Trialswest

Help us to help you

Participating in a clinical trial knowing that you or someone in the future is going to benefit is a huge gift. Make that choice to make a difference today.

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Established in 2012, TrialsWest is one of Australia’s most experienced and successful clinical research centres.

Located in Perth, Western Australia, we partner with the world’s leading pharmaceutical and biotechnology companies to help bring new medicines and vaccines to the world .

CURRENT TRIALS

Contact us to register your interest in participating in a clinical trial.

WHAT PARTICIPANTS SAY ABOUT TRIALSWEST

I participated in an asthma trial in 2021. I cannot speak highly enough of the team at TrialsWest. Naturally, I had concerns for my well-being going into the trial. This apprehension was quickly dispelled as I could see the welfare of participants was the first priority at TrialsWest. This was very reassuring. From pre-trial examination and throughout the trial, every encounter with my TrialsWest Doctor, Nurse and Support Team was meticulous. I never felt alone, and all feedback from me was warmly welcomed. I was consistently monitored and received ongoing communication throughout the trial. Given the opportunity, I would willingly participate in further studies with TrialsWest.

CA - 58 years old Asthma

I have had the good fortune of being chosen as a participant in a trial conducted by TrialsWest, since December 2020. This has involved me undertaking a fairly lengthy trial for 12 months. My experience since the trial started has been one of superb involvement and assistance from the staff at TrialsWest. Instruction, knowledge and assistance is available as required and you are made to feel a part of a very professional and caring organisation. All staff, including Doctors, Nurses and Office Staff, show great knowledge, care and a professional approach to all tasks. I would have no hesitation in recommending TrialsWest.

JR - 71 years old Asthma

My experience at TrialsWest was very professional, caring and friendly. The staff - from the front reception staff; my treating Nurse, Tracey; resident Doctor Val; plus the management team, Michelle and Helen - made me feel more like a friend than just a client. I looked forward to my visits with them andwas sad when it came to an end.

SV - 69 years old COPD

I am about halfway through my trial and have been extremely impressed with how helpful and professional all the staff have been. They all make being there a pleasure and have helped me personally understand and enjoy my time spent with them.

SJ, 68 years old COPD

I have always enjoyed complete confidence in the expertise and professionalism of everybody at WRTS, and later at TrialsWest. I have had the highest regard for the competence and diligence of Peter, Helen, Michelle, Tracey, and Melinda, and it has been a matter of great satisfaction to me to know that the trials I have participated in may have helped others, as well as me, to gain access to more effective medications.

JF, 79 years old COPD

TRIALSWEST IS PROUD TO WORK WITH THESE SPONSORS

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WHAT SPONSORS SAY ABOUT TRIALSWEST

It was a privilege to have worked with TrialsWest on the chronic cough study and see first-hand their strong focus on patient care and delivering on study commitments. This was an operationally demanding study and they were able to successfully contribute, both in exceeding their allocation and excellent data quality. Further, their team has always been reliable in regards to meeting DBL, even with extremely tight timelines! We highly value TrialsWest’s strong collaboration with us in bringing clinical trials to Australia and we look forward to our continued partnership in future studies.

The team at TrialsWest can simply be described as professional and from my experience is the ideal clinical trials site to be working with. I approached TrialsWest as a new potential site in a therapeutic area that our company was then naïve to and from our first interaction, it had been nothing but co-operative efforts. From site selection through to budget negotiation and study initiation, the processes adopted by TrialsWest were both practical and efficient, fulfilling all GCP requirements. The team were not only experienced in conducting clinical trials, but were constantly adapting to the ever-changing environment. Our study was scheduled to start in the midst of the COVID crisis but had experienced many hurdles. The flexibility shown by the team to the rapidly changing demands of the study contributed to the site’s targeted recruitment to be achieved within 1 month (from a 12-month recruitment). TrialsWest paves the road for what an ideal institution specializing in clinical trials should be like.

Pioneering Medical Breakthroughs

Enroll now in our clinical trials. We are committed to your safety and comfort.

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Participate in a Study

At Linear, we conduct studies not only with healthy participants but also with those who have existing health conditions or fall into special population categories. Let us direct you toward the most fitting studies by selecting from the options below:

How Linear paid clinical trials work

Choose a trial or express your interest in a patient trial.

Select from trials, tailored to your availability and health conditions

Pre-Screening Questionnaire and Phone Call

Find out if you’re eligible

Attend Screening Visit

Attend our world-class facility for screening. Our medical doctors will confirm your eligibility to participate

Participate

Check-In & Check-Out in our world class facility where you will be cared for by our knowledgeable team of medical doctors, nurses, and staff

Follow-up Visit

After your follow-up visit, you are remunerated for participating

Generally, payments are made two weeks after the final follow-up appointment, or as you progress through milestone appointments.

Understanding Clinical Trials

Clinical trials play a vital role in revolutionizing medical practices, and at Linear Clinical Research in Perth, Australia, we value the crucial contribution of our volunteers. Becoming part of a clinical trial journey is simple and impactful. By answering a brief online questionnaire, you initiate a process that could lead to groundbreaking medical breakthroughs. Let’s explore how clinical trials work and how you can be a part of this transformative process.

What Are Clinical Trials and How Do They Work?

Clinical trials are essential steps in the journey of developing and introducing new treatments, medicines, and therapies to the world. They ensure that these innovations are both safe and effective, instilling confidence in medical professionals and patients alike. Some trials assess the potential of already-approved drugs in treating various conditions, while most focus on novel drugs and approaches that introduce fresh ways of addressing diseases and illnesses, offering new hope and choices to patients.

At Linear Clinical Research, we specialize in both expediting Phase One studies involving healthy volunteers and administering therapies directly to patients in areas like oncology and hematology. Our dedication extends beyond patients; we provide comprehensive guidance to our clients on study design and protocols to optimize their research outcomes and accelerate the journey to bringing new therapies to market.

Studies for Specific Health Conditions

At Linear Clinical Research, we are committed to advancing medical knowledge and improving healthcare outcomes. As part of our ongoing efforts, we are excited to announce that we have plans to conduct clinical trials targeting a wide range of health conditions, including:

  • Celiac Disease
  • Crohn’s Disease
  • Cystic Fibrosis
  • Hypertension
  • IBS (Irritable Bowel Syndrome)
  • Liver Disease
  • Multiple Sclerosis
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Ulcerative Colitis

We understand that individuals with these health conditions face unique challenges, and we are dedicated to developing and testing innovative treatments to address them. Your participation could be instrumental in bringing about new hope and solutions.

How to Become a Clinical Trial Participant

Participating in our clinical trials is a straightforward process that can lead to substantial contributions to medical research and earn you financial compensation. Here’s what you need to know:

  • Preliminary Questions: Begin by answering a brief set of preliminary questions online. This step helps us determine your eligibility for participation.
  • Screening Visit: If you meet the initial criteria, a member of our team will reach out to you to schedule a screening visit. This visit helps us ensure that you are a suitable candidate for the trial.
  • Participation and Compensation: Once deemed eligible, you’ll be invited to join the clinical trial. As a participant in our trials, you’ll be compensated for your time and contribution. Remuneration is provided after your follow-up visit.

Benefits of Participating

Participating in clinical trials not only offers you an opportunity to contribute to medical advancements but also comes with several benefits:

  • Financial Compensation: All participants in our clinical trials receive compensation, recognising the value of your time and commitment.
  • Comfortable Environment: During your participation, you can relax and enjoy complimentary amenities, including free food and Wi-Fi if you choose to stay in our clinic.
  • Contributing to Research: Your involvement directly impacts medical research and the development of new therapies, including the fight against diseases like COVID-19.

Pioneering Medical Progress

Operating from state-of-the-art facilities at QEII Medical Centre and Joondalup Health Campus in Western Australia, Linear Clinical Research is at the forefront of patient-centric clinical trial initiatives. We’re committed to not only providing innovative therapies to our local community but also ensuring the rapid dissemination of these therapies to patients in need.

As a participant in a clinical trial at Linear, you become an integral part of transforming healthcare practices. By bridging the gap between medical research and patient care, you contribute to a brighter and healthier future for individuals worldwide.

Are Linear’s Trials Safe?

  • Every trial at Linear requires approval by an independent ethics committee – registered with the Australian Government’s  National Health and Medical Research Council (NHMRC)

Every trial at Linear requires approval by an independent ethics committee – registered with the Australian Government’s  National Health and Medical Research Council (NHMRC)

  • Linear follows regulations and guidelines in accordance with international certification under Good Clinical Practice (GCP) and in accordance with TGA (Australia), FDA (USA), EMA (EU) and Medicines Australia guidelines
  • Every volunteer has to provide consent, go through medical questions specific to the trial, is assessed by a qualified doctor and go through extensive medical examinations to make sure it is safe for them to participate
  • New drugs and therapies have to go through extensive years of testing before they are tested in clinical trials on humans.

Start your journey with Linear

Clinical trials are the backbone of medical innovation, and your participation with Linear Clinical Research can make a significant impact. Join our community of volunteers who are driving medical advancements, earning compensation, and contributing their data to cutting-edge therapies. Be a part of our efforts to bring hope, choices, and progress to patients and healthcare as a whole.

Participant Reviews

Don't listen to us - hear from the people who allow us to do what we do. Our Linear participants!

Linear Clinical Research

Why participate with Linear

Healthy participants are paid for their time, but that’s rarely the sole reason for someone becoming a participant. It’s also about doing something for the greater good! Support medical research that can potentially help change and even save lives.

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Final days: Don’t miss your free chance to win $10K!

Linear clinical research: big pharma stampede to perth prompts new joondalup clinical trial facility.

Linear Clinical Research chief executive Jayden Rogers at the new Joondalup clinic. Kelsey Reid

WA’s only early phase clinical trials company is expanding massively amid huge demand for its life-saving work, opening a second state-of-the-art facility in Perth’s north.

Not long ago, bio-pharmaceutical companies had no reason to be interested in the State and cancer patients wanting to take part in drug trials had to fly elsewhere.

But that all changed in 2010 when the Harry Perkins Institute of Medical Research spun off a bold and ambitious start-up, Linear Clinical Research, using funds from the State Government and philanthropists.

“At that point in time, it was hard to translate medical research into new drugs and patients in WA couldn’t access these new breakthroughs that you could over in Melbourne and Sydney, and in the US,” chief executive Jayden Rogers told The West Australian.

“Harry Perkins actually passed away because he had a certain type of lung cancer and that trial wasn’t available here. He decided to stay here with his family rather than travel over east.

“Fast forward to now, we employ a team of 220 up to 250 people ... and we are one of the preferred partners for global bio-pharmaceutical companies.

“They are coming to Australia in droves at the moment.”

Linear Clinical Research chief executive Jayden Rogers at the new Joondalup clinic with lab manager John Bonar.

The attraction is a quicker and more efficient regulatory environment than the US, cost advantages with currency exchange rates, and research and development rebates, Mr Rogers said.

He said demand for Linear’s services far exceeded its capacity, prompting the QEII Medical Centre-based organisation to open a new 24-bed facility at Joondalup.

It’s one of the most sophisticated of its type in the Asia Pacific region and only the sixth ever built in Australia.

Linear was the sole phase one trial site for the Clover Biopharmaceuticals COVID-19 vaccine, which is targeting World Health Organisation approval and distribution this year of 400 million doses by GAVI, an organisation that improves access to vaccines for children living in impoverished countries.

Mr Rogers said the vaccine was particularly stable in more challenging storage conditions in Africa and parts of Asia, unlike the Pfizer and Moderna jabs.

“People have said if it wasn’t for us, they wouldn’t be here - that’s really moving” -Chief executive Jayden Rogers

Linear has also run seven trials of COVID treatments that are at various stages of development and has been among the world’s most active sites in early phase cancer trials, putting a wide range of next-generation therapies through their paces.

“We’ve seen amazing results here with what you call a complete response, where people’s cancer is no longer detectable,” Mr Rogers said.

“We’ve had a front row seat in that.

“People have said if it wasn’t for us, they wouldn’t be here - that’s really moving.”

Medical Research Minister Stephen Dawson said the new facility would create many jobs, help diversify WA’s economy and advance the State’s standing as a global leader in health and medical research.

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Datapharm is passionate in supporting The Port Macquarie Koala Hospital and their efforts through adopting koalas. The Port Macquarie Koala Hospital has helped rescue and

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Pharmacokinetics analysis series: Compartmental analysis

Compartmental analysis (CA) is a type of pharmacokinetics (PK) analysis and is less common than non-compartmental analysis. It uses individual PK data to fit a statistical

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Pharmacokinetics analysis series: Non-compartmental analysis

Non-compartmental analysis (NCA) is a type of pharmacokinetics (PK) analysis and is the most commonly used approach for establishing initial exposure characteristics for a

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Our clinical trial Sponsors’ budgets are managed using Project Advantage® and Project Status Invoicing which present project phases by work category against estimated and actual time and cost. As part of our service to you our project managers will work with timelines for data analysis to meet prearranged presentations to client boards or funding agencies. Datapharm Australia CRO clinical trial management services include clinical trial design, preparation of all necessary clinical trial documents, clinical site monitoring, data management, statistical services and medical monitoring and pharmacovigilance.

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Meet our board of directors.

Linear board, peter leedman.

Director of the Harry Perkins Institute of Medical Research, Head of the Perkins Laboratory for Cancer Medicine and Professor of Medicine at the University of Western Australia, Peter is our inaugural chairman and has been involved with Linear since its inception. While driving our growth from three staff in 2010 to ~100 in 2017, he has pursued his long-term interest in RNA biology, in particular microRNAs, and how this information can be harnessed for therapeutics in poor prognostic tumors (head and neck, liver and colon cancer). Peter has also co-founded miReven, a spin out company established to commercialise microRNA replacement therapy for cancer.

Dr Michael Winlo

Currently CEO and Managing Director of Emyria, a listed biotech company leveraging Real World Data to accelerate drug development, Michael served as the CEO of Linear from April 2016 to October 2019. Under Michael’s leadership, Linear expanded its cancer trial team and was the first site in Australia to adopt electronic source data capture. This contributed to a period of rapid growth with clientele from the USA, Europe, Japan and China.

Prior to Linear, Michael was based in Silicon Valley as the health lead for Palantir Technologies - one of the largest privately held big data companies in the world. There, Michael led deployments for health companies and government organisations across the US and UK.

Michael has a Master of Business Administration from Stanford University and a Bachelor of Medicine, Bachelor of Surgery Degree from the University of Western Australia.

Mark has held senior executive and board positions, in start-ups and listed and unlisted entities in Australia and the USA, over a 30-year career. Most recently Mark was the worldwide CTO and VP for Corporate Strategy at Hewlett Packard Enterprise.

Prior to Hewlett Packard, Mark was the founder of several successful, venture backed start-ups, that have driven technology disruption and business innovation in varied industries. Mark is currently a non-executive director of Resolute Mining Limited (ASX:RSG appointed 2017), iCetana (appointed 2018) and was previously non-executive chairman of Decimal Software (ASX:DSX).

Fiona Harris

Currently a director of BWP Trust, Perron Group Ltd and Red 5 Ltd, Fiona has garnered a significant breadth and depth of experience in her 27-year non-executive director career. Fiona has experience in many sectors, including Energy and Resources, Utilities, Financial Services and Property. Previously Fiona was a partner with KPMG, working with the firm in Perth, San Francisco & Sydney.

Fiona’s leadership in the WA director community saw her elected as State President of the Australian Institute of Company Directors in 2005 - the first woman to hold this position. Her contribution to the economic progress of WA and to the highest standards of corporate governance was recognised in 2016 when she was awarded the AICD WA Gold Medal and in 2021 when she was made a Member of the Order of Australia (AM) for significant service to the finance, investment, resources and not-for-profit sectors.

John Atkins

Mr Atkins joined the Linear Board recently after returning to Perth from London in 2018 where he had been appointed Western Australia’s Agent General to the UK and Europe. With an extensive career in law and commerce spanning 40 years, John is well respected and highly regarded across the political and corporate divide, being awarded the honour of Officer of the Order of Australia in 2019 for his distinguished services to the business and financial sectors, the legal profession and the community.

John has significant experience as a non-executive director of public, listed and not-for-profit companies which included a five-year term as Chair of Lotterywest, ten years on the Chamber of Commerce and Industry WA Board and nine years as Deputy Chair of the Committee for Perth. He is currently Chair of Anglicare WA. In addition to a Bachelor of Laws (UWA) and Masters of Law (University of London), John is a Fellow of the Australian Institute of Company Directors.

Nina Webster

Nina has over thirty years of experience in the pharmaceutical industry, with leadership roles in investor relations, business development, and prosecution of intellectual property matters, as well as leading and managing the strategic, scientific and operational aspects of pharmaceutical product development. Nina is currently the CEO & Managing Director for Dimerix Limited (ASX:DXB), an Australian drug pharmaceutical company taking multiple products through clinical trials and commercialisation. Nina was formerly the Commercial Director for Acrux Limited (ASX:ACR), where she has successfully developed and commercialised multiple products globally. Prior to Acrux, Nina was Director of Commercialisation and Intellectual Property for Immuron Limited (ASX:IMC), and previously spent 6 years in new product development with Wyeth Pharmaceuticals in the UK. Nina holds a Ph.D in Pharmaceutics from Cardiff University, a Bachelor degree in Pharmacology, a Masters degree in Intellectual Property Law from Melbourne University and an MBA from RMIT.

Roger is currently a non-executive director of Eagle Mountain Mining Limited (ASX:EM2) and the Harry Perkins Institute of Medical Research. He has held a number of non-executive director roles over the past 25 years including in the health and medical research, aged care and education sectors.

Roger was a partner of PricewaterhouseCoopers for 19 years up to his retirement from the firm in 2016. He has extensive experience in financial analysis, company and business valuations, transaction due diligence and mergers and acquisitions across a range of industries and led the PwC Perth Deals team for seven years.

He is a graduate of Macquarie University and a Fellow of Chartered Accountants Australia and New Zealand, a Fellow of the Australian Institute of Company Directors and a former Senior Fellow of the Financial Services Institute of Australasia.

Key personnel

Andy redfern.

Andy is Consultant Medical Oncologist at Fiona Stanley Hospital, a translational cancer researcher with the University of Western Australia, and current clinical head of the Cancer Division at Harry Perkins Institute. He has active research projects in breast cancer, prostate cancer, melanoma and bowel cancer, with a focus on growth signalling and mechanisms of chemotherapy and hormone therapy resistance in cancer. In addition to conducting a variety of human trials of chemotherapies, hormone therapies and immune therapies, Andy also co-ordinates training for advanced medical oncology doctors in WA, and is the State Lead Clinical for breast cancer overseeing services.

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Clinical News

Congratulations to Dr. Lisa Corbett on her success in facilitating the application for the 2023 SOAP Center of Excellence  designation we were awarded!

Congratulations to Dr. Salameh Obeidat on a successful 2-day ICU quality improvement workshop with the Jordanian Ministry of Health ICU. Dr. Obeidat was the director of this course as well as an instructor, and he was joined by colleagues Dr. Michael Wollenberg , Critical Care fellow Dr. Rudi Zurbuchen , and Tanya Harrold as speakers and instructors. The intense 2-day course focused on "Comprehensive Quality and Safety Capacity Building in the Intensive Care Unit (ICU)" at the Ministry of Health through an in-depth exploration of quality and safety practices in the ICU, thereby aiding the Ministry of Health in Jordan to establish a robust quality control program curriculum for Critical Care fellows and staff.

Drs. Tera Cushman , Elizabeth Hays, and Andrea Nagengast published the review article Perioperative Care of the Patient with Directives Limiting Life-Sustaining Treatments in Anesthesiology Clinics . The review leverages the perspectives of pre-operative medicine, anesthesiology, and surgery to describe longitudinal best practices for each member of the perioperative care team from first pre-surgical visit to discharge and post-operative care.

Part 1. Overview Information

National Institutes of Health ( NIH )

R01 Research Project Grant

  • August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice  NOT-OD-22-198 .
  • August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice  NOT-OD-22-189 .

See Section III. 3. Additional Information on Eligibility .

This notice of funding opportunity (NOFO) will support projects proposing mechanistic studies that will transform our understanding of polysubstance use in addiction. These hypothesis-based, exploratory projects may investigate mechanisms of polysubstance use at the behavioral, cognitive, cellular, circuit, genetic, epigenetic, pharmacological and/or computational levels.

This NOFO requires a plan for enhancing diverse perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .  

June 17, 2024 

All applications are due by 5:00 PM local time of applicant organization. 

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.

Not Applicable

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  • Use the NIH ASSIST system to prepare, submit and track your application online.
  • Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
  • Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section i. notice of funding opportunity description.

Background: Research on substance use disorders (SUDs) has primarily focused on individual substances although polysubstance use is prevalent. Polysubstance use is the use of more than one addictive substance within a defined interval; the use may be sequential (use of multiple substances on separate occasions), or concurrent/simultaneous. Limiting studies to an individual addictive substance overlooks potential interactions between substances and could influence the translational potential of preclinical research findings.

Results from several studies have demonstrated that the use of multiple addictive substances produces pharmacokinetic and behavioral profiles that are distinct from those produced by a single substance. Despite this recognition, little is known about the precise pharmacological mechanisms and interactions that may contribute to such outcomes, or co-morbidities resulting from co-use. There is also a significant lack in our understanding of how the activity of discrete cells, genes, circuits, expression of receptors, ion channels, intrinsic excitability or signaling mechanisms in the reward systems synergize when exposed to distinct classes of drugs simultaneously or sequentially. Even less is known about these mechanisms in brain regions and circuits that underlie negative reinforcement, or how neurotransmitters, neuromodulators or stress interact within these circuits to contribute to the behavioral and pharmacological profiles observed following polysubstance use. In addition, there is a need for behavioral models of polysubstance use that have translational potential.

Research Objectives : The National Institute on Drug Abuse (NIDA) seeks to stimulate innovative research that will transform our understanding of the basic mechanisms that underlie polysubstance use in addiction. These studies will investigate novel neurobiological, pharmacological and/or behavioral mechanisms underlying the biobehavioral outcomes of polysubstance use.

Research areas and questions of programmatic interest include, but are not limited to :

  • Identification and/or characterization of molecules, genes, cells (including non-neuronal cells), neural pathways, circuits, receptors, ion channels, intrinsic excitability, pharmacological and signaling mechanisms mediating the effects of polysubstance use.
  • Mechanisms underlying the association of early adolescent polysubstance use with SUD’s in adulthood.
  • Sex differences in the development and trajectory of polysubstance use. What are the roles of organizational and activational effects of sex steroids on discrete brain regions and neural circuits, and how is this altered with exposure to polysubstance use?
  • What are the developmental determinants? Are there developmental windows during which polysubstance use would be facilitated?
  • What are the pharmacologic, pharmacokinetic and pharmacodynamic interactions that can impact toxicity, or the SUD trajectory?
  • How do environmental factors interact with brain circuits to influence the development and trajectory of SUDs involving polysubstance use?
  • How does stress interact with brain circuits to influence the development and trajectory of SUDs involving polysubstance use?
  • Are there neurobehavioral risk phenotypes for progression to polysubstance use? What are the neurocognitive and neurobehavioral changes that occur through experience with different patterns of polysubstance use?

Applications Not Responsive to this Notice of Funding Opportunity (NOFO)

The following types of studies are not responsive to this NOFO and will not be reviewed :

  • The major goal of the project is not targeted at delineating the basic mechanisms underlying polysubstance use in addiction.
  • Projects limited exclusively to the phenomenology of polysubstance use, consequences of polysubstance use, or those focused exclusively on the development of tools or animal models. 
  • Projects that do not focus on combinations of two or more addictive substances with well-justified translational and public health relevance. 
  • Projects that do not include a psychostimulant, opioid, or cannabinoid in the polysubstance combination. Alcohol may be included in the polysubstance combination. 
  • Research that does not pertain to at least one of the stages of the substance use trajectory, including, but not limited to initiation, escalation, withdrawal and/or relapse. 

Other application considerations :  

  • Collaborative research teams to foster the sharing of conceptual and/or technical expertise are strongly encouraged.
  • Applicants using animal models are encouraged to use models reflective of chronic and voluntary drug intake.
  • Preliminary data are not required but may be included if available. In the absence of preliminary data, a strong premise should be provided for testing a novel hypothesis based upon the scientific literature as well as evidence of the team’s ability to carry out the proposed studies through published or technical preliminary data.  

Special considerations

NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the  Special Considerations for NIDA Funding Opportunities and Awards . Upon award, these considerations will be included in the Notice of Grant Award.

Plan for Enhancing Diverse Perspectives (PEDP)

  • This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310 , submitted as Other Project Information as an attachment (see Section IV).
  • Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material . The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

The  OER Glossary  and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

NIDA intends to commit $2M in FY 2025 to fund three-five awards.

Application budgets will be limited to $350,000 in direct costs/year. The proposed budget needs to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide .

2. Cost Sharing

This NOFO does not require cost sharing as defined in the  NIH Grants Policy Statement Section 1.2 Definition of Terms .

3. Additional Information on Eligibility

Number of Applications

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the  How to Apply - Application Guide  except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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 IC 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:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to: [email protected]

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the  How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments:  Plan for Enhancing Diverse Perspectives  

  • In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
  • The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. 
  • Where possible, applicant(s) should align their description with these required elements within the research strategy section. 
  • The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
  • The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review

Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). 
  • Description of any planned partnerships that may enhance geographic and regional diversity. 
  • Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce. 
  • Proposed monitoring activities to identify and measure PEDP progress benchmarks. 
  • Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early-and mid-career researchers. 
  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds. 
  • Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s). 
  • Publication plan that enumerates planned manuscripts and proposed lead authorship.  
  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds. 

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp

R&R or Modular Budget

R&R or Modular Budget 

PEDP implementation costs 

  • Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm ).

R&R Subaward Budget

All instructions in the  How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy : The following must be described in the research strategy:

  • Significance : a) A compelling justification based upon high translational and public health relevance for examining the proposed polysubstance combination (a psychostimulant, opiate or cannabinoid must be included in the polysubstance combination), b) How the proposed studies will dramatically enhance our mechanistic understanding of polysubstance use in addiction.
  • Innovation : a) Description of how the proposed project disrupts existing paradigms and explores unanticipated biological phenomena or an unexpected result, b) Description of the risky and/or impactful nature of the proposed research in uncovering mechanisms of polysubstance use in addiction.
  • Approach: a) Well-designed experiments with adequate control conditions to test the proposed hypothesis, b) Description of statistical analyses, c) Justify that the proposed experiments are feasible, d) A timeline for the studies over the proposed funding period.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide . 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the  How to Apply - Application Guide must be followed, with the following additional instructions:

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.  

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I.  contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the  How to Apply – Application Guide .

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the  NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide . Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide .

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones for PEDP. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO: 

  • To what extent does the application provide a compelling justification based upon high translational and public health relevance for examining the proposed polysubstance combination? 
  • To what extent does the application describe how the proposed work will dramatically improve our mechanistic understanding of polysubstance use in addiction?
  • To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this NOFO:  

  • To what extent does the project disrupt existing paradigms, explore an unanticipated biological phenomenon or unexpected previous result? 
  • To what extent does the project take risks rather than simply proceeding to the next logical step?
  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

  • How adequate are the experimental designs and statistical analyses? 
  • Are the timelines and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

  •  To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms ) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the  eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the  NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the  NIH Grants Policy Statement . This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website ( https://register.clinicaltrials.gov ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the  NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities , including of note, but not limited to:

  • Federal-wide Standard Terms and Conditions for Research Grants
  • Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
  • Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance ( HHS-690 ). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website . 

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the  Research Performance Progress Report (RPPR)  annually and financial statements as required in the NIH Grants Policy Statement .

Awardees will provide updates at least annually on implementation of the PEDP

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online:  https://www.era.nih.gov/need-help  (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email:  [email protected]  (preferred method of contact) Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email:  [email protected]

Sunila Nair, PhD National Institute on Drug Abuse (NIDA) Phone: 301-827-6832 Email: [email protected]

Dharmendar Rathore, PhD National Institute on Drug Abuse (NIDA) Phone: 301-402-6965 Email:  [email protected]

Krista Lyles National Institute on Drug Abuse (NIDA) Phone: 301-480-2203 Email:  [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

NIH Office of Extramural Research Logo

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files .

IMAGES

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