Office of Responsible Research Practices
The Ohio State University

Frequently Asked Questions

Human Research Protection Program (HRPP)

Human Subjects Research, Engagement, and Review Determinations

Exempt Research

Collaborative Research and Agreements

Research Involving Secondary Use of Data and/or Specimens

Special Research Considerations

Where can I find the Ohio State Human Research Protections Program (HRPP) policies?

The HRPP Policies page contains a list of current polices related to the human subjects research at Ohio State.   The page includes polices related to the HRPP program, review of research, study procedures, special populations, special types of research,  and IRB operations.

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Where can I find human subjects research definitions?

The HRPP Glossary page contains definitions for terms related to human subjects research.

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How do I get a written determination about the review requirements necessary for my project?

If an investigator is unsure of a project’s review requirements, a determination should be requested from the Office of Responsible Research Practices (ORRP) via email at ORRPDeterminations@osu.edu.

Investigators should provide sufficient materials to allow a determination to be made: e.g., research protocol, grant (if any), contracts/agreements (if any), and any study-specific materials available.

For questions about whether a project constitutes Human Subjects Research (HSR) and/or which review process (Exempt or IRB) is required, ORRP will make one of three determinations and notify investigators as follows:

  • The proposed project/activity is not regulated HSR and may be conducted without requesting Exemption or IRB review (no formal application needed); or
  • The proposed project/activity is regulated HSR, and appears to meet the criteria for Exemption from IRB review (an Exempt application should be submitted); or
  • The proposed project/activity is regulated HSR and requires IRB review (an IRB application should be submitted for Expedited or Full-Board review).

Upon receipt of complete information, determinations regarding review requirements are usually made within five business days (additional information may be requested).

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How do I get a written determination about whether Ohio State is considered engaged in collaborative human subjects research?

If an investigator is unsure whether Ohio State is considered engaged in collaborative human subjects research (HSR) projects involving outside institutions/organizations, a determination should be requested from the Office of Responsible Research Practices (ORRP) via email at ORRPDeterminations@osu.edu.

Investigators should provide sufficient materials to allow a determination to be made: e.g., research protocol, grant (if any), contracts/agreements (if any), and a list of all individuals/institutions involved and their roles (e.g., primary awardee on grant, design, analysis, authorship credit, providing specimens, etc.).

For questions about whether Ohio State is engaged in the research, ORRP will make one of two determinations, and notify investigators as follows:

  • Ohio State is not engaged in HSR and Ohio State’s role in the project may be performed or carried out without requesting Exemption or IRB review (no formal application needed); or
  • Ohio State is engaged in HSR and further action is required on the part of the Ohio State investigators:
    • If the project appears to meet the criteria for Exemption from IRB review (according to OSU’s policies and procedures), an Exempt application should be submitted to ORRP;
    • If the project requires IRB review, ORRP staff will notify OSU investigators that their activities require IRB oversight. In most cases, an application for OSU IRB review (Expedited or Full-Board review) is required. In some cases however, OSU investigators can explore the possibility of requesting that another institution’s IRB review their role in the project. For more information on ceding review, email IRBAgreements@osu.edu.

Upon receipt of complete information, determinations regarding engagement are usually made within five business days (additional information may be requested).

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Ohio State is receiving federal funding as a direct awardee for a project involving human subjects research, but none of the work will actually be completed at OSU or by Ohio State personnel—is OSU considered engaged in the research?

It depends:

  • Yes, if the project contains non-exempt activities. If Ohio State is receiving a direct federal award that involves non-exempt human subjects research, then OSU is considered engaged in the research and Ohio State investigators must obtain IRB approval or formally request to cede review. Section III.A.1. of Engagement of Institutions in Human Subjects Research (2008) indicates:

In general, institutions are considered engaged in an HHS-conducted or -supported non-exempt human subjects research project (and, therefore, would need to hold or obtain OHRP-approved FWAs and certify IRB review and approval to HHS) when the involvement of their employees or agents in that project includes any of the following:

    1. Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another institution.
  • If all activities conducted as part of the funded project qualify for exempt review, then Ohio State may not be considered engaged. Contact ORRP at ORRPDeterminations@osu.edu for a determination.

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What if a sponsor is requesting proof of IRB approval or exemption, but the specific elements and/or materials for the portion of the project that involves human subjects have not been developed?

Under applicable regulations, some applications for federal awards currently lacking definite plans for human subjects involvement (such as projects in which human subjects’ involvement will first depend upon analysis of publicly available data, the creation of instruments, prior animal studies, or purification of compounds) do not need to be reviewed by an IRB before an award is made. For private awards, there may be similar flexibility. If a sponsor is requesting proof of IRB approval or exemption, but the specific elements and/or materials for the portion of the project that involves human subjects have not yet been developed or rely on additional phases that do not involve human subjects research activities, ORRP may be able to provide a preliminary determination letter that partially satisfies the sponsor’s requirement. Such a letter may allow for an award to continue to be considered while the appropriate application process is completed, and/or allow for partial funding to be awarded for projects that involve additional activities that do not involve human subjects. Please note that such a letter is not considered an official exempt determination or IRB approval, and may not satisfy the sponsor’s requirements; investigators are encourage to determine sponsor requirements as soon as possible so that any necessary approvals can be obtained.

The preliminary determination letter will establish a time limit for a specific scope of the project or the specific activities that do not involve research with human subjects, cite applicable policies, and emphasize that no work with human subjects (including recruitment, pilot testing, etc.), may be conducted under the determination. It will require investigators to return to ORRP or the IRB for an official exempt determination or IRB approval before any human subjects research activities can occur.

Requesting a determination letter can be done via email using the contact information below. In order to request a preliminary determination letter from ORRP, please provide the following:

  • Specific information regarding the nature of the request: a copy of any communication or requirements from the sponsor can assist ORRP staff in determining if such a letter will be acceptable and, if so, the type of letter that may be required.
  • The timeline for the phases/activities that do not involve human subjects research activities.
  • The title of the project and specific investigator information to be used for the determination letter.
  • Sufficient materials to allow a determination to be made (generally, at minimum, a copy of the research protocol, grant, and any other materials already developed).

Once materials are received, ORRP staff will determine if such a letter is appropriate and provide a determination, letter, or request for additional information (as applicable) by email within 3 business days.

Contact: ORRPDeterminations@osu.edu

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Does my quality assessment or quality improvement project constitute human subjects research requiring review?

QA/QI activities constitute human subject research and require IRB review or exemption when they are also designed or intended to develop or contribute to generalizable knowledge and meet the federal definition of human subjects research. QA/QI activities that are designed solely for internal purposes, with no external application or generalization, usually do not constitute human subject research and usually do not require IRB review or exemption.

For more information, please see QA, QI, and Human Subjects Research.

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Can a research project that contains both exempt and non-exempt activities be split apart, with portions submitted for exempt review and the rest later submitted to the IRB?

No, research that includes both exempt and non-exempt activities cannot be determined to be exempt. This determination is true both internally and when collaborating with outside universities. If all activities to be conducted for the study as a whole do not fall under one or more of the exemption categories, then no portion of the project can be submitted for exemption.

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Do I need to create a protocol or proposal for exempt research?

Yes. Please see Guidelines for Writing a Research Protocol (opens as a PDF) for a list of elements generally contained in a research protocol (all elements may not apply, depending on the project).

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In general, consent is required for exempt research unless the research could not be practicably carried out without waiving the requirement to obtain consent. The Ohio State Exempt Research policy requires consent if there will be interactions with participants.

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No, but there are required elements that must be communicated to participants. When creating your consent materials, please be sure to include all elements required for exempt consent: see Consent Template Guidance.

  • Remember that consent is a process, and the elements of consent can be provided using more than one method (e.g. part of the information provided in a verbal script, part on the actual instrument, and part via a handout or contact card).
  • In some cases, the recruitment materials can also serve as the consent.

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If a collaborative project is determined exempt from IRB review at another institution, will I still need to seek review at Ohio State?

Yes. Ohio State does not cede review for exempt research. Ohio State researchers must submit an exempt application and obtain an official exemption determination from Ohio State. The only exception is for certain research conducted with Nationwide Children’s Hospital under our reciprocity agreement.

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If a project is determined exempt from IRB review at Ohio State, does that exemption cover my collaborators at other institutions?

No. External collaborators will need to complete whatever review is required by their respective organizations/institutions. The only exception is for certain research conducted with Nationwide Children’s Hospital under our reciprocity agreement.

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What constitutes “commonly accepted educational settings” for exempt submissions attempting to qualify under exempt category #1?

Commonly accepted educational settings can be almost anywhere as long as the setting is one in which the specific educational offering normally takes place (e.g. hotel conference room for work-place related education, elementary school classroom, soccer field for learning soccer, etc.).

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What constitutes “normal educational practices” for exempt submissions attempting to qualify under exempt category #1?

Normal educational practices are those educational activities commonly accepted/established in the field that would be occurring regardless of the research. They cannot be untested in the setting or untested with a specific population.  They also cannot involve novel methods, software, or curriculum.

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What are some common reasons my research with may not qualify for exempt review under category #2?

  • Research involving prisoners cannot be exempt under category #2.
  • Research involving deception or interventions cannot be exempt under category #2.
  • Research involving children generally cannot be exempt under category #2. The only exception is for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed. Observations of public behavior must occur in truly public places (e.g., a public park, a library, city sidewalk). Federal guidance has indicated that classrooms are not considered public places.
  • If the data collected is identifiable (or potentially identifiable) and the responses could harm participants or put participants at risk in some way, then such research cannot be exempt, and will generally require IRB review. For example, questions regarding critiques of employers or illegal behavior could reasonably place subjects at risk if responses were known outside the research, and therefore cannot be exempt from IRB review if there is a way (even temporarily) for someone to potentially identify the respondents.
  • In addition, even if anonymous, surveys containing invasive questions that may cause participants to experience emotional distress and/or discomfort while answering, or research otherwise employing psychologically invasive cognitive or diagnostic testing, cannot be not exempt.

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Can I implement an intervention or manipulate behavior under exempt category #2?

Projects cannot implement an intervention or manipulate behavior as part of the research under category #2. If an activity is involved that goes beyond a simple survey, interview, observation of public behavior, or educational test, then IRB review is required.  Please remember that the exemption categories are limited in scope, and there are many minimal risk research projects that include activities that do not fit under the exemption categories.

Some examples of research that involve interventions or manipulations and therefore require IRB review rather than exempt review:

  • An investigator provides subjects with a survey on eating habits, preferences, and intentions; shows videos about farming practices; and then repeats the survey to see if responses change. The video is considered an intervention which goes beyond a simple survey and cannot be exempt.
  • Investigators have participants listen to different types of music while completing puzzles to see if their performance changes. The music is an intervention, so the study cannot qualify for exempt review.
  • Two versions of a survey are conducted on personal habits—one with multiple questions about hand sanitizer use, and one version without. Free hand sanitizer is offered in a bowl that participants can take on their way out. Investigators want to observe if there is a difference in who takes what and also send a follow up survey a week later to see if usage has changed. Here, the survey is intended as an intervention to manipulate behavior and also likely also involves deception or incomplete disclosure which cannot fall under exempt review at Ohio State.
  • An investigator asks subjects to use an iPhone app for a week and then asks questions about their use. Using the app is an intervention that goes beyond a simple survey.
  • A pair of investigators observe restaurant patrons. As part of the observation one investigator coughs in the direction of individuals to see their reaction. The investigator coughing at patrons is a manipulation of the subject’s environment (no longer only observing public behavior) and therefore an intervention.

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How do I know if my research qualifies for exemption under category #4?

In order to qualify for exempt review under category #4, all data/specimens to be collected must currently be in existence at the time the research is proposed, and must be collected/obtained without any identifiers. It is important to keep the following points in mind:

  • “Existing data or specimens” means that the materials must be “on the shelf” at the time (or before) the research is submitted for determination of exemption. There must be no plans for ongoing collection. Serial applications (e.g., intending to submit an application at the end of each year to obtain the year’s data) are not permitted.
  • The data collected/received must be de-identified—no direct or indirect identifiers can be collected. For research involving use of or access of protected health information (PHI), this means that no HIPAA identifiers (which include dates, zip codes, etc.) can be collected or received: for more information, please see the definitions on our HIPAA Guidance page.
  • For projects involving patient information to be considered potentially able to be de-identified, there must be more than 25 potential subjects that fit the inclusion criteria at Ohio State. Please note that projects with more than 25 individuals may still be considered potentially identifiable. The ability to de-identify data depends on the specific project, the data point(s) in question, and the potential for indirect identification. Materials are considered de-identified when all direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s).
  • In some instances, investigators can create and use a temporary list or key to access information from more than one location, but only if it is part of the same record (e.g. the patient’s regular OSU medical record information is housed in two different databases). Only a simply list (e.g., a list of MRNs) or a simple key (e.g., MRN = random study number) can be created, and this list/key must be destroyed immediately after collection, prior to any analysis, processing, or use of the data/specimens. If investigators need to retain a link, IRB review is required. Please note, the link can only be used to access information for a single source (e.g. the patient’s OSU medical record), and it cannot be used to combine completely separate sources of data (e.g. the OSU medical record with data from the patient’s nursing home record, school record, work record, and/or private physician’s record).

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Does obtaining Exemption or IRB approval for my research involving access to Protected Health Information (PHI) or specimens automatically grant me access to the materials I need at Ohio State or elsewhere?

Not necessarily; the stewards of the materials have ultimate control over access to the materials in question, and they ultimately decide whether to grant access to researchers.

Obtaining an exemption or approval from the IRB is only the first step to starting research involving access to PHI. Once obtained, the research team will need to contact the appropriate Privacy Officer to request access to the materials in question and provide proof of the Exemption or IRB approval.  As applicable, investigators will also need to provide documentation of any approved waivers or partial waivers of HIPAA authorization.  Additional forms may need to be completed.

  • Within the OSU Medical Center:

Contact the department of Medical Information Management in order to access PHI from patient medical records for the purposes of research. For more information, please see OSU Medical Center: Guide to Information Access for Research Activities (requires OSUMC logon ID).

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What type of research qualifies for exemption under category #5?

In order to qualify under category 5, the research must be on federal programs and subject to the approval of federal department or agency heads—research on a local/state program does not qualify under this exemption (thought it may fall under one or more of the other exemption categories).  In general, if your research is eligible for this exemption, the federal agency will provide a letter indicating that the research is eligible for exemption under category 5.

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Do I need to complete the International Research Sites pages of Buck-IRB when Ohio State investigators will not physically be on site for the international research?

The International Research Sites pages are meant to capture enough information to determine if any site-specific requirements for the research may apply that could affect participants, applicable permissions, laws, and/or regulations. Even if investigators are not personally on-site, the participant is participating from that site and international laws could still apply.

For example, even if you will be in the US conducting interviews via Skype, if the participant is participating from an organization located in Country X, then both US and Country X laws would apply (to both the participant and, in some instances, to you as a researcher conducting research with a Country X participant/organization). For instance:

  • Country X may require that research with its citizens/organizations of a certain type be reviewed by a local ethics committee or governmental agency (many projects could require at least a local sponsor/collaborator);
  • Research conducted by non-Country X researchers that could reflect on Country X as a nation or involve perceptions of government decisions may need to be reviewed or documented through a national process; and/or,
  • If certain behaviors were illegal in County X but not in the US, then the participant could face legal issues/risks in Country X for what was revealed during the interview, etc.

The International Research Sites pages of Buck-IRB are meant to collect information on these issues and prompt investigators to check for any international requirements. For a list of regulations, laws, and guidelines pertaining to international human subjects research for selected countries, see International Compilation of Human Research Protections.

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If my project is determined exempt from IRB review at Ohio State, will I still need local review in other countries?

It depends. As the designation of “exempt from IRB review” is based on U.S. law and Ohio State policy, another country may not have any equivalent designation.  Some countries consider all research subject to specific rules, some only regulate biomedical research, and some base the rules on other topics (e.g. related to the government, related to local health concerns, etc.).  The level of involvement of local personnel and local collaborators can also impact review requirements.  Investigators are responsible for assuring that all international requirements are met.

For a list of regulations, laws, and guidelines pertaining to international human subjects research for selected countries, see International Compilation of Human Research Protections.

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Do I need to provide translated documents for exempt research?

No. Only English-language versions of the materials need to be submitted. If you intend to have translated documents available, then just explain your intent to use non-English materials in your application and protocol. Please note that IRB-reviewed research has different requirements.

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What is a ceded review request?

A ceded review request is an administrative review performed by a designated ORRP staff member when an Ohio State PI requests that an external IRB review their human subjects research. If Ohio State relies on an external IRB to review and approve research occurring at Ohio State, a reliance agreement is required. ORRP staff will facilitate this agreement once a submission requesting ceded review is received in Buck-IRB.

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How do I request a ceded review for an external IRB (other than WIRB, NCH, or NCI CIRB) in Buck-IRB?

This type of review is abbreviated but still requires that you submit a new research application through Buck-IRB.

  • To request a ceded review, you must first start a new application in Buck-IRB. Select “Create a New Study” and fill in the study title and Ohio State PI.
  • On the Type of Research page, select “IRB-reviewed research (includes WIRB, NCI, CIRB, and other external IRB review).”
  • On the Review Board page, select “Other external IRB” to activate an abbreviated ceded review application.
  • List at least one Ohio State site on the Location of Research If participants will not be enrolled at Ohio State, please list an office or lab location where data will be analyzed. Note that the lead/reviewing site should not be listed as a non-Ohio State location.
  • On the Research Methods and Activities page, please select “Other,” at a minimum, and provide an overview of Ohio State’s research involvement. If the study involves drugs, biologics, or radiation, ensure that these options are selected to activate the corresponding Buck-IRB pages.
  • Please upload a copy of the IRB approval and/or IRB application form from the reviewing IRB, as well as the protocol and any other documents relevant to Ohio State’s participation, such as consent forms, recruitment materials, etc.

Once the submission is received, ORRP staff will screen it for completeness and work with the IRB of record to execute a reliance agreement. This agreement must be complete before Ohio State will formally cede review to the external IRB.

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How do I request a ceded review for WIRB, NCH, or NCI CIRB in Buck-IRB?

  • To request a ceded review, you must first start a new application in Buck-IRB. Select “Create a New Study” and fill in the study title and Ohio State PI.
  • On the Type of Research page, select “IRB-reviewed research (includes WIRB, NCI, CIRB, and other external IRB review).”
  • On the Review Board page, select “Western IRB (WIRB)” to request review by WIRB. Select “Nationwide Children’s Hospital IRB” if NCH will serve as the IRB of record. Select “National Cancer Institute Central IRB (CIRB)” for studies reviewed and approved by the NCIC IRB.
  • These selections will activate an abbreviated application allowing you to request ceded review.

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What is the reciprocity agreement between Ohio State University and Nationwide Children’s Hospital (NCH) and how does it help my study?

Ohio State University and NCH have a long-standing reciprocity agreement for conducting human subjects research. The reciprocity agreement allows the Ohio State  and NCH IRBs to cede review to the other when specific criteria are met. To learn more about the reciprocity agreement, see http://orrp.osu.edu/irb/osuirbpolicies/childrens/.

The reciprocity benefits researchers because for most studies, IRB review will be provided by only one organization. The organization responsible for review (Ohio State or NCH) is determined primarily by the location of the research, the PI’s primary appointment location, and/or location of primary grant or other funding. Efforts are made to avoid duplicative review whenever possible. If uncertain about which IRB to apply to for initial review, contact IRBAgreements@osu.edu, or Elaine Wakely at (Elaine.Wakely@Nationwidechildrens.org).

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How do I obtain approval for the external researchers from Nationwide Children’s Hospital (NCH) who are collaborating on Ohio State research?

In order to confirm CITI training and conflict of interest (COI) for NCH personnel on Ohio State IRB protocols, the principal investigator will need to submit an abbreviated application to the NCH IRB system. A reliance acceptance letter will be generated indicating that specific NCH personnel have completed their CITI training and COI disclosure. This reliance documentation must be submitted in Buck-IRB when adding NCH collaborators to research reviewed and approved by an Ohio State IRB.

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How do I obtain an Individual Investigator Agreement (IIA) for an external researcher? What are the requirements for external independent collaborators?

An external individual investigator is someone who is not an employee or agent of Ohio State, who is conducting research activities on behalf of Ohio State on an IRB approved research study, and who is not acting as an employee of any other institution with respect to his/her involvement in the research being conducted by Ohio State. For researchers meeting this criteria, Ohio State requires the individual to sign an Individual Investigator Agreement (IIA). Please note that if an external collaborator with another institutional affiliation is added to the study team, ORRP staff may contact the collaborator’s home institution for confirmation that they are not acting as an employee or agent of their home institution.
External personnel added via an IIA are required to maintain an Ohio State guest account. In addition, the collaborator must complete Ohio State required CITI human subjects protection and Responsible Conduct of Research (RCR) training, and an annual Ohio State Conflict of Interest (COI) disclosure. Please see the steps below to obtain a guest account and access the institutional training/COI requirements.

    1. Acquire an Ohio State guest account (or reactivate a previous Ohio State University name.#) by contacting the Office of Research Help Desk at orhelpdesk@osu.edu or (614) 688-8288.
    2. Once the guest account is activated, add the external personnel to Buck-IRB using their Ohio State name.# lookup tool on the External Collaborators application page. If your collaborator has another email address, this may be entered as an alternate email on this page.
    3. The collaborator must register and complete the CITI human subjects protection and RCR training using their Ohio State guest account. Instructions for new users accessing the Ohio State CITI site are located below:
      • Log-on to CITI here: http://go.osu.edu/citi.
      • Note: The collaborator must renew CITI human subjects protection training every three years. RCR training is only completed one time.
    4. The Ohio State COI disclosure must be completed online by the external researcher. The process will only take a few minutes to complete.
    5. Once the training and COI requirements are complete, a member of the ORRP reliance team will draft the IIA and circulate the document for signature via DocuSign. Please note that this document will not be drafted until a submission adding the collaborator is received in Buck-IRB.

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I am conducting collaborative research with another institution. How should this be listed in my Buck-IRB application?

First, it is important to determine whether the other institution and/or your collaborators are engaged in human subjects research. Please use the ORRP Engagement Determination tool to confirm whether the collaboration engages the external institution/collaborator in the Ohio State research.

Once you have determined that external personnel are engaged, reference the ORRP Collaborative and Off-Site Research Tools packet to determine the reliance scenario represented by the proposed collaboration, as well as annotated Buck-IRB screenshots that illustrate how the collaboration should be reflected in the IRB application.

If the collaboration requires any reliance agreements, such as Individual Investigator Agreements or IRB Authorization Agreements, a member of ORRP’s reliance team will coordinate the agreement process once the submission is received in Buck-IRB.

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I am conducting collaborative research with another institution. Will an Institutional Authorization Agreement (IAA) be needed?

Research conducted at a location other than an approved Ohio State performance site may require a letter of support, another IRB’s approval, or an IAA. If the external institution is “engaged” in the research and Ohio State is the IRB of record, then an IAA will be needed. Please reference ORRP’s Collaborative and Off-Site Research Tools packet for decision trees and guidance on how your collaboration should be reflected in Buck-IRB.

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How do I obtain a letter of support for a multi-site grant submission I am working on?

Please contact ORRP’s reliance team at IRBAgreements@osu.edu to request a letter of support and/or single IRB plan for grant submission purposes. Please include the study title, PI name, name(s) of any collaborating institution(s), and confirmation that the collaborating sites are willing to rely on Ohio State’s review.

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When should external investigators be included on the External Co-Investigators & Key Personnel page for a new study in Buck-IRB?

For Ohio State IRB-reviewed studies: non-Ohio State investigators should be included when they are engaged in the Ohio State research (e.g., helping to recruit study subjects, analyzing study data, etc.) and an Ohio State IRB will serve as the IRB of record for their activities. In order to determine engagement, we recommend using ORRP’s interactive Engagement Determination tool prior to submitting your IRB application.

For Exempt studies: non-Ohio State investigators (at minimum the lead investigator at each site) should be included when they are engaged in the research (e.g., helping to recruit study subjects, analyzing study data, etc.). Please note that exempt determinations issued by Ohio State only apply to research team members from Ohio State University. ORRP will not execute reliance agreements for research that is deemed exempt; instead, external collaborators should seek a corresponding exemption from their home institution.

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What is SMART IRB?

SMART IRB is a master national reliance agreement used to easily document reliance between institutions that have signed on to the SMART IRB Agreement. Study-specific reliance agreements using the terms of the SMART IRB Agreement are documented either by the online SMART IRB platform or by a Letter of Acknowledgment which is signed by designees from each institution. ORRP’s reliance team will provide instructions and guidance on the study-specific reliance agreement during the initial or amendment screening process. Please note that SMART IRB is not an IRB and not an IRB of record; instead, SMART IRBis a way to document reliance between a reviewing IRB and relying sites.

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When are data or specimens considered individually identifiable?

Materials are considered individually identifiable when the identity of the participant is or may readily be ascertained by the investigator or the investigator’s staff, or associated with the information.

Note: Individually identifiable for the purposes of HRPP policy may be similar to, but is not the same as, individually identifiable health information or protected health information as defined by the HIPAA Privacy Rule at 45 CFR Part 160. Limited data sets released from data repositories with IRB approval to release such data sets are not considered to be individually identifiable.

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I am only using data and/or specimens from deceased individuals.  Do I need IRB review or exemption?

No. Use of existing materials from deceased individuals (e.g., autopsy materials) does not constitute research with human subjects.  Please note that other laws, university processes, and/or requirements may still apply (e.g., biosafety/IBC review, HIPAA, MTAs/DUAs, etc.).

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Do single case reports require IRB review or exemption?

It depends.  A case report is defined as a factual description of the clinical features and/or outcomes of the case(s) without any additional testing, evaluation, analysis, or review of others for comparison.

  • If the project is limited to one or two case reports (as defined above), then no human subjects research review is required.
  • If the project involves three or more reports, or if it requires additional testing, evaluation, analysis, or comparison, then the project will likely require IRB review or exemption, as applicable.

Even if no IRB review or exemption is required, investigators will still need to work with the Office of Medical Information Management and/or their Privacy Officer to satisfy HIPAA requirements (e.g., determine whether patient permission is required) and to complete the proper forms for access to and use of the data.

For materials controlled by the Wexner Medical Center, please see https://onesource.osumc.edu/departments/MIM/Pages/Research.aspx or call 614.366.6690.

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What is a Material Transfer Agreement (MTA), a Data Use Agreement (DUA), or a Confidential Disclosure Agreement (CDA)?  When are such agreements needed?

  • A Material Transfer Agreement (MTA) is a contract that allows one party to perform research using the materials (data, specimens, etc.) of another party.
  • A Data Use Agreement (DUA) is used when transferring protected health information (PHI), including limited data sets, from one party to another.
  • A Confidential Disclosure Agreement (CDA) is used when transferring non-PHI from one party to another for review only (no further use or dissemination), generally for the purpose of evaluating the potential for a future relationship between the parties.

The agreements define the rights, responsibilities, and obligations of both the providing and receiving parties regarding issues such as permitted use, ownership, publications, intellectual property, and liability.

Agreements are needed whenever transferring materials to, or receiving from, an outside party (either within the public sector, or between the public and private sectors).

All incoming and outgoing agreements must be reviewed and signed by an authorized representative from the Technology Commercialization Office (TCO).

Note that while TCO can sign data use/data transfers related to “research” purposes as designated in HIPPA Regulation Section 164.514(e), TCO does not sign data use/data transfer agreements related to “Health care operations;” these agreement requests should be reviewed by legal counsel for the appropriate health care component.

Any inquiries regarding DUAs, MTAs, or CDAs should be sent to the Contracts Department at TCO.

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What is the difference between prospective and retrospective studies?

Retrospective studies collect/evaluate materials that are existing at the time that the research is conceived and submitted for IRB review or exemption.

Prospective studies plan to collect/evaluate at least some materials that are not yet in existence at the time the research is conceived and submitted for IRB review or exemption.

Note that studies may have both prospective and retrospective elements.

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All data will come into existence regardless of the research. Does this make my research prospective or retrospective?

It depends on whether all data exists at the time that the research is conceived and submitted for IRB review or exemption. If not all materials are currently in existence at that time, then the project is considered, at least in part, prospective.

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Maybe. In order to qualify for a waiver of consent (and a waiver of HIPAA authorization if PHI is involved), investigators must meet certain regulatory criteria. In some instances the IRB may determine that consent (and authorization, when applicable) is required if the investigator does not meet the required waiver criteria (e.g., unable to justify why it is impracticable to conduct the research without a waiver).  For information on the requirements for a waiver of informed consent, see the policy Informed Consent and the Elements of Informed Consent.

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Is there a difference between the rules for use of data vs. use of tissue specimens?

In general, human subjects review requirements hinge on the DHHS and FDA (as applicable) definitions for research and human subject, and are therefore treated similarly in the human subjects research review process. It is important to remember that FDA-regulated research has a different definition of human subject that can include de-identified specimens. There may be additional laws, rules, processes, and required protections for the use of data vs. specimens to be considered (e.g., FERPA, HIPAA, GINA, IBC, etc.).

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In certain, limited circumstances, the secondary research activities may be adequately anticipated and described in the informed consent obtained for the data and/or specimen collection, and further informed consent or waiver is not required. However, in cases where the additional research is not sufficiently addressed in and “covered” by the previous consent process, then the IRB must either approve a new consent process or a waiver of the informed consent process.

Additional notes: Except in cases in which additional consent will be obtained for the secondary research, the proposed research activities must be “consistent” with the original consent process for the IRB to consider the waiver request.

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What is the difference between the terms coded, de-identified, and anonymous?

  • Coded: Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s); but the original identifiers are retained in such a way that they can be traced back to the source(s) by someone with the code. Note: A code is sometimes also referred to as a “key,” “link,” or “map.”
  • De-identified: All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). Note: For purposes of HRPP policy, protected health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule).  For more information, including the list of identifiers that must be removed to de-identify health information, see HIPAA and Human Subjects Research.
  • Anonymous data: Unidentified (i.e., personally identifiable information was not collected, or if collected, identifiers were not retained and cannot be retrieved); information or materials (e.g., data or specimens) that cannot be linked directly or indirectly by anyone to their source(s).

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I am a new Ohio State investigator.  How do I transfer my human subjects research materials to Ohio State from my former institution?

The answer to this question can vary based on project specifics. There may be many possibilities, including seeking Ohio State IRB approval or exemption, ceding review, or determining that remaining activities no longer require review. ORRP staff can assist new investigators in determining Ohio State human subjects review requirements for their ongoing research. Requests to discuss potential requirements and options can be emailed to ORRPDeterminations@osu.edu or by calling the ORRP front desk at 614-688-8457.

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I am receiving de-identified or coded data and/or specimens from an external bank/repository.  Do I need IRB review or exemption at Ohio State?

It depends on the specifics of the project. The following elements can drastically change review requirements in projects utilizing de-identified materials: the role of the providing institution’s personnel, the providing institution’s review requirements, whether the work is FDA-regulated, and whether Ohio State uses federal funds to support the work.

Below are the five possible scenarios and the associated review requirements. Note: it is assumed that the materials are from living individuals or individuals of unknown status; that the collaborating institution has an FWA/IRB; and that the terms de-identified and coded are defined according to HRPP policy:

Scenario 1

Ohio State IRB approval is needed and external IRB approval may be needed:

  • The research is FDA-regulated. FDA-regulated research involving data/specimens from living individuals or individuals of unknown status, always requires IRB review.

Scenario 2 

No Ohio State or external IRB approval is necessary:

  • The research is NOT FDA-Regulated.
  • External personnel are *NOT* engaged in the research because their only role is to provide de-identified materials (e.g., no authorship credit, no data analysis, etc.).
  • Ohio State personnel only receive de-identified materials, and the material transfer agreement (MTA) and/or data use agreement (DUA) between Ohio State and the external institution states that Ohio State personnel will never be provided with identifiers.
  • In this example, it does not matter whether or not Ohio State receives federal funding to support the project.

Scenario 3 

No Ohio State or external IRB approval is necessary:

  • The research is NOT FDA-Regulated.
  • External personnelare given authorship credit and/or assist in data analysis, but their institution determines that the project does not require IRB review or an amendment to a currently IRB-approved project (e.g., project is exempt at the external site, or the bank can act as an honest broker to the external investigators involved, etc.).
  • Ohio State personnel only receive de-identified materials, and the MTA/DUA between Ohio State and external site states that Ohio State personnel will never be provided with identifiers.
  • In this example, it does not matter whether or not Ohio State receives federal funding.

Scenario 4

No Ohio State IRB approval is needed, however external site IRB approval is necessary:

  • The research is NOT FDA-Regulated.
  • External personnel are engaged in the research (e.g., given authorship credit, assist in data analysis, etc.) and their institution determines that they are engaged in non-exempt human subjects research (e.g., they need to amend their current IRB-approved project to include the work, or they need to submit a new IRB-approved protocol).
  • Ohio State personnel only receive de-identified materials (or coded materials that are not identifiable), and the MTA/DUA between Ohio State and the external site states that Ohio State personnel will never be provided with identifiers or links to the codes.
  • Ohio State is *not* using federal funds to support the research.

Scenario 5

Ohio State IRB and external IRB approval is necessary:

  • The research is NOT FDA-Regulated.
  • External personnelare engaged in the research (e.g., provided authorship credit, assist in data analysis) and their institution determines that they are engaged in non-exempt human subjects research (e.g., they need to amend their current IRB-approved project to include the work, or they need to submit a new IRB-approved protocol).
  • Ohio State personnel only receive de-identified materials.
  • Ohio State *is* using federal funds to support the research. Note: If Ohio State is the primary awardee of a project involving non-exempt human subjects research, Ohio State IRB review is required, even if Ohio State investigators only receive de-identified materials from the external site.

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My research project involves data and/or specimens from living individuals or individuals of unknown status and is FDA-regulated.  What review type is required?

IRB review is required.

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Do I need IRB review or exemption if I am purchasing materials from a commercial entity?

No, except when the research is FDA-regulated.  As long as the research is not subject to FDA regulations (which includes in vitro diagnostic device development/testing and data collection for reports/ applications to the FDA), and the materials are not otherwise restricted from use in the state of Ohio, then no human subjects research review is required to use commercially available materials.  You may still need to obtain other approvals and/or agreements, as applicable (e.g., IBC, IACUC, material transfer agreements, purchasing agreements, etc.).

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Do I need IRB review or exemption if I am receiving materials from a public database or registry?

No, as long as the source is truly publicly available (i.e., available to anyone on request, without qualification or restriction). If receiving a restricted version dataset or a dataset not considered publicly available, then review may be required if the data is considered identifiable or potentially identifiable. Materials are considered individually identifiable when the identity of the participant is or may readily be ascertained by the investigator or the investigator’s staff, or associated with the information. Note: Individually identifiable for the purposes of HRPP policy may be similar to, but is not the same as, individually identifiable health information or protected health information as defined by the HIPAA Privacy Rule at 45 CFR Part 160. Limited data sets released from data repositories with IRB approval to release such data sets are not considered to be individually identifiable.

If an investigator is unsure if access to a specific dataset for research purposes requires review, a determination from ORRP can be requested by sending an email to ORRPDeterminations@osu.edu.

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I have left-over or existing materials from a research project.  Can I de-identify them and share them with other investigators?  Can I de-identify them and use them myself for other work?

No. An investigator may not de-identify data and/or specimens under his or her control (such as materials collected by the investigator for another study) in order to share them with others or use them for future research without IRB review and approval.

Secondary (i.e., “new”) use of materials obtained for primary research purposes by an investigator with IRB approval (or exemption) requires either IRB review of an amendment or a new protocol describing the proposed secondary use, depending on the previous approval (or exemption) and the new research objective. Informed consent may also be required for this new use, depending on the scope of the original consent and the newly proposed research.

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It depends. In certain circumstances outlined below you may be able to extend the date range.

Exempt Studies:
Exempt category #4 requires materials to be existing, or “on the shelf,” at the time (or before) the research is submitted for an exemption determination; therefore, the date range cannot be extended to include materials that have come into existence since the original exempt application submission. Serial applications or amendments (i.e., intending to submit a new application or amendment at the end of each year to obtain the year’s data) are not permitted under exempt review. If investigators need to adjust the date range to collected data that was not in existence when the original exempt application was submitted, then an application for IRB review is required. The IRB will decide if additional collection under waivers of consent and/or HIPAA authorization is appropriate.

Investigators can, however, submit a new application for exemption that goes further back in time from the original submission (e.g., the current approved date range includes materials that came into existence between 09/01/2010 – 09/01/2016, and the new proposed range includes materials that came into existence between 09/01/2005 and 09/01/2016).

IRB-reviewed Studies:
Investigators can submit an amendment request to collect materials that goes further back in time from the original submission (e.g., the current approved date range includes materials that came into existence between 09/01/2010 – 09/01/2016, and the new proposed range includes materials that came into existence between 09/01/2005 and 09/01/2016). However, in general, to extend the date range of data/specimens to be collected under waivers of consent and HIPAA authorization to include materials that were not yet in existence at the time of original review, a onetime exception can be approved when investigators can provide valid justification for the request.

Examples of acceptable justification:

  • A journal requested additional data be collected
  • After analyzing the data, unexpected results require additional collection. Provide the specific explanation (e.g., after collection and preliminary analysis, there were fewer individuals who actually met the inclusion criteria than originally expected, so additional data collection is needed)

Investigators must provide a specific rationale for expanding the collection of materials under waivers of consent and, where applicable, HIPAA authorization in the “Supplemental Questions” section of the Buck-IRB amendment request form.

For continued, prospective collection or for future, additional requests to expand the range when a one-time expansion has already been granted, investigators should be prepared to submit a plan/materials for obtaining consent and HIPAA authorization (as applicable).

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A project involves deception when an investigator gives false information to, or otherwise intentionally misleads, a research participants about some key aspect of the research to avoid biased responses. If participants will be given false information or otherwise misled during a study, then the participants are not provided with all of the required elements of informed consent and IRB approval for a waiver or alteration of informed consent is required. Examples include:

  • Participants are told they scored poorly on a writing assignment completed as part of a study (regardless of how well they actually did) to see how that information influences their performance throughout the remainder of the study.
  • The study involves confederates (individuals who appeared to be research participants but who are actually part of the experiment) who act to manipulate the participant or their environment as part of the study (e.g., Asch’s study of conformity).

A project involves incomplete disclosure when an investigator withholds or conceals information from a participant about the specific purpose of, or activities involved in, the research. Not all incomplete disclosure requires a waiver or alteration of consent; however, if material information or aspects are withheld that could potentially influence the decision of prospective participants to take part in the research, then the participants are not provided with all of the required elements of informed consent and IRB approval for a waiver or alteration of informed consent is required. Examples include:

  • A study is vaguely described as a simple economics game to study decision-making in pairs. Participants are not informed that their interactions are actually being recorded and that people are paired according to race in order to study interracial interactions and body language.
  • Participants are only told that they are participating in a simple survey of knowledge, when actually the information contained in the survey is meant to be an intervention/catalyst to see if it causes the participants’ behavior to change between two time points or causes them to take a certain action based on the survey information.

Debriefing is often required when the research involves deception or involves incomplete disclosure of material information/aspects related to the research purpose or activities. In general, the debriefing will explain any deception or incomplete disclosure, provide information about why it was necessary to use deception or incomplete disclosure in the research, and provide other options available to participants (e.g., the ability to withdraw their data). Debriefing is not always required when researchers can provide the IRB with adequate justification for why debriefing is not appropriate.