AAUP proposal for IRB reform: redefining exempt status

The American Association of University Professors (AAUP) recently released a report titled “Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board”.  The AAUP’s report is based on an analysis of responses from various professional societies (including LSA) to a July 2011 document released by the Department of Health and Human Services, the ANPRM (advance notice of proposed rule-making), which set out some proposals for IRB reform and asked for feedback. 

Here, I discuss one of the report’s recommendations, which is relevant for linguists, but wasn’t the focus of the LSA’s official response to the ANPRM.  I hope this can start a conversation following up on the earlier (August 2011) discussion on this blog.

The AAUP report recommends that all minimal-risk research on autonomous adults be included in the “exempt” category, not just the short list of procedures (such as survey forms, interviews, and observational research) that is currently included.  This would include much of what currently qualifies for expedited review.  Furthermore, the report proposes that the determination of “exempt” status no longer be subject to IRB review, but rather should be determined by the researchers themselves. 

This is similar to one of the proposals in the ANPRM — a new category of “excused” research to replace the “exempt” category.  This category would similarly expand the scope of the exempt category, but the researcher would still have to “register” their project with the IRB.  The registration forms would then be subject to possible random audit later, but the researcher would be allowed to begin research right away without waiting for approval. 

I think that both proposals would enhance academic freedom and relieve administrative burdens from researchers and IRBs.  Of particular value for linguists is the expansion of the exempt category to include additional types of minimal-risk research.  For example, my own experimental protocols, which consist in adult participants speaking sentences and/or pressing buttons in response to linguistic stimuli, are non-exempt under the current guidelines.  Under either set of revised guidelines, most types of psycholinguistic experiments and other low-risk methods would become exempt.  This would be a welcome change for me, since I would no longer have to wait for approval (which sometimes takes several weeks) every time I need to make a minor change in the protocol.

Would this revised system for exempt research provide adequate protection for participants?  

In a recent email to the Ethics Committee, James Crippen brought up two potential problems regarding the proposed expansion of the exempt category:  (1) how to define low-risk methods for each discipline; and (2) how to take into account subject matter in addition to the actual methods.  

The AAUP solution to both problems is to allow researchers themselves to make those determinations, with the help of a standardized list of exempt methods and the advice of the IRB or a departmental representative as to how discipline-specific methods should fit into the standardized categories.   But does this give too much discretion to researchers? 

I think the idea of having researchers on exempt projects register their projects with the IRB is a good idea, and helps ensure appropriate protection of participants in minimal-risk studies.  Registration of the project forces researchers to explain their procedures and how the rights of participants will be protected (just as in the current system). This would encourage researchers to make a careful, reasoned decision about whether a particular project qualifies as exempt and to seek advice from the IRB or other experts when needed.  I believe that the threat of a random audit would discourage people from inappropriately stretching the definition of exempt status. 

What do you all think?  Do you agree with the proposal to expand the list of exempt categories of research to a larger number of minimal-risk procedures?  Would simple registration of exempt projects be enough to ensure appropriate protection of participants?  If the proposed changes go through, should the LSA provide their own guidelines for how to interpret the new exempt categories with respect to common research protocols in linguistics?

Please post your comments here!

Elaine Francis

Purdue University

Junior Co-Chair, LSA Ethics Committee

Informed Consent

Informed Consent: Regulatory Background

Over the next several months the LSA Ethics Blog will host a discussion of informed consent by posting a number of case studies for comment.  I am getting the ball rolling here today with a brief overview of the U.S. regulatory requirements for informed consent so that we have a shared understanding of institutional review board (IRB) decision making mechanisms and importantly, so that we might more readily separate the regulatory requirements from the varying ethical (and perhaps for some, moral) responsibilities we have as researchers of language.  My review of the regulations is cursory so please feel free to ask questions if you have them.

The U.S. federal research regulations, also know as 45CFR46, don’t define informed consent, but instead provide a list of the elements that informed consent should include and the ways in which researchers might document that consent has taken place.  As an IRB administrator and a generally hopeful human being, I take this as evidence that the federal regulators really do want researchers and IRBs to have flexibility when it comes to approvable consent materials. We will discuss ways in which you and your IRB might use this flexibility in the upcoming posts.

The canonical model

One thing to keep in mind about the regulations and about IRB review in general is that research projects are viewed through the lens of a canonical (and hypothetical) norm.  For example, an IRB might see the canonical model for an interview study as one in which the researcher interviews subjects (generally strangers), audio records the interview, transcribes the recordings, removes all identifiers from the transcripts, and then erases the audio-recordings.  Though this is not the only model, it is the starting point for IRB review. If an interview study varies from this model, the IRB needs to document how and why.  The regulations governing consent work much in the same way.  They describe a signed written consent form as the norm and when a study varies from this model the IRB has to document how and why.

Three regulatory “types” of consent

There are three regulatory “types” of consent.

I. Written documentation of consent. This is the default type of consent and it what most people think of when they hear “informed consent.”  Written documentation of consent is a written document that research participants (or their representatives) sign to indicate that they have been informed about the study and agree to participate.  Sometimes researchers will sign these too.

II. Waiver of written documentation of consent. This is a consent process that does not involve a written signed consent form. A researcher would need to request this waiver in order to use a consent process that is not signed by the subject.  This is relevant for studies that have oral consent, consent letters, and information statements.  Researchers need to supply the IRB with written versions of the consent process they will use. (Much more on this below.)

III. Waiver of informed consent. This is a consent process that does not require researchers to inform subjects’ of their participation in research. This will not likely apply to much linguistic work or to the case studies that we present, but I would be remiss if I didn’t fill out the Big Three consent regulations. Some research studies can be conducted without any type of informed consent at all.  Studies that meet the threshold for waiving informed consent are nearly always those that are using identifiable secondary data in which the researcher will not have contact with the study subjects—like a review of identifiable medical records. Some IRBs use this as the threshold for opt out consent.

What the regulations say might/should be included in consent

The regulations list a number of elements that an IRB should take into consideration as they review a consent document.  During the review, the IRB has the choice to either require these elements or waive their inclusion. Here are a few examples of the elements of consent:

• Statement of the research purpose
• Statement describing the study procedures
• Statement explaining how long participation may take
• A description of any reasonably foreseeable risks
• Approximate number of subjects in the study

For a full list of consent elements see 45CFR46.116.

Justifying a waiver of written documentation of consent

In order for a research project to use a consent process that does not include a consent form signed by subjects, an IRB must document in their files that they have granted a “waiver of documentation of informed consent.”  The are two regulatory grounds on which an IRB can grant such a waiver:

45CFR46.117 (C) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

A waiver request needs to respond to either (1) or (2) but not both.  For nearly all linguistic research point (2) is the point to address.

A note on parental consent & minor assent

Parental permission for participation of a minor in a research follows the same model described above and requires written documentation of consent, a waiver of documentation of consent, or an informed consent waiver.  A study might require two parent signatures or it might only require one parent signature.  The consent process for minors is called “assent” and there are no regulatorily required elements, the IRB can determine what is appropriate.  See 45CFR46.408.

IRB Spotlight: Benefits

IRB Spotlight: Benefits

Since understanding the question gets you half way to the answer on your IRB application, today’s post about one of the questions that is on all human subjects applications.  Your IRB application will ask you to explain the direct benefits of your research project for (1) the individual subjects, and (2) society or the research community as a while.  Even if your application doesn’t divide it into two questions, they are still looking for two answers.

(1) What are the anticipated benefits for individual subjects?

The purpose of this question is to find out if individual subjects will receive some benefit from participation in your study, but in order to answer the question, you need to know what the IRB means by benefit.

Benefits to individual subjects are thought of in terms of therapeutic or educational interventions, or results from hearing tests, lab tests, and other cognitive measurements.  IRBs do not generally consider the opportunity ‘to express an opinion,’ ‘reflect on a given topic,’ or ‘talk to a researcher’ to be benefits for individual subjects.  So even though the subjects may enjoy the chance to talk about a given topic, the IRB will likely not consider it a benefit. If the potential risks to your subjects are low, or if you take strong measures to protect confidentiality, then it is perfectly acceptable to say that subjects will not benefit from participation.

Payment to study participants is NOT considered a benefit of research participation. Payment is considered to be compensation for time and inconvenience.

(2) What are the anticipated benefits for society?

This is a section that causes most researchers little trouble, given that they have defended their research proposal, written grant applications, and spent endless hours figuring out just where the research project might fill a gap in our existing knowledge about a given area.

For researchers who are working with small, vulnerable, or easily identifiable communities (e.g., Native American communities, rural—or island bound—communities, etc.) your research may not directly benefit individual subjects, but may have the potential to directly benefit their larger community.  If this is the case for your research, please make this clear because it is something that your IRB should know. But be aware that in these circumstances there are often community level risks that you should address in the application.