University Research Compliance

Institutional Review Board

Research Design Guidance

Recruitment Materials

Subject Population

The investigator will need to describe the population from which the subjects will be selected. This description should be as specific as possible. It must identify the source(s) of the potential subjects, data or derived materials (i.e., organizations, institutions, businesses, or the general public). Additionally it should describe the characteristics of the population as appropriate for the research such as age or age range, sex, ethnic background and state of health. The investigator must specify if the subjects will include members of a special population as defined by IRB policy.

As appropriate to the research, the description of the subject population should also include the following:

If there are gender-based or ethnic/race based restrictions to enrollment in the research please explain and justify.
Describe any inclusion criteria. These should be based on the scientific rationale and safety considerations and should define who will be eligible as a subject.
Describe any exclusion criteria. These should be scientifically valid and help to further define the subject population.

Recruitment

Recruiting participants for research projects actually begins the process of consent and is an important part of informing participants about your project. Investigators must describe how prospective subjects will be recruited in the IRB application. This should include who will be involved in the recruiting, the methods to be used for recruitment (i.e., flyers, letters, emails, etc.) and, if appropriate to the research, how the researcher will obtain the names of the perspective subjects.

When reviewing recruitment methods and materials, the IRB must determine that they are not coercive and that they accurately describe the likely risks and benefits to participants (i.e. that they do not state or imply a certainty of favorable outcome or other benefit beyond what is outlined in the consent document and the protocol).

Any form of advertising for recruiting of human subjects to participate in research projects must be submitted for review and approval by the IRB, either with the initial IRB application, or as a modification as it is developed.

Some of the more commonly used types of advertising include flyers, posters, brochures, media advertisements, recruitment letters and word-of-mouth recruiting.

When appropriate, the following items may be included (but are not required) in advertisements and recruiting materials:

Name and address of the investigator(s) and/or research facility;
Condition under study and/or the purpose of the research;
In summary form, the criteria that will be used to determine eligibility for the study;
A brief list of participation benefits, if any (e.g., a no-cost health examination);
The time or other commitment required of the subjects; and
The location of the research and the person or office to contact for further information.

Advertisements should:

Not emphasize monetary compensation;
Not use catchy words like “free” or “exciting”;
Not be misleading about the purposes of the research
Not use words that are insulting like “fat”; and
Be very clear that research participation is what is being solicited.

*Remember, any flyer or poster to be displayed anywhere on the OSU-Stillwater campus must also be approved by OSU Office of Campus Life. Campus Life views any research flyer or poster that contains the IRB approval stamp as officially sanctioned and will allow it to be posted. Campus Life can be contacted at 211 Student Union, 405-744-5488.

Defining the Subject Population

As appropriate to the research, the description of the subject population should also include the following:

If there are gender-based or ethnic/race based restrictions to enrollment in the research please explain and justify.
Describe any inclusion criteria. These should be based on the scientific rationale and safety considerations and should define who will be eligible as a subject.
Describe any exclusion criteria. These should be scientifically valid and help to further define the subject population.

Methods and Procedures

Describing the methods and procedures:

The description of the methods and procedures of the research should explain what information the PI will be gathering and exactly how it will be collected and recorded. When appropriate this should include a description of any existing data sets to be accessed for information.

The PI should state the location where they will work with the participants. The specific processes to be used to collect the data should be presented in sequence and include details of any equipment or interventions to be used, and descriptions of any testing instruments, surveys, questionnaires or interviews to be used or conducted.

The PI should clearly distinguish between any procedures that are part of the research and those procedures that would occur regardless of the research. Describe any procedures, situations or materials that may present risk and describe the precautions to be used to reduce risk.

The PI must indicate if any personnel, in addition to the PI, will be interacting with the subjects or will be present during the subject’s participation. The qualifications, role and training of the personnel must be presented

State whether the data are anonymous or will be kept confidential. If the data collected has no identifying information to link a subject to his/her data, the data areanonymous. If the investigator will not share subject’s data with anyone except in aggregate form, the data areconfidential. Even if only the PI knows who the subjects are, the data are still considered confidential.

Study Recruitment and Consent Document Readability

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