The IRB Process and IRB Approval For Your Human Subjects Research
Does My Project Require an IRB Review?
In general, yes! Your project requires IRB if it involves research with human subjects.
- Research is defined as a systematic investigation designed to produce or contribute to generalizable knowledge. This includes research development, testing, evaluation, AND pilot studies.
- This means that your QI project is research if: you intend it be generalizable beyond just improving quality at a particular site or for a particular program. This applies to and implies that you may intend to present it somewhere where others could learn from it and potentially replicate and/or implement it themselves.
- Don’t hobble yourself in the beginning of a project by deciding that you won’t want to generalize/present it. What if you uncover something really novel?
Do I have the Appropriate Certifications?
o See this document for a description of the trainings you must have to conduct research.
The IRB process begins with a well-conceived research question and appropriate methods identified to answer the question. To that end, the first step should be to write a study protocol, even if one is not required in your application.
Your study protocol should include details on all of the important elements of the planned research, including:
1. A sentence or two describing the current state of the literature, and the addition that the current study will make (If there is very little/no previous research done in the area, this is an acceptable justification);
2. The number and nature of the proposed research participants, including where they will come from, how they will be recruited into participation, if, when and how they will be consented, and the measures taken to protect their anonymity or confidentiality;
3. The methods of the study, including where, when and how data collection will take place, all the procedures for storing and maintaining the data and;
4. The data analysis plan. The protocol should address the balance between risks to participants and potential knowledge or other benefit gained. Remember, even things like inconvenience and boredom count as risks!
A good study protocol will help clarify for you how the research will be conducted and who should be involved.
You may not begin data collection prior to IRB approval.
Choosing an Application Type
To determine what forms are needed for your IRB proposal, see the Overview of IRB Submissions for New Studies. IRB forms and submission materials can be found here. In general terms, there are 3 types of application reviews: exemption request, expedited review, and full review.
ALL NEW APPLICATIONS require the IRB submission checklist, so prepare that first.
An exemption request is a special request to be exempt from IRB review when the research meets some special criteria, those criteria can be found on the exemption request IRB form itself but generally speak to research in which NO identifying information AND NO protected health information is being collected. Examples would be a) assessing knowledge after a curricular intervention when NO identifying information is recorded, b) survey research when NO identifiers are collected or recorded from participants AND when accidental disclosure of participation would not reasonably be expected to bring harm to the participant in terms of legal, monetary or status/reputation and c) data analysis of publicly available data sources OR fully de-identified data.
Forms: OHR-18 (Exemption Request) and either OHR-5 (De-identification of protected health information certification) OR OHR-3 (Waiver of authorization to collect protected health information (PHI)).
Important note: Exempt research requires an approved exemption request. If your research meets one of these criteria, you must still apply to the IRB for the exemption. You cannot begin the research until the approval letter is issued from the IRB.
Chart review is exactly what it sounds like, any review (both retrospective and prospective) of information from a human when that person is identifiable.
Forms: OHR-4 (Record/chart review/electronic database study) and either OHR-5 (De-identification of protected health information certification) OR OHR-3 (Waiver of authorization to collect protected health information (PHI)).
‘Other” expedited research encompasses observational studies, surveys when PHI is collected, and non-invasive physical procedures, including blood draws.
Forms: OHR-1 (Proposal), OHR-2 (Protocol), OHR-15, either OHR-5 (De-identification of protected health information certification) OR OHR-3 (Waiver of authorization to collect protected health information (PHI)), OR a consent form (8/8A/8B).
A full review is indicated for all phases of clinical trial research when it involves investigational devices or drugs, or procedures posing more than minimal risk to participants.
Also a full review is indicated for all studies involving a vulnerable population (children, elderly, prisoners, or cognitively impaired) when such studies pose more than minimal psychological, social, or economic risks.
Forms: OHR-1 (Proposal), OHR-2 (Protocol), a consent form (OHR8/8A/8B).
Other forms apply when the research in genetic in nature, or uses biological specimens. See the IRB website for guidance.