CONSENT FORM - East Carolina University



IRB Consent Form

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Here is an IRB consent form for a study approved in October of 2005, followed by some helpful comments from Dr. Susan McCammon.

CONSENT FORM

Title of Research Study: Investigating the Effects of Personality on Subjective Well-Being

Principal Investigator: Anne Hoops

Supervisor: Dr. Karl Wuensch

Institution: East Carolina University

Address: 104 Rawl Building, Greenville, NC 27858

INTRODUCTION

You are invited to participate in a research study examining the effects of personality on subjective well-being, or life satisfaction. My name is Anne Hoops, and I am a graduate student at East Carolina University currently pursuing a Master’s degree in Research Psychology. This study constitutes the research aspect of my Master’s thesis. You have been selected as a possible participant because you are enrolled in a psychology course in which credit is being offered for research participation.

PLAN AND PROCEDURES

If you decide to participate, you will be asked to fill out a questionnaire assessing various aspects of demographic information, personality measures, and social support. We expect that your participation today will take approximately thirty minutes, which equates to one credit on the Experimentrak system.

POTENTIAL RISKS AND DISCOMFORTS

We anticipate that this study poses no potential risks. However, in the event that you are uncomfortable answering any question, please feel free to leave the question(s) blank.

POTENTIAL BENEFITS

Participation in the study will provide an educational benefit by helping you understand how psychological research is conducted.

SUBJECT PRIVACY AND CONFIDENTIALITY OF RECORDS

Any information that is obtained in connection with this study will remain confidential, will be known only to the researcher and her supervisor, and will be disclosed only with your permission. No names or other personally identifying information will be included on your questionnaires, or in any analyses or reports that result from this study. Your completed questionnaires will be kept in a safe place and destroyed after six years.

COSTS OF PARTICIPATION

There will not be any additionally costs to you resulting from participation in this study.

VOLUNTARY PARTICIPATION

Participating in this study is voluntary. Refusal to participate will not involve penalty or loss of benefits to which you are otherwise entitled. However, if you elect not to participate in this study, you will not receive any research credits. If you start participation but then decide to withdraw from the study prior to completing participation, any information you have given will not be used for research purposes and you will receive partial credit based on the amount of time you did participate.

PERSONS TO CONTACT WITH QUESTIONS

The investigator will be available to answer any questions concerning this research, now or in the future. You may contact the investigator, Anne Hoops, by email at ASH0508@ECU.edu. If you have questions about your rights as a research participant you may call the Chair of the University and Medical Center Institutional Review Board at phone number 252-744-2914.

CONSENT TO PARTICIPATE

I have read all of the above information, and have received satisfactory explanations in areas I did not understand. (A copy of this signed and dated consent form will be provided to the participant if desired).

_______________________________________________________________

Participant’s Name (PRINT) Signature Date Time

PRINCIPAL INVESTIGATOR: I confirm that the participant has read the contents of this consent document, the participant has indicated all questions have been answered to his or her satisfaction, and the participant has signed the document.

________________________________________________________________

Principal Investigator’s Name (PRINT) Signature Date Time

Helpful Comments From Dr. Susan McCammon

• See the consent form template Informed Consent Document Template--for no more than minimal risk studies.

• Anne had originally described as a “research benefit” the course credits awarded for participation in the research. Dr McCammon advised not to do so: “’Payment’ to a subject is not considered a research benefit. It is fine to leave the statement about the credit in Plan and Procedures. (Some investigators put this under a Costs and Compensation heading.)”

• Dr. McCammon also advised: “The APA Publication Manual (5th Ed.) states on p. 137 that authors should have their raw data available throughout the editorial review process and for at least 5 years after the date of publication.” It is not clear to me exactly what “raw data” means in this context. Is it the response sheets submitted by the respondent or the computer data file containing the coded responses? For a medical study is it the tissue samples and specimens collected from the participants or is it the computer data file containing the coded data from those samples and specimens?

• Anne had included the statement “ However, if you elect to withdraw from the study, you will not receive credit for the amount of time you participated, and any information you have given will not be used” under “Potential Risks and Discomforts.” I commented that encouraging respondents not to respond to all questions creates lots of statistical problems after the data have been collected. Dr. McCammon also objected to that statement and suggested it be removed.

• If a student shows up for the study but then elects not to participate or withdraws from the study after having started participation, does that student get any credits for having participated in that study? Dr. McCammon has suggested the following guidelines, which I think are quite reasonable:

o If the student shows up, reads the informed consent document, and then declines to participate, that student receives no credits.

o If the student shows up, reads and signs the informed consent document, starts the research, and then later decides to stop and withdraw, the student should receive one credit for each half hour or fraction of half an hour of participation prior to withdrawal.

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