Advocacy PATHs: September 17, 2018

This issue of Advocacy PATHs is ALL about the Common Rule!  As you most likely know, an update has been issued for the Protection of Human Subjects in Research, known as the Common Rule. The first tier of changes applies to the Informed Consent Process, which is designed to facilitate the comprehension of candidates for participation.

Requirements include:

• A brief summary of the study that includes specific activities, risks, benefits prior to the content of the consent form, itself.
• Five points are to be presented in the body of the consent
  1. A statement that the project is research and that participation is voluntary
  2. A description of the research, including the purpose, duration, list of procedures
  3. Potential risks and discomforts
  4. Potential benefits
  5. Alternative procedures or changes in the course of therapy, if any.
• One of two statements should be included:
  1. Identification will be removed and data/biospecimens can be used for future research without additional informed consent.
  2. Information/biospecimens will not be used for future research, even if the identification is removed.
• Three additional requirements include:
  1. Biospecimens may be used for commercial profit and whether or not the subject may share in the profit.
  2. Whether clinically relevant research results will be shared with subjects.
  3. Whether research may include whole genome sequencing.

Additional considerations have been included for the request of waivers for review.

• Activities considered not to constitute research include:
  1. Public health surveillance - this allows public health authorities to identify biospecimens to monitor, assess, or investigate events of importance to public health, such as disease outbreaks;
  2. Collection and analysis of identifying information, biospecimens, or documents, when authorized by a court for investigation in the context of criminal justice;
  3. Scholarly and journalistic activities;
  4. Activities authorized for the support of national security missions.
• In order to receive a waiver to use identified data and biospecimens, the IRB must consider it would be impracticable to use de-identified data/biospecimens.
• Minimal risk studies that are approved by expedited review no longer have a requirement for annual continuing review. The new requirement is a biannual brief update.
• There is no change in the requirement to submit amendments and report events regarding safety issues.
• The changes in the Common Rule are not relevant to studies regulated by the FDA.
• The consent form approved by the IRB for federally funded studies must be posted to a publically available Federal website (to be determined) within 60 days of the last study visit/after the last subject is enrolled.
• Guidelines for the use of a “broad consent” have been established. This enables biospecimen storage and secondary research using identifiable private information and biospecimens.
  1. Policy must be implemented at the level of the institution.
  2. Tracking of all individuals who decline participation must be performed.
• The IRB may approve a research proposal for screening or determining eligibility for participation in a study without informed consent if appropriate criteria are fulfilled.