Chapter 3 – Your Project Requires Review
What you are proposing is human subjects research, but now what?
- Exempt categories
- Additional information regarding exempt research
- How is exempt research reviewed at Ohio State?
3.3 What is involved in IRB review?
3.4 What is expedited review?
3.5 How is expedited research reviewed at Ohio State?
3.6 What is convened (full board) review?
3.7 How is convened research reviewed at Ohio State?
3.8 What Ohio State research is sent to Western IRB for review?
3.9 What is the process for WIRB review?
Projects that involve human subjects research may receive one of the following three types of review: exempt, expedited, or convened (full Board) review, as explained below. Studies involving minimal risk (or less) will generally receive exempt or expedited review. For studies that involve greater than minimal risk, IRB review by the full Board will be conducted. Student investigators should consult with their faculty advisors or ORRP staff if they are unsure of which review is required.
Exempt research is research involving human subjects that is “exempt” from the requirements for initial and continuing IRB review and other provisions of the federal regulations. For research to be exempt, it must also fit into one (or more) of the categories described below.
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 1 exemption is limited to the study of “normal” educational practices conducted in commonly accepted settings such as elementary, secondary and post-secondary schools. Exemption does not apply to normal educational practices occurring outside of the traditional setting for those practices. Also, radically new forms of instruction, randomization of participants, and/or deception are not considered normal educational practices and cannot be considered for exemption. Physical education studies cannot be considered as exempt if the study involves exercise that has been altered for the purposes of the research. In addition, elements of risk may preclude exemption and necessitate IRB review (e.g., if there is intense exercise involved).
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Note: The exemption under Category 2 does not apply to research involving survey or interview procedures or observation of public behavior when children are the subjects of the activity, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
If the data collected could harm participants in any way, additional measures to protect confidentiality of the data are required, and such research will generally require IRB review. For example, questions regarding sexual preference or illegal behavior could reasonably place subjects at risk if responses were known, and therefore, cannot be exempt from IRB review if there is any way to identify the respondents. This kind of research should include an unsigned consent form (or recruitment script or letter) that clearly describes the risks of the research. In some studies, even when the data collected are anonymous the potential for social stigma of an identifiable group can make IRB review a requirement. Surveys that contain invasive questions that may cause participants to experience emotional distress or discomfort while answering are also not exempt from IRB review, even if the data are collected from participants who remain anonymous. Research employing cognitive or diagnostic tests is not exempt if the testing is psychologically invasive and could potentially cause the participants some discomfort or distress.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2, IF the human subjects are elected or appointed public officials or candidates for public office, OR federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Exempt category 3 represents an extension of exempt category 2, but without the same level of oversight of the participants’ right to privacy. Category 3 is used for public officials and candidates for public office or when a federal statute protects confidentiality when personal identifiers are maintained.
Research, involving the collection or study or existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
- Existing refers to the date of exempt determination. The data, documents, etc. must be in existence (i.e., “on the shelf”) before the study is determined to be exempt from IRB review. Data or specimens that come into existence after the date of exempt determination cannot be included in exempt research.
- Publicly available refers to materials that can be accessed by anyone, without special permission. If data are not publicly available, then it is considered private information.
Research involving data or specimens is exempt under Category 4 when the data/specimens obtained from private sources are in existence before the research is proposed, provided that the information is recorded by the investigator without subject identifiers or codes that can link the data/specimen to its sources (persons). Proposed use of private data that have not yet been generated or collected (i.e., not existing) is not exempt and requires IRB review. If the study involves some data or specimens that are existing and some that are not, the project also requires IRB review. Similarly, research is not exempt when it involves privately held data/specimens that retain linked codes that could identify the subjects. Activities involving use of publicly available data (regardless of whether the subjects are identifiable) or data/specimens from decedents are not human subjects research. Note: Data or specimens obtained from a repository or bank are generally not considered to be publicly available.
When Data or Specimens Include Protected Health Information (PHI)
Access to protected health information requires specific permission for its use (i.e., HIPAA authorization) from the individual whose PHI is accessed for research purposes, or a waiver of authorization granted by the Privacy Board. Requests for waiver of HIPAA authorization are reviewed by The Ohio State University Privacy Board, following a determination that the research is exempt. To be considered “de-identified” under the HIPAA Privacy Rule, 18 identifiers – including identifying dates (e.g., date of birth) and zip codes – must be removed from the recorded data. Exempt research involving PHI must meet the requirements of both human subjects protection regulations and the HIPAA Privacy Rule regarding identifiable information.
Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: public benefit or service programs; 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.
Category 5 is allows research on public benefit or service programs such as welfare, unemployment, Medicaid, and Social Security. The research is performed at the request of or with permission of a federal agency. Exempt category 5 allows the use of coded and/or identifiable data that are routinely compiled by the public office that administers the program even though the participant might consider the data private. Vulnerable populations, such as children or decisionally impaired adults, may be studied in category 5. It is essential that data be well protected against breaches of confidentiality. All ethical considerations still apply when dealing with participants.
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 US Department of Agriculture.
Exempt category 6 is limited to taste and food quality evaluation studies that do not involve consumption by the participant of any type or volume of food that has any potential risks, such as indigestion or vitamin deficiencies. The consumption of food should constitute reasonable eating behaviors. Studies that involve consumption of alcohol or vitamins or supplements such as protein powder, creatine, and glucosamine chondroitin sulfate do not qualify as exempt studies.
At Ohio State, research meeting any of the following conditions will receive IRB review (regardless of whether the research would otherwise be exempt):
- Research involving prisoners (with the exception of emergency uses)
- Research that is greater than minimal risk, involves coercion, undue influence, deception, or any practice that does not follow the ethical principles described in the Belmont Report
- Research in categories 1-5 (even if it would otherwise qualify for exemption) that is subject to FDA regulations.
Exempt research requires submission of an exempt application. A designated ORRP Protocol Analyst will review the completed application and associated materials (e.g., recruitment script, data collection form, etc.) to determine if the research fits one (or more) of the categories described above and will notify the PI of the results of the review. The PI will receive email notification that:
- The research is exempt and may be conducted without IRB review, indicating the category under which the determination was made; or
- The research is not exempt and requires IRB review, with an explanation as to why the proposed study does not meet the exempt criteria; or
- The proposed activity is not research involving human subjects and may be conducted without further IRB review or exemption.
On average, requests for exemption are reviewed and determinations made within five to seven business days of receipt of a complete application. When the use of protected health information in exempt research is proposed, subsequent review by the Privacy Board is required. Up to two additional weeks may be required for Privacy Board review. Research activities may not begin until documentation of the exempt determination is received and, when applicable, notification that waiver of HIPAA authorization was granted by the Privacy Board.
Exempt research projects do not “expire” and do not require continuing review. Exempt studies are to be conducted as proposed. To ensure that revisions continue to meet the exempt criteria, a new application for exempt determination is required prior to initiating any changes in the research. If a project is changed in such a way that it no longer meets exemption criteria, IRB review and approval will be required.
For more information, see HRPP policy Exempt Research.
In accordance with OHRP and FDA requirements, the IRBs review human subjects research proposals before research is conducted to ensure that risks to potential participants have been minimized and the potential for benefit has been maximized. The IRB also ensures, when applicable, that human subjects will only participate in research after providing legally effective informed consent. Investigators may not solicit participants or begin data collection until obtaining approval from the appropriate IRB or documented concurrence that the research is exempt.
To approve a given research project, the IRBs must make the following (regulatory) determinations:
- Risks to subjects are minimized: (i) by using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).
- Selection of subjects is equitable. In making this assessment the IRB takes into account the purposes of the research and the setting in which the research will be conducted, as well as any special concerns or regulatory requirements when the research involves vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116 and 21 CFR 50.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117 and 21 CFR 50.27; or, if requested, that the research meets the requirements for any waivers or alterations.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Upon review, the IRB will notify investigators of one of the following actions:
Approval – The application is complete, risks to participants are minimal or minimized, and the procedures are appropriate. The IRB gives approval for the research to be conducted.
Modifications Required – The application is complete, but there are administrative or minor issues/changes that must be addressed before the project is approved. A letter detailing these required modifications will be sent to the principal investigator. Upon satisfactory response to the contingencies, following IRB review and approval, the investigator will be notified that the research may be initiated.
Deferred –Applications that are found to have deficiencies (unreasonable risk to participants, unclear procedures, serious omissions, ethical issues, or major contingencies) will be deferred. Note: Questions or unresolved issues involving the regulatory criteria for approval described above will result in deferral. The investigator is sent a memorandum listing the concerns that must be addressed for review to proceed. The investigator’s response is reviewed by the IRB and can be approved, require modifications (as above), or be deferred again until all issues are satisfactorily addressed.
Disapproval – Applications that are found to have risks outweighing the potential benefits to participants and/or society will be disapproved, and the research will not be approved. This action can only be taken by the full Board at a convened meeting, and investigators will be sent a rationale for the disapproval. An investigator may request that the IRB reconsider the disapproval, but institutional administrative officials may not override this decision.
Federal regulations specify conditions under which research may be reviewed by the IRB using “expedited review procedures.” Under the expedited review procedure, IRB review is carried out by the IRB Chairperson or by one (or more) experienced IRB member(s) designated by the Chair. Note: When performing expedited review, a reviewer may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The standard IRB application, requirements for protocols, recruitment materials, informed consent (or its waiver, alteration, or exception), etc., apply regardless of the type of review performed – expedited or convened.
Research activities that meet both of the following conditions may be reviewed using expedited review procedures:
- The research presents no more than minimal risk to human subjects, AND
- The research involves only procedures listed in one or more of the allowed categories below (Note: Categories 1-7 apply to both initial and continuing IRB review):
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period, and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period, and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation)routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications).
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the DHHS regulations. This listing refers only to research that is not exempt.)
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the DHHS regulations. This listing refers only to research that is not exempt.)
- Continuing review of research previously approved by the convened IRB as follows:
- Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- Where no subjects have been enrolled and no additional risks have been identified; or
- Where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption, where categories 2 through 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Note: The specific circumstances of the proposed research must be considered when determining whether an activity listed above involves minimal risk.
The expedited review procedure may not be used for:
- Research where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are not greater than minimal.
- Classified research involving human subjects.
Pre-screening by ORRP staff includes a preliminary determination about whether the application meets the criteria for exempt, expedited, or convened review. If the research qualifies for expedited review, the IRB Chair and/or a designated experienced IRB member will review the submission. The IRB member(s) will complete the review and take action outside of the convened IRB meeting. The reviewer may approve the research, require modifications in the research before approval, or refer the submission to the full Board for further review. A protocol is referred to the full Board when the reviewer believes that the research does not meet the criteria for expedited review or approval. Investigators may not begin research activities until documentation of IRB approval is received. The expedited review process (from submission to approval) takes an average of 4 to 8 weeks.
For more information, see HRPP policy Expedited Review Procedures.
Projects that involve more than minimal risk, do not fit into one or more of the specified categories, or otherwise do not meet the criteria for expedited review must be reviewed by the full Board at a convened meeting where a majority of the IRB membership is present, including at least one member whose primary interests are non-scientific.
Examples of projects requiring review by the full Board include the following:
- Studies involving investigational drugs or devices
- Studies involving x-ray, surgery, or other medical procedure requiring general anesthesia or sedation
- Studies including information that may be disclosed requiring mandatory legal reporting (e.g., child/elder abuse, HIV infection, etc.)
- Studies involving deception, when withholding information or debriefing raises the risk level of the study beyond minimal
- Studies involving populations requiring additional protections because of cultural, economic, or educational vulnerability
- Studies performed in populations different from the one(s) in whom risks have been identified and the possibility of unknown or increased risk exists (e.g., studies in children involving drugs previously tested only in adults).
Pre-screening by ORRP staff includes a preliminary determination about whether the application meets the criteria for exempt, expedited, or convened review. If the research does not qualify for exempt or expedited review, the protocol will be added to the next available meeting agenda, assigned to IRB reviewers, and materials will be delivered to all IRB members for review prior to the convened meeting date. A primary IRB reviewer is responsible for presenting the proposed research to the Board at the convened meeting. All members can review the submission materials – including (but not limited to) the application, recruitment materials, informed consent documents, and data collection instruments – and participate in the review and discussion of the proposed research at the meeting. Consultants may also be invited to assist in the review of research where additional expertise is necessary. After the meeting, minutes are drafted by ORRP staff and approved by the IRB Chair before Board actions are communicated to investigators. The convened review process (from submission to approval), on average, takes from 8 to 12 weeks.
For more information, see HRPP policy Review of Research by the Convened IRB.
For Board-specific meeting schedules, see Meeting Dates.
The Western Institutional Review Board is a commercial IRB under contract with The Ohio State University to review and monitor Ohio State research projects that are industry-sponsored and industry-initiated. The proposed research must also meet the NIH definition of a clinical trial:
A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices) NIH Glossary of Terms for Human Subjects Protection.
According to this definition, biomedical research involving drugs, treatments, and devices, and behavioral research involving an intervention to modify behavior (e.g., diet, physical activity, cognitive therapy) are considered clinical trials. Also, studies to develop or evaluate clinical laboratory tests, such as imaging or molecular diagnostic tests, can be considered clinical trials if the test will be used for medical decision-making for the participant or the test itself imposes more than minimal risk. “Sub-studies” of clinical trials are also sent to WIRB for review.
The following types of studies are not sent to WIRB for review, even if these projects would otherwise fit the definition of a clinical trial:
- Planned emergency research
- Human xenotransplantation
- Gene transfer research
- Embryonic stem cell
- “Registries” involving access to Ohio State data and/or PHI
- Federally funded research (in whole or part)
To submit proposed research to WIRB, the Ohio State University Application for Protocol Review by WIRB should be forwarded to ORRP with all other required materials (e.g., WIRB application, protocol, recruitment materials, informed consent documents, investigational brochures, data collection instruments, etc.). Investigators must also meet university requirements to serve as PI on a research project reviewed by WIRB. Pre-screening by ORRP staff includes a determination about whether the application meets the criteria for WIRB submission, confirming that all investigators and key personnel have received appropriate training in human subjects research, and verifying that the consent form language meets university requirements. ORRP staff will fax a signed Authorization Form to the PI upon verification. After Ohio State authorization is given, the PI can submit protocol materials and the signed Authorization Form to WIRB. Materials submitted to ORRP will be kept on file by ORRP.
ORRP staff screen applications usually within two business days of submission. Timelines for Western IRB review vary. WIRB will notify the PI of its decision and will provide copies of all regulatory documents to the PI, sponsor, and ORRP. Note: Charges for WIRB review are based on a fee schedule maintained at WIRB, which varies depending on the type of review (initial, continuing review, amendment, etc.). For questions about WIRB submission requirements or to obtain WIRB’s current fee schedule, contact ORRP.
The Ohio State University Application for Protocol Review by WIRB can be found at WIRB – ORRP.