This is Part II of a two-part entry. See Part I here.
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. Paula McAllister, PhD, who presented the webinars on informed consent and exemption 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.
If a research data repository contains only de-identified data, is an institution still required to obtain broad consent since there is no risk of harm? My assumption is yes; institutions continue to have an ethical obligation to do so as part of respect for persons… specifically, the “informing” part of the consent process. Is that right?
PM: Broad consent applies to research on identifiable information and identifiable biospecimens. If the identities of the people from whom the information/biospecimens were collected cannot be ascertained, then this is not an appropriate situation for broad consent.
How does this new broad consent regulation impact retrospective chart reviews that contain data of deceased individuals?
The Office of Human Research Protections rules and regulations do not apply to the deceased. HIPAA regulations, however, do have regulations related to decedent research.
My understanding was that broad consent is an all-or-nothing type of consent. So, if a subject refused to sign the broad consent, they could not participate at all. Is this correct?
PM: For practical purposes, yes, that is correct because broad consent is only used for secondary research purposes (tied to exempt categories 7 and 8).
When the research is due for annual continuing reviews, can we then apply the new requirements for consent?
PM: According to the preamble, research that was approved prior to the January 19, 2018 compliance date of the revised Common Rule is not required to transition to the new regulations, if the IRB determines so on a case by case basis, in order to avoid a situation where research is subject to two sets of rules over the course of the research.
The preamble then goes on to state: “However, we also recognize that institutions may prefer for a particular study, initiated before January 19, 2018, to comply with this final rule [i.e., the revised regulations] given the benefits that it offers and for administrative simplicity such as common regulatory requirements across an institution” (Federal Register, Vol. 82, No. 12, p. 7161). In such cases, that particular study would have to comply with all aspects of the revised rule, including but not limited to new informed consent requirements. Note that this determination should be formally made by the institution and documented by the IRB. On the other hand, if such a determination is not made, then research initiated before January 19, 2018 remains under the pre-2018 regulations as a default.
After January 2018, do researchers need to submit amendments to revise consent forms that are used in existing studies to meet the new regulations?
PM: The revision of a consent form is usually done through an amendment process unless the changes are nominal. I would imagine that, depending on the study, the changes that must be made in order to comply with the new regulations would be substantial enough to warrant a full amendment process. However, see answer above (question 13) regarding the transition of existing studies.
For non-English speaking subjects and the short form: we use the full English version of the consent form as the IRB-approved summary. If the IRB-approved summary now needs the key information included, does that mean we can’t use pre-2018 consent forms when we enroll non-English speakers in the future? They won’t have had that key information part up front.
PM: For research initiated prior to January 19, 2018, your institution could choose to not migrate those studies to the new regulations, in which case you would not need to revise your short form or summary. For research approved after January 19, 2018 the summary would need to include the key information and you would also need to revise the short form to include mention of the key information.
Screening, Recruiting, or Determining Eligibility
How do the HIPAA regulations align with the new common rule change regarding Preparatory to Research contact with potential subjects?
PM: Although both mechanisms allow for the determination of subject eligibility and study feasibility without informed consent, there are some key differences between HIPAA’s Preparatory to Research and the new Screening, Recruiting, or Determining Eligibility provision.
HIPAA’s Preparatory to Research has the following requirements:
- The use or disclosure is sought solely to review PHI as necessary to prepare the research protocol or other similar preparatory purposes.
- No PHI will be removed from the covered entity during the review.
- The PHI that the researcher seeks to use or access is necessary for the research purposes.
Although it does not need to be approved by the IRB, a “notice” that Preparatory to Research will occur should be documented, and the required elements should be verified by someone in the IRB office in the event of an audit (see Bankert & Amdur, p. 275).
Under the new Common Rule provision, the IRB can approve a study in which “investigators obtain identifiable private information without individuals’ informed consent for the purpose of screening, recruiting or determining eligibility of prospective human subjects of research” (Federal Register, Vol. 82, No. 12, p. 7227). The IRB will still review the research in its entirety, meaning that all other aspects of the research should be in compliance with the regulations, including the adequacy of protection of privacy and confidentiality.
Another key difference is that this new provision allows for researchers to have direct contact (i.e., oral or written communication) with prospective subjects or their LARs prior to engaging the informed consent process, during which they may collect information about prospective subjects in order to determine eligibility. If it is determined that a prospective subject is eligible to participate, then all other relevant requirements, including informed consent, must be met.
The part that is similar to the HIPAA provision is that, under the new Screening, Recruiting, or Determining Eligibility provision, researchers can obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens without informed consent. Now, institutions that are not covered entities can utilize this provision as long as it is for the purposes of screening, recruiting, or determining eligibility. This had not been allowable without informed consent under the pre-2018 Common Rule.
At our institution, the Research Compliance Board issues HIPAA waivers when appropriate. We follow HIPAA regulations regarding patient record review for preparatory activities (screening, determining eligibility, recruiting). Do the revised rules require that the IRB issue a separate approval for such activities? Or is the revision a measure for to be applied when personally identifiable information is not HIPAA-protected, for example, where there are no electronic medical/health records, or information other than health information?
PM: The true impact on this Screening, Recruiting, or Determining Eligibility provision is on institutions that are not covered entities. If you are a covered entity and you have been using the Preparatory to Research provision allowed under HIPAA, then this new provision may not have much of an effect on your institution’s practices regarding patient records review. With regard to other personally identifiable information that is not HIPAA-protected, then this provision would come in handy as long as the research activity is reviewed and approved by the IRB. See answer to question 16 above for more information.
Return of results to subjects
When the regulations talk about making a statement as to whether clinically relevant research results will be given to the subject, do they mean that the info will be given directly to the subject, or could it be done globally (in a non-individualized fashion) in a newspaper advertisement or on clinicaltrials.gov?
PM: There is not much guidance on how this should be accomplished, but it should be in the spirit of the respect for persons as described in the Belmont Report, meaning that the information should be provided to subjects in a way that is accessible and convenient to them, not to the researchers. Depending on the research context, subjects may not be very likely to go to clinicaltrials.gov for information that is relevant to them. The IRB should review the plan for dissemination of research results to ensure that subjects will receive the information in a way that is convenient, accessible, and verifiable by the IRB (in case of audit), rather than allowing researchers to provide a “passive” type of dissemination such as publication in newspapers or websites.
This is Part II of a two-part entry. See Part I here.
PRIM&R thanks Dr. McAllister 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.