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.

Updates to the informed consent form (ICF)

If the new consent form section can never be waived, there always needs to be a consent form to contain that new section. Does this mean the end of IRB chair consent form waivers for minimal risk research?
Paula McAllister (PM): Informed consent can still be waived if the IRB finds and documents that the research involves no more than minimal risk to the subjects, the research could not practicably be carried out without the requested waiver or alteration, the waiver or alteration will not adversely affect the rights and welfare of the subjects, and whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participating (.116(f)(1-3)). A newly added criterion is: “if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.” All of these criteria must be met in order for the waiver (or alteration) of consent to be allowable, in which case there is no consent form and no consent process for subjects.

Most of my institution’s studies are minimal risk. Our informed consent documents are typically one-to-four pages long, if that. Will we still be “required” to include a concise summary at the beginning of the form? Even if it already is only one page long?
PM: Yes, the “key information” section must be included no matter how long your consent documents are. There is no guidance on what information should be included in that section, other than it should be focused, concise, and facilitate comprehension, and that it should help the reader decide whether or not to participate. Right now, it is up to individual IRBs to determine, on a study by study basis, which information should be included in the “key information” section.

Would a general one-page consent form used in a lot of social, behavioral, and educational research meet the criteria for presentation of key information?
PM: This would depend on whether or not the document is focused, concise, and facilitates comprehension, and that it assists in understanding the reasons why one might or might not want to participate in research. These are the main criteria for the new “key information” section. Other elements of informed consent should follow.

For the required element of consent, I wonder if it applies to data collected from a behavioral type of study.
PM: It applies to all studies that are being reviewed according to the Common Rule, regardless of whether they are SBER or biomedical studies. If a study involves collection of data in such a way that the identities of human subjects cannot be readily ascertained, then it may qualify as exempt, in which case consent is not mandated. However, some exempt studies, such as those falling under exempt category 7, do require informed consent under the new “limited IRB review” provision, so that is something to keep in mind when making this determination.

How will the use of the new consent section affect research involving deception?
PM: The preamble and the final rule address deception as research that would qualify as exempt, specifically exempt category 3 (research involving benign behavioral interventions), and that withholds information about the true purpose of the activity, but in which the subject has prospectively agreed to participate in the research. So, it’s possible that the new “key information” section would include this agreement and that the subject will be “unaware of or misled regarding the nature or purposes of the research.”

See exempt category 3 (research involving benign behavioral interventions) in _.104(d)(3)(iii), which states: “(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.”

One of the new elements of informed consent is that for research involving identifiable private information or biospecimens the informed consent form (ICF) must state that collected samples/data may be de-identified and used for future research or that they will not be used for future research. Does this mean that subjects will no longer have the ability to indicate on the ICF whether they agree to their data/specimens being used in future research, as they often do now via a checkbox in the ICF?

PM: This new basic element does not necessarily preclude the option to include such a checkbox. This new element mainly serves to force researchers to consider more carefully any future plans when preparing consent forms, and, ideally, stick with their decisions about whether or not to re-use data/specimens.

Waivers of Informed Consent

Are the criteria below for a waiver of consent “and” criteria (as in, all must apply) or “or” criteria (only one must apply):

The specific criteria that an IRB must find and document in order to waive the requirements for informed consent are:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver
3. If the research involves using identifiable private information or identifiable bio-specimens, the research could not practicably be carried out without using such information or bio-specimens in an identifiable format;
4. The waiver will not adversely affect the rights and welfare of the subjects;
5. Whenever appropriate, the subjects will be provided with additional pertinent information after participation
6. If the research involves using identifiable private information or identifiable biospecimens and could not practicably be carried out without using identifiable private information or identifiable biospecimens”

PM: The list of criteria is “and,” as in all must apply in order to allow a waiver or alteration of consent for general purposes. Similarly, they are “and” criteria for waiver or alteration of consent for public benefit or service-related activities (exempt category 5). Also note that waivers and alterations cannot be applied if a broad consent procedure was used. They can, however, be used if information or biospecimens are un-identifiable.

Broad Consent and Secondary Use of Biospecimens and Identifiable Private Information

Regarding broad consent, is it the intent that a previously approved comprehensive consent can be accepted under the new regulations as a “broad consent”?
PM: If so, then it would need to include the usual elements of consent plus two new additional elements if biospecimens are involved (i. statement that biospecimens, even if de-identified, may be used for commercial profit, and whether or not that profit will be shared; and ii. whether the research will or might include whole genome or exome sequencing) in addition to elements specific to broad consent:

1. Description of the types of research that may be conducted with the information or biospecimens;
2. Whether sharing of information or biospecimens may occur;
3. The types of institutions or researchers that might conduct research with the information or biospecimens;
4. The period of time that the identifiable private information or identifiable biospecimens may be stored/maintained (could be indefinite);
5. The period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (could be indefinite);
6. Statement that subject/legally authorized representative (LAR) will not be informed of the details (or purpose) of future research studies that might be conducted with identifiable private information or identifiable biospecimens and that they might have chosen not to consent to some of the future research studies, OR you can notify the subject/(LAR) of each future study;
7. Unless all clinically relevant research results, including all individual research results, will be disclosed to the subject, a statement that such results may not be disclosed;
8. An explanation of who to contact with questions about subject’s rights, and about storage and use of identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.

In Oregon, health care providers who are “covered entities” must notify their patients that any specimens or health information collected will be available for anonymous or coded genetic research unless the person “opts out.” Other health care providers are encouraged to do the same. A person “opts out” by completing an opt-out form in writing and notifying the health care provider that s/he does not want her/his specimen or information available for coded or anonymous genetic research. Is this not the same as “broad consent”?
PM: Broad consent applies to research on identifiable information and identifiable biospecimens. If the identities of the people from whom the information and/or biospecimens were collected cannot be ascertained, then this is not an appropriate situation for broad consent.

Check back tomorrow for Part II of this post.

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.