Informed Consent and Documentation of Consent are important elements of human subjects research at CHOP. At CHOP, these processes and procedures are managed by the IRB.

  • Informed Consent is the process in which the study staff member(s) make clear the goals of the study, procedures involved, risks, benefits, voluntary nature of the study, etc. It is the responsibility of the research staff to ensure that the participant(s) and/or their authorized representatives have been provided with accurate and complete informed consent.
  • Documentation of Consent is exactly what it sounds like: the documentation that participants have been provided with informed consent, and documents their consent/assent to participate in research. It essentially consists of the completed consent form, assent, consent to screen, waiver of documentation of consent, etc.

Importantly, consent does not end with the collection of a signed consent form. Each person’s specific consent should be tied to the data that is collected as a result of their consenting to a research study. Depending on what a person consented to, their data may be used or shared in different ways. Once you have obtained informed consent and documentation of consent, you will likely then collect research data for those who have provided their consent. No matter where or how you store and share that research data, it is important that it be tied to the documentation of consent.

What to record: When it comes to recording and storing consent information, all data from the consent form (or other source) are important. For example, you will want to record in an easily accessible (i.e. digital) format like a REDCap database or .csv, the following:

  • IRB #
  • Consent Form Version Date
  • Consent Form Effective Date
  • Consent Form Expiration Date
  • Name of the Person Obtaining Consent
  • Name(s) of persons giving consent (subject, parent, LAR)
  • Name of Subject
  • Whether Consent was given (surprisingly this sometimes doesn’t make it in!)
  • Date of Consent
  • Answers to opt-in / opt-out questions such as:
    • Future Use of Data
    • Future Use of Audio/Video recordings or other highly sensitive data
    • Consent to share with applicable registries
    • Contact for future research

For Assent

  • Name of Person Obtaining Assent
  • Whether Assent was collected
  • Date of Assent

A few tips about collecting this data so that it is most useful in the future:

  • Make sure that each question is its own field
  • Supply a good data dictionary with full descriptions and text of questions asked on consent form
  • Realize that various versions of a consent / assent form may have different questions (you might add some questions as your data collection strategies change).

If you’ve recorded your consent information in the same system as your research data (for example, in a REDCap database), you’ve linked your complete and accurate consent information to your research data. When you export your data or pull it via API key, you are able to filter your data based on consent information for each subject.

If you have your consent data in one location (like a .csv) and your research data in another location (such as a REDCap project, and/or .csv with other research data), you can merge those data to create a unified dataset.

Sharing data with others

When it comes time to share your data with others, you will now have your data ready to filter by consent, to quickly, easily, and appropriately share data in a way that respects subjects’ wishes and keeps you compliant!