| OFFICE OF RESEARCH INTEGRITY |
Question: If I'm not really doing research, I'm just talking to people and asking questions...it's not like I'm taking blood or anything...do I have to submit an IRB application?
Answer: YES! If you are collecting information from an individual (whether it is blood or information about how a person feels about 8 am classes) and you plan to disseminate that information outside of the OSU community (e.g., a published thesis; a presentation at a meeting), you are conducting research and your project must be reviewed and approved by the IRB before you begin the project. For more detailed information see the Human Research Handbook section "Projects That Require IRB Review" on the OSU IRB website.
Question: What do I need to do to get IRB approval?
Answer: All staff involved in the research activities will need to complete the required training in the ethical use of human participants in research projects (this includes the Principal Investigator, all students engaged in thesis/dissertation/projects or research involving human participants, staff members involved in data collection, etc.). To document that you have completed the required training, each individual will need to submit a completed Certification of Education form. Then an "Initial Application" must be submitted. Forms are available on the OSU IRB website. Each section of the protocol as outlined in the application instructions must be thoughtfully and thoroughly addressed. The application may be submitted via mail or e-mail attachment (the signature page (page 4) must be submitted via fax or by mail as the PI's signature is required).
Question: What does the IRB look at when conducting a review?
Answer: The IRB weighs the following ethical considerations:
Question: What is the IRB?
Answer: The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with validating the participation of humans in research and protecting their welfare, rights, and privacy. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member from the local community and one member who is not a scientist. The IRB has several Special Advisors who advise the Board and are periodically involved in protocol review.
Question: But the research is not funded?
Answer: Safeguarding the rights and welfare of humans in research is a general institutional policy of OSU. The OSU IRB is charged with responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants.
Question: Can a student be a Principal Investigator?
Answer: No. Only an OSU faculty or staff member can be a Principal Investigator (PI) on an IRB project. The PI is responsible for mentoring the student researcher(s), reviewing all application materials prior to submission to the IRB, and overseeing conduct as listed below (“What are the responsibilities of a Principal Investigator?”). If the faculty or staff member is not willing or able to work in this capacity, the student should find an alternative mentor.
Question: What are the responsibilities of a Principal Investigator?
Answer: In addition to overseeing the conduct of the project, principal investigators must:
Question: Where do I find the "IRB Application Number"?
Answer: The IRB application number is assigned by the IRB. You should leave this area blank when filling out the Initial Application. The IRB application number can be found on all communications/approvals for your project.
Question: What is the difference between the three levels of IRB review (Exempt from Full Board, Expedited, and Full Board)?
Answer: The main difference is the level of risk posed to the participant and the composition of the participant population. Certain categories of research qualify for Exempt from Full Board review. These applications are reviewed and approved by the Human Protections Administrator in the Office of Sponsored Programs and Research Compliance. The specific categories that apply to the Exempt from Full Board review can be found in Attachment A of the Initial Application (available on the OSU IRB website). Allow a minimum of two weeks for the initial review and additional time for required modifications, if required for approval. Exempt from Full Board review does not apply to research involving vulnerable populations (e.g., children, prisoners, pregnancy women) or audio or videotaping.
Expedited reviews do not require a convened meeting of the IRB. A subcommittee of Board members reviews the submitted protocol. The categories allowed for Expedited reviews can be found in Attachment B of the Initial Application (available on the OSU IRB website). Allow a minimum of one month for the initial review and additional time for required modifications, if required for approval. The Expedited review category does not apply to research involving prisoners, fetuses, or pregnant women.
The IRB meets at least once a month to review all protocols that do not fall into the Exempt from Full Board or Expedited categories, or that the Chair determines must receive a Full Board review. A full listing of the deadlines for submission of IRB Applications for review at IRB Full Board meetings is available on the OSU IRB website.
Question: Doesn't "Exempt from Full Board" review mean “excused from review”?
Answer: No. The federal guidelines, which are the minimum required, do not require IRB review for projects that are considered "Exempt," but OSU IRB policy requires full review of all levels of projects that involve human participants, even projects that meet the federal definition of "exempt." "Exempt from Full Board" review level applications go through a review process similar to Expedited or Full Board review level applications. A full application must be submitted for IRB review and approval before any work with human participants begins.
Question: What is "External Funding"?
Answer: Funds that are received (or proposed to be received) from sources outside Oregon State University are considered external funding. An award from the National Science Foundation is an example of external funding. Using your own money to print surveys is not an example of external funding.
Question: What date should I put for the "Project Start Date"?
Answer: Indicate the date that you would like to start recruiting individuals to participate in your project. This date should NOT be before you submit the IRB application or within a week of the submission of the IRB application. You must have IRB approval before you begin recruiting individuals to participate in your project. See the first page of the IRB application for the review timelines for each level of review.
Question: What is the Certification of Education?
Answer: The Certification of Education form is used to document that an individual has completed the required ethics training for working with human participants. See the "IRB Educational Requirement" link on the OSU IRB website for more information.
Question: If I've already submitted the Certification of Education form, do I have to submit it again?
Answer: No. Once the form has been submitted and received by the IRB, you have satisfied the policy and do not have to re-submit the form.
Question: What is "lay language"?
Answer: "Lay language" means using language that everyone can understand. Informed Consent documents are to be written in language that can be understood by a middle school student. Always use easily understood definitions and examples, avoiding technical terms. You can use technical information in your IRB application, but you must explain each term in plain English. Applications submitted using technical terminology without clear explanation of those terms will be returned to the Principal Investigator for revision before the IRB will review the application.
Question: Is there a sample application I can look at?
Answer: No, but there are some common elements that need to be addressed in each IRB application:
Question: Why does the informed consent information have to be on my home department's letterhead?
Answer: It helps participants easily identify that the research team is from OSU.
Question: What are "debriefing materials"?
Answer: For experiments where deception or misrepresentations are involved, the participants must receive an explanation (debriefing) after participation about the nature of the experiment and why such manipulation was critical to its success. This information should be included with the materials submitted for IRB review and approval.
Question: Do I need letters of approval?
Answer: A letter of approval is required for studies taking place in institutionalized locations, like another university or school, a hospital, or a company, or participants are recruited through another site or organization. Studies conducted at OSU do not require a letter of approval. For example, if a survey is to be distributed to a group of employees at a private company, a letter of approval from the leader of the company (or group) should be included with the IRB application. The employees may spend a portion of their work time completing the survey, and the decision maker for the company must be informed and give her or his approval for this activity.
Question: Can I submit the "Initial Application" electronically?
Answer: Yes. However, the fourth page of the Initial Application must be signed by the PI and sent to the Human Protections Administrator via fax or mail to complete the application. This signature page (page four) can be sent by fax (541) 737-3093 or by mail to: Oregon State University, Office of Sponsored Programs and Research Compliance, 312 Kerr Administration Building, Corvallis, OR 97331-2140.
Question: What is a "protocol"?
Answer: The protocol is the section of the application that explains to the IRB what your project is about, what group of people will be involved in your project, how you will conduct your project, etc.
Question: What is "recruitment"?
Answer: When you inform individuals about your study (through posters/fliers, verbal announcements, e-mails, letters, etc.) you are recruiting an individual to be a part of your study. Copies of all recruitment materials must be submitted to the IRB with the application to ensure that appropriate information is shared with these individuals. Include the IRB application number on all recruitment materials (i.e., flyers, emails, advertisements, etc.). It is important that these individuals understand that their participation is completely voluntary and that if they choose to participate, they can withdraw at any time without any consequences. Recruitment may not begin until full approval for the protocol has been granted by the IRB.
Question: I'm planning to audio/video tape my interviews; do I need include any special information?
Answer: You'll need to be sure to indicate that it is the participant's choice to be audio or videotaped and explain what alternate recording methods (e.g., handwritten notes) will be used if the individual doesn't want to be audio or videotaped. You'll also need to explain how a participant will be identified on the tape (by name or by code name), who will have access to the tapes, who will listen or view the tapes, how the tapes will be stored, who will transcribe the tapes, and when the tapes will be erased or destroyed. This information should appear in both the protocol and in the informed consent document. Protocols that include audio or videotaping cannot be reviewed at the Exempt from Full Board level.
Question: I'm planning to conduct my project in another country. Are there any special considerations I need to be aware of?
Answer: YES! In your application, you will need to describe the norms and values of the culture you will be conducting your research in (e.g., describe such things as the community structure, the education level of the participant population, common beliefs, social norms.) This must be well researched before your application is submitted. In addition, you will need to obtain appropriate local permissions from the country where you will be performing your research (e.g., from the local government, local IRB [or equivalent], and organizational permission [such as from a school or hospital]). You will need to provide documentation of the local ethics committee or government approval. If that is not possible, you must submit an explanation from a local source or contact about why this approval cannot be obtained. Additional guidance is available on the OSU IRB website under the International Research link.
Question: What is "minimal risk"?
Answer: The federal guidelines define minimal risk as "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (45 CFR 46.102(i)). Minimal risk indicates that risks are designated as minor impositions on the participant. The IRB considers both the magnitude and likelihood of risk. For example, driving or being a passenger in a car carries a risk of injury or death, but it occurs relatively infrequently for most drivers and passengers. Significant risks include all risks that are of greater consequence. Any study involving significant risk must be reviewed at the Full Board level.
Question: Are projects involving oral histories subject to review by the IRB?
Answer: Yes. Oral History describes a technique whereby a researcher conducts taped interviews with participants in regard to particular historical events or periods. Often, the researcher may desire to make the tapes available to the public at a specified future time in order to provide historical insight. Oral histories may convey a historical recollection of the character of a society of an institution rather that the participant's subjective perceptions. Audio or videotaped oral histories are eligible for the Expedited or Full Board level of review, depending on the nature of the project. In particular, the IRB will review whether the conditions of use or publication of the taping/recording are clearly understood by the participant, and whether adequate means have been provided for the protection of the privacy of any third parties who may be named in the taping/recording.
Question: What happens to my project after it has been submitted to the IRB?
Answer: Once the IRB has reviewed the application, a Report of Review, which details any requested clarifications, questions, or concerns the IRB has concerning your application, will be sent to the PI. It is the PI's responsibility to ensure that a revised application or information is submitted within two months of receiving the IRB's Report of Review. If the revisions haven't been received by that two-month date, the IRB application will be withdrawn and the process must begin again.
Question: How long does it take to get IRB approval?
Answer: Almost all IRB applications require modifications. The initial review time for each level of review is noted on the first page of the "Initial Application" (available on the OSU IRB website). Once the Report of Review has been sent to the PI, it depends upon how quickly the PI (and student researcher) responds. Once the revised application has been received by the IRB, if no further modifications are requested, the approval generally follows within a few days.
Question: How do I submit my modified application?
Answer: You can submit the modified protocol or attachments of your application by e-mail attachment or mail. Do not resubmit the "Initial Application" forms unless specifically requested.
Question: How will I know when my project has been approved by the IRB?
Answer: A signed approval letter and the IRB date-stamped informed consent document(s) will be sent by campus or US mail.
Question: What do I do with the IRB date-stamped consent information?
Answer: Once you receive the original date-stamped consent document(s), you must make photocopies of the original to distribute to the participants in your study. There are few exceptions to this policy, typically these exceptions are for studies that involve sending the approved consent information electronically (by email or website posting).
Question: Why does the IRB date-stamp informed consent documents?
Answer: IRB approval for a project is valid for one year only. The date-stamped consent document shows the approval period during which the document is valid. Each year a Continuing Review form must be submitted, and a copy of both the currently approved informed consent document (with the date-stamp) and a copy without the date-stamp are requested. Once the project has received approval to continue for another year, the new consent documents will be given a date-stamp with a new approval period. The consent documents with the new date stamp should be given to all new participants recruited and enrolled during the new approval period.
Question: What do I do with the signed informed consent documents?
Answer: Keep them in a secure location for however long was approved in the protocol; the clock starts after you have finished your research project. Make sure you give a copy to each participant; this is a federal requirement. Once the retention period has passed, the documents must be destroyed; do not just throw them away.
Question: Can I make changes to the project after it has been approved?
Answer: If you find that you need to make changes to your approved application (including changes in research personnel, number of participants to be recruited, methods and procedures, informed consent form), submit the Project Revision form (available on the OSU IRB website). Project Revision requests must be submitted for review and approval before any changes are implemented.
Question: How do I close a study?
Answer: When ALL research activities by the investigators are complete, including data analysis, then the project no longer requires continuing review by the IRB. To close a project, a Final Report (available on the OSU IRB website) must be submitted to the IRB for review.
Question: The site where I intend to conduct my research has its own IRB. Does my application have to be reviewed by their IRB as well as the OSU IRB? If so, how do I do this?
Answer: OSU IRB policy requires that a full application be submitted to the OSU IRB (using the OSU IRB forms and format). Once the application has been received and preliminarily reviewed, it is at the discretion of the OSU IRB whether the review and approval of the project will be deferred to the other institution's IRB, or whether an OSU IRB review will be required in addition to the other institution's IRB review. Each situation is considered individually. If you have questions, contact the Human Protections Administrator for advice. For College of Pharmacy faculty housed at Oregon Health and Science University (OHSU), there is a special review policy arranged with OHSU's IRBs. See the policy on the OSU IRB website.
Question: What happens if I've already started or finished my research and I didn't know I was suppose to go through the IRB process? Can I still use my data?
Answer: That question should be directed to the Human Protections Administrator at IRB@oregonstate.edu.
Question: Now that I have IRB approval, what do I do?
Answer: Make sure you conduct your research as you've explained it to the IRB. If you find that you need to make any changes, submit a Project Revision form before implementing the changes.
Question: What documents do I have to keep?
Answer: You need to keep a copy of all IRB correspondence, all versions of the approved applications (including Project Revision requests), and approval letters. Signed informed consent documents should be kept in a file separate from the data collection files. Keep documents in a secure location for however long was approved in the protocol; the clock starts after you have finished your research project.
Consent and assent documents should use clear, easy to understand language. Write consent forms at an eighth-grade level and assent forms for the appropriate age group. Information must be presented in a logical format that is easy for participants to read through (e.g., if your project involves using elderly participants, using a large font is appropriate). There are some words frequently used by researchers that may not be easily understood by participants. Check the following list and replace any unfamiliar words with the more familiar synonym. Informed Consent and Assent document templates can be found on the OSU IRB website; the templates include standard language for use in documents.
Translation of Unfamiliar Terminology into Lay Friendly Terms:
| Unfamiliar Words | Familiar Words |
| abstain | avoid, stay away from |
| aggregate | group together |
| alternative | choice |
| assist | help |
| baseline | initial, starting point |
| catheter | tube |
| chronic | long-term |
| confidential | keep private |
| consent | agree |
| discontinue | stop |
| induce | cause |
| new indication | new use |
| randomly | by chance, like tossing a coin |
| sensation | feeling |
| uncommonly | rarely |
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