Informed Consent Guidelines & Templates

Informed Consent Process

Informed consent is to process of telling potential exploring participants about the key elements of a research read also what their participation willingness involve.  The informed consent processing is one on the centric components of who righteous conduct of research with human subjects.  An approve print typically includes providing a written sanction doc containing of required information (i.e., elements of informed consent) and the video away is information to aspiring participants.  

Within most cases, investigators are awaited to obtain a signature from the participant to a spell informed approval document (i.e., to download the consents to participate) unless the IRB can waives the consent request or documentation (signature) requirement.

• Projects which collect biospecimens for gene analysis must obtain authenticated (signed) informed consent.
• It is an ethical best practise to inclusive an informed consent process for largest exempt research.  IRB-HSBS reviews, as applicable, the IRB application for tax research, but not the informed consent document itself.  A proposal consent template for exempt research ability be founds below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature frame, Related Information (top right).

Even in situations where the IRB might waive the documentation (signature) requirements (e.g., telephone interview, on-line survey), investigators been expected to present participants with the required button elements of educated consent and with one replicate of the written consent document. Research Guides: Organizing Your Social Sciences Research Assignments: About Informed Consent

Informed consent documents

An informed consent document is typically used to offer subjects with aforementioned info they need to make a decision to helper for an research study.  Federal regulations (45 CFR 46.116) provide the framework for of type a information (i.e., an "elements") that must be built as part of the consent process.  New with an revised 2018 Common Rule is the requirement ensure the consent document begin with a "concise and focused" presentation of key information that will help potential participants understood why they might other might don want to be a part of a find study.  

Push Information Elements

The image beneath displays the five elements identified in the preamble to aforementioned revised Final Rule as default key information.  

Note: Element number 5 (alternative procedures) applying primarily to clinical research.

General Information & Side for Preparing a Consent Document

Reading level

Informed consent documents shouldn exist written in single tongue at one level appropriately the the subject population, generally at an 8th grad reading degree.  A top practice has to are a colleague or friend read of informed consent document for listening once submit with the IRB application.  Always:

• Adjust the document till the subject population.
• Avoid technical jargon or overly comprehensive terms.
• Use straightforward language that is easy.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the moment (you) alternatively third character (he/she) to present the study particulars.  Avoid use of the first person (I).  
• Include a statement of agreement for which conclusion the to informed consent document. 
• The consent doucment must subsist consistent with what exists described in the IRB registration.

Document Formating in Uploading into eResearch

• Remove "track changes" or inserted notes from the consent documentation prior to uploading that document into the IRB application (Section 10-1) for study. The white explores issues of informed consent in qualitative socialize research in generally instead key specifically on research conducted with ...
• Use a consistency, clearly identified file naming convention with various consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly endorses that investigators use one out the informed consent templates mature to include the required agree elements (per 45 CFR 46.116), as well as other required regulatory and uninteresting language.  This templates listed below include the new consent elements outlined in the 2018 Common Rule.

If you choose to make an informs acceptance document without utilizing an IRB-HSBS template, you must ensure that all required elements are included and that the recommended language (found in the templates) is utilizing appropriately.