The Capella IRB application checklist: every document the board reads as one file
A Capella IRB application is not a form with attachments; it is one file the board reads as a whole. The pieces are the IRBManager application itself, the SMR-approved research plan (or SMART form or proposal), informed consent on Capella's template, recruitment materials, every instrument with written permission to use it, a site permission letter for every site, the CITI completion report, and a data security plan, plus agreements, incentive details and a pilot statement where they apply. The IRB Office screens the packet for completeness before any reviewer sees it, and the reviewer then reads each document against the others. Version-matching, the same study described the same way in every piece, is what gets a Capella file through.
The Capella IRB reads one file: the application form, SMR-approved plan, consent on Capella's template, recruitment materials, instruments with permissions, site letters, CITI report and data security plan. Screening checks completeness; the reviewer checks that every document describes the same study.
What does the Capella IRB actually receive?
A web form plus attachments, submitted by your mentor. Capella's FAQ on completing the application explains that IRBManager uses built-in web forms (xForms) completed online, and that the application responds to your answers, asking for further documents depending on population and procedures. The published portal instructions add the mechanics: the researcher answers every question on each page, including the conflict-of-interest question, enters the mentor's registered email, verifies alignment between the approved Research Plan or SMART form and the application, and signs with their portal password. Clicking submit sends the study to the mentor, not the IRB; the mentor submits it, or returns it for changes.
Then the IRB Office screens. Capella's IRB interactive describes the screen as a check that the researcher responded to every item and uploaded the necessary supporting documents; incomplete applications are returned for revision. Only complete packets go to a reviewer, hence the order below.
The checklist
- CITI completion report, current and in the right course track; mentors must hold current training too. The Dissertation Process Manual makes the completion report a milestone in itself, and Policy 3.03.01 requires researchers and faculty to maintain currency.
- The approved Research Plan, SMART form or proposal, in the version the school approved, with evidence of that approval. Capella's FAQ lists it as the first required document; the SOPs treat it as the reference the IRB reads against and say anything in it that is not also in the application is not approved.
- The IRB application form itself, answered completely and consistently with the plan, including the conflict-of-interest disclosure; filed as the Records Based Research application where the study analyses only existing data, and as the DNP IRB Application for DNP learners.
- Informed consent, built on Capella's own template, carrying the elements 45 CFR 46.116 requires: a concise key-information opening, purpose, procedures and expected duration, foreseeable risks, benefits, confidentiality, whom to contact, and the statement that participation is voluntary and may be withdrawn. Parental permission and child assent where minors are involved; a waiver request with its 46.117(c) justification where documentation will not be obtained.
- Recruitment materials: every email, flyer, script, social post or listserv notice, in final draft, describing the same study, population and burden as the consent.
- Instruments: every survey, interview guide, observation protocol or questionnaire, exactly as it will be used, with written permission to use any existing instrument and, if modified, permission that clearly allows modification. The SOPs call unlicensed use a copyright violation and ask for purchase agreements where an instrument was bought.
- Site permission letters, one per site, meeting the SOPs' four tests: on the organization's official letterhead; signed by an authorized official (or the site's IRB chair where one exists); dated within the freshness window the SOPs set; and clearly stating that the researcher has permission to conduct this research at the organization. Implied consent is not site permission, and complex organizations (school districts, VA and military sites) often need more than one letter.
- Agreements and contracts, signed or not: any affiliation agreement, memorandum of understanding, research agreement or data use agreement. If Capella must sign, the IRB Office initiates legal review and no learner, mentor or chair may sign for the university; if only the researcher signs, the agreement still goes in the file.
- Data security plan: where identifiable data and recordings are stored, who can access them, how and when they are de-identified, how long they are kept and how they are destroyed, consistent with the consent's confidentiality section and Capella's records-retention expectation.
- HIPAA or FERPA specifics where protected health information or education records are involved: how PHI is viewed but not recorded or removed, how education records are accessed with written site approval, and any required releases.
- Incentive details, if any, on the application and in the consent; the SOPs say incentives must be commensurate with time, not coercive, and not listed as a benefit.
- Pilot study statement, if you intend one: a pilot may not be run without IRB approval, and changes arising from it go back as a modification.
- For capstone and DNP projects: the Doctoral Capstone IRB Screening Form where your program uses one, with site permission and data-use permission attached even when the expected outcome is Not Human Subjects Research.
What does the board check each document against?
| Document | Read against | Classic reason it comes back |
|---|---|---|
| CITI report | Capella's training requirement; the mentor's currency | Expired, wrong track, or missing for the mentor |
| Approved plan | The application, consent, recruitment and instruments | The application describes a different sample, site, instrument or procedure than the plan |
| Application form | 45 CFR 46.111 criteria; the level-of-review questions | Answers that contradict the attachments, or an exempt claim the design does not support |
| Consent | 45 CFR 46.116 elements; Capella's template; the recruitment script and instruments | Not on the template; missing elements; promises (duration, anonymity, recording) that other documents contradict |
| Recruitment materials | Consent; site letters; equitable selection under 46.111(a)(3) | A channel or population the plan and letters do not cover; coercive or misleading wording |
| Instruments | The plan's named measures; permission letters | No written permission; modified without permission; a different version than the plan |
| Site letters | The SOPs' four tests; the sites the plan names | Not on letterhead, unsigned, undated or stale, from the wrong official, or silent on permission |
| Agreements | Capella policy; legal review where Capella signs | Clauses that conflict with Capella policy or put participants at risk; a signature Capella cannot give |
| Data security plan | 46.111(a)(7) privacy and confidentiality; the consent's confidentiality section; HIPAA/FERPA | Plan says de-identified, procedures collect names; recordings with no destruction date; identifiers that should never be recorded |
What does "version-matched" mean, and why does the board care?
It means every document describes the same study in the same terms: the same title, purpose sentence, population and inclusion criteria, sample size, number and length of sessions, instruments by name, sites, promise about identifiability, and retention and destruction plan. Version-matching is not pedantry. The IRB approves a protocol, and the protocol is the application plus its attachments. If the consent promises anonymity and the survey asks for an email, the board cannot tell which one you will do, so it approves neither. If the plan says two interviews and the consent says one, the approved study is undefined. And because the SOPs treat the application, not the plan, as what is approved, anything the plan contains that the application omits is not covered by the approval you receive.
The simplest discipline is a single alignment sheet drawn from the SMR-approved plan, with every other document drafted from that sheet. When anything changes, the sheet changes first, then every document that touches it; if the change is methodological, the school approves it before the IRB sees it. What the approved plan locks, and why drift is the classic return, is explained in Scientific Merit Review at Capella: why it comes before the IRB and what it locks.
What happens after you submit?
Capella's portal instructions name the stages: Mentor Review (your mentor can submit or return it), Internal IRB Review (received and in screening for completeness), Under Review (screened and with a reviewer), and then a decision. Deferred means changes are necessary and a decision letter will say which. Approved with Conditions means only minor changes or site permission letters are still needed, and nothing may begin until full approval is granted. Approved means the approval letter is on its way, and only then may recruitment, consent and data collection start; Capella states flatly that conducting research activities before IRB approval violates federal regulations and university policy. Which path the office assigns is in Exempt, expedited or full board: which Capella IRB review path is your study on?; the application's place among Capella's four gates is in Capella IRB process, step by step.
The file does not close at approval. Modifications go through the IRB Modification Form and take effect only when approved; expedited and full-board studies have continuing review; a study closure form ends the board's oversight.
How do we handle the file end to end?
We build it from the approved plan outward: the determination and plan, the alignment sheet, then every document on the list above, drafted for your signature and your mentor's submission, including site letters drafted for the site to put on its letterhead and sign. We assemble the packet so it clears screening, and we write every reply to the board, after a deferral, after an approval with conditions, through modifications and continuing review, until the study is approved and closed. The research stays yours throughout: your question, your data, your findings. The board's decision is always its own.
What to do next
If you have an application in draft, a deferral letter, or a site that will not sign until it sees the packet, start with the free application review at the contact page. We read what you have against this checklist and Capella's posted requirements and tell you, in writing, what is missing and what does not match. Then we take the whole process off your desk. See how it works, the three packages on pricing, quoted in writing after the free review, and the FAQ.
Sources
- Capella FAQ, How do I complete the IRB Application?: capella.libanswers.com/doctoralsupport/faq/132954
- Capella FAQ, Where can I find IRB forms and templates?: capella.libanswers.com/doctoralsupport/faq/132851
- Capella FAQ, How do I submit my study to the IRB?: capella.libanswers.com/doctoralsupport/faq/132839
- Capella, IRB Application Instructions (IRBManager): capella.libanswers.com (IRB Application Instructions PDF)
- Capella, IRB process interactive transcript: capella.edu/interactivemedia/IRBprocess/irb_ts.html
- Capella, Research Integrity SOPs: capella.edu/assets/pdf/policies/HRPP-SOPs.pdf
- Capella Policy 3.03.01, Human Research Protections: capella.edu/content/dam/capella/PDF/policies/3.03.01.pdf
- Capella, PhD Dissertation Process Manual: assets.capella.edu/campus/doctoral-programs/DissertationManual.pdf
- Capella IRB, What is "Not Human Subjects Research?": assets.capella.edu/campus/doctoral-programs/IRB-Information-NHSR-Projects.pdf
- Capella FAQ, How do I amend/modify my approved IRB application?: capella.libanswers.com/doctoralsupport/faq/132931
- 45 CFR 46.111, Criteria for IRB approval: law.cornell.edu/cfr/text/45/46.111
- 45 CFR 46.116, Informed consent: law.cornell.edu/cfr/text/45/46.116
- CITI Program, Human Subjects Research series: about.citiprogram.org/series/human-subjects-research-hsr/