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What is IRB?
IRB is the acronym for Institutional Review Board for Human Participants. Any institution that receives federal funding to conduct research with human participants, such as Concordia University, is required to establish an IRB to review all research that directly or indirectly involves human participants, and to set forth institutional policy governing such research. Concordia University IRB operates under a charge.
The IRB for Human Participants has the authority to review, approve, disapprove or require changes in research or related activities involving human participants. Research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at Concordia University. However, those officials may not approve research that has not been approved by the IRB for Human Participants. The IRB primary role is to ensure the protection of human participants as subjects of research at Concordia University.
How do I know if I am conducting research with human participants?
According to Concordia University Policy, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Activities which meet this definition constitute research for 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.
Human Subjects are defined as a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention includes both physical procedures by which information or biospecimens 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.
Identifiable private information is private information must be individually identifiable for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information
When am I required to submit a proposal regarding research with human participants to the IRB?
All research projects that will involve human participants must be submitted for review and approval before beginning the study. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.
I am just doing a simple survey; do I need to submit my proposal to the IRB?
Yes, if the study meets the definition for research with human participants, as explained above. Concordia University’s Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.
I am not collecting any identifying information in my research project. Do I need to submit my proposal to the IRB for review?
Yes, if your research project involves active data collection. Federal regulations and Concordia University policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review.
Do research projects conducted by Concordia, St. Paul students need IRB approval?
Yes. Projects conducted by Concordia undergraduate and graduate students need IRB approval, if the project fits the definitions of “research” and “human participants” as described above. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.
If my research qualifies as exempt, does this mean that I don’t have to submit a protocol for review?
No. The Federal Regulations do make certain categories of research exempt from IRB review. However, Concordia University policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff.
I will be collaborating with another institution; do I need to submit to Concordia’s IRB and the other institution?
If you are a member of the Concordia University faculty or staff, or a Concordia University student, and you are the person responsible for the conduct of the study (PI), you must get Concordia IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.
My research will be done in another country. Do I have to obtain IRB review and approval from Concordia?
Yes. If you are a member of the Concordia University faculty or staff, or a Concordia University student, and you are the person responsible for the conduct of the study (PI), you must get Concordia IRB approval to conduct your research regardless of where the research takes place.
I want to conduct a study that involves the use of deception. Is this allowed? What do I need to consider?
The use of deception in research is not prohibited by either the federal regulations or Concordia. However, because at some level the use of deception in research violates the trust that the participant puts in the researcher, this method should be considered carefully. Deliberate deception of participants may occur only in situations where withholding information about the nature of the study is necessary to ensure valid results, and never to get participants to do something that they would not do if the information was fully disclosed to them.
Researchers should describe for the IRB the method, rationale and the process of informing participants of the purpose of the research as early as is feasible – preferably at the conclusion of an individual’s participation (but no later than at the conclusion of data collection) to permit participants to withdraw their data. Additionally, researchers should provide a justification for the deception techniques and document that there are no equally effective non-deceptive techniques available.
I am planning to do an oral history project; do I need to submit my proposal to the IRB?
Some research involving the collection and use of oral histories or life histories meets the federal definition of ‘human subjects research’ and requires an application to the IRB office, while other research using the same methods does not. The IRB Chair can be consulted to help determine the appropriate process.
I am developing case studies; do I need to submit my proposal to the IRB?
Studies that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, meets the federal definition of ‘human subjects research’ and requires review by the IRB office. Other case studies may not require IRB review.
Does journalism require IRB review?
The reporting of current events, trends, newsworthy issues or stories about people or events generally does not meet the federal definition of ‘human subjects research’ and therefore requires no application to the IRB office. However, reporting intended to draw conclusions may require review by the IRB.
When may I begin data collection for my study?
You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRB approval.
How long will it take for me to obtain approval to do my study?
That depends on the nature of your study and the characteristics of the people you intend to recruit. Research projects that involve only minimal risks are eligible for expedited review, for which you should allow at least 4 weeks for IRB review.
Research projects that involve greater than minimal risk to participants will need to go to the full board for review. For applications requiring full board review, you should allow at least 4-6 weeks for review and approval of your study.
How long do I need to keep my research data/records?
Compliance with 45 CFR 46.115(b) requires that all records relating to IRB approved research be retained for a minimum 3 years after closure of the project. Records may be preserved in hard-copy, electronic or other media form, and must be accessible for audit purposes.
Can the IRB approve a project “retro-actively”?
No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.
Can incentives be used with participants in a research study?
Payment or incentive based procedures may be provided to subjects. However, all human subjects research projects that offer compensation for participation must comply with Concordia University Business Services procedures and policies as well as Institutional Review Board (IRB) review and approval to ensure the compensation amount does not exert undue influence on a subject’s decision to participate. The nature, amount, and method of payment or other remuneration should not constitute excessive enticement to participate (i.e., the payment should not serve as sufficient inducement for the subject to volunteer). The IRB will consider the impact participation poses on the daily life of the potential subject. For example, the IRB will consider compensation of subjects for inconvenience posed by the research, such as: the time required to participate; travel involved and/or parking costs; lost time from work, and babysitters, etc. Investigators should include provisions in the protocol for addressing these concerns, especially for research that poses little or no direct benefit for the subjects.
In some instances it is acceptable for the researcher to recruit students as long as they will have no knowledge of who decided to participate. The purpose of this measure is to remove the teacher as much as possible from the participants without compromising the data collection. If students will be offered extra credit as compensation for participation in a study, an alternative extra credit option must also be available if study participation is declined.
The Application Process:
I don’t know where to start to write a protocol. What needs to be included?
Every new protocol submitted to the IRB must include completed and signed forms for the correct submission type (available on the IRB Forms page).
What does the IRB look for in an application? Are there standard criteria for evaluation?
The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html). Basically, this means the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.
Considered another way, investigators could look at their plans from the point of view of a subject, or an observer concerned about responsible research. Who are the subjects and how are they recruited? Could they be lured or coerced to participate? Is it through an institution that may have responsibilities toward them (e.g., a school or hospital) and should be consulted? Do they understand, in advance, what they are agreeing to participate in and give their consent willingly? What will they actually do, and what is done to them, during the study? Is it possible that the experience might be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful? Might there be long-term consequences? Could the subject be endangered, compromised or embarrassed if information collected leaked out? There are many possible considerations, but they should not be difficult to understand if one assumes the subject’s perspective. The IRB’s role is to look at the study from this perspective and to ensure that proper precautions are taken to protect individuals when they agree to participate in research.