Social and Behavioral Sciences Institutional Review Board

UB SBS IRB Telephone Guidelines

The Social and Behavioral Sciences IRB reviews scripts that are used to screen prospective subjects and to obtain their consent on the telephone before presenting a survey. The IRB requires PI's to have an informative introduction with the usual research volunteer's rights included at the beginning. Please see the sample below.

No participant should be asked for identifying information before the interview is complete. Any identifying information should be asked for only at the end. At the conclusion of the screening interview, the researcher should thank the person and then indicate that the person is eligible, and ask if the person would like to participate, could he or she please provide whatever identifiers are needed. If the person did not qualify but the researcher wants the name for a database to contact in the future, that should be said very clearly.

The phone staff should be trained, just as we would expect our local research staff to be trained in the conduct of the approved protocol.

Rationale
The IRB urges PIs to consider the proposition that telephone contact is not risk-free or of negligible risk. There are groups of people for whom the risk is real. For instance, people with autism or their caregivers may have mishaps resulting from telephone interruptions: missed medications, complex rituals that had to be started over, injuries and even hospitalizations. In an unselected calling sample, there will be a subset (likely of unpredictable size) for whom the risk is real.

Furthermore, the way we live now has an impact upon the size of the at-risk pool in an unselected sample. Consider the following trends of the last 30 years:

· There are more two-wage-earner families for whom time together is scarcer and accordingly more valued. Interruption of time together is resented more strongly.

· There has been an increase in the intensity of telemarketing.

· There has been an increase in the proportion of the workforce working nights or rotating shifts, so the proportion of calls that will interrupt sleep is higher.

· There has been an increase in the proportion of the workforce working at home, so the proportion of calls that interrupt employment activities is higher.

· There has been a shortening of hospital stays and an increase in the proportion of injured and disabled people being cared for at home. This increases the proportion of calls that reach sick or disabled people, as well as the proportion that interrupt the caregivers for those sick and disabled people. Some of these sick and disabled people will have altered sleep patterns; some will be on drugs that interfere with consent competence.

· There has been an almost complete transition from institutional care to home-based care for the mentally retarded and psychiatrically ill, increasing the proportion of calls reaching people who may be unable to assess such a call accurately.

· It has become routine for new immigrants, including those who speak little or no English, to have telephones. Such calls may now reach people who find them to be threatening. Anecdotes tell of Southeast Asian patients who thought research survey calls were governmental surveillance, and thought they were required by law to co-operate.

For the above reasons, the IRB urges PIs to consider the proposition that telephone contact is not risk-free or of negligible risk. This issue speaks directly to ethical standards when making judgements about approaching prospective subjects in their own homes, where they have every right to expect to be treated with respect.

(The above rationale is a compilation of list-serv postings on this topic to The IRB Discussion Forum)

This is a model letter created by the Social and Behavioral Sciences Institutional Review Board at the University at Buffalo, the State University of New York.

VOLUNTARY INFORMED CONSENT

The Functional Health Project is an evaluation study. It is being conducted under the sponsorship of North West Buffalo Community Health Care Center and the School of Social Work at the University at Buffalo. Dr. Bahta Dodoria, a faculty member at the School of Social Work, is the researcher in charge of the project.

The main aim of the study is to gather information about the health-related practices and health service use of older adults in the Riverside/Black Rock community.

You are invited to consider voluntary participation in the project. If you choose to participate, you have the right to withdraw at any time without penalty.

Interviews will be conducted over the telephone by staff of the Research and Development Office, Department of Family Medicine, SUNY at Buffalo. The questionnaire will take no more than 25 minutes to administer.

There is only one interview for this project.

The researchers will report the data only in summary form. Individuals will not be identified. Information collected during the interview will be maintained in a locked file cabinet in Dr. Dodoria's office, which is also locked and has limited access. Confidentiality of this material is governed by Federal laws and regulations. If you have questions about any aspect of your participation in this study you may call Dr. Dodoria at (716) 645-3X8H.

You may refuse to answer any individual question and you have the right to withdraw your participation at any time.

The information collected from you during the survey interview is unlikely to cause stress or embarrassment. It has been our experience that any reactions to the questions are unlikely to be riskier than reactions to everyday occurrences.

It is possible that you will gain satisfaction from the fact that your participation in this research will help to improve our knowledge of health service delivery to older adults such as yourself.

Questions about your rights as a volunteer in research can be directed to the Social and Behavioral Sciences Institutional Review Board at the phone number 645-3321.

A copy of this consent will be mailed to you should you agree to participate.

I have read the above informed consent to the respondent and he or she has agreed to participate in the telephone interview.

Signature of person reading this
consent to the participant: __________________________

Date: _______________________________