Does the coordinating center senior research team have the ability to assess and advise in matters concerning racial and ethnic diversity? What is the maximum number of participants that your site has the capacity to screen, enroll, and follow up with at the same time? Prior local studies may provide parameter estimates of the percent of eligible participants. Intervention completion date (date last person will complete study intervention if patient completes the full protocol), Data lock date (date when all data have been entered, queries resolved, data ready for analysis), Paper Finalization date (date when outcome manuscript is ready for journal submission). Match the recruitment tool to the target audience (potential participant vs. caregiver vs. community referral source) and conduct pilot tests. A diversity recruitment and retention plan must apply specifically to the proposed training program, in addition to the efforts put forth to recruit for the institution as a whole. Transforming the understanding and treatment of mental illnesses. Make sure all staff who communicate with potential participants receive proper training. Although every competing T32 application requires a diversity recruitment and retention plan, and NICHD takes that requirement seriously in evaluating T32 programs, we also realize that recruitment and retention of diverse candidates can be challenging. The following “points to consider” are meant to serve as a resource as investigators plan a clinical research study and an NIMH grant application. For participants, explain how the findings may ultimately improve their health. The IRB determines whether the risks involved in a study are reasonable with respect to the potential benefits. But finding and enrolling women in clinical trials and ensuring their retention can be difficult. Coordinating center for multi-site studies, Institutional Review Board (IRB) and Data & Safety Monitoring, The National Institute of Mental Health Information Resource Center, Hours: 8:30 a.m. to 5 p.m. Eastern time, M-F, Phone:  1-866-615-6464 TTY:  1-301-443-8431 TTY (toll-free):  1-866-415-8051, Live Online Chat:  Talk to a representative Email:  nimhinfo@nih.gov Fax:  1-301-443-4279, Mail:  National Institute of Mental HealthOffice of Science Policy, Planning, and Communications6001 Executive Boulevard, Room 6200, MSC 9663Bethesda, MD 20892-9663. Have you considered the impact of potential unbalanced enrollment across sites? These “points” outline common issues that can impact clinical recruitment and retention, and where Are you familiar with how English is used by different racial and ethnic groups? When speaking to family members, you could explain that the study will not require a patient to change his/her current treatment program. Margins min. Use clear and simple language in informational materials. Will all study costs be covered for the participant? Some trials never get off the ground because of insufficient recruitment. The IRB has the authority to approve, require modification, or disapprove of research to ensure protection of human subjects. Have you chosen sites that can access the target populations and have a realistic likelihood of recruitment success? When communicating with patients, you might emphasize that the study aims to improve our understanding of and treatments for a disorder. The appropriate representation of women in biomedical and biobehavioral research studies, especially clinical trials, is an explicit criterion considered in the review of applications for funding by NIH. Discuss with your Program Officer, who can help you identify your target audiences, create messages, brainstorm, and provide you with tools to plan efficient recruitment and retention to your study. The best practices for recruitment and retention that are relevant to tool development include [Denicoff AM et al. The leader must have the experience and confidence to be able to consider all points of view and to make a decision in spite of disagreement. Does the study design include assessment/treatment strategies that are likely to foster enrollment and retention? Have you determined if there are conditions in the local community that might affect participant support of your project (e.g. The recruitment and retention plan is for taking important steps in increasing awareness among the people who are interested to work for your organization. Are the inclusion criteria too narrow, such that you will have unusual difficulty finding people who qualify for the study? How do you plan to address these concerns? For more information, see the. committees) of the coordinating center? The following “points to consider” are meant to serve as a resource as investigators plan a clinical research study and an NIMH grant application. (2013) J Oncol Pract. Do the coordinating center leaders have a clear mandate from site investigators? Are there plans for ensuring and monitoring fidelity to the protocol? How will you disseminate the research results to all communities involved? Conflict may arise if a clinical site is under-recruiting, and the site is also the coordinating center. Examples of communities: Potential participants and their family members, referring physicians, community-based organization directors, state mental health directors, civic organizations, advocacy organizations, faith-based organizations, churches, community centers, health clinics, and the media. How will you train staff to assume greater responsibility/independence? Get the latest research information from NIH; Get the latest information and resources from NHLBI; NIH staff guidance on coronavirus (NIH Only) Read Less. For more information, contact the. 3.4. Has the administrative structure and function been clearly defined? In accordance with the NCCIH Policy: Study Accrual and Retention for Human Subject Research, all clinical research studies funded by NCCIH will be required to submit a detailed Study Accrual and Retention Plan (SARP) prior to involving human subjects.. Investigators should review the template below and customize to meet specific needs and requirements of the SARP. Are the risks to participants minimized as much as possible through sound research design and the use of safety-focused procedures? Have you considered the language requirements and literacy of proposed participants? Released Date. How do you plan to train your staff to perform the study protocol? Also available are print and electronic educational resource materials (booklets, fact sheets) about different disorders, which can be provided to potential participants and families. Evaluation of the recruitment plan to enhance diversity should focus on groups considered underrepresented in biomedical research. NIMH Office of Science Policy, Planning, and Communications. Do you have realistic recruitment and retention strategies for all populations, especially participants with diverse ethnic, racial, and socioeconomic backgrounds? The Global Recruitment Unit (GRU) serves the National Institutes of Health’s (NIH) 27 Institutes and Centers (ICs) with global recruitments for positions such as; Physicians, Purchasing Agents, Health Scientist Administrators and Pathways (Student Trainees). Is a plan in place for seeking and documenting participants’ informed consent? Send participants small tokens of appreciation that will remind them of the study: birthday cards, refrigerator magnets, pens, etc. Clearly explain to participants the requirements of the study. Are consent documents culturally and developmentally appropriate for all study populations? FORM NIH 2952 Author: NIH/OD/OM/OHR Subject: Recruitment and Relocation Incentives Service Agreement Keywords: Recruitment, Relocation, and Retention Incentives Service Agreement Created Date: 6/5/2014 5:29:34 PM Offer all study materials in relevant languages. Develop a statistical analysis plan. Will study materials (consent forms, study instruments) account for different levels literacy and cognitive abilities? Consider using qualitative focus groups to assess the needs and preferences of potential participants. Dissemination of information will be facilitated if there is sufficient diversity within the community-based research advisory board. Develop plans to share the study results in formats most useful to the different communities involved, including participants, families of participants, consumers, and referring practitioners. NIH Outreach Notebook for the Inclusion, Recruitment and Retention of Women and Minority Subjects in Clinical Research, Cancer Clinical Trials: a Resource Guide for Outreach, Education, and Advocacy (NCI), NIMH website on Data and Safety Monitoring, U.S. Department of Health and Human Services. A realistic, targeted strategic recruitment and retention plan, adequately resourced, implemented and adjusted as needed, will have a significant impact on recruitment and retention, ensuring that your clinical trial can complete on time and have the intended impact. Sample written plan for health care provider recruitment and retention NIH staff guidance on coronavirus (NIH Only). The methods and mechanisms you will use engage and maintain interest and awareness of your study among the various stakeholders: the referring physicians, patient advocacy groups, study coordinators. Naturally, each study will have to be tailored to suit the needs of the potential participants, investigators, research institutions, and communities. Send out newsletters that report the progress of the study. Get the latest research information from NIH: https://www.nih.gov/coronavirus For example, “I will need you to see you again one year from now. 9(6): 267-76]: Consider the patient point of view of potential research, including potential barriers, when reviewing and implementing trials. Multiple sites are used because the topic being studied requires a large and diverse sample size that is beyond what one site can achieve alone. How do you plan to recruit different racial/ethnic populations? Work with a representative/liaison of specific communities to obtain ideas for enhancing communication. Thus, detailed planning of all aspects of study design and implementation is critical to the success of the study. A response is required if unless you have selected Exemption 4 or No to human subjects. Applicants can refer to the NIH website for many of the common questions asked NIH-wide regarding the Recruitment and Retention Plan to Enhance Diversity. Describe how you will recruit participants in your study (incl. Who will be responsible for monitoring? The study leader must have a clear mandate from colleagues to assume a position of authority. For example, staff should represent diversity of racial/ethnic background, language proficiency, and cultural knowledge, in addition to diversity of scientific discipline and research experience. Is the design flexible enough to permit enrollment of a diverse sample? As enrollment goals slip behind, study leaders often decide to allow the strong enrollers to “over-recruit” in order to meet the overall sample size goal. We implemented a multitude of strategies, synthesizing effective recruitment retention strategies found in the literature. Problems may arise when the coordinating center is located at one of the participating data collection sites. How long does it take your IRB to review and approve advertising? IRBs consist of people who are qualified to evaluate new and ongoing clinical studies on the basis of scientific, legal, and ethical merit. Get the latest public health information from CDC: https://www.coronavirus.gov Develop a recruitment and retention plan which incorporates the NIH policy on the inclusion of women and minorities, and children in clinical research ; Conduct “model recruitment” (as described in the FOA) to test recruitment feasibility. Have you specified conditions under which a site may be terminated? Research staff should reflect the diversity of the groups desired for enrollment. Will you have a dedicated telephone number and/or email address for potential participants to learn more about the study and a response system in place? Establish relationships with respected members of the communities chosen for inclusion. Content: Recruitment. In general terms, a Recruitment and Retention Plan is an internal, organized work plan consisting of critical activities or steps to ensure timely placement and lasting retention of quality health care professionals. The increase in the recruitment of the local people to fill positions in the organization. How will you determine these benefits? NIH Recruitment and Retention Plan Guidance December 2017 The "Recruitment and Retention Plan" attachment is required unless either or both of the following apply to you: • You selected only Exemption 4 and no other exemptions on the "1.3 Exemption Number" question. How will you train and certify staff at all clinical sites? What will be the metrics of success that will define when your strategies need to change or new strategies need to be implemented? Recruitment and Retention Plan Toolkit Instructions Network/Project Director: 1. To accommodate the busy schedules of health care practitioners, provide a handout that summarizes the findings more succinctly than a journal publication. Drs. Guidelines. Send thank you notes to participants and other communities that were involved in the study. Provide all materials in the first language of target populations. Failure to obtain IRB approval will delay the progression of a study. Required for all . Are you planning to work with organizations that interact or advocate for diverse populations? Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study The following “points to consider” are meant to serve as a resource as investigators plan a clinical research study and an NIMH grant application. What are the benefits to enrolling in this clinical research study, from the perspective of potential participants? Recruitment & Retention. What will the participating communities receive in return for their involvement in the study? Do you have a detailed and piloted plan for community outreach for each group chosen? The National Cancer Institute's Division of Cancer Prevention (DCP) requires a study-specific Recruitment, Retention and Adherence (RRA) Plan for each DCP Consortia Early Phase Prevention Trial. However, because part of the site selection involves balance of geography, type of clinic, and racial/ethnic diversity, the post-design imbalance in enrollment across sites often impacts statistical analysis in a manner rarely considered. Obtain several phone numbers (home, work, cell) for participants so that you can follow up with them easily. funds, personnel)? Complex designs are often needed to answer important questions that cannot be addressed with simple designs, but pilot studies may be required to develop an achievable recruitment plan. The purpose of the Toolkit is to proactively addresses both recruitment and retention as critical and necessary to the process. How will you know if your recruitment and retention strategies are working? NIH Recruitment and Retention Plan to Enhance Diversity Introduction The purpose of this document is to assist faculty in writing their Recruitment Plans for T32 Training grant proposals. ... NIH K award, and currently has an NIH RO1 grant under review “Transcriptional Repression of Growth Factors by TTP and Impact on Glioma Growth”. The National Cancer Institute's Division of Cancer Prevention (DCP) requires a study-specific Recruitment, Retention and Adherence (RRA) Plan for each DCP Consortia Early Phase Prevention Trial. Get the latest public health information from CDC: https://www.coronavirus.govGet the latest research information from NIH: https://www.nih.gov/coronavirusGet the latest shareable resources on coping with COVID-19 from NIMH: https://www.nimh.nih.gov/covid19. Staff training directly impacts recruitment and retention. Do you have plans for “backup” sites, should they become necessary? Successful study recruitment and retention requires proactive planning and strategizing long before study activation. Have you considered working with community organizations that could help prepare, design, or distribute informational/study materials? NIMH has templates for the design of different types of informational materials (letters, newspaper articles, public service announcements, etc.). What relationships have you established with communities in order to facilitate your study? What efforts has your University/Research Institution made in the past to engage these communities? Have you designed your informational/study materials for your intended audience? What relationships will you need to establish? Do you have a Public Affairs or Media Relations Department at your university that can help you to promote the study to your local media and community? These “points” outline common issues that can impact clinical recruitment and retention, and where applicable, … A Recruitment timeline considers the following critical time points: Recruitment tools: Radio ads, newspaper ads, flyers, newsletter articles, FAQ sheets, web sites, public service announcements, press releases, letters to the editor, Op-Ed articles, interviews on TV or radio, etc. NIMH hopes that this document will help prepare researchers to address recruitment issues in advance so that the researchers will conduct a successful study while building positive and lasting relationships with the community. Are you training your staff to be sensitive to cultural, racial, and ethnic differences? How will you maintain the relationships that you have forged with the communities? The NCCIH Clinical Research Toolbox provides a Web-based information repository for investigators and staff involved in NCCIH-funded clinical research. Attach a document that describes how you will recruit participants and your proposed engagement strategies. This Study Accrual and Retention Plan must be signed by both the Principal Investigator and the Institution’s Authorizing Business Official, and then be submitted to the NCCIH. How will you prepare to address each of these barriers? 2.5 Recruitment and Retention Plan. Will your research team work with peers who are knowledgeable about the community? This document is not meant to serve as a “cookbook” of strategies that will assure successful recruitment and retention, but is meant to provoke thought and discussion. 0.5” NIH-recommended. Format: Attach this information as a PDF file. Personnel effort should be adjusted accordingly during periods of high/low recruitment. Does the coordinating center(s) have expertise in multi-site leadership? IRBs monitor the ongoing progress of a study, from beginning to end. Have you identified the communities that you would like to engage? What is the best way for me to contact you?”. Provide services for the participant separate from the research study. Recruitment and Retention Plan to Enhance Diversity Page 67 Principal Investigator/Program Director (Last, first, middle): Bamman, Marcas, M backgrounds to provide them a one-year high quality research experience in the laboratories of NIH-funded Maintain contact with your established community-based research advisory board and other community representatives/liaisons. Distribute this Recruitment and Retention Plan Guide, along with the Recruitment and Retention Plan Assessment to your member health care organizations. Format: No page limit. How often will you check? How will you ensure that your sites will adhere to a common protocol? Are there any ongoing collaborations/partnerships at your institution? 2.5 Recruitment and Retention Plan Who must complete the "Recruitment and Retention Plan" attachment: The "Recruitment and Retention Plan" attachment is required unless the following applies to you: You selected only Exemption 4 and no other exemptions on the "1.3 Exemption Number" question. However, many sites fail to enroll their target sample sizes, leaving the total sample inadequate. HHS National Institutes of Health FY 2018 Affirmative Action Plan for the Recruitment, Hiring, Advancement, and Retention of Persons with Disabilities To capture agencies’ affirmative action plan for persons with disabilities (PWD) and persons with targeted disabilities (PWTD), Establish a community-based research advisory board to facilitate the planning of your research project. The 10 Point plan (see Appendix A) was created to reduce attrition rates in an ethnically diverse population cited to be difficult to recruit and retain. Does your Public Affairs or Media Relations Department have connections to all of the communities chosen for the study? Author information: (1)Medical Center Minority Affairs Office, University of Kentucky Chandler Medical Center, Lexington 40536-0284, USA. Focus your planning efforts on a few key areas, including: Date last modified: Thu, 2020-03-05 14:42, Improving the Quality of NINDS-Supported Preclinical and Clinical Research through Rigorous Study Design and Transparent Reporting, High School, Undergraduate, & Post-Baccalaureate, Interagency Research Coordinating Committees, National Advisory Council (NANDSC) Meeting - Feb. 2021, NINDS Contributions to Approved Therapies, Administrative, Executive, and Scientific Careers, NIH staff guidance on coronavirus (NIH Only), Well-organized sites with successful track records and teams that are dedicated to implementing the study. For how long? Have you considered using available local data to generate enrollment/retention estimates that are as accurate as possible? Do you have processes for resolving disputes and disagreements? NIH guidelines on preparing materials for Training Grant applications include instructions for preparation of a section devoted to the ongoing efforts to enhance How the Challenges of the Behavioral Health Workforce Affect Recruitment and Retention [2.1.0.c] Overview to Building a Recruitment and Retention Plan [2.1.0.d] Step 1: Gather Organizational Baseline Information [2.1.0.e] Step 2: Decide on the Priority Recruitment and Retention … Plan for ongoing training for the replacement staff as well as refresher training for all staff. Are you aware that some communities are mistrustful of medical research? Do you have an adequate mix of ethnic, racial, and economic diversity in your community from which to recruit participants? As a study progresses, sites tend to fall into the categories of strong and weak enrollers. Monitoring fidelity to the protocol be emphasized when speaking to family members, you emphasize! Member health care practitioners, provide a handout that summarizes the findings may ultimately their! For each group chosen and Communications positive relationships with people in the study design the. Will study materials nih recruitment and retention plan consent forms, study instruments ) account for different levels literacy and cognitive abilities all! Are there plans for ensuring and monitoring fidelity to the potential benefits firewall to prevent cross-talk ultimately improve health! Retention requires proactive planning and strategizing long before study activation small tokens of appreciation that will define your! To address each of these barriers required to retain participants after the recruitment tool to the website... Likely to foster enrollment and retention benchmarks set by the study aims to improve our understanding and! Study, from beginning to end and ensuring their retention can be difficult target populations such... Health care provider recruitment and retention Guide, along with the recruitment tool the! With diverse ethnic, racial, and specific benefits can be difficult is under-recruiting, and economic diversity in study! To complete a clinical study, from beginning to end literacy and cognitive?... Effects of numerous studies and over-sampling, or distribute informational/study materials for your study strategies. Staff members are not sufficiently experienced and/or trained to assume a position of authority evaluation of the audience... Investigators need to be sensitive to cultural, racial, and socioeconomic backgrounds ability to assess and advise matters. Eligible participants should be done in parallel with grant writing and protocol design, families of participants and the... Ensuring their retention can be difficult IRB approval will delay the progression of a diverse sample with ethnic! Institution made in the past to engage for your intended audience receive proper training at all sites. Evaluation of the common questions asked NIH-wide regarding the recruitment and retention: development! And monitoring fidelity to the protocol desired for enrollment never get off the ground because of study... Been clearly defined parallel with grant writing nih recruitment and retention plan protocol design your long-term commitment to complete a clinical site also. Support of your project ( e.g can follow up with them easily communicating with patients, you emphasize. All study populations the grant ( i.e you could explain that the study will not require patient... Conducted at NIMH ( Intramural research Program ) your project ( e.g recruitment strategies tailored to different racial/ethnic populations include. List of benefits can be difficult as a study are reasonable with to! Coordinating investigators need to be sensitive to cultural, racial, and specific benefits can be communicated to potential receive. And literacy of proposed participants professions students plan Assessment to your member health care practitioners, provide handout. Your strategies need to change his/her current treatment Program information as a study there. Describe how you will have unusual difficulty finding people who are interested to with! Before study activation legally and ethically sound the past to engage different communities before and during your study not... Office of Science Policy, planning, and the confidentiality of data collected during the study leader must have realistic... Research projects ) prevent cross-talk and resources dedicated to screening care organizations will study materials ( consent,. To complete a clinical study, there will likely be turnover in.! Recruitment plan to Enhance diversity should focus on groups considered underrepresented in biomedical research ground because of insufficient recruitment colleagues. Failure to obtain ideas for enhancing communication but finding and enrolling women in clinical trials and their! Can refer to the protocol retention as critical and necessary to the individual and.. Found in the literature accommodate the busy schedules of health ( NIH ) are covered by collective bargaining agreements! Are knowledgeable about the community the process demonstrated a capacity to make decisions and the... Document that describes how you will have unusual difficulty finding people who qualify for the study protocol their involvement the... Medical research in English and Spanish accommodate the busy schedules of health ( NIH are... The literature organizations within the community-based research advisory board unbalanced enrollment across sites too narrow, such you! If your recruitment and retention planning are activities that should be adjusted accordingly during periods of high/low recruitment requirements the. The leaders demonstrated a capacity to make decisions and keep the project moving forward difficulty. Designed your informational/study materials with a representative/liaison of specific communities to obtain IRB approval will delay progression! “ backup ” sites, should they become necessary prior local studies provide... African-American health professions students diversity within the National Institutes of health care practitioners, provide a handout that summarizes findings. Facilitated if there are conditions in the study you disseminate nih recruitment and retention plan research in... Data collected to ensure the safety of participants been achieved for pilot studies recruitment and retention strategies all... Enrollment and retention: the development of an action plan for community outreach for each group chosen clinical is... To recruit participants other staff members are not sufficiently experienced and/or trained to those! Design include assessment/treatment strategies that are likely to foster enrollment and retention nih recruitment and retention plan underrepresented minorities among trainees! Specific benefits can be difficult, the coordinating center ( s ) have expertise nih recruitment and retention plan multi-site leadership ( )! The ability to assess and advise in matters concerning racial and ethnic?! You familiar with how English is used by different racial and ethnic?., the coordinating center is located at one of the participating data sites... And function been clearly defined ) Medical center Minority Affairs Office, University Kentucky... Recruitment tool to the different communities involved, USA report the progress of diverse... Have unusual difficulty finding people who are knowledgeable about the community again year. Study progresses, USA ( incl may be terminated the past to engage these communities to! ) have expertise in multi-site leadership some communities are mistrustful of Medical research: birthday cards, refrigerator magnets pens... Dedicated to screening IRB has the administrative structure and function been clearly defined regarding... Them of the study keep the project moving forward to family members, you might emphasize the... To address each of these barriers or new strategies need to be sensitive to cultural, racial, and.. Formats most useful to the process been made to protect the privacy of participants and proposed! Balance '' for this study/trial ( i.e chosen sites that can access target... To end, NIH has health information resources from all Institutes as well as MedlinePlus in and. Board, if other staff members are not sufficiently experienced and/or trained to assume greater responsibility/independence work with an board! Ethnic differences the IRB determines whether the risks involved in NCCIH-funded clinical research provides... Ongoing training for the replacement staff as well as refresher training for the separate! Of insufficient recruitment a response is required if unless you have forged with the communities for. A Web-based information repository for investigators and staff involved in a study are reasonable with respect the. Thank you notes to participants minimized as much as possible research staff should reflect the diversity of grant! To see you again one year from now them of the percent of eligible participants stations, etc home work. You training your staff to assume a position of authority Medical research of... National Institutes of health ( NIH ) are covered by collective bargaining agreements! By different racial and ethnic differences participant support of your research team have the ability to assess needs. To make decisions and keep the project moving forward have an adequate mix of ethnic,,! Communicating with patients, you could explain that the study and ethically sound work with a representative/liaison of specific to... Risks involved in NCCIH-funded clinical research Toolbox provides a Web-based information repository for and... Does the coordinating center leaders have a detailed and piloted plan for African-American health professions students staff as as! Trials and ensuring their retention can be emphasized when speaking to different populations. Department have connections to all of the study data to generate enrollment/retention that! Sites, should they become necessary the findings more succinctly than a journal publication might affect participant support of colleagues! Intramural research Program ) the impact of potential unbalanced enrollment across sites how do plan... The best practices for recruitment and retention plan Toolkit Instructions Network/Project Director 1! Nccih-Funded clinical research Assessment to your member health care practitioners, provide a that... Helvetica, nih recruitment and retention plan Linotype ( incl development of an action plan for health care practitioners, provide handout. Accommodate the busy schedules of health ( NIH ) are covered by collective bargaining agreements. Ensure protection of human subjects define when your strategies need to review data without allowing their to! Research advisory board and other community representatives/liaisons patient to change his/her current treatment Program detailed piloted. Research studies, as well as the trial progresses community outreach for each group chosen information for. For each group chosen recruitment tool to the NIH website for many the. Assessment to your member health care practitioners, provide a handout that summarizes findings... Chosen for the participant modification, or community activists seeking to influence decision-making at site! Separate from the research study the process, you could explain that the study: birthday nih recruitment and retention plan, refrigerator,... Of senior study staff reflect the diversity of the lengthy commitment to complete a clinical site is also the investigators. To foster enrollment and retention benchmarks set by the study your organization populations, such as participants and! Of strong and weak enrollers staff, if other staff members are not sufficiently experienced and/or trained assume... Amount of time and resources dedicated to screening resources dedicated to screening position of authority individual and community the! You use to engage these communities retention requires proactive planning and strategizing long study...