Consider a study that has the following characteristics:
1. The procedure will consist of the researcher telling people things and/or asking them questions, and recording their responses in some fashion.
2. The participants are all legal adults, and are not drawn from any population or setting that compromises their ability to give consent (e.g., prisoners or the severely mentally ill).
3. The participants are all free to decline to participate or to discontinue participating after they start. “Free” means that if they decline or discontinue, they will face no negative consquences (relative to if they had never been invited to participate in the first place) .
4. Everything the researcher says to the participant must be true. The researcher cannot deceive people, and the researcher cannot make promises or commitments that will not be kept in good faith.
5. At the start of any interaction with participants, the researcher will identify him- or herself as such.
6. The researcher will not break any applicable laws.
If an investigator certifies that a study meets these criteria, should the government or a university scrutinize and regulate it any further?
Under the current IRB regulatory system, if a researcher wants to ask people some questions and find out their answers, the researcher has to jump through a whole lot of hoops and wait for various administrative delays. You have to complete pages and pages of paperwork, which includes submitting all of the questions you want to ask; wait a period of time (often weeks or longer) for administrators and IRB members to review the application, which will include somebody reading over the questions and deciding if you are permitted ask them; obtain consent in writing (unless it’s waived, which only happens under narrow and unusual circumstances); and if your inquiry takes longer than a year, go back to your IRB annually to get your permission renewed.
Yet if the researcher’s interactions with participants only involve talking with them, isn’t it just speech (you know, the free kind)? There has been a movement in recent years to clarify that fields like journalism, oral history, and folklore are exempt from IRB oversight. Unfortunately, the debate is being waged on the wrong terms: whether these fields produce “generalizable knowledge,” rather than whether their activities are protected by the First Amendment.
I think it’s fair to ask whether anybody doing #1 above is engaging in protected speech, regardless of whether they are a journalist or a political scientist or anything else; and if it’s speech, whether the government and universities ought to treat it accordingly. (I added nos. 2-6 to address some common and reasonable boundaries on free speech; e.g., we regulate speech to children more carefully; we don’t protect fraud; etc.) I’ll admit there may be something I’m missing out on — some way that a researcher could harm people with questions — besides boring them to death, of course. Sadly, the standard argument for regulation rests upon comparisons to Nazi war crimes. It would be nice to hear the advocates of regulation give a serious response to the free speech and academic freedom issues.
Advocates argue that there are a number of ethical issues that arise even with a study that is just “speech” related. For example, if a researcher wanted to know more about sexual assault issues than the questions asked would bring to light past psychological issues for the subject which could cause mental stress
As a matter of free speech, those kinds of considerations must be balanced against the rather heavy-handed effects of a system of prior restraint. We do not have laws (or legally mandated regulatory bodies) forbidding journalists from asking people about abuse.
As a matter of research ethics and care for human subjects, it’s not such a straightforward proposition that asking people about abuse will cause harm. That may be a gut reaction based on personal discomfort, rather than a scientifically or ethically informed judgment. A good, nuanced discussion is in Becker-Blease & Freyd (2006): Research participants telling the truth about their lives: The ethics of asking and not asking about abuse.
I don’t work in the US so there might be some details of the IRB system that I don’t understand (for example, is IRB review mandated by federal law or is it some sort of self-regulation system put in place by universities or grant-giving institutions?) but I don’t really see the relevance of the whole free speech issue.
There are many situations in which you have to sign non-disclosure agreements and those are not illegal. I know some institutes working on sensitive topics require their researchers to clear any publication with their supervisor (dysfunctional but not illegal as far as I know) and folks working in the private sector certainly need some sort of authorization before publishing papers about company’s work. Even at universities, if you want to do a study – speech-based or not – you often need some aspects of its design to be approved by other people (a lab director if you don’t have your own budget for it, your thesis adviser if your are a PhD candidate, some external institution if your are planning it as part of a grant application, external partners that will give you access to the relevant participants, etc.)
In fact scientific papers are certainly covered by the first amendment (and other mechanisms protecting free speech elsewhere) but we still have to deal with reviewers. An IRB review does not seem all that different from that to me. Free speech law forbids the government to enact a statute against it, it does not force anybody else to condone or fund your speech or publish it in their journal. You’re still free to get out and ask whatever you want after you retire but, from a legal point of view, if it’s done while you are working for someone else or funded by a third party, they can in principle impose any type of review based nearly any criteria they see fit and withdraw their support accordingly, however silly or counterproductive. What happens if you “forget” to submit your study for review or disregard the advice from the IRB, by the way?
In the U.S. IRBs are federally mandated. The U.S. constitution greatly limits the power of the federal government to regulate speech. Universities (in contrast to private individuals or businesses) also have strong moral and in some cases legal obligations to very broadly protect free speech and free inquiry.
Everything you are saying about reviewers, publishers, etc. is beside the point. Of course private parties (like publishing companies or private foundations) can choose what to say, publish, fund, etc. I am talking about the role of government-mandated regulations when a researcher at a university wants to engage in a pure speech act like asking somebody some questions. Under the current system a researcher has to submit the questions for a board to review, and cannot go forward without approval. If a researcher “forgets” to submit a study for review or disregards the IRB they could be severely sanctioned or even fired by their university. If a university is found not to be properly following the federal IRB regulations it could have all of its human subjects research shut down (this has happened before).
The type of consequences you describe do sound a lot like the kind of things that happen between private parties (i.e. no penal consequences, fine or jail time) so I still see some relevance to the comparison with reviewers or publishers. Of course, I agree that it’s morally questionable and ultimately counterproductive for universities to limit legitimate research but that’s not quite the same thing as having a state forbidding all its citizens to ask some questions.
In the mean time, I did some reading on the US situation and from what I understand, it seems that IRB review is enforced by the government through its funding activities and through specific regulations by agencies like the FDA (cf. the link you provided to the Code of federal regulations or the Wikipedia article on the topic). It does give a broad mandate to the system but again does not seem all that relevant to free speech. Legally forbidding universities or the Department of Health and Human Services to withdraw support to individuals or institutions because their research only involve asking questions amounts to an obligation to positively support some type of speech. I have no idea if that reasoning has some merits under US law but I am not sure I am convinced that refusing support (all the way to firing someone) violates anyone’s right to free speech. I mentioned other analogies than publishers by the way, how is a professor altering a student’s research protocol all that different from a university restricting its employees’ activities to keep access to federal funding?
I mean I can see where you are coming from with this, it could be a useful line of argumentation but it’s not really obvious that it is legally sound or that focusing instead on “generalizable knowledge” is necessarily the wrong way to approach the debate.