Informed consent is a key aspect of planning and maintaining a research registry. The information in this section will help your team consider the different aspects of this important topic.
When conducting research, it is the ethical obligation of the research team to obtain informed consent from research participants. The process of obtaining informed consent ensures that participants understand the nature of the research project and any risks and/or benefits of participating and allows them to decide whether they would like to participate in the research.
Generally speaking, informed consent must be obtained from participants in order to be included in research if individually identifiable participant information is collected (45 CFR 46.116(a); 21 CFR 50.25(a)). Unless waived by the IRB, informed consent must be obtained from individuals providing data or specimens for research registries, databases, and repositories.
In order to establish informed consent, information shared with participants about a research registry, database, or repository should include:
Other information, such as the length of time that data will be stored, subjects’ access to information learned from the research, and secondary uses of the samples should be considered as appropriate. Below is a list of other topics that should be included, where relevant:
Depending on the nature and purpose of your registry, the IRB may allow a study team to alter the standard approach of obtaining written informed consent. For example, the IRB may approve a consent process that does not require a subject to sign the consent document or allows that a subject click a box in an online survey to indicating their agreement to participate in the registry. These approaches would fall under the category of waiver or alteration of consent requirements, which includes a waiver of written documentation of informed consent.
Your study may be eligible to receive a waiver or alteration of consent requirements (i.e., written documentation) if you are conducting minimal risk research and:
Your study may be eligible to receive a waiver of written documentation if you are conducting research where:
It is important to note that receiving a waiver for the requirement of signed consent, does not waive the requirement for any form of informed consent. There are several potential approaches to obtain consent from a research registry participant without the signed document:
In more limited scenarios, the IRB may waive the requirement for informed consent in its entirety. Federal regulation 45 CFR 46.116(d) establishes four criteria for waiving consent:
Meeting all four of these criteria is most common in retrospective chart-review studies, so not likely to be applicable for registries, in which there is typically potential contact or ongoing prospective chart review.
Participants must consent to inclusion in registries that are designed for the purpose of identifying potential participants for future research opportunities. However, researchers may use a staged consent process in which preliminary consent is granted by participants when they are included in the registry and additional consent is obtained when those participants agree to participate in a study.
It is important to consider potential future uses of data and/or specimens after completion of a study, as additional questions may arise in the future that can be addressed using the same dataset or leftover specimens. If there is an intent to set up a registry or repository, then the informed consent document of the original study should include language for subjects to opt-in or opt-out of storage of their data / specimens for future research purposes. The subject’s decision as indicated on the consent/authorization form must be respected and tracked.
Generally, IRB oversight is required for each new research protocol that uses identifiable or re-identifiable information contained in the database.
Subjects must consent to inclusion in the registry. However, researchers may use a staged consent process in which preliminary consent is granted by subjects when they are included in the registry and additional consent is obtained when those subjects participate in a study. The language in the informed consent should specify the nature and purposes of the future research. The consent form and process for maintaining human specimens in a repository for future research uses must inform the subjects explicitly about the unspecified possible future use of the specimens and related personal information.
The consent process should consider the following:
Repositories and/or Registries should have data submission policies to ensure that the data are collected in an ethical manner, with informed consent and IRB approval. The repository should have a sample storage and management plan and written policies on:
Recipient‐investigators should have a written agreement with the repository. The agreement should specify under what conditions the data are being released to the recipient‐investigator(s).