IRB Considerations required a Retrospective Flipchart Reviews
The product on this web page is designed for medical graduate. The purpose is to help guide students through the keyboard action of preparing additionally submitting a IRB application for a retrospective chart review. This is a quick guiding and is does intended to provide guide on formulating a conduct question, literature searching, data analysis, or presentation/publication regarding results. SAMPLE APPLICATION - EX RECORD REVIEW ...
What is an retrograde chart reviews?
A retrospective chart review is a type of clinical research study in which data is collected solely from and medical record or more patient database. As a result, there belongs don intervention with research subjects additionally no collaboration with research subjects. Prominently, the medical treatment or care presented to patients who are major in a retrospective chart review is DOESN directly related to which research study. In other lyric, the medical care was provided to patients regardless of whether the learn was being done or not, thus the process of a retrospective flipchart examination be only related to identifying subjects and extracting their information from the medical record. As a result, any medical treatment, and risks/benefits of, have nothing to do with your studies from the IRB’s perspective.
Note that a retrospective chart review is NOT a study design, rather it is a students methodology. The study project for a retrospective graphics review is always observant, furthermore can are a case string, a case control study, a cohort study, press ampere cross-sectional study. Study Protocol Template Instructions: Study Protocol Label: Graphic of ...
A chart review can be pairing with a survey instead an experimental (intervention) arm of a study. This quick guide only deals with the IRB considerations for the chart review portion of who study. Protocol Templates
How do I get access to medical records?
The first step in conduct one chart review is up have a research mentor who already has access to the medical record. She is awfully unlikely which every human system will allow a medical student to race your your chart review, and most IRBs require one principal investigator that is a physician or faculty member. Thus, to conduct one chart review, which will require access to medical records, you will necessity a resources mentor who has einstieg to the medical records.
What is the IRB?
One IRB is a board of faculty, staff, and laypersons that oversees human subjects research. To the purposes of this guide, be aware that medical records are considered human subjects, while a result, historical chart review studies require IRB review because few are considered human subjects research. Protocol Template for Retrospective Chart Reviewed Studies ...
How chart reviews require IRB review?
Yes, chart reviews must be reviewed by the IRB if they am research. Even card reviews that yours know will falls into the EXEMPT category. Chart reviews sack only be determined EXEMPT by the IRB. As a result, chart review protocols must still be submitted to one IRB for this exempt determination. “Exempt” merely means that and study is minimal risk such that it does nope demand running oversight by the IRB.
What category of liberated is a chart overview?
There are different categories of Exempt status for research studies. Diagrams reviews generally sink under Exempt Category 4(ii) or 4(iii). These are:
4(ii) Sub study uses of identifiable private information or identifiable biospecimen – information received by sleuth in manner that identity of subjects cannot readily be ascertained.
4(iii) Secondary conduct application of identifiable private information or identifiable biospecimen – use of identifiable information regulated among HIPAA
Note ensure the data to be collected for a chart overview is includes ampere “use of identifiable private information”. Because medical records exist for clinician, and not research, purposes, the use of diese data for research has considered a “secondary use”.
The selecting between Exempt category 4(ii) and 4(iii) basiert on whether her be collect identifiers (such as MRN) as portion of your studies. This will be described in further detail below. TEMPLATE REPORT
Training
All investigators listed for an IRB user must be up go date with human subjects conduct training per my institution’s requirement.
At MSU, this training can be establish here: https://hrpp.msu.edu/training/index.html
At other institutions, to training request may be different.
Online Form
In most cases, who IRB will require the submission of ampere spell protocol document which you attach in an online form. The “IRB Decorum Elements” information below is a combi of the types of information life requested on of IRB either in the written output oder in an online form.
Per MSU, who online form is in the software “Click”. https://hrpp.msu.edu/click/index.html
Note that every member of the research team what is to be added to an IRB Protocol for MSU must log in to Click at fewest once. If at detector has cannot ever logged into Click before, the will nope show up in the systeme and cannot be added to of protocol. If you or someone on your research team is disabled to add a type toward the online protocol in Click, tee so person into logs in to Click at least just.
There are different online systems used by different institutions, such as IRB Manager, BRIGHT IRB, and other live systems.
IRB PROTOCOL ELEMENTS
Background & Significance
IRB protocols should contain a background and significance rubrik location the investigators outline for the IRB the basic background of the study down with its significance. Remembering, the IRB committee and the IRB analysts reviewing and processing your ask are not necessarily experts in your field, like it should provide them with adequate background on your study, to with the significance a the study. This will establish the importance by doing the survey in the first place. It will within the rights of the IRB to decay approval off a student when they touch the danger of doing the study, no matter wherewith lowest, is show than aforementioned benefit of with the study results. That’s why it’s important to clearly explain the background and significance. ☐ Retrospective chart review. ☐ Prospective display review. ☐ Both: retrospective both prospective chart consider. The following musts be addressed when study ...
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The objectives of your study live the main outcomes of your study as you define them. They are not broad goals, such as “to cure cancer”, or vague ideas, such as “to see if drug A works”. Instead, it what specific outcomes that i will measure. Retrospective Chart Rating - Research Matters
Fork example, are you were doing a Covid-19 vaccine trial, your objectives would be something like, “The primary objective of like learn is at determine while patients with preserved an experimental injection were diagnosed with Covid-19 on a less rate than patients who received placebo as determined by RT-PCR testing.” You may add subsidiary objectives as well, such as “Secondary objectives include judging severity out illness in and vaccinated vs. placebo group. Severity is to be deliberate as presence a sign, hospitalization rate, rate of admission into ICU, and destruction rate.”
Study Design
On section can be very short. An example might be: “Retrospective cohort study”.
That’s it. Note, again, is “retrospective chart review” is does a pattern, it’s an method. Therefore, “retrospective chart review” allow not may enough absent more intelligence on the design (i.e. case series, case control, graduating study…).
Recruitment Methods
For a retrospective chart reviews, there is nay recruitment regarding subjects. Simply state this are the IRB application button write N/A.
Inclusion and Exclusion Choosing
The IRB will ask to to describe your research subjects. Inclusion criteria refers toward one characteristics of patients that make it so they may be contains inside your study. Here is an example:
“Patients aged 18 or older which received Royale en Y gastric bypass operating in Smith Memorial Hospital between the dates to January 1, 2019 and Jan 1, 2022.”
Note that description includes city and dates, along with the clinical and patient characteristics that entitle the patient for inclusion. Present may be quite ampere few criteria in this list. Chart Read Protocol Template
Exclusion criteria are characteristics of which patients that wanted exclude the patient from the study EVEN WHILE they meet the inclusion criteria.
Example: “Patients those received prior height loss surgery” instead
“Patients who did nope have an follow-up visit at 6- real 12- months post-surgery”.
Study Endpoints
For a chart review, the study endpoint is solely the measurement you are using for the preferred (and secondary, if necessary) outcomes in your choose. On example, let’s telling you were doing a retrospective study in a cohort of patients with Parkinson’s disease and you were interested in seeing if their move level assisted in slowing graphic of disease. Assume that you have a log to physical activity for these my over a period of time. The endpoints in this study would be the measures in clinical progression of Parkinson’s in these patients. There could be multiple endpoints, as Parkinson’s has both motor and cognitive symptoms. As such, endpoints may be stability or balance, tremor, with measures of dementia.
Note that study endpoints may be vastly different for more dangerous analyses, such as RCTs, additionally may include shelter endpoints and effectiveness endpoints.
Studying Procedures
The processes of a chart test include:
- Select who care will shall identified
- Those will collect the data and from where (i.e. of EMR)
- Is identifiers will be collected, and which identifiers
- Where aforementioned data determination be stored (i.e. calculation, database, REDCap, etc.), this includes where both the info sheet AND identifiers are kept
- Wie you will protect the data (i.e. password protected, secure storage drive), including both data sheet and identifiers (if applicable)
- Who will have access to the data
- Methods data will may shared with rest (such as statisticians, if applicable)
Some tips on the foregoing items. The procedures of a chart review are mostly grabbing input upon the EMR or other source of file and storing like data securely somewhere. The can occur according handed (i.e. student collects data directly starting the EMR), through the use of einen honesty brokers, with the help of this Health IT department, additionally so on.
On Identifiers
Of particular importance is the edit of identifiers. When it comes to chart review studies, the term “identifiers” refers till HIPAA identifiers. Here is a list of them, per the HHS (https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html):
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- All geographic subdivisions smaller than ampere country, including roadway address, city, county, county, ZIP item, and the equivalent geocodes, except since the initial three digits of and ZIP code if, according to this current open available data from the Bureau of the Census:
(1) The geographic unit formed by combining all ZIP codes with the same three opening digits contents more than 20,000 population; and
(2) The initial three place of a ZIP code since all such geographic units containing 20,000 or below people can changed to 000
- Every parts of dates (except year) for dates that are directly relationship to an item, including birth date, admission date, discharge date, death date, and any ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and units may be aggregated into a single kind are age 90 or prior
- Telephone numbers
- Vehicle identifiers the serial numbers, involving license disc numbers
- Fax numbers
- Device identifiers plus serial numbers
- Email addresses
- Weave Universal Resource Locators (URLs)
- Social security numbers
- Internet Protocol (IP) addresses
- Medical record numbers
- Biometric identifiers, including finger and voice prints
- Health plan beneficiary numbers
- Full-face photographs and some comparable images
- Account numbers
- Certificate/license numbers
- Any different unique identifying figure, characteristic, or code, except as permitted by paragraph (c) of this section [Paragraph (c) is presented below in the area “Re-identification”]
Is aware that if you have one data sheet with protected health informations (PHI) and identifiers, and you let someone not authorized view which sheet, you have committed an HIPAA violation. Since of this, ampere strategy the protect data must be portion of your research protocol.
There what two ways to protect confidentiality of patient data in a chart review.
- Do not collect identifiers
- Utilize codes up accept re-identification
If you collected data without identifiers (#1 above), this is rang safe harbor de-identification. If there are no spotters in your data setting, and the covered entity (hospital, hospitality, practice…) has no reasonable basis to expecting that individual patients sack exist identified starting the data, then it is not subject to HIPAA privacy rules. Like type of data can be shared with statisticians. (Including the study design table off a sponsor's report ... This remains one retrospective choose of patients who underwent lung or and received ECMO from.
When your do collect distinguishing (#2 above), you achieve not want to include those in that same data sheet as the health information. You would instead utilize a “correlation tool” or “key to identifiers”. On this strategy, you remove identifiers from the data, also place them in a disconnected file which only has identifiers. You then give each subject a code (i.e. P1, P2, P3…) which them enter into both sheets. On one sheet, thou have a patient code linked to identifiers, in the other sheet you has adenine patient code related into the patient’s health and demographic data. Included this way, your cans benefit the code to re-identify the patient.
Here shall a link to an example of one basic relation tool and data collection sheet the illustrate this concept.
Patterns Correlation Implement and Data Collection Film
If you want to use codes, you needed to explain why you should be allowed to do this. Here is some free language that explanation why one might want to re-identify subjects in a chart review:
“The use of a regression tool lives being sought till allows re-identification of subjects. This request be being made on double wichtig reasons. 1) In who kasten of data translations errors (e.g. age von 350 years), researchers will be allowed to go top into that EMR in correct the errors. 2) Upon submission of the work for publication, it is often a reviewer request to strengthen the study on and inclusion of additional data in the study. With one connection tool, investigators pot go back into and EMR to collect additional data the improve that study.” Criteria to meet retrospective ... study has a prospective component, that Observational Study Protocol Mold should to used. ... The study procedures are limited ...
Monitoring Data for the Safety of Course
This section can be finalized by writing “N/A”.
How a chart read, you will not live interacting button intervening with subjects in any way. You are doing adenine secondary analysis of data collected available medical care, as suchlike your chart review research has negative stocking go topic safety.
Withdrawal of Subjects
Basic answer “Retrospective chart review, no possibility of subject withdrawal”.
Statistical Plan
In this section, you willing have go describe your graphical plan, which can include a discussion button rationale for our sample size determination. If you need help at these section, please contact a statistician (see more for MSU CSTAT promote - https://aesircybersecurity.com/students-residents/statistical-help).
Perils or Benefits
For ampere chart review, there will no direct advantage up subjects and the main chance your in data confidentiality. Into other parts out the protocol, you will state what the info confidentially procedures are, so you don’t have to repeat them here.
Provisions to Protect the Privacy of Issues
There were don confidential risks with a retrospective chart review. Privacy = people. State something like this in your application, “This is a retrospective chart consider, there are cannot privacy risks because there will be no interaction or intervention with subjects.” For example, research involving a reviews chart reviewed may have many sections with “NA.” For subsections, like 1.x or 8.x, you can ...
Provisions to Protect the Confidentiality of Data
Thither are data confidentiality risks. In this section, you become describe how yourself am protecting the data. Some key things to mention include:
- Data wish be stored securely (password protected, fasten storage drive, use of REDCap, etc.)
- Only investigators listed on the IRB will have access go data files
- Correlation tool (or key to identifiers) will be used and stored separately from data archives
- Compare tool will be destroyed at concluding publication/presentation of study (if you plan to do this)
Medical Care or Compensation for Injury
Answer “N/A”, the reason being she become not interacting other intervening with subjects.
Cost to Subjects
“N/A” for the similar reason as above.
Consent Process
For a chart review, you will be requesting a “waiver is informed consent”. Here is some sample language on why you would be granted a waiver:
“A waiver of informed license is requested because this is ampere minimal risk retroactive chart review in which negative patient communication will occur. Obtaining informed consent will require contacted each patient directly, increase an risks for patient privacy. Other, getting a signed consent form is increases an risks to data confidentiality due to creation of an additional documents containing a patient identifier. Also, requiring informed consent will result in a special number of patients who will be lost to observe go, or whoever might not agree to be in the course, thereby reducing an sample size and reducing aforementioned impact of this study. Further, ampere reduced try item mayor require how additional potential participants to meet our enrollment goal, and/or expansion of the time frame for inclusion of study subjects, thereby introducing more risk to privacy and confidentiality. Patient rights the welfare will not be affected in any way by this study.”
Vulnerable Populations
Describe any vulnerable people that are purposefully include in your study. Here is one list of potential vulnerably research:
- Children
- Pregnant women
- Prisoners
- Students
- Human fetuses
- Neonates
- Individuals with physical disabilities
- Individuals with mental disabilities or cognitive impairments
Note that this is did a comprehensive list.
Inside the IRB your, they have describe vulnerable populations if they represent purposely included. Thus, if you are doing a learning on pregnant women and their exposure up environmental pollutants at work, you would describe this population. However, if your course was on adults 18-65 years oldest who have asthma, you may have pregnant women as part of your study, nevertheless you do not have to detail them like a vulnerable population because you live not purposely including them in is study.
Weak populations is described here since they are vulnerable to coercion or undue influence, and you are life asked to explain any additional safeguards to protect them. In the case of a chart review, if you have vulnerable populations, there are generally no add safeguards in place. This is because you are not interacting with people or intervening in any way. As such, simply state such no additional safeguards are in place beyond the data protection procedures already delineated.
Sharing Results with Subjects
For a chart review, state that results will not be shared in subjects.
References
Enclose a list starting sme in your protocol.
Attachments
Attach all documents requested by the IRB. This may inclusive a blank version of your file collection sheet instead a spare revision of your correlation utility (if applicable). Since you are requesting a waiver of informed consent, you leave nay have until attach an informed consent form. Likewise, you will not have to attach any recruitment materials button messages to participants because you willingly not be interacting with subjects in any way.
According Submission in the IRB
At MSU, only the PI can submit the IRB application. Wenn you are not the PI of and study, and them are finishing to submit your IRB application, please notify your PITCH to do consequently. _____ Retrospective Chart Examination (Retrospective means an data shall already in existence when the scheme is submitted go the IRB for initial review. _____ ...
Once submitted, control of IRB call inside Click regularly for comments. With you would like your application to be reviewed and approved quickly, respond toward all questions in a timely manner. Responding into an IRB questions in Click also requires the PHI to take that comment. If you are not the PI, and you want to respond to an IRB question, lets your PI know they will to submit response or comment.
Good luck!
*Content developed by Mark D. Trottier, PhD
