In an effort to gain understanding of what it means to live with a serious disease, researchers in the Division of Nursing are planning to work with participants suffering from a rare form of cancer. They believe that the results of their study may ultimately improve health care delivery and provide guidance to people suffering from this disease.
Since they are looking for volunteers from a select group of people who are under treatment, they decide to post a flyer announcing the study in the lobby of a medical center known for its work in this area. The flyer will give details of how to contact researchers and a private telephone answering service will be set up to handle these calls. They are also considering additional ways of recruiting, e.g., ads in newspapers, recruiting through local churches, and asking physicians and nurses to help in the recruitment by speaking to patients.
How best should the researchers carry out the recruitment?
The preferred method of recruitment is to disseminate information about the research study to potential subjects and to ask them to contact the investigator if they are interested in participating. Names and addresses should never be directly requested from referral sources unless permission has been given by individuals to release their names.
Researchers should also avoid recruitment from among their own patients or students due to the nature of the existing relationship and the unavoidable potential for coercion or the perception of coercion by potential subjects.
In certain cases in which reaching a specific population by disseminating information is difficult, a subject's right to privacy may be superceded by a desire to minimize coercion. In such cases, a researcher might propose a method of contacting potential subjects directly rather than having their doctor, teacher or supervisor do the recruiting. In a corporate setting, for example, a researcher might be given direct access to a personnel e-mail roster to be used in approaching subjects directly so that the employer and supervisors will not know which employees are potential or actual subjects.
Although indirect methods of recruitment are always preferable, the UCAIHS will look at the balance between the right to privacy and the problem of potential coercion. Some acceptable and non-intrusive means of recruiting subjects include:
If subjects from another institution, such as another university, school system, or medical center, are to be recruited for a study, IRB approval from that institution, or, if the institution does not have an IRB, written permission from an authorized official representing the institution, is required and should be submitted with the Application for Review. Full approval may not be granted until such permissions are received.
There are issues that require attention when employees are used as subjects. See the UCAIHS policy on Employees as Subjects in Applied Research.
Selection of subjects should be equitable and inclusive of all appropriate groups so that the burdens and benefits of research are reasonably distributed. If women and / or minorities or other specific groups are excluded from a subject population, a scientific justification is required as part of the Application.
In addition, protected populations such as prisoners, pregnant women, children, or institutionalized mentally disabled people may only be studied under certain conditions and with special safeguards. However, researchers should be careful not to overprotect vulnerable populations and as a result exclude them from research which may be beneficial to them or which may have results skewed because of their exclusion.
Investigators should try to list inclusion and/or exclusion criteria in recruitment materials, so that potential subjects who would not qualify for inclusion in the study do not make a wasted effort in contacting the researcher. Common criteria are age, geographic location, English or foreign language fluency, health status or presence of a particular disease or condition.
Children are considered particularly vulnerable to coercion and are therefore a "protected" population as research subjects. In New York State, children are defined as those who are under 18 years of age; they are considered minors, people who have not reached the legal age for consent to treatment or procedures involved in research.
If researchers are planning to include minors as subjects in their research, additional material must be included in the Application for Review submitted to the UCAIHS, including:
Next Chapter: What is informed consent and how is it documented?