IRB review
How to get a transcription vendor approved by your IRB (what to submit)
IRBs approve protocols, not vendors. To use an outside transcription service, your protocol has to say who will hear the recordings, how the files travel and where they live, who can access them, whether transcripts are de-identified, and what happens to the data afterward, with the vendor’s confidentiality agreement or BAA and security documentation attached and a sentence in the consent form telling participants a transcription service is involved. Landmark supplies the agreement, the documentation and Safe Harbor de-identification, and its security practices have been through university IRB and IT reviews before.
What to write in the data-handling section
Who will transcribe
Name the vendor and state that transcription is performed by the vendor’s trained staff under a signed confidentiality agreement (or BAA), not by an automated service or crowd platform.
How recordings travel
State the transfer method and that it is encrypted. "Recordings are uploaded to the vendor’s encrypted platform; no recordings are sent by email."
Where data live and who can see them
Storage location (U.S. infrastructure), who has access (transcription staff assigned to the project), and that access is limited and logged by the vendor’s platform.
De-identification
Whether transcripts are de-identified before analysis, by which standard (HIPAA Safe Harbor, 18 identifier categories), and who does it (the vendor at delivery, or the team).
Retention and destruction
How long the vendor keeps recordings and transcripts and how deletion is requested. Ask the vendor for its practice in writing and quote it.
Participant notice
The consent form tells participants a professional transcription service will hear the recording under a confidentiality agreement.
What to attach
| Document | From Landmark |
|---|---|
| Confidentiality agreement: NDA, or a Business Associate Agreement when the data are PHI from a covered entity | Either, on Landmark’s form or your institution’s template; BAAs in place with many universities. |
| Security summary: encryption, access controls, staff training, storage location | IRB-ready security documentation on request; staff complete human subjects protection and HIPAA training. |
| De-identification description | Safe Harbor de-identification of all 18 identifier categories, included at no extra charge. |
Not sure whether your study needs a BAA at all? The HIPAA-compliant transcription guide covers when HIPAA applies and what to require either way.
Consent-form wording that reviewers accept
Adapt to your IRB’s template; the elements reviewers look for are the outside party, the confidentiality agreement, and de-identification:
Audio recordings will be transcribed by a professional transcription service (Landmark Associates) that has signed a confidentiality agreement. Identifying information will be removed from the transcripts, and recordings will be transferred and stored using encrypted systems.
Focus groups: three extra lines
- Consent covers the group. Every participant is recorded and transcribed; the consent language applies to all of them, and participants should be reminded that others in the room will hear what they say.
- Speakers by label, not name. Ask for speaker identification (an optional add-on) as Participant 1, Participant 2, or pseudonyms you assign; names spoken in the room are de-identified in the transcript.
- De-identify what people say about each other. Safe Harbor covers third parties’ identifiers as well as the speaker’s own; say so in the protocol.
Focus groups and recordings with three or more speakers are transcribed at the Plus rate, from $2.69 per audio minute; one-on-one interviews from $1.99. See qualitative research transcription for methods coverage and formats.
Questions researchers ask
- Does an IRB approve transcription vendors?
- Not directly. IRBs approve protocols. Your protocol describes how recordings leave your team, who hears them, how they are protected, and what happens to them afterward, and the IRB approves that description. A vendor becomes "IRB-approved" for your study when those sections are accurate and the vendor’s agreements and security documentation are attached.
- What documents should I attach for the transcription vendor?
- Three things cover most reviews: the signed confidentiality agreement (an NDA, or a Business Associate Agreement if the data are protected health information), a security summary describing encryption, access controls, staff training and where files are stored, and a description of de-identification. Landmark provides all three on request: BAA or NDA, IRB-ready security documentation, and Safe Harbor de-identification included with transcription.
- Do I need a BAA or is an NDA enough?
- A BAA is required when the recordings contain protected health information from a HIPAA covered entity, such as an academic medical center or clinic partner. For other studies a confidentiality agreement or NDA is usually what the IRB expects. If you are unsure, ask your IRB or privacy office; Landmark will sign whichever applies, on your institution’s template if you prefer.
- What should the consent form say about transcription?
- Participants should know that a professional transcription service will hear the recording under a confidentiality agreement. Wording researchers commonly use: "Audio recordings will be transcribed by a professional transcription service that has signed a confidentiality agreement. Identifying information will be removed from the transcripts." Adapt it to your IRB’s template.
- Can the vendor de-identify transcripts before I analyze them?
- Yes. Landmark applies HIPAA Safe Harbor de-identification, removing all 18 identifier categories, at no extra charge with transcription. You choose whether identifiers are removed, replaced with placeholders such as [NAME] or [CITY], or left in place for your own coding.
- What is different for focus groups?
- Every participant consents, so the consent language applies to the group; transcripts identify speakers by label or pseudonym rather than name (speaker identification is an optional add-on); and de-identification has to cover what participants say about each other, not only about themselves. Focus groups and recordings with three or more speakers are transcribed at the Plus rate, from $2.69 per audio minute.