation, or dissemination to "generalizable knowledge", then the activity requires review and approval by the UCR Institutional Review Board (IRB) before any recruitment or research involving human participants may begin. IRB review and approval is required for all research projects involving human participants, regardless of: 1) whether the project is funded or not, 2) the source of the funds, if funded or 3) the level of risk posed to participants.Who serves on the IRB?
IRB membership varies place to place. The UCR IRB consists of faculty members, student representatives, community members and staff members. These members have varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB is sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB is able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB include persons knowledgeable in the areas of research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, and/or handicapped or mentally disabled persons.
General Questions about the Regulations and Policies
General Questions about the Application Procedures
Do I need to file a human subjects protocol?
It can be very difficult to determine what constitutes human subjects research and when to file a human subjects protocol. 45 CFR 46 offers the following definitions as guidance for determining human subjects research. The definitions are intentionally broad to include a wide range of research in hopes of capturing both the biomedical and humanities spectrums. These definitions are the starting point for anyone attempting to determine whether their research requires IRB review:
§ The first question to ask is if your project involves human subjects. Human Subject is defined as a living individual about whom the investigator conducting research obtains
(a) data through intervention or interaction with the individual or
(b) identifiable private information (45 CFR 46.102(f)).
Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
§ The second question is if your project is actually research as defined by the common rule. Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities meeting this definition constitute research for purposes of this policy, 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)).
If the answer to both questions is ye
What kind of information does the IRB look for on protocols?
The IRBs main concern is the protection of human participants. Therefore, we are concerned about recruitment methods, study procedures as it relates to the participants, confidentiality, the consent procedure, and the benefits of the study to the participants and to generalizable knowledge (risk-benefit ratio). For more information, please see the section “Informed Consent”.
What are the different levels of review?
There are 3 levels of review that an IRB protocol can be approve under: (1) Exempt Review, (2) Expedited Review and (3) Full Committee Review. The categories for the Exempt and Expedited reviews can be found in our Human Subjects Guide, appendices A and B.
Examples of protocols that may require Full Committee Review are studies involving children at risk, deception, research that explores sensitive-natured items, and medical procedures. If you wish, you may email IRB@UR.EDU to obtain clarification of your protocol’s review category.
How long does it take to get my protocol approved?
Approval of most protocols in all research integrity areas takes from 2 to 8 weeks. Some protocols may require additional review time depending on the complexity of the project and the timing of the submission of the protocol to the research integrity office.
Once the IRB receives a new protocol, it takes about 2 weeks to give it a preliminary review and email our questions or comments to the PI. After we receive the PI’s responses to our questions or comments, the IRB staff and chair determines if the protocol is exempt from review, or eligible for expedited review or full review.
§ If the protocol is exempt from review, you should get an approval notice within 2-3 weeks.
§ If the protocol is eligible for expedited review, your protocol is sent to 1-2 designated IRB reviewers, who may have additional questions that must be satisfied before approval. Protocols undergoing expedited reviews therefore take a little longer to obtain approval than exempt protocols.
If the protocol is eligible for review by the full IRB committee, the protocol will be presented at the next IRB committee meeting as long as it meets the submission deadline. The IRB committee may have additional questions that must be satisfied before approval. For the 2007-2008 school year, please see the IRB timeline found on our website at: http://or.ucr.edu/RI/IRB.aspx.
General Questions about the Application Requirements
I have not finalized my interview questions. Do I still need to submit them?
The IRB does need to see the interview questions. However, we recognize that interviews can be very spontaneous and you may think of additional questions on the spot. To accommodate researchers, we will accept a list of the general topics and questions that you want to ask during each interview. These may be questions that you plan to use to begin discussions or to change topics.I’ve begun running my study and found that I would like to revise my protocol (e.g., add or delete interview questions, add subjects, change locations, etc.) Do I need to inform the IRB each time I wish revise my protocol?
Anytime you would like to add something new to the study, whether it is a procedural change or a new question or set of questions, please fill out an Amendment Request form and submit it to the IRB for review. Once it is reviewed and approved, an approval email will be sent to you.I want to conduct my research at an outside organization (school, hospital, company). What does the IRB require?
Before conducting research at an outside organization, researchers must first obtain permission from that organization. The IRB will need to see an access/authorization letter on the organization’s letterhead before approving a protocol.I’ve talked to an outside organization (school, hospital, company), but they will not grant me access until I get IRB approval. Will I be able to conduct my project?
In some cases, the IRB will approve a protocol on a special condition. A special condition would therefore apply to this case, and on your approval notice you will see a statement to this effect: “The project is approved but data cannot be collected until access letters are received by the ORI.”My study involves interacting with people whose primary language is not English. How does that affect my protocol?
All protocols that involve participants who are more comfortable speaking a language other than English must attach a translation of their consent forms, surveys/measures/ interview questions, recruitment materials, and anything else their participants will see or hear. We also require verification that these forms were back-translated (translations from the other language back to English) to ensure consistency.
General Questions about the Informed Consent and its process
Is there a template that will help me construct an informed consent document?
Yes. The Consent Writer program that ensures all the required elements of informed consent are addressed. It can also be used as guidance on what information should be on an informed consent form, and you can use it as a model.
However, you may construct your own consent document using the basic required elements of informed consent which can be found in the Criteria for IRB approval of research (45 CFR 46.111).
The Consent Writer program created a form that is too long and contains too much information irrelevant to my study. Can I edit it to fit my study?
Yes, you may change the format and wording, and take out anything that is not relevant to your study. Please note that UCR IRB does require the contact information for the Office of Research Integrity on all informed consent documentation and verbal scripts.I plan on using a verbal consent script for my study. Do I still need to use the Consent Writer program?
Even if you are using a verbal consent script, the IRB requires a copy of the script for our records.
We recommend that you use the Consent Writer program to verify that your verbal consent script includes all the information that participants deserve to know.
Can I request a waiver of “Informed Consent?”
The federal government and UCR recognize that it is not always for the researcher’s best interest to obtain informed consent. As a result, researchers may obtain a waiver of a waiver of the informed consent process as long as their study meets these conditions:
§ The research involves no more than minimal risk to the subjects;
§ The waiver or alteration will not adversely affect the rights and welfare of the subjects;
§ The research could not practicably be carried out without the waiver or alteration; and
§ Whenever appropriate, the subjects will be provided with additional pertinent information after participation
For the complete explanation, please see section 45 CFR 46.116(d).
Can I request a waiver of ‘Documentation of Consent’?
Yes, an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
§ The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject must still be asked wither the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
§ The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. For the complete explanation, please see section 45 CFR 46.117(c).Are there specific statements that I need to have on my consent form (part 1 of 2)?
Yes, the IRB always looks for statements like these on the consent form (when applicable):
- “You are free to withdraw from the study at any time.”
- You do not have to answer any question you are not comfortable with.”
- If you are videotaping or audiotaping, please give participants the opportunity to decline to be videotaped or audiotaped, yet still remain in the study without any consequences.
- If participants will be videotaped or audiotaped, please inform participants that they can erase the video-/audiotape immediately after completing the study if they wish.
- If you are obtaining assent from children, please let them and their parents know that children do not have to participate or can withdraw at any time even if their parents gave them permission to participate.
- Under Risks, it is more accurate to say “There are no foreseeable risks at this time,” rather than “There are no risks.”
Are there specific statements that I need to have on my consent form (part 2 of 2)?
Yes, the IRB always looks for statements like these on the consent form (when applicable):
- If you have any questions or comments regarding the conduct of this research or your rights as a research subject, please contact the Office of Research Integrity at the University Office Building, #200 or Monica Wicker (951-827-4811 or mwro@ucr.edu), Joanne Hsu (951-827-4861 or joannhsu@ucr.edu) or Bill Schmechel (951-827-4810 or bsro@ucr.edu).
- Your contact information, as well as other researchers and professionals relevant to your study.
- Conflict of Interest statement. This is required. Researchers must inform participants whether or not researchers have a financial conflict of interest in the study. An example of the statement is as follows:
“Investigators must satisfy campus requirements for identifying and managing potential conflicts of interest before a research study can be approved. The purpose of these requirements is to ensure that the design, conduct, and reporting of the research will not be affected by any conflicting interests. If at any time you have specific questions about the financial arrangements or other potential conflicts for this study, please feel free to contact any of the individuals listed above.”
The investigators of this research do not have any financial interest in the study; this means that the investigators will not be financially affected by the results of this study (positive or negative)
What is a “Short Form” consent and when can it be used?
In certain circumstances (e.g., illiterate research subjects, blind research subjects), an IRB may approve an oral consent process (see 45 CFR 46.117(b)(2), and 21 CFR 50.27(b)(2), for FDA regulated research) for documentation of informed consent (http://ohsr.od.nih.gov/irb/Attachments/5-6_Oral_Short_Form.htm). This process requires that the IRB review and approve:
• a written summary of what the PI (or person authorized to obtain consent) will say to the subject or his/her legally authorized representative. The summary must be signed by the person obtaining consent and a witness to the oral presentation, and
• a short written consent form stating that the required elements of consent as required by 45 CFR 46.116 were presented orally to the subject by the PI (or his designate). This short written consent form must be signed by the subject and a witness who observed the presentation of information. In the case of illiterate subjects, "making their mark" is adequate. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
Whenever possible, information in these documents should be provided to the subject or authorized representative in the way that she/he can review and understand (e.g., a tape recording, a Braille document).
General Questions about Oral History
My research involves oral history – is this considered human subjects research?
Please review the following policy:
http://or.ucr.edu/Policies/Policies.aspx If you are not still not sure if your study involving oral history requires IRB approval, please contact the UCR IRB (irb@ucr.edu).
General Questions about Classroom Projects
I am a professor and as part of the course curriculum students will be conducting a research activity involving human participants. What IRB approvals are necessary?
The short answer to this question is no. For more information, please go to the Policy 529-001 located under “Research Integrity” on the Office of Research policies page.
General Questions about Non-UCR Researchers
I’m not a researcher from UCR. Can I still conduct research using UCR facilities and people?
Even if you are not from UCR, you can still conduct research at UCR as long as you have an approved protocol from another institution. In addition, you will need to submit an application for non-UCR researchers.
For more information, please go to the Policy 529-002 located under “Research Integrity” on the Office of Research policies page.
General Questions about Required Education
I need to take the UCR Human Subjects tutorial – where is that located?
The human subjects tutorial can be found at online http://or.ucr.edu/appTutorial/TutorialClient/Login.asp. You will need to register BEFORE completing the tutorial, because taking the tutorial as a "guest" WILL NOT capture the required information in our master database.
For more information, please go to the Policy 529-004 located under “Research Integrity” on the Office of Research policies page.
General Questions about Health Insurance Portability And Accountability Act (HIPAA)
What are the HIPAA requirements?
Information about the Health Insurance Portability and Accountability Act (HIPAA) can be found in the UCR HIPPAA policy.
Anyone conducting research dealing with HIPAA also needs to complete the HIPPA tutorial. You will need to register BEFORE completing the tutorial, because taking the tutorial as a "guest" WILL NOT capture the required information in our master database.
I need to take the UCR HIPAA tutorial – where is that located?
The HIPPAA tutorial can be found at online http://or.ucr.edu/appTutorial/TutorialClient/Login.asp. You will need to register BEFORE completing the tutorial, because taking the tutorial as a "guest" WILL NOT capture the required information in our master database.
General Questions about Unanticipated Problem or Adverse Event
There was an incident of an unanticipated problem or adverse event during my study – what do I do?
Please file an adverse event report and follow the directions given.
Inviting the IRB Staff to Discuss Compliance Issues
I would like to invite the ORI staff to come to my class and talk about compliance issues, is that possible?
Yes, the ORI staff is more than happy to discuss compliance issues with faculty and staff. Please email your request to IRB@UCR.EDU and we will work with you to set up a time.
Still Unsure About Things?
I’m still lost! This FAQ has not answered my questions.
If you have other questions not addressed by this FAQ, or would like additional guidance, please contact us at