Opinion: Shedding Light on the Impact of the Revised Common Rule on the Informed Consent Document

Clinical Research—December 2019 (Volume 33, Issue 10)


Joy Jurnack, RN, CCRC, CIP, FACRP


As of January 21, 2019, updates to the Common Rule (the Federal Policy for the Protection of Human Subjects governing institutional review boards [IRBs]) were implemented for the first time since the Rule was originally made into law in 1981. The policy gained its nickname because it is the “common rule” enforced on all agencies conducting human research within the U.S. government.{1}

As is the case during any regulatory update, revisions to the Common Rule took years to finalize, endured public comment, and were long anticipated by those “in the know” about them pending their eventual enaction. However, not everyone in clinical research lives on both the clinical side and the administrative side to the extent of being aware of what was happening with the Common Rule and what the updates mean to the clinical research enterprise today.

Exploring the Rules

As both a certified clinical research coordinator (CCRC) and a certified institutional review board professional (CIP), I find knowledge of how to conduct research from a sound scientific perspective as important and interesting as the regulations governing the ethical realm of human subject protections. I can assure you, not everyone shares my passion, which is exactly why, after reviewing the details about the research team’s responsibility in the Common Rule revisions, I felt some further clarity could be helpful to those of us affected by this revision.

When involved in federally funded studies, all research within the institution must adhere to the Office for Human Research Protections’ (OHRP’s) Common Rule. Research involving drugs and devices are federally regulated by the U.S. Food and Drug Administration (FDA), and while FDA and OHRP are both under the U.S. Department of Health and Human Services, their individual regulations are similar but not exact. Keeping the regulations straight can lead to confusion, and this is where your IRB, the committees operating on a local (site) or central (for-profit) level to which research teams submit all required paperwork for review before the trial can launch, becomes your lifeline. Embedded within the IRB’s procedures are all the necessary questions to ensure you have met the requirements for having the conduct of your research approved, regardless of funding or region.

In addition, any pharmaceutical-sponsored research ideally follows the guidance of the International Council for Harmonization (ICH) E6(R2) guideline for Good Clinical Practice (GCP) and the tenets of the Nuremberg Code,{4} both of which are widely incorporated into research conducted internationally. As a clinical research professional, your knowledge of these documents and the application of their contents can weigh heavy when trying to write or implement a protocol. Again, this is where the IRB of record offers directions and will be the only way for you to craft informed consent documents that will be approved, not to mention actually conduct your study.

Let’s imagine for a moment that your team focuses on sponsored studies of potential new drugs and/or devices at an academic medical center following the OHRP’s Common Rule. This agreement with the federal government allows it to hold a Federalwide Assurance (FWA),{5} which is a number given to IRBs and commits them to follow OHRP in order to accept federal funds or grants, as in a National Institutes of Health (NIH) award. An institution can have its FWA taken away, thus losing all its federal money, including NIH funding, unless the entire institution follows all the rules of OHRP. The IRB stands as the gatekeepers, whether centrally or locally, minding all research on human subjects (and animals, but that’s a topic for a different author to tackle).

What’s New for the Research Team

The change I want to summarize here for my fellow research professionals is the impact the revisions to the Common Rule have on the informed consent document. But to be clear, when working with either investigational drugs or devices with financial support from any kind of sponsor organization, the research team is advised to comply with the Common Rule (OHRP), FDA regulations, ICH GCP, and Nuremburg Code.

As a research nurse, I have done extensive training and research on language and understanding the document of informed consent. I have been one who has advocated for informed consents to have “information that is given to the subject or representative (that) shall be in a language understandable to the subject or the representative” (21 CFR 50.20 in the Code of Federal Regulations).{6} This has been a part of the FDA regulations for years, but implementation of it has remained unclear to research teams and largely unfollowed in terms of the consent document presented to the subject.

The Common Rule updates many items, and the informed consent is the focus here. The Rule says that it establishes “new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.” It looks like OHRP is requiring what has already been required, but not enforced, in FDA regulations. In broad strokes, the following are changes to the general requirements for informed consent (for all the details, see Federal Register Vol. 82, No. 12 from January 19, 2017, pages 7210 to 7231){7}:

  1. The content, organization, and presentation of the informed consent form are designed such that the subject can decide to participate or not participate in the research.
  2. Additions have been made to the elements/sections of the consent.
  3. Broad consent may be given for storage, maintenance, or secondary research use if using identifiable biospecimens.
  4. Changes have been made to how any waivers and later alterations of consent are handled.
  5. If certain conditions are met, the IRB may approve research where the investigator collects biospecimens without the subjects’ consent for purposes of determining the eligibility of subjects.
  6. The IRB-approved consent is available on a federal website for review.

IRBs were left to interpret and implement these changes. An institution receiving federal funds, as mentioned above, is expected to incorporate the changes within a concise summary (not defined in the regulations) on the front page on the informed consent—before any of the medical jargon included in the first few pages of a “greater than minimal risk” study. Since individual IRBs are left to their own resources to craft this additional information, you likely will see a revised informed consent form laid out differently depending upon the IRB. In essence, an IRB wants potential subjects to know:

  • Why should I be in this study?
  • Why shouldn’t I be in this study?
  • What is the research question and why am I a candidate for the research?
  • What types of activities are considered research?
  • How much personal, identifiable information will be collected?
  • If biosamples are taken from me, how will they be identified, stored, and used, and will any information either be connected to me or returned to me after completion of the study?

What runs consistently through the request for key information is the call for simplicity in language, including a clear description of why one might (or might not) want to participate in the study. For all studies, regardless of their funding source, such important information should be right up front in the document for the subject to read and understand; they shouldn’t have to sift through endless scientific jargon and medical lingo to tease out the essence of what the research study is all about.

To date, OHRP has not offered guidance on the revisions. IRBs want to honor the revisions and will assist the research team, but it is up to the team to complete whatever template the IRB supplies with the details required to comply with the Common Rule. IRBs will assist and edit, but the initial work is on the research team. Research staff should be ready and willing to compile this information initially; having an educated potential subject to deal with makes the job of either explaining a study or obtaining consent easier.


The complexities inherent in any regulatory revisions to key human subject protections–related documents are exactly, in my humble opinion, why having a working knowledge of the responsibilities of the IRB and appreciating the impact of its functions on the research team are necessary for fostering collective collaboration and a collegial working relationship between these two arms of the clinical research enterprise. Toward this end, I suggest it’s time for the Public Responsibility in Medicine and Research (PRIM&R){8} and Association of Clinical Research Professionals (ACRP){9} organizations to form an alliance, working together through education and annual conferences to update research professionals on all aspects of research—both administratively and clinically. Upholding the tenets of human subject protection is our shared goal.


  1. The Common Rule: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
  2. OHRP: https://www.hhs.gov/ohrp/
  3. FDA guidance on revised Common Rule: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM623211.pdf
  4. Nuremburg Code: https://history.nih.gov/research/downloads/nuremberg.pdf
  5. Federalwide Assurance: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html
  6. 21 CFR 50.20: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50
  7. Federal Register on revised Common Rule: https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/FR-2017-01-19.pdf
  8. PRIM&R: https://www.primr.org/
  9. ACRP: acrpnet.org

Joy Jurnack, RN, CCRC, CIP, FACRP, is a patient/subject advocate, Senior Director in Site Engagement with Slope.io, Inc, and a member of the Board of Trustees of the Academy of Clinical Research Professionals, which oversees the ACRP certification programs.