'Of Men…' (Or How to Obtain Approval from the Human Subjects Review Board)

By Debra M. McCallum

The IRB has two major concerns in reviewing research proposals- ensuring your participants are protected from harm, and ensuring the rights of your participants are protected. Ancillary to these, the IRB wants to be sure the procedures are well documented, so that any one looking at your research will see that your participants are protected in these two areas. It is not thze job of the IRB to protect your research participants-that is your job; their job is to review your plans for doing your job. Because psychologists have their own set of professional ethical guidelines, most of the IRB's concerns will already be familiar to you.

Most large universities, hospitals, and other settings that regularly conduct research funded by federal dollars have one or more IRBs to review research. These IRBs are approved by the Federal Office for Human Research Protections (OHRP), and they must agree to follow federal guidelines in their reviews of all research conducted by members of that institution (even if the research is not federally funded). Another set of guidelines issued by the Food and Drug Administration (FDA) must be followed for certain kinds of medical research. Institutions that do not receive federal research grants are not required to have an IRB, but many (such as small colleges) do have informal boards that review research using the same guidelines as the more formally constituted IRBs. In most places the IRB members are volunteers-this is just one committee on which they serve. They don't get extra pay, and they are rarely thanked for the time they spend reviewing research protocols and attending meetings.

There is much controversy about the work and role of IRBs (see Observer, March 2001), and many people have expressed opinions about this. Rather than joining the debate, however, I am going to try to give you some practical information and advice. Although the system is likely to go through some changes as the debate evolves, if you are a student, your time is best spent learning to live and work with the system we have, as it is implemented at your institution, rather than complaining or waiting for it to change.

HOW TO BEGIN
Well before you need IRB approval (months before, if possible), find out exactly what you need to do, what paperwork you should complete, and when and where it should be submitted. Don't be shy: ask a professor, look for an IRB listing in your school's directory or on the website, or ask an older student. Find out about deadlines, meeting dates, and typical turn-around time. Early preparation can save you a lot of trouble. Both investigators and IRB members become irritable and demonstrate all the symptoms of reactance when things get in a rush or approach a crisis point. You want to avoid this if you can. Also check for policies for special situations, such as recruiting participants from students in classes you teach or using medical records for research.

You will probably find that your IRB has procedures for conducting full board reviews (i.e., all of the board reviews the project and votes on it), expedited reviews (i.e., one or two IRB members review and determine approval of the project), and possibly exemptions (i.e., there is no formal review). Although you might have an idea about which type of review your research will receive, only the IRB or IRB staff can make the final decision; and they base their decision on federal guidelines. A note of caution: the term "exempt" is often misunderstood to mean there are types of research that do not need to be sent to the IRB at all. Generally this is not true. Even a project that falls into the exempt categories must be described in enough detail that such a determination can be made, and there must be documentation that this decision was made by the IRB.

PREPARING YOUR PROPOSAL
In addition to specific procedures, you may find your IRB has special forms that need to be submitted with your application, as well as a list of materials or items that should be included. For the most efficient review process, I suggest you follow the instructions exactly. Our IRB has a checklist of items that should be in the proposal; in spite of this, we routinely receive incomplete applications. This simply wastes time, and the review ends up taking longer than it should. When the checklist says, "Include copies of all questionnaires used in the study," why not include copies of all questionnaires used in the study?

Most of the information you need to provide will fall into five broad categories: subjects, procedures, risks and benefits, confidentiality, and informed consent. Remember that the IRB is interested in protecting the rights and the welfare of the research participants and in documenting these protections. The first three categories of information generally help to assess protection of your subjects' welfare. You will describe the subjects, recruitment procedures, instructions to the subjects, research design, what the subjects will be asked to do, variables measured, debriefing procedures, and the potential risks and benefits of the research. You and the IRB must determine that the benefits outweigh any foreseeable physical or psychological risks to the participants. Be complete in your descriptions. Leaving out crucial information in these areas (or any part of your application) will just make the process take longer. Also remember that many of the IRB members will not be familiar with your specific area of research. Describe your study procedures and equipment so that people from other disciplines and from the community will understand it.

The protection of participants' rights is assessed through your descriptions of how you will handle confidentiality and the informed consent process. If appropriate, describe the steps you will take to maintain the confidentiality of your data. Will personal identifying information be part of your data, where and how will it be stored, who will have access to it, how will it be reported, is there a possibility of harmful consequences if there is a breach of confidentiality? These issues need to be addressed in your proposal. The informed consent process covers the most fundamental right of research participants-the right to be fully informed and to freely consent to participate. There are very clear guidelines about what should be included in the consent information, and your proposal will be reviewed more favorably if you follow the guidelines and include all the appropriate elements. It is not enough to say you will inform them, rather what you will say and what participants will sign need to be in writing for the IRB members to read. Most of your participants won't be able to or won't want to wade through complex explanations of your study. Keep the language in your consent form simple, straightforward, and as free of technical jargon as possible. The process and documentation of informed consent are very important, and the IRB will spend considerable time reviewing your consent form and process.

Before you submit your proposal to the IRB, I suggest you have your faculty advisor review it for clarity and completeness, and that you proofread it carefully for grammatical errors, misspellings, and other mistakes. What you submit should be prepared in a professional manner, just as you would prepare a paper for a course or a journal manuscript.

AFTER SUBMITTING THE PROPOSAL
After you submit your proposal to the IRB office or board, you might be asked to make some revisions or respond to questions. These requests might come from an IRB staff person who screens proposals for compliance with guidelines, or they might come from a review by IRB members. For a full board review, you might be asked to attend the IRB meeting when it is on the agenda so you can answer questions in person. Whatever the source of these requests, you should: (1) not get defensive; (2) not see them as an attack on your research; (3) make all the revisions you can without changing the fundamental aspects of your research; (4) explain your reasons, if there are changes suggested that you feel you cannot make. Stubbornness and claims of superiority or inconvenience are not good justifications, but there probably are some explanations your IRB will accept. There usually is some room for negotiation-but you'll get farther if you approach it rationally.

When you receive approval for your study, you are ready to start, but you have several continuing responsibilities. First, if you make any changes to your study, communicate those changes to the IRB. Second, if you have any difficulties, "adverse" events, or harm to participants, you must report these to the IRB immediately. Third, note the effective time period for your approval (one year at the most). It is important that you apply for renewal early enough to provide continuous coverage. Don't wait until one approval period ends before applying for the renewal. Fourth, many institutions require a closeout form when your study is finished. This officially closes the IRB file for your study.

If you are confused or need help, I think most IRB members or staff would be happy to talk with you and help you prepare a proposal that will sail through the approval process. Approach the IRB process with a positive frame of mind, and I think you will do just fine.

BASIC ADVICE: