IRB Corner: Recruiting Human Subjects

IRB Corner: Recruiting Human Subjects

NOTE:  IRBNet system upgrade.  The University of Phoenix IRB online application smart form (i.e., IRBNet application wizard) will be updated effective Friday, August 5, 2016.  Any researcher using IRBNet who begins a new IRB online application smart form, edits an IRB online application smart form, or copies an existing an IRB online project application smart form after the system upgrade will be required to respond to all new and edited questions on the updated IRB online application smart form.  Please contact the IRB Office at IRB@phoenix.edu with any questions.

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In this month’s IRB Corner, we discuss recruitment. Recruitment involves the identification and selection of human subjects. We explain the relationship between recruitment and informed consent. We outline a number of researcher considerations when designing your recruitment plans, including unique considerations for online recruitment and soliciting participants through social media. Finally, we describe important elements of recruitment materials, including flyers, scripts, and web postings, and explain the role of the IRB to review recruitment materials and permissions to recruit. 

What is the relationship between recruitment and informed consent?

Recruitment is considered the first stage of the informed consent process. Recruitment is when the researcher initially connects with potential research subjects and invites participation in the study. According to the federal human subjects regulations (45 CFR 46), all research activities, including recruitment and informed consent, should be designed to minimize any risk to the human subjects. The informed consent process is formally documented through the signing of an informed consent form, which includes specific components required by the federal regulations. For more on the informed consent process, see the GUIDANCE – Informed Consent document.

What should researchers consider as they develop plans to recruit subjects?

Responsible human subjects research depends on the researcher constructing an appropriate and successful recruitment strategy. Recruitment plans are important in that these plans identify how a researcher will appropriately select human subjects based on the specifics of the research questions and research design. While researchers should consider how to best select the most appropriate subjects for the study, researchers must also keep in mind 1) privacy concerns, 2) cultural and organizational considerations and necessary permissions, 3) vulnerable subjects, and 4) the investigator’s relationship to the research and research participants.

First, researchers must ensure that their recruitment strategy respects the privacy a potential participant might reasonably expect. In other words, if individuals share personal information with another individual or organization for one purpose, then this information should not be given to, or shared with, the researcher for recruitment purposes. Examples of privacy concerns with recruitment can be related to personal records kept within a school, business, healthcare organization, or other association. For more on privacy issues, see the GUIDANCE – Privacy, Confidentiality, and Anonymity document.

Second, researchers must design their recruitment strategies to take into consideration the cultural and organizational affiliations of potential subjects. For example, if recruitment plans propose inviting members of a particular school, employees from a particular business, or patients from a particular healthcare system, then the school, business, or healthcare organization must provide permissions for the researcher to recruit its members. If the research involves recruiting active duty military, then the Department of Defense must review the study and provide permissions. In short, targeted recruitment within a particular organization requires permission from an individual in a position of authority to provide permission. Similarly, if the research involves recruiting within a particular culture, such as on an American Indian Reservation or in another country, then a tribal IRB review or a local research review may also be needed. For more on obtaining necessary permissions, see the GUIDANCE – Permissions document.

Third, researchers must consider whether the potential subjects are members of a vulnerable population. If the study population is likely to include individuals who may be susceptible to coercion or undue influence, then the researcher must build in additional safeguards to protect these individuals. Examples of individuals who may be members of vulnerable groups include children, mentally incompetent individuals, pregnant women, and prisoners, as well as educationally or financially disadvantaged individuals or others who may have a limited capacity with regards to their ability to voluntarily participate in research.

Fourth, the relationship of the investigator to the research must also be considered. Specifically, the researcher must address whether his or her personal or professional associations might influence the proposed recruits. Concerns arise when a researcher contacts those over which he might have significant influence, especially in an employer-employee situation or a supervisory-report situation. In particular, a faculty member aiming to recruit students or an employer aiming to recruit subordinates at work can create a situation where those being recruited for research may feel pressure to comply. Researchers can avoid these potential conflicts by posting information about a research study and allowing potential subjects to initiate contact with the investigator. Recruitment strategies must be developed to mitigate any potential coercion. To better understand this issue, please see the GUIDANCE – Relationship to Research and GUIDANCE – Conflicts of Interest documents.

Are there any special considerations if I intend to recruit online or using social media?

Internet technologies have changed the ways many researchers conduct research with human subjects. Sometimes researchers feel that if they recruit online or use social media for recruiting subjects, then the researchers are able to avoid some of the above considerations. On the contrary, researchers who intend to recruit online are required to address issues related to privacy, local permissions, vulnerable groups, and the researcher’s relationship to subjects. In addition, researchers must also consider whether their intended population is best accessed online or using social media. The Office for Human Research Protections (OHRP) Guidance on Internet Research explains that the Internet has also created new challenges for researchers (see http://www.hhs.gov/ohrp/sachrp/mtgings/2013%20March%20Mtg/internet_research.pdf).

At times, researchers propose sampling strategies that are not technically possible or that don’t align with their research design. Researchers who design recruitment strategies using online technologies such as LinkedIn, Facebook, Twitter, or others must keep in mind the same considerations as those outlined above. Permissions are required before members of an online group or organization are recruited, as those groups are constructed around private interests. LinkedIn and Facebook have many groups that are “owned” or “managed” by private individuals or organizations that must provide permission before a researcher can post a recruitment announcement. If a researcher intends to recruit through his or her own personal network using online or social media tools, then the researcher must still consider each of the issues outlined above, and the researcher must consider whether the online application facilitates posting a recruitment announcement that meets the standards outlined below. For example, LinkedIn does not allow a homepage post over 600 characters in many cases, and only the individual’s personal connections can receive the recruitment announcement. Similarly, Twitter limits tweets to 140 characters. In summary, online recruitment strategies must be designed with the same considerations as those recruitment strategies that do not use these technologies. And the bottom line, is that the sampling and recruitment strategy proposed by the researcher 1) must protect potential subjects, 2) must be technically possible, and 3) must align with the research design.

What information should be included in recruitment materials?

Recruitment materials should provide enough information for the potential subject to be able to effectively understand what participating in the study entails so that the subjects may make an educated decision about whether or not to participate in the research. Typically, a recruitment announcement, flyer, or script will include the following information:

1)      a brief description of the research purpose;

2)      the name of the researcher (including university affiliation and/or department);

3)      eligibility criteria;

4)      time commitments required;

5)      location of the research; and

6)      the person to contact for further information.

Note: Highlighting incentives on recruitment materials should be considered in connection with aims to mitigate possible coercion, especially with vulnerable groups. Researchers should include copies of all recruitment material as part of their IRB project submission in IRBNet and should explain in the discussion about the population and recruitment how they intend to implement the recruitment plan and selection of subjects, including the inclusion and exclusion criteria to be used in the study.

All guidance documents, templates, and forms are available in the IRBNet Forms and Templates library (accessible from the left menu within IRBNet). After reviewing the guidance materials recommended in this article, please contact The University of Phoenix IRB Office at IRB@phoenix.edu if you have a question about recruitment plans.

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