In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics of informed consent, exemptions and types of review, biospecimens and identifiable private information, and implications for social, behavioral, and educational research (SBER), these webinars provided a close look at the most significant areas of change described in the revised Common Rule.
The effective and compliance date for the revised rule is January 19, 2018, and with this date on the horizon, webinar attendees had many questions for the presenters about the new rule and what implementation might look like in their own human research protections program (HRPP). Time did not allow us to answer all of the attendee questions that were submitted during the live webinar. Karen Christianson, RN, BSN, CCRP, who presented the webinar on exemptions and types of review, responded to some of the audience’s additional questions after the webinar. We’re pleased to share those responses with the readers of Ampersand.
For new exempt category 2, my reading of the rule is that investigators can obtain information that is recorded in such a way that the identity of the human subjects can be ascertained as long as disclosure of the responses would not place the subjects at risk. It looks to me as if this can be done under criterion ii without requiring a limited IRB review. Am I reading this rule correctly?
Karen Christianson (KC): Your interpretation is correct. Under exempt category 2, only one of the three sub-criteria must be satisfied for the research to qualify for the exemption; and, only the third criterion (below) leads to the additional requirement for limited IRB review.
“The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7).”
In exempt category 3, how does a potential subject authorize deception? How would a researcher obtain the authorization to deceive?
KC: One example would be to include the possibility of deception as an opt-in when seeking consent from students to participate in a research pool.
With the new allowance to include prisoners when they are not the targeted population, should an investigator wish to apply exempt category 3 to subjects who are under house arrest, would this be allowed?
KC: I think the question that would need to be resolved is whether the subjects who are under house arrest would be considered prisoners. If they are, and the research specifically targets such subjects for inclusion, then I do not believe the exemption could be applied. On the other hand, if subjects who are under house arrest are not considered prisoners, and all other criteria for exempt category 3 are satisfied, the exemption could be applied.
Current Office of Human Research Protections (OHRP) guidance states that “Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted.” But, within the examples, the following is called out: “Probationers and individuals wearing monitoring devices are generally not considered to be prisoners; however, situations of this kind frequently require an analysis of the particular circumstances of the planned subject population. Institutions may consult with OHRP when questions arise about research involving these populations.”
Given that the circumstances of “house arrest” may be variable, I think it would be wise to consult with OHRP prior to applying the exemption.
Can you provide an example of, or some additional commentary on, the allowance for including prisoners in an exempt research study if they’re incidentally recruited? It’s difficult to envision a situation in which a researcher enrolls a prisoner without specifically targeting a population of incarcerated individuals.
KC: Certainly, under exempt category 4, one could envision researchers gathering data from medical records from a broad population of eligible patients (e.g., adult patients with a particular condition) without needing to screen out any of those records that may come from patients who are also prisoners.
Another example, from the preamble, speaks to when subjects already participating in exempt research become prisoners:
“Similarly, the narrow expansion would allow a subject to continue participation in exempt research if he or she became a prisoner during the course of an exempt study, assuming the study was aimed at a broad nonprisoner population, without the need for subpart C IRB review and certification to OHRP. For example, an exempt study that recruited subjects from a local community center to participate in a comparison of HIV educational materials would continue to be exempt, and would not trigger the need for review under subpart C, even if some of the subjects became prisoners after enrollment.”
If information is found in a data set that the data owner requires the researcher to complete a data access confidentiality agreement and the researcher can identify subjects by accessing the data to collect data elements, does this fall under category 4 as exempt?
KC: This is an area where guidance would be helpful. It’s possible that the research could be exempt under Category 4 so long as the investigator does not record identifiers in the research data set itself, does not maintain a linking key, and agrees to not contact or re-identify subjects. It also could potentially qualify for exemption under Category 4 if the data is protected under HIPAA.
If category 4 covers secondary use of data, how can this category cover both prospective and retrospective data?
KC: “Secondary” as used in this exemption means that the data was or will be collected for another “primary” purpose. An example may help: a researcher proposes use of medical record data for research; some of this data exists today (retrospective) and some will be generated in the future (prospective). All of the data will be gathered as the result of clinical care. Assuming all other criteria are satisfied, this research would qualify under the new exempt category 4, while under the current rule it would not qualify for exemption because the data is not all “pre-existing”.
For exempt category 5, is it mandatory that the study be directed to improvement? That would be good.
KC: No. Because the language in the new category 5 uses “or”, there is no mandate that such studies be directed towards improvement: “and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs….” The word “improve” was added to the exempt category to make it explicitly clear that the exemption was not limited to assessments of a program. Research proposing improvements to such programs could also qualify for exemption.
Would it be possible for an institution to choose to not implement exempt categories 7 and 8 and instead send all those studies for expedited review under category 5?
KC: If an organization chose not to implement or permit broad consent, it then also would not use exempt categories 7 and 8 (since broad consent is a requirement of both). Any such research would then have to either qualify for exemption under another category (e.g., exempt category 4), or would have to be reviewed using expedited or convened board procedures. Whether all such research would qualify under expedited category 5 is unknown especially given that changes to the expedited categories are anticipated.
As a point of clarification: if a research team were to receive an exemption category 7 (for storage and maintenance), is the implication that when they get to the point that they want to conduct actual research that they would need to seek a new approval, e.g. exemption category 8, from the IRB?
KC: That’s correct. Exempt category 7 only covers storage and maintenance. Any subsequent studies using the data or specimens for which broad consent was obtained would require separate review or determination of exempt status.
Exempt Category 8 on return of results to subjects: this would affect consenters presenting MyCode to patients and the biggest seller to patients is that they would receive results regarding the research, since essentially it may have an impact on their overall health care.
KC: I agree, but keep in mind that the potential return of results only means that such research could not qualify for exemption. Instead it would need to be reviewed either using expedited or convened IRB review. Since the commitment to return results when researchers find something important to a subject’s health is such a strong driver, I would hope that researchers will recognize this and apply for IRB review instead of exemption so that they retain the option to return results.
With regard to exemption category 8, has anyone given any thought to how this might be implemented in the case of research collaborations in which the consent process was conducted at another institution and the identifiable specimens/data would be coming to a new institution (who would now need to review the consent process and provide the exemption…)?
KC: That’s a good question. I think that there is still much to be sorted out in the application of many of these changes. I do know that some organizations are choosing not to adopt broad consent themselves and/or not to accept broad consent obtained by external investigators. Other organizations are evaluating whether to apply the HHS exemptions (and other components of the Common Rule) to research that is not conducted or supported by a Common Rule agency. And then on top of that are the variations in statements of IRB jurisdiction. These variations in approach are going to present challenges to the research community.
What’s the difference between limited and expedited review?
KC: Under limited IRB review, the IRB evaluates whether specified criteria for approval are satisfied a subset of exempt studies. The IRB can do so using expedited review procedures. This differs from other research that qualifies for expedited review in that not all criteria for approval need to be assessed by the IRB, only those specified in the exempt category.
Could you clarify the difference between “prospective agreement” and “informed consent”? Is it the lack of a signature?
KC: While I think that guidance in this area is needed (along with a broader need to define or explain many of the terms included in the new rule), we may be able to extrapolate from the following statement in the preamble that “prospective agreement” does not have to include all of the elements of consent nor meet the signature or process requirements expressed at §.116 and .117:
“For the purpose of this provision, authorized deception would be prospective agreement by the subject to participate in research where the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. The final rule allows this type of research to occur without the requirements of informed consent because the intervention is not likely to result in harm or offense to the subject, and the subject must prospectively agree to the intervention and the data collection.”
PRIM&R thanks Ms. Christianson for sharing her expertise with the readers of Ampersand! For more updates and resources about the revised Common Rule, please visit PRIM&R’s revised Common Rule webpage.
The recordings of the Focus on the Revised Common Rule webinar series are available for purchase online as individual webinars and as discounted bundles.