Office of Research, UC Riverside
Office of Research Integrity

Frequently Asked Questions

Question


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:

AVC Charles Greer, Director, Office of Research Integrity, (951) 827-3093

Monica Wicker, Principal IRB/COIC Analyst, (951) 827-4811

Patricia Steen, Principal IACUC/IBC Analyst, (951) 827-4809

Lorraine Joy Castro, Senior Compliance Analyst, (951) 827-5549



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

What are the Federal regulations that govern human subjects research?

The Institutional Review Board operates under the “Code of Federal Regulations, Title 45, Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects” (commonly referred to as the 45 CFR 46, or the “Common Rule”).

What are the State of California regulations that govern human subjects research?

Information about the State of California policies can be found on our website.



Where are the UCR IRB compliance policies?

This site is in the process of being populated but in the meantime, all the policies can be viewed at the Office of Research policies page.

Some or all of my research will take place outside of the U.S. Are there any special requirements or procedures for transnational research of which I need to be aware?

You must specifically indicate in your general protocol application that you are conducting some or all of your research transnationally. If applicable, please submit a letter of access from the international institution or agency that may be assisting you with your study. The institution or agency may be a university, government office, community leader, etc. This letter should be written in or translated into English; the original language of the letter (if applicable) and the translation must both be submitted to the HRRB. This letter of access should explain that they understand the purpose and procedures of your research and support your research. It may also need to include language about their respect for participant confidentiality.

If a letter of access cannot be obtained (for example, you are interviewing people who are not affiliated with any institution or agency), a formal letter from an expert on the political climate and/or culture of that country or region will need to be submitted with your application. This letter must describe the writer’s qualifications for writing the letter and indicate that it would be acceptable, according to the culture of the local peoples in that country or region, to conduct the proposed research there. This letter may NOT be written by the PI.

If this will pose a hardship for the PI, the HRRB will provide assistance by finding an expert for the PI. This expert could be affiliated or unaffiliated with UCR. Please note that in such a situation, the review process could be prolonged for at least one (1) week. The HRRB will do its best to ensure that the external review will take place in a timely manner.




General Questions about the Application Procedures

Do I need to file a human subjects protocol?

All human subjects research, and all other activities, which in part involve human subject research, regardless of sponsorship, must be reviewed and approved by the UCR HRRB, or registered exempt by the Office of Research Integrity prior to initiation. This includes all interventions and interactions with human subjects for research, including advertising, recruitment and/or screening of potential subjects. Additionally, use of state death data records must be reviewed and approved by the UCR HRRB prior to initiation. Please review the information below to understand what activities meet the definition of human subjects research.

DEFINATION OF HUMAN SUBJECTS RESEARCH

Human subjects research is any research or clinical investigation that involves human subjects.

Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable.

When considering whether an activity meets the definition of human subjects research per DHHS regulations [45 CFR Part 46] one must consider two federal definitions: research and human subject

Research is as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

"systematic investigation" is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

Examples of systematic investigations include:

  • surveys and questionnaires
  • interviews and focus groups
  • analyses of existing data or biological specimens
  • epidemiological studies
  • evaluations of social or educational programs
  • cognitive and perceptual experiments
  • medical chart review studies

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.) However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication.

Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.

Examples of activities that typically are not generalizable include:

  • biographies
  • oral histories that are designed solely to create a record of specific historical events
  • service or course evaluations, unless they can be generalized to other individuals
  • services, courses, or concepts where it is not the intention to share the results beyond the UCR community
  • classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
  • quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the UCR community.
  •  

human subject is as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

  • Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
  • Interaction includes communication or interpersonal contact between investigator and subject.
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). 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.

Note: Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require HRRB review and approval.

FDA regulations [21 CFR Part 50 and 56] define a clinical investigation as any experiment that involves a test article and one or more human subjects and that either is:

  • subject to requirements for prior submission to the FDA, or
  • not subject to requirements for prior submission to the FDA under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

test article is any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act.

FDA regulations define human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Examples of clinical investigations include:

  • Investigational drug clinical trials
  • Research testing the safety and effectiveness of an investigational device
  • Medical outcomes study comparing approved drugs/devices

Note:

  • Research testing the safety and effectiveness of an In Vitro Diagnostic (IVD) device using human tissue specimens (identifiable or unidentifiable) requires HRRB review per FDA 21 CFR Parts 50 and 56, even though under DHHS regulations research involving unidentified tissue specimens would not be considered human subjects research.
  • The state of California also requires HRRB review of studies using state issued death records (certificates and indices). See the CA Health and Safety Code, Sections 102231-102232 for more information.

EDUCATIONAL ACTIVITIES THAT ARE NOT HUMAN SUBJECTS RESEARCH

Although all human subjects research requires prior institutional approval, not all data gathering by students constitutes human subjects research. To be research, an activity must be designed with the intent to develop or contribute to "generalizeable knowledge." Clearly, some classroom activities are designed to teach research techniques and have no such intent.

Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and

  • the data will not be generalized outside the classroom (reporting of data within the class is acceptable because the activities were performed solely for teaching purposes); and
  • the data will not result in a master's thesis, doctoral dissertation, poster session, abstract, or other publication or presentation; and
  • the student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research.

Exceptions:

Any activity that is a clinical investigation or involves medical intervention or procedures, even when they are a part of a course curriculum, always constitutes human subjects research and requires prior HRRB review and approval.

EDUCATIONAL ACTIVITIES THAT ARE HUMAN SUBJECTS RESEARCH

If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for HRRB review before beginning the study.

There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the HRRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge. For more information, please see the definition of human subjects research.

Examples:

  • An instructor is surprised at some of the unique findings that appeared when students completed surveys as part of a classroom activity. The instructor would like to do additional analysis on the data and submit it for presentation or publication when the course ends. The instructor's intent has changed and an HRRB application is necessary because the instructor will now be analyzing existing data that was collected for a non-research purpose.
  • An undergraduate junior psychology major wishes to conduct research in the hopes of having a publication to list on her application to graduate school. She plans to devise an experiment, enroll subjects, analyze the results and write a manuscript. This is human subjects research. Prior HRRB Review and approval is necessary.




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, Attachments 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 2010-2011 school year, please see the IRB timeline.


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 HRRB 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?

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).



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.



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) 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 the Assenting Minors and that process

I'm using minors in my research, what is the process for obtaining consent from them?

When children are involved in research the Federal regulations require Investigators to have the child’s agreement to take part in the study.  This is known as assent and means that the study has been explained to the child and the child is willing to take part.  This is separate from getting a parent or guardian’s permission for the child to participate.  Generally, IRBs require that the assent of a minor child be sought when the child is seven years of age or older, unless the child’s decision-making capacity is impaired.
For children 7 to 11 years of age, the assent form should be simple enough for the child to understand what he/she is agreeing to do.  In general, it should briefly explain in basic terms:

  • that they are being asked to participate in a research study;
  • the purpose of the study;
  • an estimate of how much time is involved in participating;
  • what will happen to them if they agree to participate (e.g., “answer some questions”);
  • the foreseeable risks and/or discomfort and any benefits they may experience (immediate risks and/or discomfort and benefits, rather than future or theoretical possibilities);
  • that they should ask their parents or researcher any questions they have about participating;
  • that their participation is voluntary (up to them), and that they may stop at any time;
  • that their father/mother/guardian knows they have been asked to be a part of the study.

For children between the ages of 12 and 14, investigators should use their judgment in deciding which of the required elements of informed consent (Basic Elements of a Consent Form) would be most appropriate for their study population. 

For adolescents between the ages of 15 and 17, the assent form should closely follow the consent form used for consenting adult participants. Please see Basic Elements of a Consent Form to guide the development of the adolescent (ages 15 to 17) consent forms.
It is very important that the language be appropriate to the subject’s reading level; if the subject population includes a wide range of ages it may be necessary to use more than one form. 

If appropriate the child should sign the form and a copy should be given to them or their parent/guardian where appropriate. 




General Questions about Posting Posters, Flyers, etc.

I have a poster, flyer, etc. I'd like to post on campus. Are there requirements?

If you plan on posting advertisements, please be aware UCR has Posting Regulations which can be found at: http://fboapps.ucr.edu/policies/index.php?path=viewPolicies.php&policy=700-50.


General Questions about Oral History

My research involves oral history – is this considered human subjects research?

Please review policy 529-007 on Oral History located under “Research Integrity” on the Office of Research policies page, our FAQ page, point #9 and our Standard Operating Procedures, Section 15.5 on Oral History. If you are not still not sure if your study involving oral history requires IRB approval, please contact the UCR IRB (irb@ucr.edu). You may be asked to complete the UCR HRRB Request for Determination of Activity as Research with Human Subjects.


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 online at http://research.ucr.edu/OrApps/RI/Training/Tutorial/.  You will need to register in order to complete the tutorial.

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 HIPAA policy.  

Anyone conducting research dealing with HIPAA also needs to complete the HIPAA tutorial. You will need to register in order to complete the tutorial.



I need to take the UCR HIPAA tutorial – where is that located?

The HIPAA tutorial can be found at online here.  You will need to register in order to complete the tutorial.


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 unanticipated problem 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 Monica Wicker (951-827-4811 or mwro@ucr.edu) or Bill Schmechel (951-827-4810 or bsro@ucr.edu).  We would be happy to help, and if necessary, we can set up an in-person appointment to discuss your protocol and answer questions you may have.




Have a Question You'd Like to Ask?

Is there a question (or questions) you would like to ask?

The UCR ORI and IRB are happy to answer general questions and post them to this site for additional information.  If there is anything you'd like to see asked and answered here, please submit those questions to HRRB1@UCR.EDU.