Changes to the Common Rule

Changes to the Common Rule

IRB REVIEW PROCESS FOR COMMON RULE CHANGES

IRB REVIEW PROCESS FOR COMMON RULE CHANGES

Exempt Review Application and Process

  1. Rowan Decision making chart for Exempt Review: found here.
  2. OHRP Decision making chart: found here
  3. Review Categories
    1. As a result of Common Rule Changes, there are now eight categories that fall under exempt reviews, as opposed to six categories in the past. Unlike in the past where exempt reviews were done outside the IRB, some of these categories now require limited IRB review.  Wherever a limited IRB review is required, investigators are guided to submit an expedited review application for such categories. The application form on the Cayuse IRB submission and review platform has already been modified to implement these changes.  Please go to the following link to submit: Cayuse IRB Sumission
    2. Category 1 allows studies about normal educational practices, as long as the research is not likely to have adverse impacts on students learning, required educational content, or assessment of educators who provide instruction.
    3. Category 2 will not permit children, hence an expedited review application is required if category 2 research involves children. This category allows exemption as long as the information obtained is not identifiable and disclosure outside of the research would not put subjects at risk of harm.
    4. Categories 3 is a new category. Category 3 (Subparts A and B) allow behavioral studies. This allows benign behavioral interventions in conjunction with the collection of information from adult subjects. Benign behavioral interventions are defined as “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing”. Research using deception is not eligible for exemption and therefore requires expedited review. This exemption is permitted if the data are recorded in such a way that the identities of the subjects cannot be readily ascertained either directly or indirectly or if the identities can be ascertained, a disclosure of the subjects’ responses outside the research setting would not reasonably place the subjects at risk of harm.
    5. Category 4 is same as in the past except when protected health information with identifiers are used, they will be reviewed under expedited review process.
    6. Category 5 is revised to include research and demonstration projects that are conducted or supported by a Federal Department or Agency.
    7. Category 6 is unchanged. It includes Taste and Food Quality Evaluation and Consumer Acceptance Studies
    8. *Category 7 is new. This category is for the storage of identifiable biospecimens and identifiable private information, prior to secondary analysis including collection, storage and maintenance. Applications that fall under this category will be reviewed under the expedited review category and require submission of an adult consent form.
    9. *Category 8 is new. This allows the secondary analysis of existing private identifiable data and identifiable biospecimens provided a consent has been obtained and the documentation of consent was either obtained or waived. Applications that fall under this category will be reviewed under the expedited review category.

*Categories 7 and 8 may be widely used by biomedical researchers. However, social and behavioral researchers may also use identifiable private information for secondary analysis.

Note: Each of the exemptions can be applied to research subjects that consist of pregnant women.  Each of the exemptions allow prisoners as research subjects only if the research incidentally (not directed at this subpopulation) include prisoners.  Exemption allows research with children in categories, 1, 4, 5, 6, 7 and 8. 

 
Changes to the Consent Forms

The new rule requires investigators to provide more information (key information) to subjects making sure that that subjects get precise information and sufficient time and opportunity to discuss the research with prospective subjects. The research team must also be able to provide answers to their questions before the subject makes a decision to participate in the study.  This includes five major points:

  1. A statement that the project is research and that participation is voluntary;
  2. Summary of research that includes purpose of research, precise information about the study and study procedures, duration and number of study visits;
  3. Reasonable foreseeable risks and discomforts;
  4. Reasonable expected benefits and;
  5. Alternative procedures

As a result of this, the consent/permission have changed by mostly rearranging the same questions to provide key information on top of the consent form as required by the regulations.  These consent forms are uploaded in the following link: Consent Templates

Please discard any old consent forms you may have saved on your desktop or laptop.  Please note that these consent forms may periodically change since the regulatory agencies are yet to provide proper guidance relative to the changes to the consent form. 

Continuing Reviews

In order to reduce continuing review burden, research projects that fall under minimal risk and reviewed under one of the expedited review categories no longer require annual continuing reviews.  Instead, the IRB will inform researchers 90, 60 and 30 days before the protocol expiration date to submit a “Progress Report”.  For additional information on progress reports please go to the following link: Progress Reports

 If the research study contains protected health information such studies will require annual continuing review.  Reminders will be sent to investigators 90, 60 and 30 days before the expiration date to submit a “Continuing Review”.

Effective January 21, 2019, projects that are in the data analysis phase no longer require to submit continuing review or progress report.  Instead, researchers should submit a Final Report or Study Closure if data collection is complete and the project is in the data analysis phase.  This policy will not apply to projects that are under the FDA regulation (drugs, devices and biologicals). 

Research That Is In The Final Data Analysis Phase

If the data collection is complete and the study is in the data analysis phase and no additional data to be collected, investigator may close the study by submitting a Final Report.  Studies in data analysis phase no longer require continuing review unless data contains protected health information (PHI) and a link is maintained during the data analysis phase.