Recommendations on how to avoid some common mistakes seen by the Screening Committee:
When assuring subjects who are currently receiving benefits from a program (e.g., they are being assisted by a public service agency or recruited through their employer or school) that their participation is entirely voluntary, make sure you also tell them that neither their participation nor their non-participation will incur any loss of benefits, and that they can withdraw at any time.
If you are paying subjects for their participation, payment cannot be contingent upon completing their participation and, where appropriate, must be prorated based on the amount of time they participate.
There must be some discussion of direct and/or indirect benefits that subjects might expect from participating in the study (or an indication that there are no anticipated benefits). Payment to subjects is not a benefit--it is simply remuneration for their time, loss of wages, and/or expenses.
Be careful to distinguish between procedures or activities that you are asking subjects to undergo versus procedures or activities they would be doing anyway even if your study were not being done. For example, when discussing risks and benefits in both the Petition and in the Consent Form, you should talk only about additional risks/benefits that may result from their agreeing to participate in your study. Another example: in providing background information to the Screening Committee for studies that involve evaluations of programs, investigators sometimes give too much information about the program being evaluated and hence the appearance that the program itself is part of their research project.
Remember that anonymity refers to the fact that subjects cannot be identified; confidentiality refers to the fact that the experimental data are protected.
If you are a student, provide full contact information about both yourself and your faculty advisor on any cover letter, and make sure both of you sign it. But don't use home phone numbers; if you have no office number, use the departmental number. Identify the Principal Investigator's credentials by suffix (e.g., Ph.D.) rather than prefix (e.g., Dr.).
If you are using a survey/questionnaire, and it is not self-generated, let the Committee know that you have permission to use it, especially if the document is copyrighted.
Test your questionnaire to verify the accuracy of your estimated time to complete it. All too often we see unrealistically low estimates.
If you later submit an amendment to change procedures that subjects undergo (for example, you want to add an additional questionnaire), make sure that you consider whether this change will affect the estimate of the time needed to complete these procedures, which which you have given in the existing consent form. If the time will be affected significantly, submit a revised consent form for approval as part of the amendment.
If there are multiple surveys, provide a chart/timeline so that committee members can easily tell when a particular instrument is being used, and how the results will relate to specific research hypotheses.
If you are administering a survey during a class, meeting, or similar venue, provide information on what folks who choose not to participate are expected to do instead.
Make sure experimental procedures are described in sufficient detail in the consent form to enable the subjects to know what their participation will involve.
Be consistent in your grammar: if you start out using the first person in your consent form, use the first person throughout.
Run spell check on your documents, and a grammar checker if you have one, before submitting them to the Screening Committee.
If you plan to use an off-site location, make sure you get letters of permission from those sites and include these letters in your petition.
Don't use words like "need" (as in "you will need to do such-and-such") in your cover letter or consent document. Instead, say things like "you will be asked to " Don't use adjectives such as "very important study" or "very valuable participation."
The cover letter should begin with an overt invitation to participate in the research study and should at the outset identify who is conducting the study and why they are interested in conducting the research..
If you tell subjects that they may obtain study results, make sure you explain how and when they can obtain those results.
Avoid use of the phrase "I understand that" in the consent form; use "I have been informed that" instead.
If you need to make any changes after your protocol has been approved (e.g., in the consent form or in questionnaires), submit an amendment (with the required number of copies!) to the Screening Committee that clearly indicates what the changes are. Best bet is to highlight the changed text.
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