March 2005, Issue 4

Frequently Asked Questions

What is the IRB?

The Institutional Review Board is a committee that reviews research protocols involving human subjects to determine whether their design assures adequate protection of the study participants. The IRB is made up of Tufts faculty and staff and at least one individual who is not affiliated with Tufts. The University has three IRBs, one on the Medford Campus and two on the Boston Health Sciences Campus. The Social & Behavioral Sciences IRB (Medford Campus) is administered by the Office of the Vice Provost at 20 Professors Row. The Health Sciences IRBs are administered through the Office for Research Integrity.

How do I know if my project needs to be looked at by the IRB?

If you’re a student, please ask your advisor. If your advisor is unfamiliar with human subjects research and the IRB, seek information from our website or contact Helen Page in the Office of the Vice Provost. Students cannot be principal investigators (PIs). They need to do research under the guidance of a faculty member. Guidelines for what is considered human subjects research can be found at http://www.tufts.edu/central/research/IRB/ToBeReviewed.htm. You can also get information from articles about the Medford IRB in previous issues of Research News @Tufts, archived at http://www.tufts.edu/central/research/ResearchNews/Archives.htm.

I’m not receiving any federal funds to do my research. Do I still need to get IRB approval?

Yes. Although you may not be receiving direct federal funding, the University as a whole receives federal funds and, like most universities, Tufts has assured that all research will comply with the code of federal regulations for the use of human subjects.

Do classroom projects involving human subjects need IRB approval?

The answer depends on whether the project falls under the definition of research. Research is defined as "a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to general knowledge" [Code of Federal Regulations: Title 45, Part 46.102 (d)]. For a project to be classified as research, two elements, "systematic investigation" and "contribution to general knowledge," are necessary. Although publication of study results is often the element that defines a contribution to general knowledge, any public dissemination of your results, such as presentation to a group outside your classroom, could cause the project to be deemed research. Because it can be difficult to assess whether your project is research or may evolve into research, and because you must ensure adequate protection of study participants even if the project is not considered research, Tufts requires that you request IRB approval (or exemption) before conducting your research. Your ability to protect and preserve future use of study information also depends on your having obtained IRB approval or exemption before starting the project. Federal regulations prohibit retroactive IRB approval after a study has been completed.

What do I do if I think my research might need review but am not sure?

It is better to err on the side of safety. Please submit the protocol for review rather than risk the consequences of conducting human subjects research without IRB approval. Consquences to you of noncompliance with federal regulations include suspension of research, inability to publish, and destruction of data. Consequences to the university could include suspension of its Federal Wide Assurance (FWA), which would put all human-subjects research projects on hold until an external review allowed reinstatement of the FWA.

How do I go about submitting my protocol for review?

You should have all key personnel complete the Required Education in the Protection of Human Subjects, then submit the following forms to the Office of the Vice Provost:

(1) Human Subjects Review Form signed by the PI(s),

(2) consent form,

(3) copy of survey/interview questions, and

(4) proof of completion of educational requirements.

Please go to the Forms & Requirements section for forms and tutorial.

What do I do if I’ve already started research that might need IRB approval?

Put the research on hold and prepare a protocol for the IRB, then send it to the Office of the Vice Provost. If you wait until the research is complete, you will not be able to get IRB approval after the fact and may face the consequences stated above. By coming to the IRB as soon as you realize that you have made the mistake of not getting IRB approval in advance, you may be able to salvage some of your project.

Are there special guidelines if my research will be carried out in a foreign country?

Yes. You can find helpful information in the Medford IRB article for Issue 3 of Research News @ Tufts, archived at http://www.tufts.edu/central/research/ResearchNews/Archives.htm.

Can I call the IRB office for advice on my protocol?

Sure. Helen Page (617-627-5187), the IRB administrator, can give you general advice over the phone, but she is not able to make a determination about your particular protocol without seeing it in print. You can submit your protocol electronically to helen.page@tufts.edu. However, you must also send in a signed copy of the face page of the Human Subjects Review Form.

When should I submit my protocol?

Submit your protocol before you begin research and at least three weeks prior to the next scheduled IRB meeting. Meetings are once a month, every month except August, usually on the second Wednesday. The IRB meeting schedule can be found at http://www.tufts.edu/central/research/IRB/MeetingDates.htm.

Do I submit the protocol to the IRB before or after submitting a proposal for funding?

Since you have to address the question of IRB approval in your proposal, and because comments from the IRB may help you strengthen your proposal, it is best to seek approval before submitting a proposal for funding. However, if you are requesting funding from the National Institutes of Health or the National Science Foundation, these agencies will review the proposal first and then request an IRB protocol approval number if they are likely to fund it. If your proposal scores high with the NIH or the NSF, you can then submit the protocol to the IRB. Funding will not be awarded unless the protocol has received IRB approval.

How can I find out about the status of my protocol?

Contact the IRB administrator, Helen Page (617-627-5187), about a week after submitting the protocol. If your protocol qualifies for exemption, you will in most cases be notified by email within a week. Please be sure to print out a copy for your files of any IRB determination that is sent electronically. If your protocol qualifies for expedited review, expect to receive written notification within two weeks. If it requires full review, you may expect an IRB determination within four weeks, depending on when you submitted the protocol relative to the meeting schedule. Occasionally a protocol will be tabled until the next month’s meeting, which will delay notification for another month. You can start your research only after you’ve received your IRB approval letter.

What might cause a protocol to be tabled?

The IRB cannot respond to an incomplete or ambiguous submission. If the IRB has not been presented the information it needs in a clear, complete and easily understood manner, the protocol will be tabled while the information is gathered. Another cause can be if the investigator proposes research that is beyond the range of the IRB’s expertise. In that case the IRB must find an expert to attend the meeting at which that protocol will be reviewed. Also, whenever a protocol involves a protected population, such as children or prisoners, the IRB must call in an advocate for that population.

What might cause a protocol to be returned to the investigator for revision?

Your protocol will be sent back to you for revision if you have not fully addressed all concerns for human subjects protection. Occasionally recruitment strategies need to be revised because the protocol doesn’t ensure that potential subjects are completely free to say “No.” The protocol should not subject potential participants to undue influence. For example, subjects should not be asked to participate by a group of officials.

If I’m the PI on a collaborative research project involving another institution, which IRB do I use?

Your protocol has to be approved by both institutions' IRBs. In some cases, one IRB can defer to the other IRB and accept its decision. However, this is an institutional decision that is based on a number of factors. If you are the PI, it is likely that Tufts will want to do the IRB review. If you are not the PI, Tufts would consider deferring to the other IRB if it is duly constituted and approved by the Office of Human Research Protections. Contact Helen Page for further information.

Does the protocol approval last as long as the research project?

No. You must request a continuing review each year by filling out the Human Subjects Review Form (the same form you filled out originally). Continuing reviews need to be voted on by the full IRB committee if the protocol required full committee review in the first place, so you should get the form to the office at least three weeks before your approval is due to expire. Protocols that were approved by expedited review can receive continuing review by expedited review. Please be sure to fill out Question 9 on the Human Subjects Review Form, which asks for updates on the progress of the research. If a protocol approval expires before it has been approved for continuation, you must stop all research.

Do I need to let the IRB know the results of my research throughout the year?

No. But if any harm, serious incident, or adverse event occurs, you need to report it immediately. The IRB may ask you to stop your research until the issues are resolved or to amend your consent form.

What if I change my protocol after approval?

Any change to an approved protocol must be approved by the IRB. If you anticipate a change in a protocol, please submit a modification request to the IRB in time to have it approved before you make the change.

For more information, go to http://www.tufts.edu/central/research/IRB/main.htm

 

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