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Update: Thanks for the answers. I reworded and numbered the questions for clarification.

As a volunteer endeavor, I want to do online survey and education research. I am not being paid for the work, and the research participants are also not being paid. I am in the United States.

  1. Legally, do I need to obtain IRB approval to conduct the research?
  2. Legally, can I self-publish (e.g. blog)?
  3. Would any reputable journal accept results obtained without any IRB approval?
  4. What might the legal consequences be for not obtaining approval?
  5. If I'm not associated with any IRB, how would I get approval?
  6. Does it matter what my job is if I do the research in my personal time?
  7. What about a collaborator at a university who is helping as a volunteer researcher in their personal time?
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    IRB approval has nothing to do with whether the researcher or the subjects are paid or are volunteers. It is to assure ethical standards of research with human subjects. – Buffy May 21 '19 at 10:47
  • Search for "Belmont Report" and give that a read in order to get started understanding what constitutes human subjects research and the ethical issues that accompany it. – Matt May 21 '19 at 19:50
  • @Buffy That is incorrect because an IRB approval often requires that the subjects be paid (but not too much). – Anonymous Physicist May 20 at 10:12
  • I was on three IRBs. None of them required that subjects be paid. Most social research, survey research, and public health research makes no payment. Payment is usually standardized by a sponsor. Often, payment cannot be so great as to amount to coercion. I have been on IRBs that discussed whether a research project did this. Often, payment is limited to the reasonable expenses incurred by a participant, eg, transportation, meals, and a hotel stay. – David Smith Jun 3 at 22:05
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Your questions don't always have straightforward answers. It is necessary to keep in mind that there are two major components of Federal law regarding human subjects research. These are the Food and Drug Administration laws and regulations and something called 45 CFR 46, the code of Federal Regulations for Human Subjects. There are also Federal laws regarding the treatment of animals in research, which have their own CFR.

In addition, there are state laws governing human subjects research.

Starting in 1947, there were some ethical standards called the Nuremburg Code, which covered medical experimentation. The Federal Government initiated a commission in 1974 which resulted in a report called The Belmont Report, which was a statement of ethical principles for human research. Following the Belmont Report individual institutions and the the Federal Government established procedures, laws, and practices to review and approve human research.

You have to go read all these to resolve all of your questions.

The Federal regulations only apply to Federally funded research. One of the components is that researchers get to have their research approved by their local peers. So every research institution had to establish a review committee and procedures for review. Virtually every institution has decided to review all research using the same standards and procedures for all research, regardless of the funding source. They have also applied the same standards to all research done by staff they employ. There might be exceptions to both of these.

There is a lot of variation among institutions. There are explicit requirements in the 45 CFR 46 that not all institutions follow. There is also an accreditation process for institutions and their review boards.

If you now think that this is confusing, that I do not know the answer, and that you do not know the answer, then you are right.

However, it is essential to understand that the Federal government makes its review regulations only for Federally funded research, large research institutions make rules and procedures that they are certain comply, and journals that publish human research do their part to assure compliance. If a research institution does not comply then all its research funding can be suspended.

These rules and procedures than fall over into all the research that staff of institutions do and that journals publish. Nobody wants to look like they are not complying.

538 and commercial firms do research without Federal funding self publish or only write reports for clients. They are not covered either FDA regulations or 45 CFR 46. They can do what they want until someone sues them for an injury in state or Federal court. Moreover, 538 benefits from the constitutional freedom of the press.

Congress made laws about how the Federal government spends its own money and how it approves drugs and devices through the FDA.

A lot of research is just exempt anyway. The regulations tell you which. The regulations must be interpreted, of course, which isn't always easy.

Start by reading the Belmont Report and the 45 CFR 46,especially the exemptions from review.

In addition to Federal laws and institutional regulations there are also state laws that govern research. You have to find these out also.

There are some laws about calling cell phones that apply also.

"As a volunteer endeavor, I want to do online survey and education research. I am not being paid for the work, and the research participants are also not being paid. I am in the United States."

This has nothing to do with whether review and approval is required, except the volunteer part, which indicates that there is no Federal funding. Also, if you were in a different country you would have to comply with their laws.

1 "Legally, do I need to obtain IRB approval to conduct the research?" Doesn't sound like it. See 45 CFR 46.

2 "Legally, can I self-publish (e.g. blog)?" Probably, why not? Federal regulations are about conducting the research, not about publishing it, despite mistaken beliefs to the contrary.

3 "Would any reputable journal accept results obtained without any IRB approval?"

It is entirely possible. There are mechanisms in 45 CFR 46 to achieve this. One would be to make the data a public source by giving it to anyone who asks for it. Better yet, deposit it with a data archive where anyone can download it.

4 "What might the legal consequences be for not obtaining approval?"

Nothing. if approval is not required. You could be sued, but only if the complainant can show actual damages. There are criminal penalties, enforced by the Attorney General Office of Civil Rights. I don't think they have ever brought a case.

5 "If I'm not associated with any IRB, how would I get approval?"

You can pay an IRB to review and approve you research. More likely, you could ask the staff of an IRB to tell you if review and approval is necessary. A remarkable amount of research is determined to not be covered by 45 CFR 46. This is done by a staff member and/or the IRB chair. They might do this pro bono.

6 "Does it matter what my job is if I do the research in my personal time?" That depends solely on who you work for and what their employee handbook says.

7 "What about a collaborator at a university who is helping as a volunteer researcher in their personal time?" That depends solely on who they work for and what their employee handbook says.

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  • In my experience, it's unlikely that an institutional IRB would be willing to review and approve a research project that wasn't in any way connected with the university. One issue is that there's no effective way to actually supervise the research and intervene if there are violations or other problems with the project. – Brian Borchers Jun 4 at 0:53
  • A smaller research institution often contracts with a nearby university to be included in the university's IRB. The IRB of the larger institution usually meets frequently and can afford a bigger staff. An IRB might agree to do an occasional proposal from a very small organization on an occasional basis. I have seen both as an IRB member. – David Smith Jun 4 at 2:47
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Many journals have policies that require authors to have obtained IRB approval (or its equivalent in countries other than the US) as a condition of publication for any paper that involves human subjects. Here, the consequence of not obtaining IRB approval would be that your paper isn't published.

If you are employed by an institution that has a policy on human subjects research than you may be required to obtain IRB approval for any research project involving human subjects by your institution's policy, whether or not the research is sponsored by the institution or makes any use of the resources of the institution. Here, the consequences of not obtaining IRB approval could include being fired from your job.

There are Commercial Institutional Review Boards that provide review and oversight for research involving human subjects outside of an institution with its own review board. These are used, for example, by companies that do human subjects research as part of the development of new products.

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  • I edited my post to number the questions from my original text. Your answer is clear regarding #3, #5, #6, and #7. Would you be willing to update your answer regarding the other issues? I also provided an answer with my best guesses. – Kayle Sawyer May 20 at 8:28
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Here are my best guesses from reading the Belmont Report Wikipedia article and from my academic experience.

  1. No, collecting informal minimal risk survey data without IRB approval is legal in the US (as far as I know, but I am not a lawyer and am not giving legal advice). I am unsure what the legality is if the information contains personally identifying information or information that could put the participants at risk (for example, medical history or embarrassing history).
  2. Yes, self-publishing results obtained without IRB approval is legal in the US (but I'm not a lawyer so am not sure). For example, I have never seen FiveThirtyEight describe IRB approval for the survey research they conduct, and I assume a major institution like that is following the law.
  3. No, most journals have a policy that human subjects research have IRB approval. The reviewers and editorial staff might miss it and let a submission slip through, but in general reputable journals require IRB approval for research reported in the manuscripts they accept.
  4. For a simple survey that is of minimal risk to participants (for example, does not contain any personally identifying information, medical information, nor other information that might risk embarrassment or other harms), I have never heard of any legal consequences for conducting and self-publishing research. I don't know the legality of conducting a survey with personally identifying information along with potentially harmful information, and then publishing the individual participant-level data. Regardless, I believe survey research conducted without IRB approval could be accepted by a pre-print server like PsyArXiv.
  5. Find a collaborator at an institution with an IRB and have them submit the paperwork, or pay for a private IRB to approve the research.
  6. No, considering the research is conducted in your personal time, your job does not matter with respect to the legality of the research. I believe your job does not matter regardless. It might matter to your employer though, depending on the contract you signed. People might feel differently about the ethics of the research depending on whether it is conducted by an amateur, a businessperson, a journalist, or a university professor.
  7. I have no idea how most university contracts impact their staff's ability to collaborate on a minimal risk survey study that does not have IRB approval.
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  • Re/point 7. Most university policies (everyone that I've looked at) say that faculty/staff and students aren't to participate in human subjects research that hasn't been approved by the IRB. The university stands to lose federal funding if someone does research that would have been stopped by an IRB review. – Brian Borchers Jun 4 at 0:57
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If you can, it would probably help if you could find an academic partner interested in the study. This way you could apply with the ethics board at their institution, and it would probably strengthen the impact of your survey.

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