Tutorial Chapter 11: How should researchers select and recruit subjects?

Case Study:

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?

  • A: Since the researchers are worried about any influence or potential coercion of potential subjects, they decide not to recruit through physicians or health care providers working with this population.
  • B: Researchers are not confident that they will be able to recruit enough subjects just through posting the flyers or placing ads, so they also plan to ask physicians and health care workers to identify patients who meet the study's inclusion criteria.

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in which reaching a specific population by disseminating information is difficult, a subject's right to privacy may be superceded by a desire to minimize coercion.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:

  • Placing an advertisement in a newspaper, journal, or other periodical requesting that interested persons who meet relevant criteria contact the investigator;
  • Posting a sign or placing flyers in a public area or, with permission from the appropriate authority, in a private area (e.g., store, library, health club, etc.) requesting that interested persons who meet the relevant criteria contact the investigator;
  • Obtaining names from public records, such as telephone directories;
  • Obtaining names from organization membership or client records which the investigator has legal access and for which s/he has obtained permission from the appropriate authority.

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

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.

Working With Minors

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:

  • a Parental or Guardian Permission Form including all elements of informed consent as they refer to the subject; and,
  • for subjects 12 to 18 years old, a children's written consent form; or
  • for children under 12 years of age, the script for an oral assent procedure which explains the task(s) involved, stresses the right not to participate and to withdraw without penalty at any time, and requires an active indication of willingness to participate. Assent is thus defined as an affirmative agreement rather than tacit consent to participate in the research or an unclear response after the subjects have been fully informed about the project.

Chapter Review

Question 1

A scientific justification is required if minorities are excluded from a subject population.

Question 2

Women may be excluded from a study if (select as many as apply):

  • there is a scientific rationale
  • they are pregnant
  • they are past child bearing age
  • they are not readily available

Question 3

Which of the following methods of recruitment is encouraged (select all that apply)?

  • accessing medical records
  • posting flyers
  • making announcements at public meetings
  • asking employers to identify employees

Question 4

In certain cases a subject's right to privacy may be superceded by a desire to minimize coercion.

Question 5

Using one's own students in a study is acceptable if:

  • they are told that participation is voluntary
  • they are assured that grades will not be affected
  • they are paid adequately
  • none of the above

Question 6

Children between the ages of 12 and 18 may participate in research if they have parental permission and:

  • they sign a Consent Form in language appropriate for their age
  • they indicate to the researcher that they would like to
  • they are consented through an assent procedure
  • none of the above

Next Chapter: What is informed consent and how is it documented?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Take the Certification Exam!
  • Glossary
  • References