(1) Clarify Or Add to Information Previously Obtained in an Existing IRB Protocol
Re-Contacting Subjects
Background In some cases, investigators may wish to re-contact subjects for any number of reasons:
(1) Clarify or add to information previously obtained in an existing IRB protocol,
(2) Invite to participate in a future study being conducted by the investigator who initially recruited them,
(3) Build a Study Subject Registry to be used by the investigator for future research projects, or
(4) Refer subjects to a study being conducted by another investigator.
In compliance with the Belmont Report principle of “respect for persons” it is important to keep in mind basic concepts when using a “re-contact option” and to apply them at the time of the subject’s agreement to participate in research project X if the investigator would like to offer an option to be re-contacted for one or more of the reasons listed above.
Without such a “re-contact” permission from the subjects, investigators should refrain from re-contacting them, or sharing such contact information with other investigators. Not only is this common courtesy and respect for persons, but it is a breach of privacy and confidentiality for investigators to share identifiable information with unauthorized persons. Subjects in a specific study mare persons who have volunteered for THAT specific study. If you (or your colleagues) want to re-contact and invite them into other or future projects, you need to state that opportunity and get that permission up front in the initial study.
Thus, if you wish to re-contact subjects for future projects, it is important to decide ahead of time, which type of re-contacting you wish to include, and place that written option clearly into the consent document with a designated Opt In-Opt out provision.
Key Components to Consider
There are many points to consider when developing a re-contacting provision: this would be critical information to describe in the protocol synopsis to justify a re-contact provision:
(1) Specify why the subject would be re-contacted and what study would be involved (the current one? Future ones by that original investigator? Other studies by other investigators?
- The key is to truly inform the subject and avoid being vague or open-ended.
- Remember, these are not “your subjects” with whom you can do what you want or share
their identifiable data with whomever you please.
(2) Will a simple Recontact Registry be developed? Names and Phone numbers/addresses only? Or will research data or protected health information (PHI) be attached to those individual identifiers and contact information? If the latter, current federal agency guidance and “best practices” states that it is better to develop a stand-alone research registry for such an endeavor.
(3) Will the re-contact list be shared with other investigators? How will that be described to subjects, and who will manage that sharing process? Who manages the re-contact list…and who can use it?
(4) What if a subject wants to be taken off a Re-Contact list? How will that be done…and how will other investigators, who may have added that name to their own “recontact list” be notified?
Note that the same process applies to sharing of identifiable data and biospecimens. If you anticipate that you will be collaborating with other investigators who may wish access to your data and samples, better develop those procedures and informed consent processes BEFOREHAND to properly manage data security and respect for persons.
RE-CONTACT PROVISION CONSENT FORM SAMPLES:
Note that these are “starting examples” – please expand and add information as needed:
Consent for specific re-contact only by PI (restricted to a given research team):
Is it OK if we re-contact you about being part of our additional future research projects?
(Initials) _____ Yes, I would like to be re-contacted for additional future research projects.
Here is my contact information:Phone Number:
Mailing Address:
(Initials) _____ No, I would NOT like to be re-contacted for any of your additional future research projects.
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Consent for re-contact only by any UNTHSC researcher (open to other investigators):
Is it OK if we re-contact you about being part of additional future UNTHSC research projects?
(Initials) _____ Yes, I would like to be re-contacted for additional future research projects conducted by UNTHSC researchers.
Here is my contact information:Phone Number:
Mailing Address:
(Initials) _____ No, I would NOT like to be re-contacted for any future research projects conducted
by UNTHSC researchers.
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Consent for re-contact and sharing of your research information from this study with other researchers at UNTHSC:
We would like your permission to invite you to be in other research studies with us or other research teams. To do this, we will need to share your research and contact information with other scientists. Is it OK for us to share your research records (including your name and contact information) with other researchers here at UNTHSC?
(Initials) _____ Yes, I agree to have my personal research information and contact information shared with other UNTHSC researchers.
(Initials _____ No, I do NOT want to have my personal research information or contact information shared with other researchers.
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[Note: this approach can be expanded to non-UNTHSC researchers with appropriate text change.]