Frequently Asked Questions - HRPO/IRB

A Certificate of Confidentiality (CoC) is deemed to be applicable, as part of the award, for National Institutes of Health (NIH) funded research involving identifiable, sensitive data and may be requested for projects that are not funded by the NIH or for which NIH funding has ended. The CU process for submitting and reviewing the CoC request to the NIH is available on the Human Research Protection/IRB Office (HRPO/IRB) website.

Other HHS agencies issue Certificates of Confidentiality (CoCs), including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), and Substance Abuse and Mental Health Services Administration (SAMHSA). Please refer to the list of CoC contact information for non-NIH HHS Agencies that issue Certificates:https://grants.nih.gov/policy-and-compliance/policy-topics/human-subjects/coc/co-ordinators-list

Date added: 5/19/2025

Columbia University offers resources that include the following:

• Report an incident of discrimination, discriminatory harassment, or other prohibited conduct to Columbia University’s Office of Institutional Equity.
• Report criminal incidents or an incident that involves an immediate safety concern to Columbia University’s Department of Public Safety.
• Counseling:
  • Sexual Violence Response
  • Counseling Services for Morningside and Manhattanville Campuses
  • Counseling Services for Columbia University Irving Medical Center
  • Employee Assistance Program

Date added: 8/14/2025

What are the Columbia University IRB training requirements for the Principal Investigator (PI) and/or study team members?

All personnel engaged in human subject research must have completed the following training requirements, as relevant to the research study and their role, before participating in the conduct of research.

•    HIPAA training [TC0019]: required for all research originating from the medical center campus, and for research originating from other campuses that involve PHI.
•    HSP (Human Subject Protection) training [TC-0087] including Research with Minors and/or FDA regulated Research, as applicable: required for all personnel involved in human subjects research. Completion of the HSP basic course is valid for 3 years, after which the HSP refresher training is then required every 3 years.
•    S-I (FDA Requirements of Sponsor-Investigators) training [TC0096]: required for Principal Investigators (PI) and Investigators if they are the holder of an IND or IDE. 
•    Clinical Research Coordinator [TC0098]: required for greater than minimal risk studies or Clinical Research Coordinators or personnel with the following similar roles such as Regulatory Coordinator, Research Nurse, Data Manager, or Research Assistant.
•    Informed Consent in genetic research [TC3700]: required for research coordinators who are obtaining consent for genetic research that is subject to NYS 79-l and for which results are proposed to be returned.
•    GCP training [TC3450 or third-party training]: required for personnel on NIH-funded clinical trials. Completion of the GCP basic course is valid for 3 years, after which the GCP refresher training (TC3452) is then required every 3 years.

Researchers should access the training courses via the "Training Center" module in Rascal. Once the course is completed, the date of completion is updated in Rascal (personnel section). FYI, "TC" number refers to the course number in Rascal, but these numbers are not reflected on the datasheet.

Date added 02/10/2026

I need to submit my research proposal to the IRB. I am a student at Columbia University and will be the only one involved in the conduct of this research. Do I need a faculty member to serve as the Principal Investigator (PI)?

Yes, you will need to identify a Faculty Member at Columbia University (CU) who is eligible and willing to serve as Principal Investigator.

Please see below the CU PI eligibility requirements as noted in the CU Faculty Handbook:

A PI normally must have a full-time appointment and must be an:

• Officer of Instruction in the rank of:

-Professor
-Associate Professor
-Assistant Professor
-Instructor (a limited term appointment for a maximum of two years when someone has been offered a position as an assistant professor, but has not completed the educational requirements before assuming the appointment)
or an
• Officer of Research in the rank of:
-Senior Research Scientist/Scholar
-Research Scientist/Scholar
-Lamont Research Professor
-Lamont Associate Research Professor
-Lamont Assistant Research Professor

Individuals with appointments carrying other titles, including those in a visiting or adjunct grade, may act as co-PIs with officers in one of the instructional or research grades cited above. However, individuals who do not meet the above criteria may not serve as the sole PI without the approval of the appropriate Chair and Dean (or equivalent officers).

Date added: 02/10/2026

My advisor is an adjunct professor. Can they act as PI?

No. A person carrying the title of adjunct professor cannot serve as Principal Investigator (PI), however they can serve as Investigator.

Please see below the CU PI eligibility requirements as noted in the CU Faculty Handbook:

A PI normally must have a full-time appointment and must be an:
• Officer of Instruction in the rank of:
-Professor
-Associate Professor
-Assistant Professor
-Instructor (a limited term appointment for a maximum of two years when someone has been offered a position as an assistant professor, but has not completed the educational requirements before assuming the appointment)
or an
• Officer of Research in the rank of:
-Senior Research Scientist/Scholar
-Research Scientist/Scholar
-Lamont Research Professor
-Lamont Associate Research Professor
-Lamont Assistant Research Professor

Individuals with appointments carrying other titles, including those in a visiting or adjunct grade, may act as co-PIs with officers in one of the instructional or research grades cited above. However, individuals who do not meet the above criteria may not serve as the sole PI without the approval of the appropriate Chair and Dean (or equivalent officers).

Date added: 2/10/2026

My advisor is at Barnard College. Can they act as PI?
No. The Principal Investigator must have a full-time appointment at Columbia University.

Please see below the CU PI eligibility requirements as noted in the CU Faculty Handbook:

Please see below the CU PI eligibility requirements as noted in the CU Faculty Handbook:

A PI normally must have a full-time appointment and must be an:
• Officer of Instruction in the rank of:
-Professor
-Associate Professor
-Assistant Professor
-Instructor (a limited term appointment for a maximum of two years when someone has been offered a position as an assistant professor, but has not completed the educational requirements before assuming the appointment)
or an
• Officer of Research in the rank of:
-Senior Research Scientist/Scholar
-Research Scientist/Scholar
-Lamont Research Professor
-Lamont Associate Research Professor
-Lamont Assistant Research Professor

Date added: 8/10/2026
 

I have received a request to execute a Data Use Agreement (DUA)/Material Transfer Agreement (MTA) for human material from an external collaborator who is planning to send me human data/materials for my research. Who should I send it to for review and signature?

Information on how to request a DUA or MTA and Frequently Asked Questions about DUA/MTA are available on the Sponsored Projects Administration (SPA) website.

For non-human MTA, visit the Columbia Technology Ventures (CTV) submission portal.

Date added: 2/10/2026

I need a Confidentiality or Non-Disclosure Agreement to receive and/or disclose confidential information related to an external party, who should I send my request to?

You should complete and submit the Confidential Disclosure Agreement Request available on the Columbia Technology Ventures website at: https://techventures.columbia.edu/content/confidential-disclosure-agreement-request

Date added: 2/10/2026

I have received a clinical trial contract from the company that will provide support to a clinical trial that will be implemented at Columbia University. Who should review it?

The Clinical trial Office (CTO) reviews and negotiates contracts for all industry-supported clinical trials and clinical research. Additional information is available on the CTO website at: https://research.columbia.edu/contracts.

Date added: 2/10/2026
 

I need receipt books (receipts for compensation to research participants). Where can I obtain them?

The receipt books are available for pick up at any time from the Human Research Protection/IRB Office located at 154 Haven Avenue 2nd floor.  They are placed on a table that is immediately visible upon exit from the elevator. You will need to complete a sign-in sheet and provide your name, department, and the number of receipt books taken. If you need to pick up more than 2 books at a time, please send an email to [email protected].    

Date added: 2/10/2026

All reliance situations are considered on a case-by-case basis upon review of a reliance request form submitted by the study team. The form and additional information can be found on the Human Research Protection/IRB Office (HRPO/IRB) website. The process should be started prior to submission of an application for federal funding and prior to any commitment for reliance in other situations. The form will be promptly reviewed by the Human Research Protection Office (HRPO).

A determination for the CU IRB to serve as the reviewing IRB or to rely on an external IRB may take several work days for federal funding applications, and longer for other situations that may require contact with other institutions.

Date added: 5/19/2025

Columbia University will generally rely on an external IRB when a federal requirement for single IRB review applies. The 2018 revised Common Rule (Subpart A of 45 CFR 46, Federal Policy for the Protection of Human Subjects) and the NIH Single IRB Review Policy both require certain federally-funded, non-exempt research studies involving more than one site in the United States to use a single IRB for review and approval. All reliance situations are considered on a case-by-case basis upon review of a reliance request form submitted by the study team. 

The form and additional information can be found on the Human Research Protection Office (HRPO) website.  Additional questions about reliance should be directed to: [email protected].

Date added: 5/19/2025

U.S. territories are considered domestic sites that are subject to the single IRB requirements [source: https://grants.nih.gov/sites/default/files/Transcript-12-06-22Grants_PreCon_NIH_sIRB_session.pdf]. According to the World Atlas, the U.S. has 14 territories: American Samoa, Northern Mariana Islands, Guam, U.S. Virgin Islands, Baker Island, Puerto Rico, Howland Island, Palmyra Atoll, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Atoll, Navassa Island, and Wake Island.

Date added: 5/19/2025

A reliance agreement is not necessary. NewYork-Presbyterian Westchester is considered part of NewYork-Presbyterian at Columbia University Irving Medical Center (NYP-CUIMC [not a legal name]) so it is covered by the Federalwide Assurance “NYP-CUIMC” (FWA00002635). This is consistent with coverage for Milstein Hospital, CHONY, and Allen Hospital, all of which are also covered by the FWA for NYP-CUIMC that was approved by the Office for Human Research Protections (OHRP) and lists the Columbia IRBs as the reviewing IRBs for NYP-CUIMC.

Dated added: 5/19/2025

A reliance agreement is not necessary. The NewYork-Presbyterian Hudson Valley Hospital Federalwide Assurance (FWA00025403), approved by the Office for Human Research Protections (OHRP), lists the Columbia IRBs as the reviewing IRBs for human subjects research at this facility. Because the Columbia IRBs are designated on the FWA, a reliance agreement was not executed.

Date added: 5/19/2025

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

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

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

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

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

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

A medical record review will not qualify for exemption as the study involves access to Protected Health Information (PHI). Research would require a HIPAA waiver of authorization and, since a HIPAA waiver of authorization has to be approved by a Privacy Board (Columbia University IRBs serve as Privacy Boards), these research protocols have to be routed to the IRB for review by an expedited review so that the HIPAA waiver can be approved.

Date added: 5/19/2025

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The system does not currently release a determination letter for protocols submitted and determined to be not human subject research. Note however that a correspondence is released to convey the determination.

Date added: 5/19/2025

The system does not currently release a determination letter upon acknowledgement of an Unanticipated Problem (UP) Report. Note however that a correspondence is released upon review of the UP to convey the outcome of the IRB review.

Date added: 5/19/2025

The system does not currently release a determination letter upon acknowledgement of a closure report. Note however that a correspondence is released to acknowledge closure of the study.

Date added: 5/19/2025

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

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

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

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

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

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

The requirement to list a Department Approver under the Personnel page in Rascal originates from the department. It is not an IRB requirement. Please contact your Department Administrator to clarify whether an approver is required by your department before submission of your protocol to the IRB.

Date added: 2/19/2026

Below are the steps to create and attach a HIPAA form to an IRB protocol:
a. Working from the HIPAA module in Rascal: Select "Create HIPAA Authorization/Waiver form" and select the applicable Form Template (e.g. HIPAA Form B).   
b. Working from the Human Subjects module: retrieve the IRB protocol and select "Submit"
c. From the protocol left side menu, select "HIPAA forms" under the "attachments" option
d. The HIPAA form you created can be viewed.
e.  Select "Select Submit Attached HIPAA form"

Date added: 2/19/2026

A Personnel Modification is a new event type in Rascal that allows for the automatic approval of changes that strictly involve the addition and/or removal of personnel, provided all training requirements have been completed and specific criteria are met. No other changes may be made to the protocol through a Personnel Modification event. Except in limited circumstances (i.e. defined exceptions), personnel modifications will not be routed for HRPO/IRB review.

Date added: 4/26/2026

The exceptions to the automatic review process are listed below:

1. If an individual being added to the personnel list has submitted a financial conflict of interest (COI) disclosure, the modification will not be automatically approved until the disclosure has been cleared. In some cases, for example, when the disclosure requires a management plan, the modification will require IRB review and therefore cannot be automatically approved.
2. Individuals who are not listed in the Columbia University Human Resources system (PAC) or Student Information System (SIS).
3. Changes to the Principal Investigator cannot be made through the Personnel Modification Event.
4. When a Faculty Member who is both an Investigator and the IND/IDE holder is being removed from the personnel list, S-I training (TC0096] cannot be automatically verified.

Date added: 4/26/2026

An algorithm incorporating the IRB training requirements* has been integrated into Rascal. This algorithm notifies initiators when any research personnel listed in the IRB protocol have not completed all required training. A red warning message is automatically generated in the Personnel section based on the information entered in the Rascal application and based on the individuals’ role in the research. Any incomplete training courses identified in the warning message must be completed before a personnel modification can be submitted for automatic approval.

*Please refer to the FAQ “Conduct of Research – Training” for a list of training requirements.

Date added: 4/26/2026

Yes. You will be able to submit a Personnel Modification when an individual listed as non-engaged personnel has not completed the training as it is not required for that role.

Date added: 4/26/2026

No. Changes in PI will need to be submitted via a standard modification.

Date added: 4/26/2026

Yes. You may still submit personnel changes with your renewal event.

Date added: 4/26/2026

The determination letter is released upon the auto-approval of the personnel modification.

Date added: 4/26/2026

No. You will have to wait to submit until the event being reviewed is approved.  

Date added: 4/26/2026

Yes, no changes can be made without the PI’s approval.

Date added: 4/26/2026

No changes other than personnel changes can be made.

Date added: 4/26/2026

If the protocol includes a Rascal-built consent form and you have checked the following statement when adding the new person: “This person should be listed on attached consent forms as a contact”, the contact information section of the consent form will be updated automatically to reflect the new person.

Date added: 4/26/2026