Frequently Asked Questions - HRPO/IRB

Q. I am writing a case report. Do I need to submit anything to the IRB?

A case report of a couple of patients (limited to a clinical description of a non-investigational treatment) does not meet the definition of research and therefore IRB review is not required.
Please refer to the IRB Case Report Policy available on the HRPO/IRB website.

Note that a HIPAA authorization form may need to be signed by the patient. Please see additional information and the Case Report Authorization Form template available on the Privacy Office page:  https://www.hipaa.cuimc.columbia.edu/resources

Date added: 5/19/2025

Q. I am analyzing existing data for research. Do I need to submit a protocol to the IRB?

You will need to submit a protocol to the IRB if the analysis of existing data constitutes human subject research.

Under the Department of Health and Human Services (DHHS) regulations “human subject” means a living individual about whom an investigator (whether professional or student) conducting research:
• obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or
• obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Date added: 5/19/2025

Q. I am conducting a research project but I am not collecting identifying information about the people I interview, so I don't believe my study is human subjects research. Do I need to submit a protocol to the IRB?

You will need to submit a protocol for review, as you will be interacting with living individuals, if you will be collecting information about the interviewees.

Under the Department of Human and Health Services (DHHS) regulations, which Columbia applies to all research, “human subject” means a living individual about whom an investigator (whether professional or student) conducting research:
• obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or
• obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research that is limited to interview procedures may be determined to be exempt from the requirements of the federal regulations, if it falls into one or more exempt research categories, in which case it would be reviewed only by HRPO staff.
Research involving human subjects that is not exempt will require review by a single IRB member, if all procedures are minimal risk and fall into one or more categories of research that are eligible for expedited review, or by a convened IRB, if not eligible for expedited review.
The determination of whether your research proposal is eligible for exemption, or requires IRB review, will be made by HRPO staff following an administrative review.

Date added: 5/19/2025

Q. My colleague at another university asked if I could hand out a recruitment flyer for a clinical trial to patients seen at my clinic. The clinical trial will not be conducted at Columbia University. Should I submit the flyer for review by the IRB?

If your role as a Columbia University affiliate is limited to distributing flyers to Columbia University Irving Medical Center (CUIMC) patients to inform them of a research study that is implemented at another institution, and you will not have a role in selecting potential participants for eligibility and/or obtaining consent, and will not provide any identifiable health information to your external colleague,  Columbia University (CU) is not engaged in the research conducted by the other institution and therefore review by the CU IRB is not required.

The Office for Human Research Protection (OHRP) Guidance “Engagement of Institutions in Human Subjects Research (2008)” describes the types of institutional involvement that generally would or would not result in an institution being engaged in human subjects research.

Date added: 5/19/2025

Q. I am analyzing existing data for research. Do I need to submit to the IRB?

You will need to submit a protocol to the IRB if the analysis of existing data constitutes human subject research.

Under the Department of Health and Human Services (DHHS) regulations “human subject” means a living individual about whom an investigator (whether professional or student) conducting research:
• obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or
• obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Date added: 5/19/2025

Q.    What is considered research and what is considered human subject research?

Under DHHS regulations at 45 CFR 46 – Protection of Human Subjects: 
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. [45 CFR 46.102 (l)]

Human subjects Research: a human subject is a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102 (e)(1)]
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Date added: 01/05/2026
 

Q. My interview guide is not developed yet. Do I need to submit it to the IRB before it may be implemented?

Yes. You will need to submit and receive IRB approval for the final interview guide before it is used. You may submit a draft of the interview guide with your initial protocol, however, approval to proceed with the interviews will be contingent upon approval of the final interview guide.

Date added: 8/6/2025

Q. Do I need to submit the Case Report Forms (CRF) provided by the Sponsor for IRB review?

Case Report Forms (CRF) are usually developed by Sponsors of research to ensure appropriate collection of data per protocol by the research team conducting the study. The IRB does not require the submission of CRFs, however the IRB requires submission of questionnaires and other study instruments administered to research participants. Case report forms are sometimes requested during the IRB review process if clarification about the data that is being collected is needed.

Date added: 8/6/2025

Q. I am collaborating with non-Columbia (external) researchers, can I list them on the personnel list of my Rascal IRB protocol?

A. Only Columbia University-affiliated research personnel should be listed in the personnel section of a Rascal IRB protocol. 'Affiliated' in this context generally means a person who is a member of the University workforce or is a student registered in a Columbia course or degree program. Visitors who are registered with an approved visitor program and whose role as described in the visitor application includes human subjects research may also be listed.

If an external collaborator will be engaged in non-exempt human subjects research that is conducted under the auspices of Columbia University, they must be covered by an appropriate IRB oversight mechanism, e.g., IRB approval at their home institution, reliance on the Columbia IRB through a reliance agreement, or execution of an Individual Investigator Agreement (IIA).

If an external collaborator will be working with a Columbia investigator on exempt human subjects research, they will need to be covered by an exempt process at their home institution.

Date added: 01/05/2026
 

Q. Does the IRB require a complete copy of the grant application for federal funding with the submission of a protocol?

A. Although DHHS federal regulations no longer require IRB review of the grant application, the HRPO still requires that the full grant proposal be attached as an external document for the IRB protocol in addition to creating a Proposal Tracking (PT) form and entering the PT number in the funding section of the IRB application.
The grant proposal will be reviewed to confirm all performance sites and research procedures have been reflected in the IRB application.

Date added: 01/05/2026

Q. I need to submit translated documents in Rascal. What is an appropriate certificate of translation?

A. Information about acceptable translators and certifications is available in the Enrollment of Non-English Speaking Subjects Policy, which is posted under the "Human Research Policy Guide" on the Human Research Protection Office (HRPO) website: https://research.columbia.edu/human-research-policy-guide.
It is recommended that translated consent forms and/or study documents be submitted only after IRB approval of the English consent form version, to avoid potential costs for revision of the translated documents if the English version is required by the IRB to be revised before approval.

Date added: 01/05/2026
 

Q. I am working on submitting a new protocol in Rascal. Where can I find information on which documents need to be provided?

A. The IRB Standard of Operations (SOPs) provide the list of materials needed for review of particular types of research or situations. The SOPs are available under the Human Research Policy Guide Page. Please refer to Section III: Preparation of Submissions of the SOPs.

Date added: 01/05/2026
 

Q. I have collected data and specimens under an IRB-approved biorepository protocol. I would like to use some of these specimens for another research proposal. Should I submit this new proposal as a new protocol or as a modification to the biorepository protocol?

A. You should submit a new protocol in Rascal and describe the subsequent use of specimens/data for this new research proposal. In the new Rascal protocol, you should reference:
1) the repository protocol (IRB protocol #),
2) attach the IRB-approved biorepository consent form for reference,
3) confirm whether there is a plan to recontact subjects who donated their specimens/data (this may be appropriate if the subsequent use does not fall under the intended use described in the biorepository protocol).

Date added: 01/05/2026

Q. What is exempt research?

Studies that meet the definition of human subject research per HHS regulation may fit within one or more of the 8 categories of “exempt” research. Studies that are deemed to be exempt are not subject to the regulations under 45 CFR 46 but are subject to institutional policy. In order for a research study to be deemed "exempt", investigators must submit a protocol in Rascal, along with study related materials (e.g., recruitment/consent material, surveys, questionnaires, interview scripts/outlines, etc.). The determination of exemption is made by HRPO staff and/or IRB members.

Note that studies involving prisoners are not eligible for exemption, except for research aimed at involving a broader subject population that only incidentally includes prisoners. In addition, all aspects of your project must fall under one or more of the exempt categories in order to qualify for an exemption determination. If one aspect of your study does not qualify for exemption, the entire project is ineligible.

Date added: 5/19/2025

Q. My study was determined to be exempt. Do I need to submit modifications or annual/progress reports?

Yes. In order to make changes to your Rascal protocol, you must submit a modification. In addition, an Annual/Progress Report is required every five (5) years, with the exception of studies that qualify for exempt category 2(iii) or exempt category 3(iii) and that are reviewed by a limited IRB review. In these cases, the IRB conducts a limited IRB review and annual/progress reports are due yearly.

Date added: 5/19/2025

Q. What type of research falls under exempt 1?

Exempt category 1 includes research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Research utilizing identifiable student records will require adherence to the Family Educational Rights and Privacy Act (FERPA).  If research will occur in New York City public school (NYC), the NYC Department of Education IRB approval is required.

Date added: 5/19/2025

Q. What is considered to be an established or commonly accepted educational setting or normal educational practice?

While the 2018 regulations do not specifically define a commonly accepted educational setting, this category is typically limited to research conducted in K-12 schools and college classrooms, after-school programs, preschools, or other education programs and sites where educational activities regularly occur. Note that not all research conducted in a commonly accepted educational setting is eligible for exemption category 1. The research must also involve normal educational practices.

Normal educational practices” are activities that typically occur in a classroom or other educational setting. These practices generally are ones that benefit the student and instructors as well as supports the curriculum. They must not take time away from the student’s opportunity to learn or instructor’s ability to teach. For example, a study that proposes to evaluate an accepted curriculum by administering a survey directly related to the curriculum may qualify for exemption. However, if the survey is beyond the scope of the ‘normal education practices’ being evaluated, the study would not qualify for exempt, even if the survey takes place in a commonly accepted educational setting. In addition, studies that evaluate an entirely new or untested instructional strategy or curriculum may not be eligible for exemption, as they would not be considered ‘normal’ educational practices.

Examples of Exempt 1 research:

• A comparison of the effectiveness of different language instruction methods
• An examination of the effectiveness of combining traditional teaching with methods adopted during the COVID 19 pandemic
• Analysis of survey data collected from participants in educational workshops or training sessions
• Assessment of educators’ ability to convey educational materials effectively

Date added: 5/19/2025

Q. What type of research falls under exempt 2?

Exempt category 2 includes research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

   (i) The information obtained 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;
   (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to determine that when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data [(45 CFR 46.111(a)(7)].

Date added: 5/19/2025

Q. My study includes children. Is it eligible for exemption?

Research involving children is only eligible for an exemption under exemption categories 1 & 2 and under the following conditions:

• Exempt category 1: Research that involves children and that meets the conditions of the category may be eligible for an exempt category 1 determination.
• Exempt category 2: The only research activities involving children that may fall under this exemption are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed. To be exempt, these activities must also meet the condition that the data are recorded without individual identifiers, or the condition that disclosure of the recorded responses would not place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation. 

Research involving interviews with children or observations in private locations are not eligible for an exempt category 2 determination.

Date added: 5/19/2025

Q. What types of observations are eligible for exemption?

The 2018 regulations (Subpart A of 45 CFR 46, Federal Policy for the Protection of Human Subjects) make the distinction that only observations of public behavior qualify for exemption. Observations of private behavior are not eligible for an exempt determination. The regulations define private information as “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).”

In order for observations to be considered public, specific conditions must be met. They must occur in a setting in which individuals being observed have no reasonable expectation of privacy and the location must be accessible to any one in the general public without need for permissions. For example, a bathroom may be accessible to members of the public, however, individuals have an expectation of privacy. Therefore, this would be considered a private setting. On the other hand, a park is open to the general public and there is no reasonable expectation of privacy, making the park a public setting.

Date added: 5/19/2025

Q. The surveys/interviews utilized in my study are identifiable. Is my project eligible for exemption?

In most cases, research studies that only involve the use of survey or interview procedures with adult subjects are eligible for exemption, regardless as to whether or not the data collected are identifiable. Studies utilizing surveys/interviews that do not collect identifiers (i.e. anonymous) may meet the criteria of exempt category 2(i) while studies that involve identifiable surveys/interviews collecting non-sensitive data may be eligible for exemption under category 2(ii).  For exempt category 2(ii), the information collected must not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.

Surveys/interviews that collect identifiable, sensitive data (for example, health information) may still meet the criteria for exempt category 2(iii). In these cases, the IRB will conduct a limited IRB review to ensure adequate provisions are in place to protect the privacy of subjects and the confidentiality of data. Studies that undergo a limited IRB review are still considered exempt, however, an Annual/Progress Report will be required every year, rather than every five (5) years.  Note that whether data is considered sensitive can be affected by the current political climate or the location where a study is conducted.

Examples of Exempt category 2 research:

• Online survey of adults, with no collection of identifiers, to examine low voter turnout in US elections
• Observations of adults and children in a public park to assess whether new or relocated amenities increase use of the space for passive or active recreation
• Interviews with adults to examine their beliefs about immigration, abortion or the teaching of African American history in elementary schools in the US. Identifiers are collected and stored with the data. Could be eligible for an exempt determination, but the IRB will conduct a limited IRB review because of the current social and political climate in the US.

Date added: 5/19/2025

Q. What type of research falls under exempt category 3?

Exempt category 3 includes research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. In order for projects to qualify under this category, information must either be collected without identifiers or not place the subject at risk of criminal or civil liability or be damaging to their reputation, employability, or financial standing in the event of a breach in confidentiality. If identifiable, sensitive data are collected through the intervention, a limited IRB review may be conducted.

Benign behavioral interventions must be brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Examples include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

Date added: 5/19/2025

Q. Use of deception in exempt research

The 2018 regulations (Subpart A of 45 CFR 46, Federal Policy for the Protection of Human Subjects) specify that if the research involves deceiving the subjects regarding the nature or purposes of the research, exemption is not applicable unless the research can be approved under category 3 and the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. In other words, subjects must be aware they may be misled or deceived and provide prospective consent to this deception.

Examples of Exempt category 3 research:

• Research in which the subjects play an online game
• Research that assesses the ease with which subjects adopt new online tools
• Research that involves subjects solving puzzles under various noise conditions
• Research that involves subjects reading various scenarios and completing surveys or essays to assess how/whether their thinking is affected by scenarios

Date added: 5/19/2025

Q. What type of research falls under exempt category 4?

Exempt category 4 includes secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) Information, which may include information about biospecimens, 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 the investigator will not re-identify subjects;

(iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E [HIPAA (Health Insurance Portability and Accountability Act)], for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities

IMPORTANT NOTE:  Research  under exemption categories 4.ii and 4.iii would require a HIPAA waiver of authorization and, since HIPAA waivers of authorization have to be approved by a Privacy Board (Columbia University (CU) IRBs serve as Privacy Boards),  these research protocols have to be routed to the expedited IRB for expedited review so that the HIPAA waiver can be approved.

Date added: 5/19/2025

Q. Is the analysis of a secondary data source always exempt?

No. The analysis of secondary data may qualify for an exemption, a not human subjects research determination, or may require IRB expedited review.
 
If data are received from an external source, the IRB will request that a data use agreement (DUA) is attached to your protocol (if required by the providing institution) in order to evaluate the confidentiality of the data. In some cases, the data source’s web site will include the appropriate information and the URL may be provided in lieu of a DUA.  If the data were collected without identifiers or the research team will not have access to identifiers, directly or indirectly, the study may qualify for either exempt category 4(ii) or may be deemed not human subject research, depending on the relationship between the study team and secondary data.

If the data received will not contain identifiers but a member of the study team was involved in the original study that collected or utilized data, the study would not be eligible for a non-human subject research determination or exemption. The research would be routed to be reviewed by an expedited category.  If Protected Health Information (PHI) will be obtained from an external source (for example, data from the Center of Medicare or Medicaid Services), the study will not qualify for exemption.

Note:

• If identifiers will be received with a secondary dataset, the study is not eligible for exemption.
• A data source may request a determination other than exempt category 4 or not human subjects research even if the data they provide is stripped of identifiers. They may be concerned about reidentification and require a more robust data security plan be in place before they provide the data. In any case, the source’s review requirements must be considered by the IRB when making determinations about a protocol involving secondary data.

Date added: 5/19/2025

Q. What is exempt category 5?

Exempt category 5 includes research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Date added: 5/19/2025

Q. What is exempt category 6?

Exempt category 6 includes taste and food quality evaluation and consumer acceptance studies if wholesome foods without additives are consumed, or if 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.

Date added: 5/19/2025

What are exempt categories 7 and 8?

Exempt categories 7 and 8 involve the use of broad consent. At this time, the Columbia University IRB does not allow for the use of broad consent, and therefore, these categories are not applicable.

Date added: 5/19/2025

Q. How often does the IRB meet?

Each Columbia University IRB that holds convened meetings [IRB 1 - IRB 2 - IRB 3 - IRB 4 - IRB 5] are scheduled to meet twice per month except during certain holiday periods. The schedule for the current calendar year is posted on the HRPO website and can be accessed by going to the "About the HRPO/IRBs" page.

Date added: 8/6/2025

Q. The IRB seems to have several different levels of review. What are they and when is each one used?

The IRB review level is determined by various factors. Initially, submissions to the IRB are reviewed by HRPO staff for completeness, to identify regulatory requirements and to assess whether any administrative changes need to be made. Human subjects research protocols that fall into several defined "exempt" categories (other than Limited Review exemption categories) are reviewed entirely by HRPO staff. All non-exempt human subjects research protocols require one of the following levels of IRB review.

Expedited IRB review: Review by the IRB Chair or an experienced member of the IRB

• Protocols involving minimal risks and eligible to be reviewed under one of the expedited review categories defined by HHS.

Convened IRB review (also known as Full Board Review): Review at a convened meeting where a valid quorum of IRB members is present

• Protocols involving greater than minimal risk or otherwise not eligible to be reviewed by one of the regulatory expedited categories, or by Chair Concurrence or by Limited IRB Review will be reviewed by the convened IRB.

Chair Concurrence:  Review by the IRB Chair or designee

• This is an alternative to the convened review and applies only for the review of non-emergency Individual Patient Expanded Access IND requests.

Limited IRB review: Review by the IRB Chair or designee (hybrid exempt-expedited process)
This level of review is for research that falls within one or more of the following four exemption categories:

• Research that only includes interactions involving educational tests when the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects [45 CFR 46.104(d)(2)(iii)],
• Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses when the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects [45 CFR 46.104(d)(3)(i)(C).
• Secondary research for which consent is not required, [45 CFR 46.104(d)(7)], and 45 CFR 46.104(d)(8). Note that these categories are not applicable at CU.

Under a Limited IRB review, the IRB needs only to confirm that one specific IRB approval criteria is met, which is  that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data [45 CFR 46.111(a)(7)], as opposed to the seven IRB approval criteria that need to be confirmed under Convened IRB review and Expedited IRB review.

Date added: 8/6/2025

Q. I would like to use EPIC to contact and recruit potential subjects in a research study. What is the process?

A. If you would like to contact CUIMC patients who have previously consented within their Connect accounts to be contacted for research by CUIMC researchers who may not be involved in their healthcare, please review the information on the Columbia Clinical Trials Office website: https://research.columbia.edu/consent-contact-research-ccr-registry.

In general, if you want to use this recruitment method, you will need to select this option in the Recruitment and Informed Consent section of your IRB protocol, including: 
- selecting the checkbox for use of the Consent to Contact for Research (CCR) registry,
- providing the written message that will be sent to potential subjects, and
- attaching a HIPAA form C: Consent to Contact for Research form, which is a HIPAA Waiver of Authorization for recruitment, for use of medical record information of patients who have provided consent to be contacted for research.

Date added: 01/06/2026
 

Q. Where can I find information on Informed Consent?

A. The Columbia University IRB Informed Consent Policy is available on the HRPO website under the "Human Research Policy Guide" Page. 

Date added: 01/06/2026
 

Q. Which consent form for research template should I use?

A. The Columbia University (CU) IRB does not require the use of a particular consent form template, however consent form templates and assent form templates, as well as tips for increasing comprehension of informed consent documents are available on the HRPO/IRB website under the Protocol and Consent Form Resources Page to facilitate the writing of consent forms.
You may also write the consent form using the consent form builder available in Rascal. Rascal IRB Workshops on how to create a consent form using the Rascal Consent Form Builder are scheduled regularly. Please consult the schedule posted on the Human Subjects Protection Training Program & Educational Resources Page> Rascal Submission Workshops.

Date added: 01/06/2026
 

Q. The sponsor is asking me for a copy of the roster. Where can I find the IRB roster?

A. Current IRB rosters are posted on the Human Research Protection Office/IRB (HRPO/IRB) website under the "About the HRPO/IRBs" Page. Note that rosters are updated regularly. If you need to obtain a copy of previous versions, please send a request to [email protected], indicating which IRB roster you need (e.g. IRB 1) and for which year.

Date added: 1/12/2026

Q. My research project was determined to be not human subject research, but my project changed since this determination. How can I modify it?

Protocols that have been determined to be Not Human Subject Research cannot be revised. Changes to the research that may alter this determination will require the submission of a new protocol in Rascal.

Date added: 5/19/2025

Q. I received a reminder to submit a renewal (or annual progress report), however I am unable to create a renewal (or annual/progress report). Can you advise?

The option to "Create Renewal" or to "Create Annual/progress Report" is available under the Protocol Overview page in Rascal. 

1) Option to "Create Renewal": you will not be able to create a renewal if you already created and/or submitted a modification that is pending IRB review. If you created a modification and your renewal is due, you will need to delete or withdraw the modification before creating the renewal. Once the modification is deleted or withdrawn, the renewal application, including any changes to be made to the protocol, should be submitted for IRB review as soon as possible to prevent a lapse of IRB approval. Please refer to the recommended timeline for submission of renewals that is available on the HRPO/IRB website.

2) Option to "Create Annual/progress Report (AR)": you will not be able to create an AR if you have already created or submitted a modification and it is pending review. Once the modification is approved, you should submit the AR for review and approval. Note that no changes can be submitted with the AR application. In addition, unlike renewal applications, if the annual report is not approved by the due date, IRB approval does not lapse and research activities may continue. 

Additional information about submitting a renewal or annual/progress report is available on the HRPO website.

Date added: 5/19/2025

Q. I completed the required training courses for an IRB submission (HSP training, FDA and research with minors modules if applicable, and/or GCP training) but they’re not reflected in Rascal. Can you update my training information in Rascal?

The HSP training, including FDA and Research with Minors training, and GCP training courses are available in CITI Program (Collaborative Institutional Training Initiative) accessible via the Training Center module in Rascal.  If the training information has not been updated in Rascal after 24 hours of completing the training courses in CITI, the request to update CITI training information in Rascal should be made via email to Mark Leneker at [email protected]. Your email should include the name of the person whose training requires updating, their UNI, the name of the specific training, and a copy of the certificate of completion.  

Date added: 5/19/2025

Q. I am submitting a modification to remove the initiator of the study as she/he is leaving Columbia University (CU). I received an error message. How can I remove the initiator from the personnel list?

You won’t be able to remove the initiator from the personnel list because the initiator is the person who created the Event, and it is important to retain documentation of that fact.  A modification should be submitted to update the initiator’s role to “non-engaged”. However, if the initiator’s COI has expired, a request to transfer the initiator’s role to the Principal Investigator (PI) should be sent via email to [email protected].

Date added: 5/19/2025

Q. How do I close a protocol?

The "Create Closure Report" link is available in Rascal from the "Protocol Overview" page after you retrieve the protocol by number. Complete and submit your closure report. This report should only be submitted after all subjects have completed the study and research-related activity has ceased, including subject follow-up, data collection, and/or data analysis. Note that the final acknowledgement of a closure report may take up to 20 business days.
Additional information about closing a research study is available on the HRPO/IRB website.

Date added: 5/19/2025

Q. I would like to access an administrative Rascal report as we need to access a list of active IRB protocols conducted by a former PI in our Department. I don’t currently have access to that report.

The request to grant an individual access to a Rascal report of IRB studies conducted by a PI in their Department, or to access their Department IRB Report, should be made via email. The request should be directed to [email protected], copying Brenda Ruotolo AVP Human Subject Protection ([email protected]) and include the following information:

• Full name and UNI of the person for which the access is requested
• Documentation of authorization from the Chair of that Department
• Reason for accessing the report

Date added: 5/19/2025

Q: Who receives the event approval email notifications? 

A: The Principal Investigator (PI) and the initiator of that event receive the Rascal-generated email notifications. 

Date added: 12/19/25

Q: Does Rascal send reminder emails regarding IRB approval expiration?

A: Yes. Rascal sends email reminders regarding an approaching IRB approval expiration at 90, 60, and 30 days prior to the expiration date, as well as upon expiration. These emails are sent to the Principal Investigator (PI) and the initiator. 

Date added: 12/19/25

Q: I have lost my Rascal access – how do I restore it? 

A: Rascal has no control over who has access to the application. You'll need to work with your Departmental Administrator, the person who set up your UNI account, to update your information in the Delegated Identity Administration (DIA) system to proceed. 

Date added: 12/19/25

Q: Who has to approve an event in Rascal before the event can be submitted? 

A: Everyone other than "Non-Engaged Personnel” have to approve a protocol. Note that study personnel should only be designated as “Non-Engaged Personnel” if they are in fact non-engaged. Non-Engaged Personnel are study personnel other than investigators or coordinators, e.g., individuals who act in a purely advisory, technical, or advisory role, or who are not sufficiently independent to be in a position to influence design, conduct or results of the research, and are not engaged, i.e., do not interact with human subjects, do not have contact with identifiable private subject data, and do not obtain informed consent. Example: some technicians, some statisticians, Department Administrators.

Date added: 12/19/25

Q: Where to access records and certificates of the training courses I completed for the Columbia University IRB?

A: All required training courses that are completed via Rascal (e.g. HIPAA research, HSP, FDA-regulated research, GCP) are available under the “Training Center” module in Rascal. Select “View Certified Test History” to access all the information about your course completion. 

Date added: 12/19/25

Q: A member of our study team is not able to “approve” the event in Rascal. How can we move forward? 

A: It is likely that their Annual Conflict of Interest (COI) disclosure has expired and needs to be filed again. Please visit Rascal.columbia.edu/coi to file a new Annual Disclosure. 

Date added: 12/19/25

Q: Once all approvers have approved the event in Rascal, is there anything else that I need to do?

A: Yes, once all approvers have approved the event in Rascal, the event will then need to be submitted. 

Date added: 12/19/25

Q: I am having trouble/issues with my annual and/or protocol-specific Conflict of Interest (COI) disclosure. Who can help me? 

A: Please contact Michael Klein (mak67), Natalie Stevens (ncs2155), and/or Carmen Nieves (nc2210).

Date added: 12/19/25

Q: I am having trouble/issues with the creation/submission of a Haz Mats Appendix. Who can help me? 

A: General Appendix guidance at https://research.columbia.edu/new-hazardous-materials-appendix-system-rascal. For questions related to a specific appendix, please contact:

• Appendix A - [email protected]
• Appendix D - [email protected]
• Appendix E - [email protected]
• Appendix H - [email protected]
• Appendix I - [email protected]
• Appendix M - [email protected]
• Appendix R - [email protected]

Date added: 12/19/25

Q: I am having trouble/issues with my Proposal Tracking submission. Who can help me? 

A: If you have any questions, please contact your SPA Project Officer: https://research.columbia.edu/department-assignments

Date added: 12/19/25

Q. I started a protocol and stopped/paused. I now cannot find it.

A. If the new protocol you created is not listed under "My Protocols", you may not have saved it. Once you select "Create Protocol" and enter the information in the “General Information" section, make sure you save the information. A protocol number in the following format: AAAX-0000 will be created only after you saved the information entered in the “General Information” section.

Date added: 01/06/2026

Q. I am unable to add someone to the personnel list of the protocol. Can you advise?

A. Only Columbia University Affiliates (faculty members, employees, staff) with an active UNI should be listed in the personnel section in Rascal. Please confirm with the Columbia User who you are trying to add that they have a valid UNI and can access Rascal using their UNI and UNI password. The user can contact their Department Administrator if there is a need to update their UNI designation.  Note that former Columbia Affiliates or external (non-Columbia University) collaborators should not be listed in the personnel section. They should be covered by their institution's IRB.

If an external collaborator is engaged in non-exempt research, an Individual Investigator Agreement (IIA) may need to be executed. A collaborating Individual Investigator is 1) not otherwise an employee or agent of Columbia University; 2) conducting collaborative research activities outside Columbia University; and 3) not acting as an employee of any institution with respect to his or her involvement in the research being conducted by Columbia University. 
Please note that this agreement would not be appropriate when an organization that does not usually conduct research and does not have an IRB is involved in collaborative research.  In such cases, Columbia may opt to provide IRB services for the organization through a reliance agreement, or the organization may obtain IRB review from a non-Columbia IRB. Please contact [email protected] for guidance in these situations. Additional information is available on the HRPO website under the Human Research Policy Guide (Collaborative Research with a Non-CU Investigator.
 

Date added: 01/12/2026

A. Who should be listed in the IRB application?

All Columbia University (CU) personnel engaged in human subject research must be listed in the personnel section in Rascal with their role specific to the research protocol. No external (i.e. non-CU affiliates) should be listed in the personnel section. Please refer below for the definition of each role available in Rascal:

Principal Investigator (PI):
The individual who has the primary responsibility to direct the project. In addition to his/her academic and scholarly duties, the PI has managerial and oversight responsibilities for the administrative aspects of a project.

The PI must be qualified to hold this role, per the requirements set forth in the Columbia University Faculty Handbook. Any exception to these requirements will require additional processing time in order to obtain the necessary reviews and approvals.

Please note: Only one individual may be assigned the role of PI for IRB purposes, even if more than one PI is permissible by the funding agency.

Investigator:
An individual involved with the scientific development, execution and/or reporting of a project or a part of a project. An Investigator typically devotes a specified percentage of time to the project and is considered part of the project leadership team.

Coordinator:
An individual who works closely with the PI to organize and manage the conduct of a study. S/He may be involved in preparing study materials, screening subjects, managing proposal submissions, preparing reports, and/or managing IRB protocol approvals, etc. Note that because study coordinators frequently are responsible for obtaining informed consent and other conduct of research, they are presumed to be investigators for PHS purposes.

Other Engaged Personnel:
Study personnel who are not investigators or coordinators, and who are responsible for the design, conduct, or reporting of the research (i.e., who are sufficiently independent to be in a position to influence the design, conduct, or results of the research). Examples: Some biostatisticians, or, rarely, consultants, e.g. consultants listed as key personnel.

Also, study personnel other than investigators or coordinators, e.g., who act in a purely advisory role, or who are not sufficiently independent to be in a position to influence design, conduct or results of the research, but are engaged. Example: technicians who interact with subjects or have contact with their identifiable data.

Note that individuals who are not part of the study team and are providing a service that would also be performed outside of the research context, e.g., phlebotomists or x-ray technicians, would not be considered to be engaged and would not have to be listed.

Guidance issued in 2008 by the U.S. Office for Human Research Protections (OHRP) stated, in part, with respect to engagement in research:  In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: data about the subjects of the research through intervention or interaction with them; identifiable private information about the subjects of the research; the informed consent of human subjects for the research. Accordingly, individuals who are involved, as described, are considered to be engaged. The guidance document includes examples of activities by individuals or institutions that would constitute engagement.

Individuals who are not agents of Columbia and do not hold UNIs should not be listed in the Personnel section. Note that Teachers College and Barnard personnel are not agents of Columbia. The involvement of individuals who are not agents of Columbia will need to be covered by their institution's IRB or via an Individual Investigator Agreement (IIA). Unique situations may require consultation with the HRPO prior to submission.

Non-Engaged Personnel are not required to be listed:
Study personnel other than investigators or coordinators, e.g., individuals who act in a purely advisory, technical, or advisory role, or who are not sufficiently independent to be in a position to influence design, conduct or results of the research, and are not engaged, i.e., do not interact with human subjects, do not have contact with identifiable private subject data, and do not obtain informed consent. Example: some technicians, some statisticians, Department Administrators.

Date added: 01/06/2026