NOT-OD Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, - New Grant Application Instructions Now Available. NOT-OD - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, See Notice NOT-OD September 13, - Updates to the Non-Discrimination Legal Requirements for NIH Recipients.

August 5, - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, August 5, - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. July 22, - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY The NIH Research Education Program R25 supports research education activities in the mission areas of the NIH.

The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:. Research Experiences Curriculum or Methods Development Outreach.

This funding opportunity seeks to facilitate the education of students from diverse backgrounds underrepresented in biomedical research who will become knowledgeable about cancer, and available to focus on cancer later in their careers.

The proposed institutional programs may also provide research experiences for the grade teachers and undergraduate faculty members who serve underrepresented student populations. The specific goals are to inspire interest in biomedical sciences, help envision research as a career path, and strengthen practical research and career skills.

In alignment with these goals, institutions may develop unique programs that capitalize on their research strengths and are responsive to their target populations.

All applications are due by PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date s.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Conformance to all requirements both in the Application Guide and the FOA is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV.

When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

The NIH Research Education Program R25 supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. This funding opportunity seeks to facilitate the education and research experience of students from diverse backgrounds underrepresented in biomedical research who are knowledgeable about cancer, and available to focus on cancer later in their careers.

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams.

Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital NOT-OD A disproportionate burden of cancer exists among many population groups, including African Americans, Hispanics or Latinos, American Indian, Alaska Natives, Native Hawaiians, Pacific Islanders, individuals with disabilities and individuals from socioeconomically disadvantaged backgrounds Betancourt et al.

These same population groups are also significantly underrepresented in the U. biomedical research and health care workforce, which contributes to and exacerbates the cancer health disparities.

This underrepresentation is clearly evident at a much earlier stage. National data for degrees conferred to U. Research has shown that students with disabilities enroll in and complete postsecondary education at only half the rate of their peers without documented disabilities.

But the problem stems from K education, where students with disabilities are not integrated with the general student body and are poorly prepared for the rigors of postsecondary education. Individuals from socioeconomically disadvantaged backgrounds have limited access to resources that would help them build solid foundations and advance in scientific research career paths.

These data suggest that intervention strategies at earlier academic levels are needed to effectively increase diversity in the biomedical research workforce.

This NCI YES program provides support for early intervention strategies that actively engage underrepresented students as early as middle school years in cancer research experiences, with the ultimate goal of improving recruitment and retention of these students in biomedical research.

Applicants are expected to develop holistic approaches that have sustained impact in student retention in the biomedical research pipeline. While matriculation through the academic levels are requisite milestones for students' progress, other predictors of success in terms of interest and retention in research careers should also be considered and addressed.

Applicants should consider the substantial literature that addresses these factors and design their approaches with these in mind. Applications that provide engagement in interdisciplinary approaches in cancer and cancer health disparities research are encouraged. Applications that enhance collaborative efforts within the YES community are encouraged.

Tracking of student participants for at least 15 years is strongly encouraged. Within seven years of making awards under this program, NCI will assess the program's overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.

Upon the completion of this evaluation, NCI will determine whether to a continue the program as currently configured, b continue the program with modifications, or c discontinue the program. Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support.

R25 programs may augment institutional research training programs e. Kirschstein National Research Service Award NRSA programs. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Renewal of applications submitted in response to PAR Only those application types listed here are allowed for this FOA. Need help determining whether you are doing a clinical trial? The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The budget request for a given application needs to be adequately justified and reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.

If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds.

Total allowable personnel including consultants cost is proportional to the number of participants in the program. All personnel and consultant costs must be adequately justified and take into consideration yearly fluctuations in required effort.

Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget. While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee.

Participants may also receive funds to defray partial tuition and other education-related expenses. Individuals supported by NIH training and career development mechanisms K, T, or F awards may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 program is not intended as a substitute for an NRSA institutional training program e. Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget.

These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

A housing allowance can be requested by the program each year. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. Institutions with existing Ruth L.

Kirschstein National Research Service Award NRSA institutional training grants e. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Non-domestic non-U. Entities Foreign Institutions are not eligible to apply. components of U. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Obtaining an eRA Commons account can take up to 2 weeks. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:. Mentors should have research expertise and experience relevant to the proposed program.

The grade and undergraduate students must be currently enrolled and in good standing at their respective middle or high school or undergraduate institutions. Teachers and faculty members must be currently employed at their respective schools or institutions and engaged in the teaching of the sciences.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all.

For this FOA, in alignment with the NIH Notice of Interest in Diversity NOT-OD , NCI particularly encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:.

The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity.

Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of , as amended.

Individuals from disadvantaged backgrounds, defined as those who meettwo or moreof the following criteria:. pdf ;. html ;. Grew up in one of the following areas: a a U. Only one of the two possibilities in 7 can be used as a criterion for the disadvantaged background definition.

asp , and are subsequently less likely to be represented in biomedical research. Student, teacher and faculty participants must be citizens or non-citizen nationals of the United States or individuals who have been lawfully admitted for permanent residence in the United States i.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions will not be reviewed. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:.

Belem G. L pez, PhD Center to Reduce Cancer Health Disparities CRCHD National Cancer Institute NCI Telephone: Email: belem. lopez nih. Note: Effective for due dates on or after January 25, a Data Management and Sharing Plan is not applicable for this FOA.

Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

An Advisory Committee is a required component of an YES Research Education program. Provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program.

The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program.

Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted.

Renewal applications with Advisory Committees should include the names of all committee members during the past project period. The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

List Program Faculty whose role is to develop, implement, direct, monitor, mentor, evaluate, consult, etc. The Research Strategy section must be used to upload the Research Education Program Plan , which must include the following components described below:.

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.

When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

Clearly state the goals and objectives of the proposed program and how they advance the mission of the NCI. Provide the underlying rationale and evidence supporting the need for the program.

Clearly articulate the integration of the Research Experiences, Curriculum or Methods Development, and Outreach activities. Applications must include detailed plans of student recruitment and mentor matching.

Applications in support of rising tenth grade students and above must include plans for assigning an individual, academic-level appropriate, mentored research project for each participant.

In addition, applications may include, but are not limited to, plans for orientation, education that enhances participants' research skills, and peer interactions and networking opportunities. Applications in support of Grades students must include plans to meaningfully engage the teachers, families and communities.

All applications are encouraged to include plans for tracking of participating students for up to at least fifteen years after completion of the program, as well as plans for evaluation of the impact of the program, including the benchmarks to be used to assess program success.

Applications are encouraged to include plans for collaboration within the YES community. Consider potential problems that may be encountered and describe alternative strategies that could be employed.

Describe arrangements for administration of the program. Provide evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished.

Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty.

Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Describe the experience of the participating faculty in teaching and mentoring, as well as their ability to serve as good role models for the participants by virtue of their own scientific accomplishments.

Program Participants. Identify the career levels for which the proposed program is planned. Provide details about the pool of expected participants in the research experiences program and the sources of the applicant pool.

Provide the criteria and strategy as to how the participants will be selected. The selection of participants should be in line with the objectives of this announcement. Institutional Environment and Commitment. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

This section should not duplicate information provided elsewhere. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support see below. Where appropriate, describe any unique features of the scientific environment, subject populations, or collaborative arrangements that may be leveraged to the advantage of the proposed program.

If multiple sites are participating, describe how this will enhance the quality of the program, as well as how activities will be coordinated and effective communication maintained among the multiple sites.

Recruitment Plan to Enhance Diversity NOT-OD :. Both Observational and Expanded Access Studies may be registered in ClinicalTrials.

Please note that while expanded access studies are not Applicable Clinical Trials, if expanded access is offered for a drug or biologic, it must be noted in the record. Additionally, if an investigator both sponsors and manufactures an expanded access drug, they must create and maintain a record for that drug on ClinicalTrials.

The Protocol Registration and Results System PRS is the database where information published on ClinicalTrials. gov is entered. To access the PRS, investigators should go to register. The PRS consists of two sections: the Protocol Section and the Results Section. The Protocol section is where registration information is entered and the results are entered in the results section along with information about participants and adverse events.

Each section is broken down into modules where specific information is entered. The system, like HawkIRB, if very complex, but becomes easier to use after becoming acclimated with the modules.

These links work in much the same way as the HawkIRB help icons in that they describe exactly what the section is looking for. Additional information and training can be found on the ClinicalTrials.

University of Iowa researchers should contact their PRS Administrator at ct-gov uiowa. edu with additional questions. Please note the following University Policies when using the PRS:.

Board Status: Approved Approval Number: Board Name: University of Iowa IRB Board Affiliation: University of Iowa. Phone: Email: irb uiowa. Hardin Library, Office Iowa City, IA The University of Iowa IRB considers the ClinicalTrials.

gov requirements in its approval. To help assure that investigators are in compliance with federal regulations, the IRB will notify investigators when these regulations apply.

The University and PRS Administrator recommend that investigators submit the HawkIRB application first to avoid needing to make additional changes to the PRS record. In addition, the IRB reviewers and PRS administrator will assist in assuring the record is updated appropriately.

The NCT number in the IRB application must be entered in VII. b of the IRB application prior to IRB approval to show that the ClinicalTrials. gov record has been created. Likewise, the ClinicalTrials. Section VII. B of the HawkIRB application is where you will identify your clinical trial and find the link to the ClinicalTrials.

gov database to register your study. Changes to the HawkIRB system are currently underway to facilitate communication with the PRS system. Once the changes occur, much of the information will auto-populate into the PRS, making the maintenance and registration in the PRS easier for investigators.

For studies where the VA is the primary study location or coordinating center of a study listed in VII. Currently, the VA is requiring investigators who need to register at ClinicalTrials.

gov under their institution to create and maintain their own institutional account in the Protocol Registration and Results System PRS for any records where the VA is the lead site.

Accounts can be created by emailing a request to register clinicaltrials. Any study with both an IRB 01 and an IRB 03 application for the same study should look to VII.

Questions can be directed to Suzanne. kieffer va. PRS administrators monitor records for the institution, provide help and feedback on using the system, create and monitor accounts for the PRS, and inform investigators of issues needing resolution in the PRS system.

Additionally, the PRS administrator reviews study applications involving clinical trials for the IRB and communicates relevant information to them.

Individuals with questions or applying for an account with ClinicalTrials. gov through UI should contact:. gov Checklist is an easy to use tool that allows investigators to prepare for registration and results reporting. The document easily lays out expectations and considerations, as well as provides links to useful materials such as planning templates.

This guide will assist you in complying with the ICMJE Data Sharing policy. The International Committee of Medical Journal Editors ICMJE requires:. Understanding which information, if any, to redact is important when uploading required documents into ClinicalTrials.

This guide indicates when it is appropriate to redact, and when it should be avoided. Redacting a document requires more than just crossing out words or placing a black box over the content to be removed.

Documents must remove the text entirely so that it is no longer searchable, and this extends to metadata which may be stored in a document, hidden from sight. There are only a few programs that have been sufficiently vetted to redact information, but the University of Iowa recommends the use of Adobe Acrobat Pro.

This presentation is presented at the ICTS Academy for Research Professionals annually. It may be accessed at anytime as a resource for new PRS users, or as an education tool for existing users. gov Office Hours are held every Wednesday from am — pm in Hardin Library for the Health Sciences HLHS room The University of Iowa PRS Administrator is available to provide help and feedback to any ClinicalTrials.

gov issues, such as:. The IRB also offers office hours for IRB-specific issues. For more information on IRB Office Hours go here. Click logo for HawkIRB application:. Click for human subjects research training info:. Thank a Staff Member.

Voice: Fax: irb uiowa. Skip to main content. The University of Iowa Search. You are here Home. About ClinicalTrials. gov ClinicalTrials. A summary of the recent updates is below: Section 4. Final Rule Update The U. Help and Resources For investigators who are new to the registration process at ClinicalTrials.

Need Help? gov Departmental Liaison 1. Many accounts of failed clinical trials have been reported — some of which resulted in costly delays and unsatisfactory trial conclusions. More importantly, those failures provided valuable lessons to those in the industry. We curated a set of best practices on how to set up your clinical trial site for success in the new year.

We assembled a bold, high-impact process to help you navigate the clinical trial process with minimal hiccups. Each step addresses areas prone to problems and benefits from early mitigation planning. By focusing upon the 3-step plan listed below, you are giving your clinical trial site the best opportunity to achieve activation status without delays.

Starting the clinical trial with a solid foothold on the process helps steer the trial process through to successful completion.

Our 3-step plan details the rigors of setting up infrastructure, team development, and patient-centric modalities.

We paired these pain points with valuable take-away prompts to assist clinical monitoring teams get a head-start. Each clinical trial presents unique challenges and needs that may make it difficult to stay on target. The principal investigator must work diligently to establish a plan to meet or exceed clinical participation and recruitment goals.

This is in addition to securing funding, potential site selection, and much more. Experts suggest that investing in digital solutions and patient-centric infrastructure is an avenue that may help boost clinical trial participation rates. For example, an NIH discussion paper highlighted the barriers affecting participation.

DCTs offer a maximum amount of flexibility for the patient. The COVID pandemic illustrated to the research community that virtual trial settings can be viable with the right provisions in place and adequate planning.

Exploring the possibility of introducing digital connective devices may assist in the clinical trial monitoring process of data collection. So, here is the thing — EHR is not always a perfect antidote to simplifying data collection processes. However, we are rapidly approaching that point in the digital learning curve where next-gen technological solutions are inevitably going to be mainstream.

Early-adaptation may be worth exploring. This is the one area where technology cannot replace human connectivity. In situations where patients are potentially compromised, the capacity to learn and make quality decisions is dramatically lessened.

Missing Our approach broadens the landscape of academic platforms for decentralized trials with unique “trial in a box” features. Recent institutional In alignment with these goals, institutions may develop unique programs that capitalize on their research strengths and are responsive to their target

Unique trial program - Trial Registration: Each clinical trial must have a unique trial number and be registered on a publicly accessible database. Trial registration helps Missing Our approach broadens the landscape of academic platforms for decentralized trials with unique “trial in a box” features. Recent institutional In alignment with these goals, institutions may develop unique programs that capitalize on their research strengths and are responsive to their target

Additionally, funding to the institution can be reduced or stopped and non-compliance could impact future funding for the institution. Besides civil penalties, criminal penalties are also possible for investigators found in non-compliance of this rule.

A checklist-based tool to assist responsible parties in evaluating whether a study is an Applicable Clinical Trial based on 42 CFR For investigators who are new to the registration process at ClinicalTrials. gov Checklist can be used to help any investigator get started and keep track of ongoing expectations related to the ClinicalTrials.

gov Protocol Registration and Results System PRS. Slides from an ICTS presentation are available for registering a record and expectations for record maintenance.

The PRS administrator, who oversees all records for the University of Iowa, provides ongoing education sessions throughout the year. Both the PRS administrator and the IRB also assist investigators by providing communications regularly regarding the application of federal regulations, providing notification when a record update is required, and by informing the Responsible Party when their record is in non-compliance with federal regulations.

Additionally, several departments have departmental liaisons who serve on a ClinicalTrials. gov working group. These liaisons are fully trained in registering a record and submitting results and can assist their departments in completing their ClinicalTrials.

gov PRS records. More information on the ClinicalTrials. gov working group can be found here. Fill out the form here to request help from a ClinicalTrials. gov Departmental Liaison. Who is required to register?

When must I register on ClinicalTrials. What should I do after registration? Getting Started - ClinicalTrials. gov Checklist. Applicable Clinical Trials ACT. Applicable Deadlines. NIH and ICMJE Reporting Requirements. Results Submission and Required Documents. Observational and Expanded Access Studies.

Protocol Registration and Results System PRS. IRB Oversight. Veteran's Affairs VA Studies. PRS Administrator. gov Office Hours. Helpful Links. gov Working Group Departmental Liaisons Page.

Registration is required for all Applicable Clinical Trials ACT based on the federal regulations 42 CFR However, other agencies have adopted their own policies in regards to ClinicalTrials. gov requirements. Studies utilizing NIH funding or wishing to publish in an International Committee of Medical Journal Editors ICMJE may also be required to register on ClinicalTrials.

gov, even if the study does not meet the criteria of an ACT. Criteria for determining if a study meets registration requirements can be found on the website of each organization.

Additionally, the University of Iowa IRB assists investigators in making determinations regarding registration requirements during their review. To register a study, investigators must use the Protocol Registration and Results System PRS at www. To get started, investigators should contact a PRS administrator by emailing ct-gov uiowa.

edu to have an account created for them. Once registered in the system, users will be able to add new projects in the PRS at any time. The University of Iowa stores and maintains their own records for ClinicalTrials. gov, but the review and publication of these records to ClinicalTrials.

gov happens outside the institution by the PRS team. Clinical trials registration and results reporting is required by law for all Applicable Clinical Trials, for clinical trials funded by NIH, and for investigators wishing to publish trial information in an ICMJE journal.

At the University of Iowa UI , the Responsible Party of a clinical trial is the person who sponsors, or initiates, the trial. For trials sponsored by an industry sponsor, the industry sponsor is required to register and maintain the study record and must provide the NCT number to the UI Principal Investigator PI.

If the sponsor is not a University of Iowa faculty or staff member, but is an investigator at another institution, the responsibility of reporting to ClinicalTrials.

If one of the following examples applies to you or your study, you are considered a sponsor-investigator:. For studies that have the UI as the IRB of record, the HawkIRB application captures trial information and NCT in Section VII.

Entering a NCT is required for Phase studies and is currently optional for Phase 1 studies and early device feasibility studies unless NIH funding is used.

Find more information at ClinicalTrials. gov under " Who is Responsible for Registering Trials and Submitting Results? Applicable Clinical Trials ACTs and NIH funded trials are requi r ed to register on ClinicalTrials.

gov within 21 days of enrollment of the first subject. Throughout the life of the record, updates must be made anytime the study plan changes, typically within 30 days. Updates are required at least every 12 months, even if nothing has changed.

Additional information can be found on ClinicalTrials. Trials planning to publish in in ICMJE journals must register a study on ClinicalTrials. gov prior to enrolling the first subject. Below is a table indicating when registration requirements apply:.

Registering in the PRS on ClinicalTrials. gov is only the first step. FDAAA and 42 CFR 11 require reporting of results, adverse events expected and unexpected , as well as modifications or updates to the study.

The record must be updated anytime the study procedures change, or when enrollment ends or is suspended. Additionally, at the time results are ready to be posted, the study protocol and Statistical Analysis Plan SAP must also be included with the record.

The University of Iowa IRB will facilitate the process of informing sponsor-investigators when updates are required by during their review of the IRB application. Even if nothing has changed in the study, the record requires yearly review and approval, even if nothing has changed.

The IRB will direct the investigator on any needed changes, and may require changes to the protocol in their own review. A tool is available for University of Iowa investigators planning to register or report results on ClinicalTrials.

The tool, ClinicalTrials. gov Checklist helps investigators determine when a specific regulation may apply to their study, what materials are needed to register and report results, and provides links to a number of useful planning materials.

gov checklist has been updated. Here is a summary of the new version's content. To determine if your study is an ACT requiring registration, use the checklist below.

pdf , but these exceptions will be evaluated by the University of Iowa PRS administrators and IRB, who will inform the investigator when they apply. In addition to this checklist, many funding applications and FDA documents require specific language when a trial meets the definition of an ACT.

More information on funding requirements can be found here , and these organizations may help in making the determination of an Applicable Clinical Trial. For a full document, please use the link at the bottom of this page.

At the time the primary completion date is changed to "actual," the actual number of participants enrolled must be submitted.

Any time the Responsible Party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time. NIH requires all clinical trials, regardless of study phase, to register on ClinicalTrials.

This definition differs from the federal regulations in that it is not required that a drug or device be involved. For example, a study of a behavioral intervention would meet the NIH definition of a clinical trial, but would not be an ACT under FDAAA because it does not involve a drug or device.

More information on NIH policies related to clinical trials can be found here. Studies wishing to publish in International Committee of Medical Journal Editors ICMJE journals may be required to register their clinical trial.

Includes phase 1 clinical trials and trials that do not involve any FDA regulated product such as trials involving only behavioral interventions. Elements defined in the final rule. Consists of descriptive information, recruitment information, location and contact information, and administrative data.

Not later than 12 months after primary completion date; possible delay of up to an additional 2 years for trials of unapproved products or of products for which initial FDA marketing approval or clearance is being sought, or approval or clearance of a new use is being sought.

Includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, and statistical analysis plan, and administrative information.

NIH and ICMJE affiliates as well as many other journals have even more stringent criteria for submitting to ClinicalTrials. It is recommended that each PI be aware of each of these rules, or to practice following the most stringent of these to assure compliance.

All Applicable Clinical Trials are required to report results within 1 year of the date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated.

Additionally, all clinical trials utilizing NIH funds must report results information. In general, the law and federal funding entities require responsible parties to report summary results information for interventional studies of drugs, biological products, and devices within 1 year of the primary completion date of the study, regardless of the funding source, presence of statistically significant findings, or journal publication status.

At the time the sponsor-investigator is ready to submit results, the Protocol and Statistical Analysis Plan SAP are required to be uploaded to the PRS record. If the SAP is included with the Protocol, then an additional document is not needed. More information on this requirement can be found here.

Both Observational and Expanded Access Studies may be registered in ClinicalTrials. Please note that while expanded access studies are not Applicable Clinical Trials, if expanded access is offered for a drug or biologic, it must be noted in the record.

Additionally, if an investigator both sponsors and manufactures an expanded access drug, they must create and maintain a record for that drug on ClinicalTrials. The Protocol Registration and Results System PRS is the database where information published on ClinicalTrials.

gov is entered. To access the PRS, investigators should go to register. The PRS consists of two sections: the Protocol Section and the Results Section.

The Protocol section is where registration information is entered and the results are entered in the results section along with information about participants and adverse events. Each section is broken down into modules where specific information is entered. The system, like HawkIRB, if very complex, but becomes easier to use after becoming acclimated with the modules.

These links work in much the same way as the HawkIRB help icons in that they describe exactly what the section is looking for. Most importantly, the FDA approach acknowledges that pay-to-participate trials should be unusual and require compelling justification.

No other U. regulations governing human subjects research directly address the issue of pay-to-participate trials. However, some of the IRB criteria for approval at 45 CFR SACHRP acknowledges that there will be proposed research that is unregulated because it is not federally funded and does not involve an FDA-regulated drug, device or biologic.

The committee believes that, because of the particular issues raised by trials that require participants to pay, such trials should be voluntarily submitted to an IRB even when there is no regulatory requirement.

First, 45 CFR Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research.

There are several reasons why a pay-to-participate trial may not have an acceptable level of scientific validity. First, if a study has not been vetted through traditional funding and peer review mechanisms, such as prior review by a study section or industry sponsor, it may be lacking in scientific merit, and exposing subjects to risks and burdens in the context of bad science is ethically unacceptable.

Scientific rigor may also be affected by the fact that pay-to-participate trials may entail an incentive to use less rigorous study design and avoid research methods such as randomization and blinding so that the paying subjects can be ensured access to the desired investigational product.

Moreover, there may be a conflict in favor of including paying subjects who can help meet funding goals even though they should be excluded for reasons of scientific validity or safety. Finally, some subjects who are so motivated to enroll that they are willing to pay may have reason to deceive the researcher about eligibility, study adverse events, and other such issues to avoid jeopardizing their enrollment and continued participation, especially when their motivation is the expectation of direct medical benefit.

Failure to provide accurate information to researchers could create risks both to those subjects and to other participants. Conversely, some subjects who are required to pay to participate might be more invested and engaged in the research and thus might comply more closely with the trial requirements.

These empirical considerations should be evaluated with evidence. Regulations at 45 CFR 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.

One purpose of this regulatory provision aims at avoiding the inclusion of subject populations solely on the basis of convenience and control, which could result in unfairly concentrating research risks and burdens in certain vulnerable populations.

Rather than targeting individuals who are economically disadvantaged, however, which may be of concern in some research, pay-to-participate trials are likely to selectively include individuals who are economically able to pay or raise the required funds.

These individuals may be vulnerable in other ways. For example, they may be desperate if they have exhausted all available treatments for a serious condition, and thus may be vulnerable to exploitation.

To the limited extent that pay-to-participate research offers the prospect of direct benefit to participants, the possibility of benefit as a participant should not be concentrated only in certain advantaged groups.

This concern about pay-to-participate trials is different from the concern about fair distribution of benefits after an experimental intervention has been shown to be a successful treatment, but it should still be considered, since those who cannot afford to pay will be excluded from potential benefits in both instances.

The economically disadvantaged may also go to great lengths to gather the resources needed to participate, for example through crowdfunding and perhaps undertaking debt, if the potential for benefits appears sufficiently great.

Whether it is appropriate to concentrate the potential benefits of pay-to-participate trials only in the economically advantaged raises an additional concern relating to scientific validity: Are those who are economically advantaged enough to pay the costs of participation sufficiently representative and diverse so that study results will not be inappropriately biased by the exclusion of those unable to pay?

That is, will the research data be broadly applicable to a diverse cohort of future recipients? If that is acceptable, then special consideration should be given to subject vulnerability and inclusion.

Importantly, efforts to make recruitment fairer should also help promote generalizability and scientific validity. Finally, pay-to-participate trials may also reduce trust in science by fostering the perception that research participation is a valuable commodity made unfairly available to those individuals with more resources.

Furthermore, these trials might divert resources both financial and human capital from better research proposals or better treatments for subjects. Because the primary goal of research is to create generalizable knowledge that may benefit patients in the future, subjects in pay-to-participate trials are asked to contribute to societal benefit both by their data and by their financial payment.

Subjects have many and often mixed reasons to enroll in research studies, including altruism and a desire for anticipated direct clinical benefit. The requirement to pay in order to participate in research will probably be a disincentive to many potential subjects, either because they are aware that research is usually cost-free to subjects and may even involve payment to them, or because they do not have sufficient funds.

However, pay-to-participate trials pose a heightened risk of fostering the therapeutic misconception, either intentionally or not, as compared with traditionally funded studies. When subjects are asked to pay to participate, they may view the amount charged as a signal that participation itself is valuable — and because price often connotes value, higher prices may signal higher value.

Moreover, because asking subjects to pay to participate is unusual among clinical trials, subjects may be more likely to view participation as something desirable and payment as an exchange for some benefit. In particular, pay-to-participate trials may exploit vulnerable patients, those for whom clinical care options may have been exhausted and who are understandably desperate to find something that works.

Asking them to pay may not only confuse research with clinical care and encourage therapeutic misconception; it may also encourage financial risk-taking in hopes of a highly unlikely medical outcome. In pay-to-participate trials, as in all research, outcomes are uncertain and benefit is far from guaranteed.

It is important for subjects to understand that they are not paying for access to a proven intervention, that they may experience no direct benefit, and that they may even be harmed by research participation. They must be given explicit information about scientific uncertainty, the nature, magnitude, and likelihood of direct benefit, the benefit-related implications of the particular study design e.

and available alternatives. Nonetheless, pay-to-participate trials may be the only way to conduct research on worthwhile projects that are not able to secure funding through traditional mechanisms.

Individuals have the right to spend their money on many activities and products that might not be regarded as benefitting them directly, such as charitable and political contributions or gifts to others. Thus, subjects willing to pay to participate may decide to be altruistic; they may also choose to take a chance on an improbable outcome, as long as they are not misinformed and are given sufficient information in the consent form and process.

The ethical acceptability of pay-to-participate trials is highly fact-specific. Therefore, SACHRP does not recommend a default presumption against pay-to-participate trials, even though in general, research subjects should not be expected to pay to contribute to socially valuable research.

Instead we recommend a careful review of each trial, based on consideration of the questions discussed below and satisfaction of all regulatory criteria for approval.

The IRB should be prepared to confirm the scientific validity and value of the proposed study and its design, either directly when they have the expertise to do so, or through reliance on expert consultants or other institutional committees.

An IRB that lacks access to sufficient expertise to conduct the necessary review of scientific quality may of course decline to review any study, including a pay-to-participate trial.

Just as payment to subjects is not to be considered as a benefit that could balance research risks, payment to participate should not be considered as a harm in the risk-benefit assessment.

If the balance is unacceptable on that account, the study should not be approved. If, however, the balance appears to be acceptable independent of any payment to participate, the IRB should next consider whether payment raises other concerns that need to be addressed to satisfy ethical and regulatory criteria for approval.

Could the study potentially be funded by means other than charging subjects? The IRB should require investigators to specifically explain and justify the rationale for charging subjects, including whether traditional funding was sought and why other funding sources are not available or appropriate.

Although it should not be necessary for investigators to demonstrate that all other funding options have been exhausted, they should demonstrate an adequate and reasonable justification for charging subjects.

Investigators should be expected to provide a detailed breakdown of the amount charged and a description of what exactly subjects will pay for. They should also explain whether the payment is expected as a lump sum or in installments, as well as the conditions under which a subject would receive a partial or complete refund, if any e.

This information should be included in the consent form. The IRB should review sufficient information to promote confidence that the payment required is minimized and reflects the actual costs of making possible the development of a potentially valuable intervention or the gathering of important information.

The FDA regulations detailed above may provide IRBs with useful guidance in this regard. If the justification for charging subjects is not compelling, then IRBs should not approve the trial.

Where the justification for charging is deemed acceptable, the IRB should then consider whether and how study results may be affected by an expectation of payment by subjects.

Investigators should be expected to make efforts to mitigate concerns regarding generalizability and inequitable subject selection, potentially considering efforts to include some subjects who are unable to pay their own way e.

If so, how can that concern be mitigated? When subjects are charged for participation, they may be more likely to expect direct benefit, or to regard trial participation as a means of gaining early access to a promising new treatment.

This raises concerns about their adequate consideration of and reflection about important study features, such as risks, burdens, discomforts, and uncertainty. IRBs and investigators and sponsors should therefore pay special attention to whether the informed consent process will provide clear and complete information about the study and support adequate consideration and comprehension of that information.

Similar consideration should be given to any recruitment materials. Although individuals are free to make decisions outside the research setting that reflect misunderstanding or insufficient consideration of key information for example, when accepting a job offer or making a purchase , IRBs and investigators fail to fulfill their responsibilities for subject protection if they do not strive to assist potential subjects in reasoned decision-making.

IRBs need not monitor the enrollment process of each individual subject, but rather should encourage investigators to adopt approaches that will support high-quality decision-making.

These may include:. Questions Potential Subjects Should Consider Asking about Pay-to-Participate Trials. The informed consent form and process offer an important source of information for prospective research subjects. Potential subjects may also find it helpful to seek information about particular studies, perhaps especially when they are considering enrollment in a pay-to-participate trial.

html ]. However, individuals considering enrollment in pay-to-participate trials may also seek more specific information.

The following questions are intended to help potential subjects in pay-to-participate trials ask questions focusing on key attributes of such trials. Many of the questions apply to all research, but should be addressed so that questions specific to payment-to-participate can be understood in the context of the whole trial.

This list is not exhaustive and is offered only as a starting point for IRBs, investigators, and sponsors to develop best practices for communicating effectively with potential subjects in the consent form and process for pay-to-participate trials.

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