Subject Selection and Recruitment Recruitment and selection of participants must be equitable (fair or just) within the confines of the study. Researchers may not exclude participants on the basis of gender, race, national origin, religion, creed, education, or socioeconomic status. The benefits and burdens of research must be fairly distributed. Definitions Coercion is the practice of persuading someone to do something by using force or threats. Coercion will generally involve physical force. No relationship between the two individuals need exist for coercion to occur. Subject selection means the process of identifying potential research subjects based on specific inclusion or exclusion criteria. Recruitment is a component of the consent process. The process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment. Undue influence means influence by which a person is induced to act otherwise than by their own free will or without adequate attention to the consequences. Undue influence will generally involve mental pressure in which one person takes advantage of the unequal relationship they have with the other person (e.g. supervisor/employee, doctor/patient,etc.). What Is the Requirement? 45 CFR 46.111 (a) (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. How Do I Comply With This Requirement? Initial Review Application On the Recruitment Information page, mark any methods that will be used to identify and recruit study participants. Below is the list of options provided, as well as definitions. You should select all that apply. Advertisements (flyers, social media, clinical trials websites, etc) Potential subjects will respond to advertisements and contact the study team if they are interested in participating. An example of any recruitment materials must be included in the application as a separate file and approved by the IRB before they are used. Medical record review: Researchers will review medical charts or other clinical information to identify potential subjects. Researchers must request a Waiver of HIPAA Authorization for subject recruitment. From a database of participants who have given prior permission to be contacted for research studies: Potential subjects have prospectively consented to be contacted regarding research opportunities. The iRIS number of the study in which they originally gave consent to be contacted for future research should be provided in the protocol. From personal contacts: Individuals whom you know personally or professionally. Referrals: Potential subjects identified by non-investigator healthcare providers or participants referring other participants. Investigators may provide their colleagues with a “Dear Patient” letter or a “Dear Potential Study Participant” letter describing the study, or researchers may provide Information Sheets to colleagues or associates. Other On the Consent Language page, you will be asked if it is possible that you will enroll participants who are unable to speak or read English. Generally, any research that holds the prospect of direct benefit should allow the enrollment of those unable to read English. Review “Overcoming Language Barriers” guidance below to learn more about enrolling non-English speaking subjects. Research Protocol Describe the inclusion and exclusion criteria for your study sample. Include the age range of individuals who may enroll in the research. Consider that if children are enrolled in the research, you may be required to obtain parental permission. List any other defining criteria for enrollment in the research. For secondary analysis research, list the criteria you will use to identify your dataset or specimens. Recruitment and/or Screening Materials Submit all information meant to be seen or heard by potential subjects to the IRB for review before they are used. Any additions or changes to these documents must be submitted via IRBNet as modifications to the study before it is used. Ethical Considerations The research team and the IRB will need to consider the following criteria when evaluating subject selection and recruitment strategies: Equitable selection of participants: Does the recruitment strategy help ensure that selection of research participants is equitable and appropriate for the study? Respect for privacy: Does the recruitment strategy respect an individual’s reasonable expectations for privacy? If the research team asks questions to screen potential participants, will the questions be asked in a private setting where others will not overhear the answers? Will patients who are recruited from a recruitment database in the clinic have given their permission beforehand for this use of their individual medical information? Voluntariness: Is the study introduced in a way that allows subjects ample time to consider participation, with no undue pressure? Is the timing reasonable? Who makes the request? How the request is made? Does the study offer excessive inducements? Will students be hesitant to say “no” to a professor? Will patients be put in a situation where they may hesitate to say “no” to their own physicians? Will adolescents whose parents give permission for them to be in a study feel they cannot now say “no”? How will pressure be minimized? Unbiased presentation: Is all information accurate, balanced, and free of any misleading emphases that make the study excessively attractive? Is the information as complete as is appropriate for each stage of recruitment? The “Therapeutic Misconception:” Patients tend to believe a clinical trial—or anything proposed by health care providers—will benefit them, even if they’re told there is no assured benefit to their participation. Does the recruitment strategy minimize the potential for misconception? Conflicting concerns: Students may feel obliged to participate in a researcher’s study if that researcher is also their teacher/professor. Although prospective participants may prefer that someone involved in their care contact them about research, they may find it hard to say “no” to a care provider. Clinicians may find their clinical judgment in conflict with a desire to enroll patients in their own studies. Keeping Information Confidential: Often the greatest risk of obtaining information during the recruitment and/or screening process is the loss of confidentiality. The researcher must consider and describe how the confidentiality of this data will be maintained. Whenever possible, information obtained during this process should not be connected with subject identifiers. As noted above, the amount of data collected should be limited. Once collected it should be kept secure. Telephone Scripts: In studies such as telephone surveys, an initial recruitment call sometimes leads directly into the consent. In such studies, the script should include, at least, the names of the persons responsible for the study, a description of the types of questions that will be asked, an estimate of the time it will take to complete the interview, and the direct question of whether or not a person wishes to participate. The interviewers also should have available an investigator’s telephone number in case the prospective subjects have questions about the study that the interviewer cannot answer, and the IRB phone number if there are questions about a research subject’s rights. Keeping Information about Refusers: In general, identifiable information may not be kept about prospective subjects unless they consent to even this limited participation. Describe how consent will be obtained for retention of personally identifiable information. Non-personally identifying information about refusers may be used for research purposes. Unacceptable Recruitment Methods Direct Recruitment by Study Sponsors: In general, Einstein does not permit its researchers to provide subject contact information to sponsors. Sponsors may not directly contact prospective subjects based on information from Einstein researchers. However, Einstein does permit researchers to be part of a national or local multi-site study which may include a national or local advertising campaign by the study sponsor to recruit. Use of Incentives and Referral Fees: Per-patient incentive payments or referral fees, whether paid for each referral or each enrollment, are not allowable. Such payments may encourage recruiters to put inappropriate pressure on prospective subjects and are illegal in New York. Lump-sum payments not tied to the number of patients referred or enrolled may be allowed in particular studies. Investigators should include all information about incentives and/or referral fees in the recruitment section of the iRIS submission. Use of Existing Records to Identify Potential Subjects Often researchers wish to use existing records or specimens to identify and recruit potential research subjects. The research team must consider if this private identifiable information has been provided by individuals for a specific purpose, such as clinical care, and the individuals have not consented to its use for research. These records are protected by laws and policies to ensure they are not misused. When accessing existing records for research, the following should be taken into consideration: The use of academic records for purpose of identifying, contacting, and recruiting participants is subject to the rules set forth in the Family Educational and Rights Privacy Act (FERPA). See Academic Records under Additional Considerations. Use of medical records or clinical information for the purpose of identifying, contacting, and recruiting participants is subject to HIPAA. The use of existing research records to identify, contact, and recruit subjects for additional research must comply with the privacy and confidentiality commitments made when the research subjects consented to participate. IRB Review of Recruitment and Screening Materials The following are general types of recruitment materials the IRB must review before they are used to recruit research subjects. Letters to or Information Sheets for Subjects: Any letter to or information sheet for subjects or their representatives. Advertisements: The text of all advertisements in all media, including flyers, posters, newspaper ads, radio or television announcements, and informational pamphlets. However, investigators are not required to submit to the IRB the final version of an advertisement as long as the template, actual text or script has been approved and does not modify what was approved. Investigators are responsible for maintaining copies of the final product in the research files. Scripts: All scripts or guides that will be used for in-person or telephone recruitment. Web Postings or Pages: Submit text of postings or pages used for direct recruitment of subjects. Note, web site postings that are limited to basic study information, such as title, purpose of the study, basic eligibility criteria and study site location, intended for informational purposes and not solely for recruitment may not require IRB review and approval. Advertisements to recruit subjects are normally limited to the following information to determine eligibility and interest. The following elements are suggested but not required. The information should be worded to be informative but not coercive, overly enticing or promising of benefit. Indication that the recruitment is for a “Research Study” Name and address of researcher and/or research facility Condition under study or the purpose of the research Criteria that will be used to determine eligibility (in summary form) A brief list of significant risks, if any A brief description of benefits of participation, if any Payment, if any Time commitment required The location of the research Person or office to contact for further information For clinical trials Whether or not the investigational agent is FDA-approved for the given indication Indication that the study participant may receive a placebo, when applicable Limitations to recruitment materials: Researchers and the IRB must ensure that all materials used for recruitment do not: Characterize payment as a benefit, be the focus of the material, emphasize payment by using a larger font or bold type, or promise a bonus for completion of the study State or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent Include any exculpatory language that appears to waive any rights of the prospective participants or indicate that the investigator or Montefiore Einstein cannot be held liable or at fault for any research-related injury For clinical trials, recruitment materials should not Make any claims, either explicitly or implicitly, that the experimental agent is known to be safe or effective, or equivalent or superior to any currently available treatment or other drugs, biologics or devices. Promise a certainty of cure or of other favorable outcomes or benefits beyond what is outlined in the consent and the protocol Use terms such as “new treatment,” “new medication” or “new drug” Promise “free treatment” when the intent was only to say participants would not be charged for taking part in the study Allow for compensation towards the investigational agent once FDA approved. Posting Recruitment Materials at Other Sites: The investigator is responsible for obtaining appropriate prior permission from agencies/institutions at which recruitment materials will be posted. Example: Veterans Administration facilities require consultation with the local VA IRB to determine if flyers for non-VA-initiated research may be posted/disseminated. Who May Recruit? Initial Contact: Prospective research subjects should be contacted by someone who is Thoroughly knowledgeable about the study, Able to answer questions, Trained in the voluntary nature of research participation and The most appropriate person to contact prospective subjects Family Member Recruitment In cases when a family member is asked to recruit another family member or members into a study, the researcher should consider how best to protect and respect the privacy of family members who may be identified as potential participants. One way to respect and preserve the privacy of family members is for the researcher to develop a strategy that allows the family member who is already in the study to provide information sheets that explain the study to other family members. This allows the potential participant to contact the research team to express interest. There are other methods to protect the privacy of the family. Whatever method is used should be carefully considered and described in the IRB application. Montefiore Einstein Employee and/or Student Recruitment If a researcher wishes to enroll his/her own students or people, whom he/she supervises into a study, there are special provisions that need to be considered and implemented so that the students or employees do not feel obliged or pressured to participate in the study. Investigators should carefully consider the appropriateness of enrolling individuals they directly supervise or instruct and will require explicit justification in the IRB application. If Montefiore Einstein employees and/or students are asked to participate in a research study, the investigator may be asked to provide written assurance in the iRIS submission and indicate in the informed consent form that willingness to enroll in the research study will in no way affect subjects’ grades, employment, or standing within the organization. Recruiting Researchers’ Students and Staff: In order to avoid undue influence or pressure on a prospective subject, researchers should not directly ask their students or staff to be research subjects. It may be difficult to refuse such a request. Rather, researchers should post flyers or provide information sheets that allow volunteers to initiate contact about the study. Recruitment in Classrooms: If researchers wish to recruit students other than their own students in a classroom the researchers must make it very clear that research is voluntary and will not be tied to grades or extra credit. It must be clear that there will be no stigmatization or ostracization of students who decline to participate. If class time will be taken for research participation, alternative activities should be provided for those who decline (especially in pre-college levels). Screening Activities Screening activities are generally defined as: Any interaction or intervention with the subjects to determine eligibility that would not otherwise have been performed if not for the study, or Accessing the results of prior interventions that were performed for purposes other than the study. Collecting data directly from prospective subjects through written screening tools or oral responses to questionnaires, or accessing private information for purposes of determining eligibility for research (screening) constitutes a research intervention or interaction that is part of the research activity and therefore requires IRB review. Screening activities are reviewed as part of the overall recruitment and consent process and evaluated with respect to the protection of privacy and confidentiality of those who are screened. In order to protect the privacy of potential participants, you should collect only the minimum information necessary for screening.