Research Exemptions from IRB Review – “Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
Exempt projects are not subject to continuing review Amendments are required only if changes to the project could alter the exempt determination An exempt determination does not lessen the investigator’s ethical obligations, including the completion of human subjects protections training (NIH or CITI) Review the Common Rule on exempt research: 45 CFR 46.104
What type of IRB review do I need?
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.
Does all research require IRB approval?
Research Requiring IRB Review – The IRB must review and approve all research involving live humans before any such research activities may begin. Research involving human subjects must receive IRB approval in accordance with federal regulations set forth by the U.S. Department of Health and Human Services (HHS) (known as the “Common Rule”) and the U.S. Food and Drug Administration (FDA). A project may be subject to one or both sets of regulations depending on whether the project meets the definition for Human Subjects Research (HHS) and/or Clinical Investigation (FDA).
Although publication is often viewed as evidence of research status, it is not the only criterion. In fact, “systematic investigations” often result in published information, yet they do not qualify as research because they were not designed to contribute to generalizable knowledge.
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, as well as information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. a medical record). Identifiable information means that the identity of the subject is, or may be readily ascertained (directly or indirectly) by the investigator (or others) or associated with the information.
Is IRB Approval Required?
What is an example of an exempt IRB review?
What does the term “exempt” actually mean in human subjects research? Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.
- Does the project meet the definition of “research”?
- Does the project meet the definition of a “human subject”, such as involving collecting data about living individuals, either through interaction or intervention, or use of identifiable private information or identifiable biospecimens?
If you can say “yes” to both these questions, then your project is considered human subjects research requiring IRB review. The next step is to submit an ORahs protocol application and determine whether your project could be exempt:
Could my project fall into one of the exemption categories of research?
Below is a quick user reference guide for the exempt categories of research that the UC Santa Barbara Human Subjects Committee reviews:
|| This category does not apply to interviews or surveys with minors. This category only applies to observation of public behavior involving children if the study team does not participate in the activities being observed. Observations must be of public behavior in a public setting (i.e., park, intersection, parking lot, lobby, etc.)
b) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (45 CFR 46 104 (d)(6))
What does the term “exempt” actually mean in human subjects research?
Does evaluation require IRB review?
Research studies involving human subjects require IRB review. Evaluative studies and activities do not. It is not always easy to distinguish between these two types of projects and projects frequently have elements of both. Therefore, the decision about whether review is required should be made in concert with the IRB.
If you think that your project is limited to evaluative activities and therefore not subject to IRB oversight, please contact the IRB office at 6-8802 to discuss. The regulatory definition of research is defined as: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Evaluative studies are defined as: Systematic collection of information about the activities, characteristics and outcomes of programs to make judgments about the program (or processes, products, systems, organizations, personnel, or policies), improve effectiveness, and/or inform decisions about future program development.
|Determines merit, worth, or value||Strives to be value-free|
|Assessment of how well a process, product, or program is working||Aims to produce new knowledge within a field (designed to develop or contribute)|
|Focus on process, product, or program||Focus on population (human subjects)|
|Designed to improve a process, product, or program and may include: -needs assessment -process, outcome, or impact evaluation -cost-benefit or cost-effectiveness analyses||May be descriptive, relational, or causal|
|Designed to assess effectiveness or a process, product, or program||Designed to be generalized to a population beyond those participating in the study or contribute broadly to knowledge or theory in a field of study (designed to develop or contribute to generalizable knowledge)|
|Assessment of program or product as it would exist regardless of the evaluation||May include an experimental or non-standard intervention|
|Rarely subject to peer review||Frequently submitted for peer review|
|Activity will rarely alter the timing or frequency of standard procedures||Standard procedures or normal activities may be altered by an experimental intervention|
|Frequently, the entity in which the activity is taking place will also be the funding source||May have external funding|
|Conducted within a setting of changing actors, priorities, resources, and timelines||Controlled setting (interaction or intervention) or natural setting (observation which may or may not include interaction or intervention)|
Informed by: Coffman, J. (2003). Ask the Expert: Michael Scriven on the Differences Between Evaluation and Social Science Research. The Evaluation Exchange, 9(4). Retrieved January 8, 2012 from http://www.hfrp.org/evaluation/the-evaluation-exchange/issue-archive/reflecting-on-the-past-and-future-of-evaluation/michael-scriven-on-the-differences-between-evaluation-and-social-science-research National Center for Justice Planning.
(2012) Research and Evaluation Overview. Retrieved on November 28, 2012 from http://www.ncjp.org National Institutes of Health (2012). Evaluation Basics. Retrieved on November 28, 2012 from http://www.nigms.nih.gov/Research/Evaluation/ Oklahoma State University Institutional Review Board. IRB Toolbox. Program Evaluation: When is it Research? Retrieved on November 28, 2012 from https://compliance.vpr.okstate.edu/irb/irb-toolbox.aspx Patton, M.Q.
(1997). Utilization focused evaluation: The new century text. Thousand Oaks, CA: Sage. Scriven, M. (1991). Evaluation thesaurus (4th ed.). Newbury Park, CA: Sage.U.S. Government Accountability Office. (2005). Performance Measurement and Evaluation. Retrieved January 8, 2012 from http://www.gao.gov/special.pubs/gg98026.pdf Source material for this policy guidance was provided by Oregon State University.
How do I choose an IRB?
Who Serves on an IRB? – An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific.
Why is IRB review required?
III. IRB Procedures – 18. The FDA regulations exempt an emergency use of a test article from prospective IRB review, however, “. any subsequent use of the test article at the institution is subject to IRB review.” What does the phrase “subsequent use” mean? FDA regulations allow for one emergency use of a test article in an institution without prospective IRB review, provided that such emergency use is reported to the IRB within five working days after such use.
- An emergency use is defined as a single use (or single course of treatment, e.g., multiple doses of antibiotic) with one subject.
- Subsequent use” would be a second use with that subject or the use with another subject.
- In its review of the emergency use, if it is anticipated that the test article may be used again, the IRB should request a protocol and consent document(s) be developed so that an approved protocol would be in place when the next need arises.
In spite of the best efforts of the clinical investigator and the IRB, a situation may occur where a second emergency use needs to be considered. FDA believes it is inappropriate to deny emergency treatment to an individual when the only obstacle is lack of time for the IRB to convene, review the use and give approval.19.
- Are there any regulations that require clinical investigators to report to the IRB when a study has been completed? IRBs are required to function under written procedures.
- One of these procedural requirements requires ensuring “prompt reporting to the IRB of changes in a research activity.” The completion of the study is a change in activity and should be reported to the IRB.
Although subjects will no longer be “at risk” under the study, a final report/notice to the IRB allows it to close its files as well as providing information that may be used by the IRB in the evaluation and approval of related studies.20. What is expedited review? Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB.
The Agency’s IRB regulations permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk. A list of categories was last published in the Federal Register on January 27, 1981, The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval.
Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval.
- Research may only be disapproved following review by the full committee.
- The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review.21.
- The number of studies we review has increased, and the size of the package of review materials we send to IRB members is becoming formidable.
Must we send the full package to all IRB members? The IRB system was designed to foster open discussion and debate at convened meetings of the full IRB membership. While it is preferable for every IRB member to have personal copies of all study materials, each member must be provided with sufficient information to be able to actively and constructively participate.
- Some institutions have developed a “primary reviewer” system to promote a thorough review.
- Under this system, studies are assigned to one or more IRB members for a full review of all materials.
- Then, at the convened IRB meeting the study is presented by the primary reviewer(s) and, after discussion by IRB members, a vote for an action is taken.
The “primary reviewer” procedure is acceptable to the FDA if each member receives, at a minimum; a copy of consent documents and a summary of the protocol in sufficient detail to determine the appropriateness of the study-specific statements in the consent documents.
In addition, the complete documentation should be available to all members for their review, both before and at the meeting. The materials for review should be received by the membership sufficiently in advance of the meeting to allow for adequate review of the materials. Some IRBs are also exploring the use of electronic submissions and computer access for IRB members.
Whatever system the IRB develops and uses, it must ensure that each study receives an adequate review and that the rights and welfare of the subjects are protected.22. Are sponsors allowed access to IRB written procedures, minutes and membership rosters? The FDA regulations do not require public or sponsor access to IRB records.
- However, FDA does not prohibit the sponsor from requesting IRB records.
- The IRB and the institution may establish a policy on whether minutes or a pertinent portion of the minutes are provided to sponsors.
- Because of variability, each IRB also needs to be aware of State and local laws regarding access to IRB records.23.
Must an investigator’s brochure be included in the documentation when an IRB reviews an investigational drug study? For studies conducted under an investigational new drug application, an investigator’s brochure is usually required by FDA, Even though 21 CFR part 56 does not mention the investigator’s brochure by name, much of the information contained in such brochures is clearly required to be reviewed by the IRB.
- The regulations do outline the criteria for IRB approval of research.21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized.21 CFR 56.111(a)(2) requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits.
- The risks cannot be adequately evaluated without review of the results of previous animal and human studies, which are summarized in the investigator’s brochure.
There is no specific regulatory requirement that the Investigator’s Brochure be submitted to the IRB. There are regulatory requirements for submission of information which normally is included in the Investigator’s Brochure. It is common that the Investigator’s Brochure is submitted to the IRB, and the IRB may establish written procedures which require its submission.
Investigator’s Brochures may be part of the investigational plan that the IRB reviews when reviewing medical device studies.24. To what extent is the IRB expected to actively audit and monitor the performance of the investigator with respect to human subject protection issues? FDA does not expect IRBs to routinely observe consent interviews, observe the conduct of the study or review study records.
However, 21 CFR 56.109(f) gives the IRB the authority to observe, or have a third party observe, the consent process and the research. When and if the IRB is concerned about the conduct of the study or the process for obtaining consent, the IRB may consider whether, as part of providing adequate oversight of the study, an active audit is warranted.25.
How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection? The Division of Scientific Investigations, Center for Drug Evaluation and Research, maintains an inventory of the IRBs that have been inspected, including dates of inspection and classification. The Division recently began including the results of inspections assigned by the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health.
This information is available through Freedom of Information Act (FOIA) procedures. Once an investigational file has been closed, the correspondence between FDA and the IRB and the narrative inspectional report are also available under FOI.26. If an IRB disapproves a study submitted to it, and it is subsequently sent to another IRB for review, should the second IRB be told of the disapproval? Yes.
When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution, If the study is submitted to a second IRB, a copy of this written statement should be included with the study documentation so that it can make an informed decision about the study.21 CFR 56.109(a) requires an IRB to “.
review, all research activities,” The FDA regulations do not prohibit submission of a study to another IRB following disapproval. However, all pertinent information about the study should be provided to the second IRB.27. May an independent IRB review a study to be conducted in an institution with an IRB? Generally, no.
- Most institutional IRB have jurisdiction over all studies conducted within that institution.
- An independent IRB may become the IRB of record for such studies only upon written agreement with the administration of the institution or the in-house IRB.28.
- Could an IRB lose its quorum when members with a conflict of interest leave the room for deliberation and voting on a study? Yes.
“The quorum is the count of the number of members present. If the number present falls below a majority, the quorum fails. The regulations only require that a member who is conflicted not participate in the deliberations and voting on a study on which he or she is conflicted.
The IRB may decide whether an individual should remain in the room.” 29. Does FDA expect the IRB chair to sign the approval letters? FDA does not specify the procedure that IRBs must use regarding signature of the IRB approval letter. The written operating procedures for the IRB should outline the procedure that is followed.30.
Does FDA prohibit direct communication between sponsors and IRBs? It is important that a formal line of communication be established between the clinical investigator and the IRB. Clinical investigators should report adverse events directly to the responsible IRB, and should send progress reports directly to that IRB.
- However, FDA does not prohibit direct communication between the sponsor and the IRB, and recognizes that doing so could result in more efficient resolution of some problems.
- FDA does require direct communication between the sponsors and the IRBs for certain studies of medical devices and when the 21 CFR 50.24 informed consent waiver has been invoked.
Sponsors and IRBs are required to communicate directly for medical device studies under 21 CFR 812.2, 812.66 and 812.150(b). For informed consent waiver studies, direct communication between sponsors and IRBs is required under 21 CFR 50.24(e), 56.109(e), 56.109(g), 312.54(b), 312.130(d), 812.38(b)(4) and 812.47(b).
Can you do research without IRB?
Abstract – Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies.
Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abide by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures.
Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research.
What is the difference between exempt and expedited IRB review?
Projects not eligible for an exempt review may be eligible for an expedited review. Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk.
Do limited data sets require IRB approval?
A Limited Data Set is information disclosed by a covered entity to a researcher who has no relationship with the individual whose information is being disclosed. WHF IRB must review and approve requests for the use or disclosure of Limited Data Sets for the purpose of research.
What is minimal risk IRB approval?
The Level of Review and Minimal Risk – If your study needs IRB review, the next step is to identify the level of review required – full committee review, expedited review or exempt certification, The level of review reflects the level of risk to the subject.
The risk level is compared to “minimal risk” as defined by the federal regulations: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).
Greater than minimal risk studies require full committee review, while minimal risk studies may be eligible for expedited review or exempt certification, Call the IRB Analyst of the Day at 415-476-1814 if you are unsure about which level of review is needed.
Are surveys exempt from IRB review?
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human subjects recruited to participate in a research study conducted under the auspices of the institution with which it is affiliated. The role of the IRB is to ensure the protection of human participants in a research study.
- Any institution that receives federal funding to conduct research with human participants is required to establish an IRB and to review and approve studies prior to collection of research data.
- The Cornell IRB operates under a Federalwide Assurance (FWA 0000 4513) through the U.S.
- Department of Health and Human Services, see charge,
Although the question may seem straightforward, not all interactions with human beings or data collected from humans are considered research under IRB rules. If your project is not considered research, you do not need to submit an application to the IRB office.
Research under IRB regulations (as specified under the ‘Common Rule’ issued by the Office of Human Research Protections, U.S. Dept. of Health and Human Services) and Cornell policy is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human participant is defined as a living (not deceased) individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or obtains (2) identifiable private information about that individual. Generalizable knowledge refers to information that expands the knowledge base of a scientific discipline or other scholarly field of study and can be expressed in theories, principles, or statements of relationships that can be generally applied to our experiences. Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program. The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc. An intervention can include physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or subject’s environment for research purposes. Interaction includes communication or interpersonal contact between the researcher 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 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.
Not all interactions with human beings or data collected from humans are considered research under IRB rules. If your project is not considered research, you do not need to submit an application to the IRB office. If your project is considered research under IRB rules, you must submit an application to the IRB office via RASS-IRB and receive approval (or an exemption determination) before research can begin.
Applications must be submitted to the IRB office for review and approval before data collection begins. This includes proposed research involving existing secondary data and previously collected human fluid and tissue samples. See Policy 1, Yes, if the study meets the definition for research with human participants, as explained above.
Cornell 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.
- Yes, if your research project involves active data collection.
- IRB regulations 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 study.
- If your research involves the use of existing data collected from human participants (e.g., secondary datasets, existing biological samples), but there are no identifiers linking human participants to the data/samples themselves, then the activity may not require IRB review and may be considered “not human participant research”.
Please see the IRB’s Decision Tree or contact the IRB staff for further guidance. Yes, studies conducted by Cornell 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. Yes, researchers can be subjects in their own studies. However, Cornell policy regards this type of research (investigator self-experimentation) as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects.
Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised.
Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers. Program Development approval is an administrative approval granted by IRB staff so that the Principal Investigator can develop research design methods and materials.
This type of approval is often used for the purpose of releasing funds. It is also useful if the actual human interaction portion of the research is expected to occur at a later date, but the researcher needs to provide proof to the sponsor that the project scope and intent has been approved by the local IRB.
Important Note: Under this type of administrative approval no human participants may be involved in any activities defined as research until the entire project, including data collection procedures and study instruments, recruitment materials and informed consent documents have been reviewed and approved by the IRB.
That is, once the project and study instruments are developed and finalized, please amend your protocol in RASS-IRB to include all relevant study details and study instruments, and the IRB will conduct a complete review and approval. Contact IRB staff with questions regarding whether a Program Development approval can be an option for your research project.
Studies that meet the definition of regulated research under the Common Rule may fit within one or more categories of “exempt” research. This does not mean that such studies do not need IRB review. In order for a research study to be deemed “exempt”, investigators will need to submit an application to the IRB office, along with study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.).
Please note that this determination of exemption must be made by IRB staff. See Policy #2, Typically, Cornell researchers must receive Cornell IRB approval to conduct research with human participants, regardless of where the research takes place. When collaborative projects are expected to involve researchers from multiple institutions, contact the IRB office to determine next steps.
While, in some cases, each investigator should work with their own institution’s IRB, in other cases it might be desirable (or required by a funder) to arrange an IRB authorization agreement (IAA) to designate one IRB to review and approve the research as a whole.
Yes, Cornell PIs must receive Cornell IRB approval to conduct research with human participants, regardless of where the research takes place. You should also be aware that your project may need local IRB approval (or the equivalent ethical review), in addition to Cornell’s. Please see SOP #14 for more information about requirements for international human participant research.
The use of deception in research is not prohibited by either the federal regulations or Cornell. 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 through a “debriefing” process (but no later than at the conclusion of data collection) to permit participants to withdraw their data, if they choose to do so.
Webinar: What You Should Know About IRB Review of Research
Additionally, researchers should provide a justification for the deception techniques and document that there are no equally effective non-deceptive techniques available. Please refer to the American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct for further guidance.
Pilot studies may not meet the regulatory definition of research in need of IRB review. If all of the following statements are true, then no IRB review or approval is needed for your pilot: 1. The sole intent of this pilot study is to determine the feasibility of a larger study. It is exploratory in nature, helping refine data collection procedures and instruments or preparing a better research design.2.
There is no intent to publish or disseminate the pilot study outcomes as research data.3. The pilot study will be conducted on a small scale (~10 or fewer participants). Such a pilot study would not contribute to generalizable knowledge and therefore is not considered research.
IRB review is not required. Data collection from the pilot cannot be used as research data. Investigators should still take proper care in protecting human participants (e.g., informed consent process, adequate data security procedures, etc.). Note : If your pilot study will involve vulnerable populations or more than minimal risk research procedures, you must consult with the IRB office prior to data collection.
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. That depends on the nature of your study and the characteristics of the people you intend to recruit.
- Research projects may be eligible for an exemption, for which you should allow at least 1 week for IRB review.
- Research projects that involve only minimal risks may be eligible for expedited review, for which you should allow at least 3 weeks for IRB review.
- Projects that involve greater than minimal risk to participants will need to go to the convened full board committee for review, which is scheduled for the first Friday of every month.
For applications requiring full board review, you should allow at least 4-6 weeks for review and approval of your study. No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data were 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.
Every new protocol application must be submitted through RASS-IRB, which uses a smart form that will lead you through the necessary steps of the application process. You can also learn more about the IRB protocol submission process and what information is needed on our website, Feel free to contact the IRB office for assistance.
Unfortunately, not at this time. The IRB staff is available to answer questions about the IRB review process and to assist investigators in the preparation of protocols. On the IRB website there are several IRB policies that can guide the researcher in determining IRB requirements in approving a protocol.
- The IRB also encourages researchers to consult with colleagues and/or faculty advisors who have done research at Cornell in for advice in preparing research protocols.
- The IRB evaluates every research protocol according to the ethical principles described in the ( Belmont Report ).
- 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. Fully informing participants of the risks, benefits, and procedures involved in a study is a standard requirement in 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.
Signed informed consent is the standard expectation in research with human participants. This is in the form of a document with the elements of informed consent, signed and dated by the participant and kept as a record by the researcher. In research with children (individuals under 18 years old), assent of the child and parental permission are standard requirements. Please refer to SOP #11, In some circumstances, investigators can seek alternatives to standard informed consent procedures, such as:
A waiver of using a signed consent form (e.g., giving participants an information sheet but not collecting signatures) A waiver of written consent (e.g., using oral consent procedures) A waiver of some or all of the elements of informed consent (e.g., in research that involves deception)
It is not uncommon for a research project to involve one or more of the above scenarios. For a complete list of the options for informed consent procedures, and the requirements for approval, please refer to SOP #10, Both consent and assent involve informing potential participants about the research and its risks and benefits, and documenting their understanding and agreement to participate.
- The reason the different terms are used has to do with the age of the participants.
- In research involving adults, “consent” is obtained from individuals to participate in the study.
- In research involving minors, a parent must give permission to allow the child to participate in the research, and children who are able to understand information about participation are asked to “assent” or agree to participate as well.
The Cornell IRB is responsible for ensuring that basic ethical principles are abided by in all research. The expectation that the informed consent of research participants be obtained is based upon the Belmont principle of respect for persons, and regarded as extremely important in conducting ethical research.
- The IRB has the authority to waive some or all of the federal requirements for informed consent in certain extenuating circumstances.
- A request for waiver of informed consent must be specifically justified by the researcher in the proposal to the IRB.
- 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.
Not always. In certain situations, the IRB can waive the requirement that you obtain the participant’s signature on the consent form. A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include implied and verbal consent.
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)
Note: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent. In the case of international research, there may be unique cultural or social circumstances that factor into the review process.
Waiver of documentation of consent” means a participant may consent by oral or implied consent, versus a “waiver of informed consent”, which could: (1) alter some or all of the required elements of informed consent, or (2) completely waive the requirement to obtain informed consent (with or without a signature).
The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:
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, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent. Note: The IRB will take into consideration the risks and potential harms involved in the research before granting a waiver of informed consent.
The first involves research or demonstration projects that
Are conducted by or subject to the approval of state or local government officials and are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and Could not practicably be carried out without the waiver or alteration.
The second involves research that
Poses no more than minimal risk to the children; Would not adversely affect the rights and welfare of children if the IRB approved a waiver or alteration of the requirement for parental permission; Could not be carried out without the waiver or alteration; and Whenever appropriate, would provide the children with additional pertinent information after participation.
Yes. If the proposed study is truly “anonymous” – no collection or use of any identifiers (e.g., names, addresses, phone numbers, signatures, social security numbers, drivers license numbers, etc.) – a modified informed consent form (often called an information sheet) 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 may be required.
For more information about the possibilities for waiver of signed or written informed consent, please refer to SOP # 10, Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task.
- By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research.
- Implied consent is actually a type of a waiver of documentation of informed consent.
- Before granting such 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.
There are a number of instances where this type of consent is helpful. 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. For 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.
If, for study design purposes, the researcher needs to keep track of who participated or if 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, chat rooms, online interviews, etc.
- Alternatively, some Internet-based survey vendors and/or software packages provide a means to record whether a respondent has consented to participate before beginning a survey (e.g., a date/time stamp feature).
For protocols involving oral consent the following information is required to be communicated to the participant:
Study purpose and procedures involved What will participant be asked to do – as well as the amount of time participant will spend The voluntary nature of participation in the study The participant is free to withdraw at any time The information collected will remain confidential Offer the participant contact information for the researcher and/or the IRB
It may be pertinent to request the PI to offer additional information depending on the nature of the study. It is up to the IRB Administrator to suggest additional information to be included in order to further protect the participant. At Cornell University, all investigators and research staff much successfully complete the CITI Program for training in the ethical conduct of research with human participants and update it at least once every five years.
Ensure the rights, welfare and safety of participants are protected Comply with regulations concerning IRB review and approval, including
Informed consent requirements Reporting requirements Maintenance and retention of records (keep complete files during and 5 years after research ends)
Supervise research conduct Apply relevant professional standards that are applicable to the research
All faculty, students, and staff proposing to use human participants in research under the auspices of Cornell University are required to complete the IRB human participants training. Approvals for including human participants in proposed research projects will not be granted until this training has been completed and verified by IRB staff.
- For additional information on this topic, please see SOP 3,
- You can access the human participant training online,
- The IRB may accept alternate training in lieu of the CITI training if the researcher can produce documentation related to the training course/s, the institution offering the training, the date of completion and the score received.
Such documentation should accompany the proposal submission or be sent to the IRB office upon request. Yes. The Institutional Review Board office staff strives to provide information and assistance to investigators and research staff in several ways. The IRB may hold formal seminars to help educate the research community about different IRB and human research topics.
Arrangements can also be made to have IRB staff present informational sessions for small groups, which can be tailored for the needs of a specific group. Any changes to a project that has received IRB approval or exemption must be reviewed and approved before the changes are implemented. Most amendment requests must be submitted through RASS-IRB ; however, for protocols that received an exemption determination prior to the implementation of RASS-IRB (which went live on Feb.1, 2022), amendments can continue to be submitted by sending an email to [email protected], identifying the protocol (protocol number, title, PI), describing the proposed changes, and attaching any documents that need to be changed, such as consent forms.
Annual continuing review (renewal) is generally required for protocols that received Full Board (Convened Committee) initial review. In some cases, an annual continuing review may also be required for protocols that received Expedited review (e.g., upon a sponsor’s request).
As a courtesy, several weeks in advance of the expiration date for protocols in need of continuing review, the IRB office will email the PI and any faculty advisor reminding them of the impending expiration. A request for continuing review must be submitted to the IRB via RASS-IRB a minimum of 4 weeks prior to the expiration date.
If the protocol is not granted continuing approval before expiration, all research on the study must cease until continuing approval is granted.
What is an IRB exception?
Exception Requests – Penn IRB An exception is a prospective, one-time, intentional action or process that departs from the IRB approved study protocol. In essence, an exception is a prospective deviation. Exceptions require approval from the IRB prior to implementation through an Exception Request.
If the same exception is requested multiple times, the IRB may require that the PI submit an amendment to the protocol. An exception is a prospective, one-time, intentional action or process that departs from the IRB approved study protocol. Prospective means that the deviation is planned, and approval is sought from the IRB prior to implementation of the change,
If an exception is submitted to the IRB for approval after it has already taken place, it is then considered a deviation regardless of whether sponsor or other monitoring approvals were obtained in advance. Intentional means that the deviation is deliberate, not accidental.
- An exception request will not be approved if it was unintentional.
- For example, if a subject is enrolled and later it is discovered that they met an exclusion criterion, this should be submitted as a deviation NOT an exception.
- This is because the deviation was not purposeful, nor planned in advance.
- An exception is considered to be a one-time request for a single occurrence.
Multiple exceptions submitted at the same time suggest a protocol modification is warranted. Each planned exception requires separate IRB approval. Multiple exceptions may adversely affect data integrity. Investigators should consider exceptions carefully.
- Penn Medicine researchers conducting clinical research should also review the Office of Clinical Research Guidance entitled: Recording, Assessment, and Reporting of Deviations Guidance to Investigators Participating in Clinical Research.
- All exception requests require use of the most recent version of the Exception Request Form from the IRB Forms page.
Supportive documentation such as approval from the study sponsor, medical monitor, and other oversight entities, as applicable, should also be included in the submission. If the study is greater than minimal risk, a document list should also be included.
A description of the exception including references to the current protocol, and associated rationale for deviating; Proposed date of the exception, declaration of time sensitivity and rationale; Clarification as to why the action is a single occurrence and why the protocol doesn’t require modification, or explanation that a future modification is planned; Plans for communicating the exception to subject; Assessment of increased risk involved in the exception; Assessment of subject benefit from the exception; and Assessment of impact of the exception on data integrity
A rush exception is an exception that needs to take place within the next 24-48 hours. If you need a rush exception, the Exception Request Form, rationale for rush review, and supporting documentation should be emailed to the IRB. All Rush Exception requests should be emailed to the,
In the case of rush exceptions, it may not be feasible to obtain Principal Investigator’s (PI) signature on the form. In these situations, please include an email from the PI approving the exception request as a supporting document. Please be sure to CC the PI on your exception request email to the IRB.
When submitting a rush exception via email for an HSERA study, a formal submission of the exception through HS ERA is required after the exception request has been processed. Attach all the documents along with the approval that was provided via email.
LEP persons are individuals who do not speak English as their primary language and who have limited ability to read, speak, write, or understand English. Incidental enrollment of LEP individuals requires prospective IRB approval via an exception request in some cases. Prospective IRB approval to enroll a LEP individual is not required when certain conditions are met.
Guidance on the incidental inclusion of LEP individuals is linked below. Please review this guidance prior to submitting an exception request to enroll a LEP individual.
What is exempt category 5 IRB?
TC IRB continues the blog series, “Get to Know a Review Category” with Expedited Category 5 – Data Collected for Non-Research Purposes. – Federal regulations stipulate that certain research studies may apply to the Expedited level of review. Expedited review may not be used if the risks related to the invasion of privacy and breach of confidentiality are greater than minimal. Additionally, research that meets the requirements for Exempt review would not be considered under Expedited review categories.
The research constitutes a minor change in a previously approved research project during an approved period; or The research is not greater than minimal risk and falls into one of the categories listed under the new common rule ( 45 CFR 46.110 or 21 CFR 56.110 ). Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). ( U.S. Department of Health and Human Services, 1998)
NOTE: Some research in this category may be exempt from the U.S. Department of Health and Human Services’ regulations for the protection of human subjects ( 45 CFR 46.101(b)(4) ). This refers only to research that is not exempt.
For help determining your review category, please download our guide: Does my human subjects research fall under the expedited review category? Researchers new to the IRB may be unfamiliar with the different activities within each Expedited review category.
This post will provide examples of research that typically falls under Expedited Review type, Category 5, Expedited Category 5 covers research “involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).” Expedited Category 5 research examples include materials collected for “non-research purposes,” but this review category can be used to cover research materials if the investigator’s role is simply to analyze them.
For example: If a researcher receives materials from colleagues with a separate IRB approval to collect them and the materials are handled using sound data security methods, protections for privacy and confidentiality, then the researcher may apply for expedited review for the analysis.
Blood samples collected for other health purposes; Academic exams; Program evaluations
Below are a few scenarios that we will review to see if they meet the requirements for Expedited Category 5. Example A: A team of physical trainers plan to evaluate their program that provides free cardiovascular fitness training to physical education educators on an accredited cardiovascular health care technique.
As part of the typical program, the trainers host sessions; individuals are asked to complete surveys and fitness tests, and track their changes over time using a Fitbit for two hours a day, over the course of two weeks. As part of their process, the trainers plan to evaluate these measures to gauge the effectiveness of the program and to develop competent cardiovascular fitness training for educators.
The information collected is identifiable, but not sensitive. No minors will participate in these activities. All data will be stored on an encrypted password-protected device. The Physical Fitness Research Lab will collaborate with the physical trainers to evaluate the program’s data.
Is it Expedited Category 5? Yes! This study proposed by the researchers at the Physical Fitness Research Lab meets the requirements for Expedited Category 5 as it is no more than minimal risk and includes information that is collected for non-research purposes. This is a program evaluation, meaning the training program and assessments would occur even if the research did not take place. The IRB would review the program evaluation based on the types of data collected for non-research purposes and the types of identifiable data in the dataset, a core aspect of the Expedited Category 5 (e.g., names, addresses, Fitbit unique identifiers, etc.). The IRB would evaluate the training setting to determine whether the information gathered is not sensitive and data security standards were met. The research team may need to provide each individual in the training program with a data release form describing the data intended to be used for research. The data release form can include a statement that allows the individual to not release their data for research purposes.
Example B: A researcher wants to run a secondary analysis examining existing data on public census data collected by a state-sponsored substance recovery program. The researcher will review the data collected annually by the state on a community’s income, occupation, and education attainment alongside quality of life measures from a state-sponsored substance recovery program that some members of the community received.
The researcher aims to evaluate the participants’ demographic data, time spent in the program, and quality of life survey measures. The data may include sensitive information (e.g., substance use disorder diagnosis) but will be de-identified by the state before it is shared with the researcher. The researcher will not interact with any participants nor collect any new data.
All information will be stored on an encrypted password-protected device.
Is it Expedited Category 5? Although the research study includes previous data collected for non-research purposes and possibly sensitive information, this study likely does not meet the requirements for Expedited Category 5. In this case, the data was de-identified before the researcher ever received the data, does not have indirect identifiers, and the researcher will not have contact with participants. Exempt Category 4 review might fit this scenario best because it stipulates; “(ii) The information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects, the investigator does not contact the subjects and will not re-identify the subjects” ( U.S. Department of Health and Human Services, 2018). The IRB would evaluate research outcomes (e.g., reporting of income, occupation, etc.) and the data-sharing agreement to assess any risk.
Example C: A researcher is interested in cross-examining two datasets to evaluate possible correlated factors between homeownership and education level. The researcher will be requesting datasets from a colleague who conducted similar studies in the past.
The researcher will combine the datasets based on identifiable participant information (e.g., name, home address, etc.). The IRB will review the data-sharing agreement to ensure secure data transfer and security. In the data-sharing agreement, only two members of the research team will have access to the identifiable data.
These two individuals will secure and de-identify the data before sharing it with the rest of the research team. No record of the identifiable data will be maintained. All information will be stored on an encrypted, password-protected device.
Is it Expedited Category 5? Yes, this is an example of an Expedited Category 5 review. The IRB would expect and require a data-sharing agreement and data security plan to ensure the protection of the data and how researchers plan to mitigate risk (e.g., loss of privacy, data breach, etc.).
Research activities may fall into one or more review categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. Researchers can access the Expedited review categories on TC IRB’s website or from the Department of Health and Human Services ( HHS ).
What is the difference between critical review and systematic review?
Tabular presentation of the systematic review and critical review –
|Used in studies that cover broader topics like child obesity, primary healthcare, and so on.||Used in studies that are much focused on nature like the role of diet in child obesity, the significance of hospital infrastructure in primary healthcare, etc.|
|The systematic review is generally arranged in a chronological manner based on the date of publication. But no comparison of one source with the other is made.||The critical review is arranged in descending order based on their date of publication. Nevertheless, a focal point of one empirical source is found and then compared with the one that appears next in order to estimate the similarities and differences in the perspectives of the scholars.|
|The systematic review is ideal for research topics that are broader in nature and have been studied from that broader perspective by many scholars.||The critical review is applicable in studies where there are contradictory views of different scholars on a particular research topic.|
|A researcher must always select the most recent sources for conducting a systematic review of a topic||The selection of sources for critical review must be such that they cover a long span of time to show how the research topic has improvised and become precise over time. Moreover, each of the sources should be critically reviewed.|
|A researcher is not supposed to compare and contrast empirical studies that have been referenced in a research||A researcher cannot present sources randomly one after the other in the critical review instead of making the critical estimation.|
|The systematic review is important in creating a database on a topic of research by consolidating the most significant and most recent sources.||The critical review is ideal for deriving at a conclusion when the research topic is focused on nature and subjected to debatable perspectives of different scholars.|
What is the difference between systematic review and critical review?