All research activities involving human subjects must be reviewed and approved by an Institutional Review Board (IRB) unless the research falls into a category of exemption established by federal regulation. Detailed information can be found at the United States Department of Health and Human Services, Office for Human Research Protection website: http://www.hhs.gov/ohrp/. A glossary of frequently-used IRB terms may be found here.
In accordance with FDA regulations, the Ohio Department of Health's (ODH) IRB reviews human subject research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research. The ODH IRB also ensures, when required, that human subjects only volunteer to participate in research after providing legally effective informed consent.
Investigators may not solicit subject participation or begin data collection until they have received approval from the appropriate IRB or written concurrence that research has been determined to be exempt from IRB review.
All standard applications to the IRB for review must include the items listed below. Please follow the links for the form and additional information:
- IRB Application Form
- Research Protocol (Study Proposal)
- IRB Curriculum Vitae Form for all researchers handling data
- The applicable Confidentiality Form for all researchers handling data
- ODH Confidentiality Form – For data from ODH Programs (except OCISS)
- ODH OCISS Confidentiality Form – For data from the ODH Ohio Cancer Information Surveillance System (OCISS)
- Generic Confidentiality Form – For data collected from other sources
5. Consent Form Checklist - For protocols using assent and/or consent forms
Expedited review is the process by which a protocol can be reviewed and approved by the ODH IRB Chair instead of going to the full board for approval. It only occurs in the rare circumstance that a protocol meets all the State and Federal qualifications for such review. Even then, some exclusions may apply. The final decision of whether a protocol qualifies for expedited review lies with the Chair.
Please Note: Applying for expedited review will not speed up the review process if you do not meet the qualifications.
The qualifications, requirements and form for expedited review can be found here.
Exemption review is the process in which a protocol is determined to not require the approval of the ODH IRB. To meet that requirement, the research must meet at least one of the Federal qualifications. Even then, some exclusions may apply. The final decision of whether a protocol qualifies for exemption lies with the Chair.
The qualifications, requirements and form for expedited review can be found here.
Changes and Renewal Applications
All ODH IRB approvals are good for one year from the data of issue. All changes to approved protocols must receive IRB approval before being implemented. All protocols must be renewed if the work will extend past the one-year approval period.
The requirements and form for changes and renewals can be found here.
Frequently Asked Questions
Under what circumstances do I need to apply for approval by the ODH IRB? You need to apply to the ODH IRB if you are conducting human subject research which, directly or indirectly, involves the State of Ohio, its agencies or instrumentalities, as well as local governmental entities over which the ODH IRB has accepted jurisdiction.
Can the ODH IRB review my protocol if it doesn’t meet the criteria above? No, Unfortunately, the ODH IRB cannot review protocols that fall outside of their jurisdiction.
Is there a fee for ODH IRB review? No, we do not charge a fee for our review.
We’re still in the process of designing our project. Can we go ahead and submit now so we can get started as soon as we’re ready? No, you shouldn’t submit until your research is fully designed. The ODH IRB needs to be able to see the final versions of all the documentation related to your protocol, including any surveys, scripts, evaluations or other materials you plan to use. If you make any changes to these documents after you receive IRB approval, you’ll have to submit a change request. Depending on the change, it may need to go back to the full board, which will delay your research. It’s better in the long run to wait and submit once everything is as complete as it can be.
Can I apply for IRB review on a project that’s already underway? No, unfortunately, we cannot review or approve any projects once they’ve been started. IRB review must be obtained before any work is begun.
I work at a university and need to obtain my institutional IRB’s approval as well as ODH’s. Which should I get first? We recommend you get the approval from your institution first and then apply to ODH.
I only plan to do research with existing data. Does that mean my research doesn’t have any human subjects? No, your research still has human subjects. Each piece of data you’re using represents the life of a real person, whether you interact with them directly or not.
What happens to applications after they’re received? Please review the flow chart available on our website for the complete step-by-step process.
How often are ODH IRB meetings held? The ODH IRB meets on the fourth Tuesday of every month, except for a combined November-December meeting that occurs on the first Tuesday of December.
Why is the ODH IRB so much stricter than other IRBs? The ODH IRB, as a public government entity, holds itself to the highest standards as guardians of the public’s trust. Sometimes our requirements exceed those of other organizations to ensure the privacy and safety of all Ohioans.
My research is going to take several years to complete. May I keep my data indefinitely? ODH IRB approvals are good for one year from the date of issue. You may apply for renewals for as many years as your research requires, but we cannot provide blanket authorization to keep data indefinitely.
I received data as part of a previously-approved protocol. Can I use it for other research purposes? No, you may not use data except for the research that has been approved. Depending on the situation, you will either need to submit an amendment to your previous protocol or a new application. This will be determined by whether the new research is an extension of the approved protocol or if it’s a new project.
What is the deadline for submissions? For January through October, the deadline is close of business on the second Tuesday of the month. For the November/December combined meeting, the deadline is the third Tuesday in November, to allow processing and review time around the Thanksgiving holiday.
Is there any benefit to submitting prior to the deadline? Yes, absolutely! Submissions are reviewed upon receipt. If any documents are missing or corrections are needed, this will give you time to make those fixes in time for that month’s meeting. Documents that are received on the deadline may be held back until the next month if they are incomplete or in need of corrections.
Why is the ODH IRB Administrator suggesting changes to my application before the board has seen it? The ODH IRB administrator has years of experience with the IRB approval process. Making the suggested changes will greatly improve your chances of a positive experience.
I’ve made the revisions you asked for. Should I resend the whole packet or just the documents I changed? Please only send documents that are new or have been revised. Everything you’ve sent has already been added to your file. Sending it a second time will slow down the processing of your application.
I thought the ODH IRB used to be able to take submissions up until one week before the meeting. What changed? The ODH IRB has seen a significant increase in the volume of applications. In the past, we had the time and open slots on our agenda to accept late arrivals. Unfortunately, this is no longer the case.
What if I have a genuine emergency and need to submit it late? The ODH IRB executive team will review emergency submissions on a case-by-case basis. If it is deemed that 1) there is a true emergency, 2) the delay in applying could not be avoided, and 3) a delay would cause irreversible harm, then every effort will be made to put the protocol on the current month’s agenda.
Do I need to be present at the meeting when my application is being reviewed? No, we do not require researchers to be present during our meetings, nor will failing to do so count against you in any way. You may request an opportunity to make a presentation to the IRB. A request to present will be evaluated in light of 1) the complexity of the project, 2) the preferences of the members, and 3) the time available on the schedule.
What can I expect if I do attend the meeting? We will ask you to give a very brief (five minutes at most) verbal description of your research. The board members will ask you any questions they have and then you will be asked to leave the room while your protocol is discussed. All notifications will be provided in writing.
How soon after the meeting will I get a response? Notifications are generally sent out within 48 hours.
Application Forms and Attachments
How much time and effort do I need to put into completing the application form? Your application form should provide enough detail to clearly answer every question being asked. Remember, the board members only know what you tell them about your research. We will return any applications which are not thoroughly filled out.
Can I just cut and paste the information from my research protocol into the application form? Technically, yes, but we would prefer that you take the time to craft your responses to match our application form. Please keep in mind that the answers on the application form should be more concise and written for a lay person to read. The research protocol should provide greater details about your intended methodology for collecting and analyzing the data.
On the application form question 15b, it asks about participant populations. Which of these boxes do I need to check? You need to check the boxes for all groups which could possibly be included in your survey. You need to consider whether any of your population may be economically or educationally disadvantaged, a prisoner, a ward of the state or an individual with impaired decision-making capacity. If it’s possible, even if you aren’t specifically targeting that population, you should still check the box. The only exception would be if your study is specifically excluding those populations. If so, that information should be provided in the answer to 15d.
On the Application form question 17, it asks about incentives. What incentives are allowable? Technically, you may offer any incentive that you wish. However, we strongly recommend that you keep your incentives to nominal cash amounts or gifts. High dollar or high value incentives may coerce people to participate against their better judgement. We do not want people to risk harming themselves or their children for the sake of earning extra money or gifts.
What is the difference between application form question 19b, which asks about personally identifiable private information, and question 21, which asks about individually identifiable protected health information? Question 19b refers to personally identifiable information (PII), or sensitive personal information (SPI), as used in information security and privacy laws. This is information that can be used on its own or with other information to identify, contact, or locate a single person, or to identify an individual in context.
The federal government defines PII as "any information about an individual maintained by an agency, including (1) any information that can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, or biometric records; and (2) any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information."
Question 21 relates to protected health information (PHI) that is subject to the HIPAA privacy rule. This rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.
“Individually identifiable health information” is information, including demographic data, that relates to the individual’s past, present or future physical or mental health or condition; the provision of health care to the individual; or the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual. Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number).
On the Application form question 20e, it references the ODH small cell size policy. What is that and why is it important? The small cell policy is intended to prevent the publication of data which could be used to identify the subject it’s derived from. More information can be found about our policy on our website. Your application must acknowledge that you understand our policy and will abide by its terms, even if your research uses deidentified information or a very large data set.
On the Application form question 23b, it asks “Describe how risks, harms, and/or discomforts will be minimized”. What does that mean? All protocols should include information on how you will keep the data secure and prevent it from being linked back to the individuals. If you are working directly with subjects and asking questions of a sensitive nature, you must also provide for interventions to mitigate any emotional distress caused by the research or to report abuse or other illegal activities to the proper authorities.
What type(s) of signature are acceptable for the assurance of the principal investigator, question 27? We can accept a handwritten signature or an electronic signature. If you have a handwritten signature, you may just scan in that page and submit it separately with the rest of the application packet. If you have an electronic signature, it must be clearly marked in some way as being official. We cannot accept it if it’s simply a name typed on the line.
What’s the difference between “consent” and “assent” forms? Consent forms are used for participants 18 years of age and older, unless they are in the care of a legal guardian. Assent forms are for minors and anyone else not legally able to sign on their own behalf. If you are working with these populations, you need to obtain both an assent from the subject and a consent form from their parent or legal guardian.
What language needs to be included on consent/assent forms? Please refer to the Consent Form Checklist for more information on consent form requirements.
What happens if my institution’s requirements for the consent form are counter to the preferences of the ODH IRB? If your institution requires you to use a boilerplate consent form, please include a copy of the original boilerplate language template and fill out the contact information on the Consent Form Checklist. We will work with the institution to try to find a solution that will work for both parties.
What is a research protocol? Is it the same as the application form? A research protocol is not the same as your application form. The research protocol is a scientific document that spells out the processes you intend to use in your research. It should provide more detail than your application form. Research protocols generally include the following: a hypothesis, specific aims, scientific justification, methodology, populations, data collection, data security, and time frame.
What groups of people fall under “vulnerable (or protected) populations”? Why are they treated differently? Vulnerable (or protected) populations are those people who are most at risk of being exploited or pressured into participation without their full consent. These categories are established by the Federal guidelines to ensure that they receive the highest possible protection from harm. The current list of vulnerable populations includes children, prisoners, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons.
Who needs to fill out the data user agreements (confidentiality forms)? The data user agreements should be filled out by the principal investigator and any other researchers who will be working with data that has not yet been de-identified or aggregated.
Which data user agreement/confidentiality form should I fill out?
If you’re requesting data from the OCISS dataset at ODH, use: OCISS Researcher DUA
If you’re requesting data from any other ODH or ODH-affiliated programs, use: IRB Confidentiality Form
If you’re requesting data from other sources or only gathering new data, use: IRB Confidentiality Form - Generic
I’m collecting my own data. Do I still need to fill out a data use agreement/confidentiality form? Yes, we still need written assurance from you that you will protect the data you’re collecting. As listed above, please use the IRB Confidentiality Form - Generic form for this purpose.
May I alter the language on the data use agreement/confidentiality form? No, these are standardized forms and may not be altered. If you or your legal department has concerns about the wording, please contact the IRB administrator to discuss.
What can I do to ensure that my application has the best possible chance of being approved?
- Complete the application thoroughly. Proofread it to make sure that there are no conflicting statements. Make sure all relevant questions are answered with enough detail for the board to understand your processes.
- Provide all the required documentation (research protocol, CV forms, and signed data user agreements) as well as any other documentation required for your particular protocol.
- Submit your application packet at least one week prior to the due date to ensure ample time for review.
- If necessary, make all changes suggested by the IRB administrator and return by the deadline.
Should I mail in hard copies or submit electronically? What format should I use? We prefer to receive all applications electronically through our email box: email@example.com. We ask you to consolidate documents where possible into the fewest number of attachments, particularly with CVs and data user agreements. We can accept both Microsoft Word documents and PDFs.
Do I need to fill out the CV form on your website? Can I just send you my existing CV instead? In general, we prefer the CV form because we only require a brief snapshot of your most relevant work experience. You may submit a biographical sketch or an existing CV in its place, but please edit it down to six pages or less.
Expedited and Exempt Applications
What is the difference between expedited review and exemption? Expedited review means that the protocol falls under the jurisdiction of the IRB but meets the qualifications to be approved by the board chair without a vote by the full board. Exemption means that the research does not require any IRB approval to continue. Exemptions are generally requested because a funding institution requires proof that the researchers have contacted the appropriate IRB before beginning their work.
What kinds of applications qualify for expedited approval? To qualify for expedited review, the following conditions must be met. There are exceptions to these rules and even protocols that meet all of these conditions may not qualify for expedited review. The final decision of whether a protocol qualifies for expedited review lies with the ODH IRB Chair.
- The research doesn’t involve more than "minimal risk". "Minimal risk" means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102(i) and 21 CFR 56.102(i)).
- The research subjects do not come from any of the following protected classes (minors, adolescents, fetuses, wards of the state, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons).
- The research falls under one of the expedited review categories listed on the ODH IRB Expedited Review Form.
Are all requests for existing data sets eligible for expedited review? No, not all existing data sets qualify for expedited review. To qualify under Category 5, the data must meet all the above criteria AND have been collected solely for non-research purposes (such as medical treatment or diagnosis). Data collected as part of any other research project doesn’t apply.
What kinds of applications qualify for exemptions? Two kinds of research can qualify for exemptions, although there are exceptions to these rules. The final decision of whether a protocol qualifies for exemption lies with the ODH IRB Chair.
- Research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (1) information obtained is recorded in such manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (2) 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.
- Research involving the collection or study of 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.
Do I need to fill out a full application form even if I’m requesting an exemption or an expedited review?
Expedited Review requests must include a full application form, research protocol, CV forms, signed data user agreements and the expedited request form, along with any other necessary attachments.
Exemption requests must include the exemption request form and a research protocol or project summary.
Post-Board Review Issues
What happens if my protocol is tabled? If your protocol is tabled, it means that there are significant changes that the board is requesting from you. Your corrections will need to go back to the full board for their approval and vote. Your corrections will be processed when they’re received and sent to the next full board meeting according to our standard timeline.
What does it mean if my protocol was tentatively approved? If your protocol is tentatively approved, it means that there were only a few small changes that the board requires before your protocol can be approved. Once you submit the revised documents, the IRB executive team will issue an approval letter once they confirm that the board’s conditions are met. Your protocol will not have to go back to the full board.
If I’m requesting ODH data, how do I receive it after my protocol has been approved? When your notification letter is sent to you, the ODH data steward responsible for that data will also receive a copy. They will work with you directly to get you the data you require.
Can the ODH IRB administrator get the data for me instead? No, the ODH IRB administrator does not work with the data sets and does not have access to them.
Under what circumstances do I need to apply for a change application? A change application needs to be submitted if 1) you have a change in your Principal Investigator or other researchers who will be directly handling the data; 2) you wish to add more data sets than you initially requested, 3) you wish to change your survey instruments; or 4) you wish to change some other aspect of your research that substantially affects the data or the subjects.
Can changes be expedited or do they have to go back to the board? Small changes, including new researchers, minor changes to your documentation, or the addition of an extra year of data sets, can generally be expedited and approved by the Board Chair. These requests can usually be turned around in one-two weeks. More substantial changes to your research methods, or changes that directly affect the research subjects, require full board approval.
How do I apply for a renewal of my application? The form for renewals and changes must be submitted to the IRB, along with a brief letter detailing your research to date and why the renewal is necessary. Renewals are usually approved by the Board Chair unless you’re also requesting changes to the research that require full board approval.
How will I know when it’s time to apply for a renewal? Your expiration date is listed on the bottom of your letter of approval. It is your responsibility to keep track of this. We do not send reminders.
How far in advance should I submit my request for renewal? We recommend that you submit your request for renewal about two weeks before your expiration date.
Oops, I just realized that my protocol’s approval already expired. What do I do now? If your protocol expired in the last calendar year, submit the renewal form and letter of explanation, including information on why the request is late. If your protocol expired more than one calendar year ago, you will need to submit a new application packet as you would for a new request. Please make note of the previous IRB case number on the application form.
What if I have other IRB questions that aren’t answered here? Please contact us at firstname.lastname@example.org or 614-995-0775.
Calendar of Events 2019
If you are new to the ODH IRB process, we STRONGLY recommend that you submit prior to the deadline.
|SUBMISSION DEADLINE||MEETING DATE|
|January 8, 2019||January 22, 2019|
|February 12, 2019||February 26, 2019|
|March 12, 2019||March 26, 2019|
|April 9, 2019||April 23, 2019|
|May 14, 2019||May 28, 2019|
|June 11, 2019||June 25, 2019|
|July 9, 2019||July 23, 2019|
|August 13, 2019||August 27, 2019|
|September 10, 2019||September 24, 2019|
|October 8, 2019||October 22, 2019|
|November 12, 2019||December 3, 2019|
Calendar of Events 2020
If you are new to the ODH IRB process, we STRONGLY recommend that you submit prior to the deadline.
|SUBMISSION DEADLINE||MEETING DATE|
|January 14, 2020||January 28, 2020|
|February 11, 2020||February 25, 2020|
|March 10, 2020||March 24, 2020|
|April 14, 2020||April 28, 2020|
|May 12, 2020||May 26, 2020|
|June 9, 2020||June 23, 2020|
|July 14, 2020||July 28, 2020|
|August 11, 2020||August 25, 2020|
|September 8, 2020||September 22, 2020|
|October 13, 2020||October 27, 2020|
|November 10, 2020||December 1, 2020|
Who We Are
Carol Carstens, PhD
Ohio Department of Mental Health and
Eben Dowell, MA
Ohio Department of Education
Gebreab, Habteab, MS
Ohio Department of Medicaid
Kaylor, Mary Beth, PhD, RN
McGonigle, Hope, PhD
Ohio Department of Developmental Disabilities
Runyon, Kevin, RN, BS
Ohio Department of Rehabilitation and
Tibbles, Lance, JD
Capital University Law School
Tuch, Socrates, JD (Chair)
Ohio Department of Health
Belenker, Rachel, JD
Ohio Department of Health
Telephone: (614) 995-0775 for Lisa Locklin, IRB Administrator