How will you maintain the relationships that you have forged with the communities? 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. NIMH Office of Science Policy, Planning, and Communications. 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. Transforming the understanding and treatment of mental illnesses. Does the coordinating center(s) have expertise in multi-site leadership? Required for all . Consider using qualitative focus groups to assess the needs and preferences of potential participants. studies involving human subjects. Have you considered the impact of potential unbalanced enrollment across sites? As a study progresses, sites tend to fall into the categories of strong and weak enrollers. Are you aware that some communities are mistrustful of medical research? Report research results in formats most useful to the different communities involved, such as participants, families of participants, and referring practitioners. These “points” outline common issues that can impact clinical recruitment and retention, and where Make sure all staff who communicate with potential participants receive proper training. The increase in the recruitment of the local people to fill positions in the organization. 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 the effects of numerous studies and over-sampling, or community activists seeking to influence research projects)? How will you replace key staff, if other staff members are not sufficiently experienced and/or trained to assume those responsibilities? 2.5 Recruitment and Retention Plan. The IRB determines whether the risks involved in a study are reasonable with respect to the potential benefits. 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. 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. 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 list of benefits can be communicated to potential participants, and specific benefits can be emphasized when speaking to different audiences. 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. Get the latest research information from NIH: https://www.nih.gov/coronavirus Are the inclusion criteria too narrow, such that you will have unusual difficulty finding people who qualify for the study? What efforts has your University/Research Institution made in the past to engage these communities? Are you training your staff to be sensitive to cultural, racial, and ethnic differences? Work with local churches, community centers, Spanish radio stations, etc. What is the best way for me to contact you?”. 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. Recruitment and retention: the development of an action plan for African-American health professions students. 0.5” NIH-recommended. Research staff should reflect the diversity of the groups desired for enrollment. Are you planning to work with organizations that interact or advocate for diverse populations? Do you plan to match resources to recruitment over the lifespan of the grant (i.e. The recruitment and retention plan is for taking important steps in increasing awareness among the people who are interested to work for your organization. A response is required if unless you have selected Exemption 4 or No to human subjects. Establish relationships with respected members of the communities chosen for inclusion. These “points” outline common issues that can impact clinical recruitment and retention, and where applicable, … Develop a statistical analysis plan. How will you train staff to assume greater responsibility/independence? 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? Work with communities through focus groups, interviews, and surveys to develop a list of benefits (as well as barriers, see next item) to participating in the research study. 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. 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. 2.5 Recruitment and Retention Plan. Be flexible when scheduling appointments. Dissemination of information will be facilitated if there is sufficient diversity within the community-based research advisory board. For more information, see the. Do the backgrounds of senior study staff reflect the diversity of the communities that you wish to engage for participation in the study? 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. For more information, contact the. How will you maintain these relationships? Will your research team work with peers who are knowledgeable about the community? How will you disseminate the research results to all communities involved? assigning staff among various trials)? Will you need different recruitment strategies tailored to different racial/ethnic populations? Staff training directly impacts recruitment and retention. 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 Besides NIMH resource materials, NIH has health information resources from all institutes as well as MedlinePlus in English and Spanish. 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. committees) of the coordinating center? 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. Are consent documents culturally and developmentally appropriate for all study populations? Successful study recruitment and retention requires proactive planning and strategizing long before study activation. Describe how you will recruit participants in your study (incl. How will you prepare to address each of these barriers? (2013) J Oncol Pract. RECRUITMENT AND RETENTION PLAN TO ENHANCE DIVERSITY 4A. 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. 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 … What are the benefits to enrolling in this clinical research study, from the perspective of potential participants? 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: email@example.com 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. The plan is to contain the increasing number of … To accommodate the busy schedules of health care practitioners, provide a handout that summarizes the findings more succinctly than a journal publication. Send out newsletters that report the progress of the study. 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. Evaluation of the recruitment plan to enhance diversity should focus on groups considered underrepresented in biomedical research. 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. NCCIH exercises stewardship of public funds by monitoring the accrual and retention benchmarks set by the study team throughout the grant lifecycle. Format: No page limit. 9(6): 267-76]: Consider the patient point of view of potential research, including potential barriers, when reviewing and implementing trials. Offer all study materials in relevant languages. All institutions carrying out a NIMH funded intervention study must establish a data monitoring system commensurate with the risks, complexity, and nature of the trial. Have you considered working with community organizations that could help prepare, design, or distribute informational/study materials? Margins min. 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. The study leader must have a clear mandate from colleagues to assume a position of authority. 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. 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). 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. Have the leaders demonstrated a capacity to make decisions and keep the project moving forward? These “points” outline common issues that can impact clinical recruitment and retention, and where applicable, strategies are suggested to address these issues. ... NIH K award, and currently has an NIH RO1 grant under review “Transcriptional Repression of Growth Factors by TTP and Impact on Glioma Growth”. 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. The NIH Interest in Diversity encourages institutions to diversify their student and faculty populations, and institutional training programs are required to include a Recruitment Plan to Enhance Diversity that addresses this goal. For participants, explain how the findings may ultimately improve their health. How will you determine these benefits? Have you considered the language requirements and literacy of proposed participants? Sample written plan for health care provider recruitment and retention Obtain several phone numbers (home, work, cell) for participants so that you can follow up with them easily. Does the coordinating center senior research team have the ability to assess and advise in matters concerning racial and ethnic diversity? 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. What resources will be required to retain participants after the recruitment phase is completed? Do you have realistic recruitment and retention strategies for all populations, especially participants with diverse ethnic, racial, and socioeconomic backgrounds? Recruitment & Retention. 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. How do you plan to address these concerns? Is a plan in place for seeking and documenting participants’ informed consent? Send thank you notes to participants and other communities that were involved in the study. Will all study costs be covered for the participant? NIH staff guidance on coronavirus (NIH Only). fonts: Arial, Georgia, Helvetica, Palatino Linotype. Has the administrative structure and function been clearly defined? How will you ensure that your sites will adhere to a common protocol? Distribute this Recruitment and Retention Plan Guide, along with the Recruitment and Retention Plan Assessment to your member health care organizations. Guidelines. Some trials never get off the ground because of insufficient recruitment. Released Date. The plan does not guarantee promotion, employment or hiring but is intended to ensure that basically qualified available applicants receive fair consideration for positions filled under competitive procedures. Review the recruitment plan with special focus on the targeted population, expected gender/minority estimates, and inclusion/exclusion criteria, as appropriate • Review retention plans, as appropriate Investigators Provide • understandable verbal and written communications between volunteers and investigative staff throughout the clinical Get the latest research information from NIH; Get the latest information and resources from NHLBI; NIH staff guidance on coronavirus (NIH Only) Read Less. Because of the lengthy commitment to complete a clinical study, there will likely be turnover in staff. What strategies will you use to engage different communities before and during your study? What will the participating communities receive in return for their involvement in the study? Wiggs JS(1), Elam CL. How will you train and certify staff at all clinical sites? Department of Health and Human Services, HHS, National Institutes of Health, NIH, NIH Clinical Center, NIH CC, Department of Bioethics, Bioethics, Courses, Lectures & Training, Ethical and Regulatory Aspects of Clinical Research, ERACR, 2020 Course, Session 3: Subject Selection, Recruitment and Retention - Dave Wendler PhD During study implementation, the coordinating investigators need to review data without allowing their knowledge to influence decision-making at a site level. 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. Do the coordinating center leaders have a clear mandate from site investigators? 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. Has retention of participants been achieved for pilot studies? The National Institute of Mental Health (NIMH) is part of the National Institutes of Health (NIH), a component of the U.S. Department of Health and Human Services. Content: Recruitment. Provide all materials in the first language of target populations. Get the latest public health information from CDC: https://www.coronavirus.gov Recruitment and retention planning are activities that should be done in parallel with grant writing and protocol design. Employees of certain organizations within the National Institutes of Health (NIH) are covered by collective bargaining unit agreements. 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. Naturally, each study will have to be tailored to suit the needs of the potential participants, investigators, research institutions, and communities. Author information: (1)Medical Center Minority Affairs Office, University of Kentucky Chandler Medical Center, Lexington 40536-0284, USA. Plan for ongoing training for the replacement staff as well as refresher training for all staff. Is there a way to reduce any costs? Take into consideration that the Spanish language differs between countries, thus translation must be performed by an individual who is familiar with the target community. funds, personnel)? How do you plan to train your staff to perform the study protocol? Clearly explain to participants the requirements of the study. Failure to obtain IRB approval will delay the progression of a study. What relationships have you established with communities in order to facilitate your study? Have you determined if there are conditions in the local community that might affect participant support of your project (e.g. 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. What is your timeline for protocol finalization, IRB approvals, development of treatment materials or experimental methods, piloting, staff training and certification, development of data collection instruments and systems, tools for quality control, acquisition of treatment products and matching placebo, etc.? 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. Does your Public Affairs or Media Relations Department have connections to all of the communities chosen for the study? What is the maximum number of participants that your site has the capacity to screen, enroll, and follow up with at the same time? Who will be responsible for monitoring? Provide services for the participant separate from the research study. 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. Use clear and simple language in informational materials. IRBs monitor the ongoing progress of a study, from beginning to end. Studies may require that people are screened at successive stages, requiring significant time and expenditure of resources on subjects who never enter the study. Conflict may arise if a clinical site is under-recruiting, and the site is also the coordinating center. Recruitment–retention plan addresses known obstacles. Health Topics; Health Topics A-Z ... New FAQs for Recruitment and Retention Plan to Enhance Diversity, and for Policies Related to Parental Leave and Child Care. What will be the metrics of success that will define when your strategies need to change or new strategies need to be implemented? A recruitment plan should be developed by principal investigators, faculty members and senior leaders to identify strategies to enhance the pool of applicants for all programs. We implemented a multitude of strategies, synthesizing effective recruitment retention strategies found in the literature. Strict inclusion criteria restrict the eligible number of participants and increase the amount of time and resources dedicated to screening. Have you piloted all relevant aspects of the methodology including recruitment, screening, assessment, randomization procedures (if required), treatment and experimental methods, data entry, etc.? Establishing and maintaining positive relationships with your community may facilitate your future research studies, as well as the studies of your colleagues. What is a realistic recruitment timeline? Rebounding from recruitment shortfalls can be difficult as a study progresses. Work with a representative/liaison of specific communities to obtain ideas for enhancing communication. But finding and enrolling women in clinical trials and ensuring their retention can be difficult. NIH guidelines on preparing materials for Training Grant applications include instructions for preparation of a section devoted to the ongoing efforts to enhance Problems may arise when the coordinating center is located at one of the participating data collection sites. Have you considered using available local data to generate enrollment/retention estimates that are as accurate as possible? Are there any ongoing collaborations/partnerships at your institution? Attach a document that describes how you will recruit participants and your proposed engagement strategies. 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. 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.. Before you are funded: Recruitment and retention planning are activities that should be done in parallel with grant … planned recruitment activities) Retention 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. Do you have plans for “backup” sites, should they become necessary? Have provisions been made for monitoring the data collected to ensure the safety of participants as the trial progresses? Will study materials (consent forms, study instruments) account for different levels literacy and cognitive abilities? 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. The best practices for recruitment and retention that are relevant to tool development include [Denicoff AM et al. Are you familiar with how English is used by different racial and ethnic groups? How will you know if your recruitment and retention strategies are working? Match the recruitment tool to the target audience (potential participant vs. caregiver vs. community referral source) and conduct pilot tests. 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. When speaking to family members, you could explain that the study will not require a patient to change his/her current treatment program. Have provisions been made to protect the privacy of participants and the confidentiality of data collected during the study? 3.4. 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). Does the study design include assessment/treatment strategies that are likely to foster enrollment and retention? NIMH has templates for the design of different types of informational materials (letters, newspaper articles, public service announcements, etc.). How long does it take your IRB to review and approve advertising? Prior local studies may provide parameter estimates of the percent of eligible participants. When communicating with patients, you might emphasize that the study aims to improve our understanding of and treatments for a disorder. For how long? Send participants small tokens of appreciation that will remind them of the study: birthday cards, refrigerator magnets, pens, etc. Is the informed consent document both legally and ethically sound? Also available are print and electronic educational resource materials (booklets, fact sheets) about different disorders, which can be provided to potential participants and families. Most institutions that carry out clinical studies have their own IRBs. Are the risks to participants minimized as much as possible through sound research design and the use of safety-focused procedures? Have you designed your informational/study materials for your intended audience? Research Conducted at NIMH (Intramural Research Program). What mechanisms will you use to encourage recruitment? The purpose of the Toolkit is to proactively addresses both recruitment and retention as critical and necessary to the process. This policy is implemented at the NIH as described below: Administrative Procedures As announced in 1989, all competing applications for institutional NRSA research training grants must include a plan to recruit minorities and renewal applications must also include a report on the recruitment and retention record during the previous award period. The coordinating center must ensure a clear line of responsibility, confidentiality of data, and a strong firewall to prevent cross-talk. Is the design flexible enough to permit enrollment of a diverse sample? For example, “I will need you to see you again one year from now. Prepare recruitment documents using the first language of the target populations, such as Spanish. 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. Thus, detailed planning of all aspects of study design and implementation is critical to the success of the study. What relationships will you need to establish? Format: Attach this information as a PDF file. Drs. Maintain contact with your established community-based research advisory board and other community representatives/liaisons. Do you have a detailed and piloted plan for community outreach for each group chosen? The IRB has the authority to approve, require modification, or disapprove of research to ensure protection of human subjects. Work with an established board, if it already exists. Are there plans for ensuring and monitoring fidelity to the protocol? How will you maintain "staff balance" for this study/trial (i.e. Have you outlined the organizational structure (e.g. Recruitment and retention of underrepresented minorities among predoctoral trainees.