Here you will find answers to frequently asked questions about human participant research at Cornell:
- General Topics
- The Application Process
- The Consenting Process
- Training-Related Topics
- Lifecycle of the Project
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. If your project is considered research under IRB rules, you must submit an application to the IRB office and receive approval before research can begin.
- 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 the classroom setting only to teach research methods (i.e., only only intended to meet a class requirement), 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.
Please note, undergraduate and graduate theses and dissertations are considered research, and will require IRB approval if human participants are involved.
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 reliance/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. 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.
Research that involves the collection and use of oral histories or life histories to draw generalizable conclusions may meet the federal definition of "human subjects research" and require an application to the IRB office. However, not all oral history projects fit this description, and thus would not need IRB review. Please see Guidance on IRB Review of Projects Collecting Oral (or Life) Histories, Journalism or Case Studies for further information.
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.
Projects that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, may meet the federal definition of "human subjects research" and require review by the IRB office. Other projects involving case studies may not require IRB review. Please see Guidance on IRB Review of Projects Collecting Oral (or Life) Histories, Journalism or Case Studies for further information.
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 generalizable conclusions may require review by the IRB. Please see Guidance on IRB Review of Projects Collecting Oral (or Life) Histories, Journalism or Case Studies for further information.
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 from IRB committee review, for which you should allow at least 2-3 weeks for administrative review. Research projects that involve only minimal risk to participants but aren't eligible for exemption may be eligible for expedited IRB review, for which you should allow at least 3-4 weeks for 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. For a complete list of the components of informed consent that are considered essential by the Cornell IRB, please refer to SOP #10.
The informed consent process can take various forms:
- 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. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:
- 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. Additionally, there are restrictions for when the IRB may waive the requirements for child assent and parental permission. Please refer to SOP #11 for full details.
No. There are two sets of circumstances where the IRB may waive the requirement for parental permission:
- 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.
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.
Additionally, investigators and research staff must be qualified by training and experience for the research they will be conducting. It is important to understand that the responsibility for the welfare of participants lies with the principal investigator, even when participants have given consent. Investigators and research staff must have the necessary training and expertise to:
- 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 firstname.lastname@example.org, 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.