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  • human studies Included
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  • A clinical study involves research using human volunteers (also called . Various Federal agencies, including the Office of Human Subjects Research Protection. Human Factors-Simulated Use Validation Studies. . combination product for review under an ANDA that may include HF studies should contact the CDER. included in the guidelines for direct food additives and color additives used in conduct human studies in support of the safety of direct food additives and.

    human studies Included

    Costs for clinical trials can range into the billions of dollars per approved drug. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.

    Only 10 percent of all drugs started in human clinical trials become an approved drug. Some clinical trials involve healthy subjects with no pre-existing medical conditions. Other clinical trials pertain to patients with specific health conditions who are willing to try an experimental treatment. When participants are healthy volunteers who receive financial incentives, the goals are different than when the participants are sick.

    During dosing periods, study subjects typically remain under supervision for one to 40 nights. Usually pilot experiments are conducted to gain insights for design of the clinical trial to follow. There are two goals to testing medical treatments: Neither is an absolute criterion; both safety and efficacy are evaluated relative to how the treatment is intended to be used, what other treatments are available, and the severity of the disease or condition.

    The benefits must outweigh the risks. Children and people with unrelated medical conditions are also frequently excluded. The sponsor designs the trial in coordination with a panel of expert clinical investigators, including what alternative or existing treatments to compare to the new drug and what type s of patients might benefit. If the sponsor cannot obtain enough test subjects at one location investigators at other locations are recruited to join the study. During the trial, investigators recruit subjects with the predetermined characteristics, administer the treatment s and collect data on the subjects' health for a defined time period.

    Data include measurements such as vital signs , concentration of the study drug in the blood or tissues, changes to symptoms, and whether improvement or worsening of the condition targeted by the study drug occurs. The researchers send the data to the trial sponsor, who then analyzes the pooled data using statistical tests. Examples of clinical trial goals include assessing the safety and relative effectiveness of a medication or device:.

    While most clinical trials test one alternative to the novel intervention, some expand to three or four and may include a placebo. Except for small, single-location trials, the design and objectives are specified in a document called a clinical trial protocol. The protocol is the trial's "operating manual" and ensures that all researchers perform the trial in the same way on similar subjects and that the data is comparable across all subjects. As a trial is designed to test hypotheses and rigorously monitor and assess outcomes, it can be seen as an application of the scientific method , specifically the experimental step.

    The most common clinical trials evaluate new pharmaceutical products , medical devices such as a new catheter , biologics , psychological therapies , or other interventions. Clinical trials may be required before a national regulatory authority [9] approves marketing of the innovation. Similarly to drugs, manufacturers of medical devices in the United States are required to conduct clinical trials for premarket approval.

    An example of the former in the field of vascular surgery is the Open versus Endovascular Repair OVER trial for the treatment of abdominal aortic aneurysm , which compared the older open aortic repair technique to the newer endovascular aneurysm repair device. Similarly to drugs, medical or surgical procedures may be subjected to clinical trials, [13] such as case-controlled studies for surgical interventions.

    The concepts behind clinical trials are ancient. The Book of Daniel chapter 1, verses 12 through 15, for instance, describes a planned experiment with both baseline and follow-up observations of two groups who either partook of, or did not partake of, "the King's meat" over a trial period of ten days. Persian physician Avicenna , in The Canon of Medicine gave similar advice for determining the efficacy of medical drugs and substances.

    Although early medical experimentation was often performed, the use of a control group to provide an accurate comparison for the demonstration of the intervention's efficacy, was generally lacking. For instance, Lady Mary Wortley Montagu , who campaigned for the introduction of inoculation then called variolation to prevent smallpox , arranged for seven prisoners who had been sentenced to death to undergo variolation in exchange for their life.

    Although they survived and did not contract smallpox, there was no control group to assess whether this result was due to the inoculation or some other factor. Similar experiments performed by Edward Jenner over his smallpox vaccine were equally conceptually flawed. The first proper clinical trial was conducted by the physician James Lind. In , the catastrophic result of Anson 's circumnavigation attracted much attention in Europe; out of men, had died, most of them allegedly from having contracted scurvy.

    Lind conducted the first systematic clinical trial in He divided twelve scorbutic sailors into six groups of two. They all received the same diet but, in addition, group one was given a quart of cider daily, group two twenty-five drops of elixir of vitriol sulfuric acid , group three six spoonfuls of vinegar , group four half a pint of seawater, group five received two oranges and one lemon , and the last group a spicy paste plus a drink of barley water.

    The treatment of group five stopped after six days when they ran out of fruit, but by that time one sailor was fit for duty while the other had almost recovered. Apart from that, only group one also showed some effect of its treatment. After , the discipline began to take its modern shape. Further work in that direction was carried out by the eminent physician Sir William Gull, 1st Baronet in the s.

    Frederick Akbar Mahomed d. He also founded the Collective Investigation Record for the British Medical Association ; this organization collected data from physicians practicing outside the hospital setting and was the precursor of modern collaborative clinical trials.

    Fisher , while working for the Rothamsted experimental station in the field of agriculture, developed his Principles of experimental design in the s as an accurate methodology for the proper design of experiments. Among his major ideas, was the importance of randomization — the random assignment of individuals to different groups for the experiment; [24] replication — to reduce uncertainty , measurements should be repeated and experiments replicated to identify sources of variation; [25] blocking — to arrange experimental units into groups of units that are similar to each other, and thus reducing irrelevant sources of variation; use of factorial experiments — efficient at evaluating the effects and possible interactions of several independent factors.

    The British Medical Research Council officially recognized the importance of clinical trials from the s. The Council established the Therapeutic Trials Committee to advise and assist in the arrangement of properly controlled clinical trials on new products that seem likely on experimental grounds to have value in the treatment of disease.

    The trial, carried out between —, aimed to test the efficacy of the chemical streptomycin for curing pulmonary tuberculosis.

    The trial was both double-blind and placebo-controlled. The methodology of clinical trials was further developed by Sir Austin Bradford Hill , who had been involved in the streptomycin trials.

    From the s, Hill applied statistics to medicine, attending the lectures of renowned mathematician Karl Pearson , among others. He became famous for a landmark study carried out in collaboration with Richard Doll on the correlation between smoking and lung cancer. They carried out a case-control study in , which compared lung cancer patients with matched control and also began a sustained long-term prospective study into the broader issue of smoking and health, which involved studying the smoking habits and health of over 30, doctors over a period of several years.

    His certificate for election to the Royal Society called him " International clinical trials day is celebrated on 20 May. Another way of classifying trials is by their purpose. A third classification is whether the trial design allows changes based on data accumulated during the trial. Finally, a common way of distinguishing trials is by phase, which in simple terms, relates to how close the drug is to being clinically proven both effective for its stated purpose and accepted by the regulatory authorities for use for that purpose.

    Clinical trials involving new drugs are commonly classified into five phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years.

    If the drug successfully passes through phases 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population. Before pharmaceutical companies start clinical trials on a drug, they will also have conducted extensive preclinical studies. Each phase has a different purpose and helps scientists answer a different question.

    A fundamental distinction in evidence-based practice is between observational studies and randomized controlled trials. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health. Currently, some phase 2 and most phase 3 drug trials are designed as randomized, double-blind , and placebo -controlled.

    Clinical studies having small numbers of subjects may be "sponsored" by single researchers or a small group of researchers, and are designed to test simple questions or feasibility to expand the research for a more comprehensive randomized controlled trial.

    In many cases, giving a placebo to a person suffering from a disease may be unethical. In trials with an active control group, subjects are given either the experimental treatment or a previously approved treatment with known effectiveness. In such studies, multiple experimental treatments are tested in a single trial. Genetic testing enables researchers to group patients according to their genetic profile, deliver drugs based on that profile to that group and compare the results.

    Multiple companies can participate, each bringing a different drug. The first such approach targets squamous cell cancer , which includes varying genetic disruptions from patient to patient. Amgen, AstraZeneca and Pfizer are involved, the first time they have worked together in a late-stage trial. Patients whose genomic profiles do not match any of the trial drugs receive a drug designed to stimulate the immune system to attack cancer.

    A clinical trial protocol is a document used to define and manage the trial. It is prepared by a panel of experts. All study investigators are expected to strictly observe the protocol. The protocol describes the scientific rationale, objective s , design, methodology, statistical considerations and organization of the planned trial. Details of the trial are provided in documents referenced in the protocol, such as an investigator's brochure.

    The protocol contains a precise study plan to assure safety and health of the trial subjects and to provide an exact template for trial conduct by investigators. The protocol also informs the study administrators often a contract research organization. The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology or medical device companies in the United States, European Union, or Japan have been standardized to follow Good Clinical Practice guidance [40] issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH.

    Journals such as Trials , encourage investigators to publish their protocols. Clinical trials recruit study subjects to sign a document representing their " informed consent ". The document is not a contract, as the participant can withdraw at any time without penalty.

    Informed consent is a legal process in which a recruit is instructed about key facts before deciding whether to participate. Researchers explain the details of the study in terms the subject can understand. The information is presented in the subject's native language. Generally, children cannot autonomously provide informed consent, but depending on their age and other factors, may be required to provide informed assent.

    The number of subjects has a large impact on the ability to reliably detect and measure effects of the intervention. This is described as its " power ". The larger the number of participants, the greater the statistical power and the greater the cost. The statistical power estimates the ability of a trial to detect a difference of a particular size or larger between the treatment and control groups.

    For example, a trial of a lipid -lowering drug versus placebo with patients in each group might have a power of 0. Merely giving a treatment can have nonspecific effects. These are controlled for by the inclusion of patients who receive only a placebo. Subjects are assigned randomly without informing them to which group they belonged.

    Many trials are doubled-blinded so that researchers do not know to which group a subject is assigned. Assigning a subject to a placebo group can pose an ethical problem if it violates his or her right to receive the best available treatment. The Declaration of Helsinki provides guidelines on this issue.

    Clinical trials are only a small part of the research that goes into developing a new treatment. Potential drugs, for example, first have to be discovered, purified, characterized, and tested in labs in cell and animal studies before ever undergoing clinical trials.

    In all, about 1, potential drugs are tested before just one reaches the point of being tested in a clinical trial. But the major holdup in making new cancer drugs available is the time it takes to complete clinical trials themselves.

    On average, about eight years pass from the time a cancer drug enters clinical trials until it receives approval from regulatory agencies for sale to the public. The biggest barrier to completing studies is the shortage of people who take part.

    All drug and many device trials target a subset of the population, meaning not everyone can participate. Some drug trials require patients to have unusual combinations of disease characteristics. It is a challenge to find the appropriate patients and obtain their consent, especially when they may receive no direct benefit because they are not paid, the study drug is not yet proven to work, or the patient may receive a placebo. Not all of these will prove to be useful, but those that are may be delayed in getting approved because the number of participants is so low.

    For clinical trials involving potential for seasonal influences such as airborne allergies , seasonal affective disorder , influenza , and skin diseases , the study may be done during a limited part of the year such as spring for pollen allergies , when the drug can be tested.

    Clinical trials that do not involve a new drug usually have a much shorter duration. Exceptions are epidemiological studies, such as the Nurses' Health Study. Clinical trials designed by a local investigator, and in the US federally funded clinical trials, are almost always administered by the researcher who designed the study and applied for the grant.

    Small-scale device studies may be administered by the sponsoring company. Clinical trials of new drugs are usually administered by a contract research organization CRO hired by the sponsoring company. The sponsor provides the drug and medical oversight. A CRO is contracted to perform all the administrative work on a clinical trial. For phases 2, 3 and 4, the CRO recruits participating researchers, trains them, provides them with supplies, coordinates study administration and data collection, sets up meetings, monitors the sites for compliance with the clinical protocol, and ensures the sponsor receives data from every site.

    Phase 1 clinical trials of new medicines are often conducted in a specialist clinical trial clinic, with dedicated pharmacologists, where the subjects can be observed by full-time staff. These clinics are often run by a CRO which specialises in these studies. At a participating site, one or more research assistants often nurses do most of the work in conducting the clinical trial. The research assistant's job can include some or all of the following: Janet Yang uses the Interactional Justice Model to test the effects of willingness to talk with a doctor and clinical trial enrollment.

    The reasoning behind this discovery may be patients are happy with their current care. Another reason for the negative relationship between perceived fairness and clinical trial enrollment is the lack of independence from the care provider. Results found that there is a positive relationship between a lack of willingness to talk with their doctor and clinical trial enrollment.

    Lack of willingness to talk about clinical trials with current care providers may be due to patients' independence from the doctor. Patients who are less likely to talk about clinical trials are more willing to use other sources of information to gain a better insight of alternative treatments. Clinical trial enrollment should be motivated to utilize websites and television advertising to inform the public about clinical trial enrollment.

    The last decade has seen a proliferation of information technology use in the planning and conduct of clinical trials. Clinical trial management systems are often used by research sponsors or CROs to help plan and manage the operational aspects of a clinical trial, particularly with respect to investigational sites. Advanced analytics for identifying researchers and research sites with expertise in a given area utilize public and private information about ongoing research.

    Interactive voice response systems are used by sites to register the enrollment of patients using a phone and to allocate patients to a particular treatment arm although phones are being increasingly replaced with web-based IWRS tools which are sometimes part of the EDC system. While patient-reported outcome were often paper based in the past, measurements are increasingly being collected using web portals or hand-held ePRO or eDiary devices, sometimes wireless.

    Access to many of these applications are increasingly aggregated in web-based clinical trial portals. In , the FDA approved a phase 1 trial that used telemonitoring, also known as remote patient monitoring, to collect biometric data in patients' homes and transmit it electronically to the trial database.

    This technology provides many more data points and is far more convenient for patients, because they have fewer visits to trial sites. Clinical trials are closely supervised by appropriate regulatory authorities. All studies involving a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial. The local ethics committee has discretion on how it will supervise noninterventional studies observational studies or those using already collected data.

    To be ethical, researchers must obtain the full and informed consent of participating human subjects. One of the IRB's main functions is to ensure potential patients are adequately informed about the clinical trial. In California , the state has prioritized the individuals who can serve as the legally authorized representative. In some US locations, the local IRB must certify researchers and their staff before they can conduct clinical trials. The International Conference of Harmonisation Guidelines for Good Clinical Practice is a set of standards used internationally for the conduct of clinical trials.

    The guidelines aim to ensure the "rights, safety and well being of trial subjects are protected". The notion of informed consent of participating human subjects exists in many countries all over the world, but its precise definition may still vary. Informed consent is clearly a 'necessary' condition for ethical conduct but does not 'ensure' ethical conduct. In compassionate use trials the latter becomes a particularly difficult problem. The final objective is to serve the community of patients or future patients in a best-possible and most responsible way.

    See also Expanded access. However, it may be hard to turn this objective into a well-defined, quantified, objective function. In some cases this can be done, however, for instance, for questions of when to stop sequential treatments see Odds algorithm , and then quantified methods may play an important role.

    Additional ethical concerns are present when conducting clinical trials on children pediatrics , and in emergency or epidemic situations. In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research were not published, the Pharmaceutical Research and Manufacturers of America published new guidelines urging companies to report all findings and limit the financial involvement in drug companies by researchers.

    Drug researchers not directly employed by pharmaceutical companies often seek grants from manufacturers, and manufacturers often look to academic researchers to conduct studies within networks of universities and their hospitals, e.

    Similarly, competition for tenured academic positions, government grants and prestige create conflicts of interest among academic scientists. In the United States, all clinical trials submitted to the FDA as part of a drug approval process are independently assessed by clinical experts within the Food and Drug Administration, [61] including inspections of primary data collection at selected clinical trial sites.

    In , the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication.

    They strengthened editorial restrictions to counter the effect. Researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results.

    Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators if different from the sponsor , the various IRBs that supervise the study, and in some cases, if the study involves a marketable drug or device , the regulatory agency for the country where the drug or device will be sold. For safety reasons, many clinical trials of drugs are designed to exclude women of childbearing age, pregnant women, or women who become pregnant during the study.

    In some cases, the male partners of these women are also excluded or required to take birth control measures. Throughout the clinical trial, the sponsor is responsible for accurately informing the local site investigators of the true historical safety record of the drug, device or other medical treatments to be tested, and of any potential interactions of the study treatment s with already approved treatments.

    This allows the local investigators to make an informed judgment on whether to participate in the study or not. The sponsor is also responsible for monitoring the results of the study as they come in from the various sites as the trial proceeds. In larger clinical trials, a sponsor will use the services of a data monitoring committee DMC, known in the US as a data safety monitoring board.

    This independent group of clinicians and statisticians meets periodically to review the unblinded data the sponsor has received so far. Each study within your application must have a unique Study Title. The first characters will display in the application image bookmarks.

    Note on multiple delayed onset studies: If you are including multiple delayed onset studies in one delayed onset study entry, you may enter "Multiple Delayed Onset Studies" as the title of this record.

    Check this box if you anticipate that this study will be a clinical trial. For help determining whether your study meets the definition of clinical trial, see the Clinical Trial Questionnaire below. Read your FOA carefully to determine whether clinical trials are allowed in your application.

    If you are including multiple delayed onset studies in one delayed onset study entry, and you anticipate that any of these studies will be a clinical trial, check the "Anticipated Clinical Trial? Follow the standard instructions. Do not check the "Anticipated Clinical Trial? Fellowship FOAs do not allow independent clinical trials.

    If you are including more than one delayed onset study in any given delayed onset study entry, address all the included studies in a single justification attachment.

    Enter a brief title that describes the study the participants will be involved in. If there is more than one study i. The first characters will display in the bookmarks of the application image. When registering a clinical trial in ClinicalTrials. This field matches a ClinicalTrials. Indicate whether the study is exempt from Federal regulations for the Protection of Human Subjects. Select the appropriate exemption number s for this particular study. Multiple selections are permitted.

    Regardless of whether these exemptions may apply to you in the future, you must fill out your application following the instructions below. The categories of research that qualify for exemption are defined in the Common Rule for the Protection of Human Subjects. These regulations can be found at 45 CFR Note for basic and mechanistic studies involving human participants: The NIH definition of a clinical trial encompasses a broad range of studies, including studies using human participants that aim to understand fundamental aspects of phenomena, the pathophysiology of a disease, or the mechanism of action of an intervention.

    Answer "Yes" or "No" to the following questions to determine whether this study involves a clinical trial. Answer the following questions based only on the study you are describing in this Study Record.

    If you answered "Yes" to all the questions in the Clinical Trial Questionnaire, this study meets the definition of a clinical trial. Refer to the table below for information about what sections of this form are required, based on your answers to Question 1.

    Even if you answered "Yes" to all the questions in the Clinical Trial Questionnaire, only certain fields of the PHS Human Subjects and Clinical Trials Information form are required and other fields are not allowed because the study is not an independent clinical trial. Inputting information into these sections will result in errors and will prevent your application from being accepted.

    If a clinical trial has already been entered into ClinicalTrials. If you are building on an existing study e. The number you enter in this field should match the ClinicalTrials.

    At least 1 entry is required, and up to 20 entries are allowed enter each entry on its own line. Each entry is limited to characters.

    Identify the name s of the disease s or condition s you are studying, or the focus of the study. Include an entry for each condition. List the study's inclusion and exclusion criteria. To provide a bulleted list, use a dash or other character followed by a space "- " at the start of each bullet.

    Be sure to check the formatting in the assembled application image. Further explanation or justification should be included in the Recruitment and Retention plan. Your text entry is limited to 15, characters but typically needs only characters. Enter the numerical value for the minimum age a potential participant can be to be eligible for the study. Provide the relevant units of time i. Enter the numerical value for the maximum age a potential participant can be to be eligible for the study.

    A new Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects policy takes effect for all applications submitted for due dates on or after January 25, Use the correct set of instructions according to your application due date. The Inclusion of Women, Minorities, and Children instructions will be changing, effective January 25, Please note that there are two sets of instructions below, based on the application due dates.

    Organize your attachment into two sections, following the headings and specified order below, and discuss each of the points listed below. Start each section with the appropriate section heading - "Inclusion of Women and Minorities" and "Inclusion of Children. Note that you may need to include multiple IERs for each study. Refer to the instructions for the IER below for more information.

    Existing Datasets or Resources. If you will use an existing dataset , resource, or samples that may have been collected as part of a different study, you must address inclusion, following the instructions above. This plan must include selection and discussion of one of the following analysis plans:. For the purposes of the Inclusion of Children, individuals under 18 are defined as a child ; however, exclusion of any specific age or age range group e.

    In addition, address the following points:. For applications submitted for due dates on or after January 25, Describe how you will recruit and retain participants in your study. You should address both planned recruitment activities as well as proposed engagement strategies for retention. From the dropdown menu, select a single "Recruitment Status" that best describes the proposed study, based upon the status of the individual sites.

    If any facility in a multi-site study has an individual site status of "recruiting," then choose "recruiting" for this question. Only one selection is allowed. Choose from the following options:. Provide a description or diagram describing the study timeline. The timeline should be general e. Additional milestones or timelines may be requested as just-in-time information or post-award. The "Enrollment of First Subject" question is otherwise required unless the following applies to you:.

    From the dropdown menu, select whether this date is anticipated or actual. An Inclusion Enrollment Report is required for all human subjects studies unless, on Question 1. However, more than one IER per study is allowed. These can be a combination of planned and cumulative reports. At a minimum, participants enrolled at non-U. It is important that the IER for a given study be associated with only one application and be provided only once in a given application e.

    If submitting individual application s as part of a network or set of linked applications, please provide the IER with the individual site applications unless otherwise directed by the FOA. When preparing a renewal or resubmission of a renewal , investigators should provide a narrative description regarding the cumulative enrollment from the previous funding period s as part of the progress report section of the research strategy attachment in the application.

    If a given study will continue with the same enrollment or additional enrollment, or if new studies are proposed, provide a new IER for each as described in the instructions below. If IERs were provided in the initial submission application, and if those studies will be part of the resubmission application, complete the IER and submit again with the resubmission application, regardless of whether the enrollment has changed or not.

    Also, provide any new additional IERs. For multi-project applications with studies that are self-contained within a single component: Should the study span more than one component, include the IER with the Study Record in the Overall Component and insert a comment in the comment field of the IER to indicate what other components it is associated with. If the study involves analysis of an existing dataset or resource e.

    If the study involves prospective recruitment or new contact with participants answer "No" to this question. Use separate IERs for studies involving use of existing datasets or resources only and for studies that involve prospective recruitment or new contact with study participants. Select whether the participants described in the IER are based at a U. Domestic or at a non-U. For additional guidance on how to complete the IER if you will be working with non-U.

    Indicate the country or countries in which participants will be enrolled. Foreign countries can be reported together in one IER.

    However, you must use separate IERs for U. You can add up to countries per IER. Indicate the type of enrollment location e. Enrollment locations are typically where the research is conducted, and can be different from the recruitment site. Enter information you wish to provide about this IER. This includes, but is not limited to, addressing information about distinctive subpopulations if relevant to the scientific hypotheses being studied. If inclusion monitoring is conducted on another study or NIH grant e.

    Instead, provide a comment in this field to the effect that previous IER s are still applicable. If you are revising the IER s in your original grant application, provide a comment here to that effect.

    Should the study span more than one component, include the IER with the Study Record in the Overall Component and insert a comment here in the comment field to indicate what other components it is associated with. All studies must enter planned enrollment counts unless your proposed study will use only an existing dataset or resource.

    Enter the expected number of females and males in the respective fields who are both Asian and Not Hispanic or Latino. Enter the expected number of females and males in the respective fields who are both Asian and Hispanic or Latino. Enter the expected number of females and males in the respective fields who are both Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino. Enter the expected number of females and males in the respective fields who are both Native Hawaiian or Other Pacific Islander and Hispanic or Latino.

    Enter the expected number of females and males in the respective fields who are both Black or African American and Not Hispanic or Latino. Enter the expected number of females and males in the respective fields who are both Black or African American and Hispanic or Latino.

    Enter the expected number of females and males in the respective fields who are both White and Not Hispanic or Latino. Enter the expected number of females and males in the respective fields who are both White and Hispanic or Latino.

    Enter the expected number of females and males in the respective fields who both identify with more than one racial category and are Not Hispanic or Latino. Enter the expected number of females and males in the respective fields who both identify with more than one racial category and are Hispanic or Latino.

    The "Total" fields in the right column will be automatically calculated to total all individuals. You must enter cumulative enrollment counts if your proposed study will use an existing dataset or resource.

    Enter the number of females and males in the respective fields who are both Asian and Not Hispanic or Latino. Enter the number of females and males in the respective fields who are both Black or African American and Not Hispanic or Latino. Enter the number of females and males in the respective fields who are both White and Not Hispanic or Latino.

    Enter the number of females and males in the respective fields who both identify with more than one racial category and are Not Hispanic or Latino. All of "Section 3 - Protection and Monitoring Plans" is required for all studies involving human subjects, unless otherwise noted. Do not use the "Protection of Human Subjects" attachment to circumvent the page limits of the Research Strategy. If you are claiming that your human subjects research falls under any exemptions, justify why the research meets the criteria for the exemption s that you have claimed.

    This justification should explain how the proposed research meets the criteria for the exemption claimed. Do not merely repeat the criteria or definitions themselves. For any proposed non-exempt study involving human subjects, NIH requires a Protection of Human Subjects attachment that is commensurate with the risks of the study, its size, and its complexity.

    Organize your attachment into four sections, following the headings and specified order below, and discuss each of the points listed below. Also include any additional information requested in the FOA. Explain the rationale for the involvement of special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

    If the study involves vulnerable subjects subject to additional protections under Subparts B and D pregnant women, fetuses, and neonates or children , provide a clear description of the risk level and additional protections necessary to meet the HHS regulatory requirements. If the study involves vulnerable subjects subject to additional protections under Subpart C prisoners , describe how proposed research meets the additional regulatory requirements, protections, and plans to obtain OHRP certification for the involvement of prisoners in research.

    Select "Yes" or "No" to indicate whether this is a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site. Applicants who check "Yes" are expected to use a single Institutional Review Board sIRB to conduct the ethical review required by HHS regulations for the Protections of Human Subjects Research unless review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy.

    Foreign sites participating in NIH-funded, multi-site studies are not expected to follow this policy. Although one sIRB attachment per application is sufficient, you must include a file for each study within your application. All filenames within your application must be unique. You may either attach the same sIRB plan with different filenames to different studies or attach a file that refers to the sIRB plan in another study within your application.

    Include a specific citation to the relevant law, policy, or regulation. For sites requesting an exception based on compelling justification: Indicate which site s is requesting an exception to the use of the sIRB and provide compelling justification based on ethical or human subjects protection issues or other well-justified reasons. NIH will determine whether to grant an exception following an assessment of the need. If you intend to request an exception to the sIRB policy based on compelling justification, do not account for this exception in your proposed budget.

    The proposed budget must reflect any necessary sIRB costs without an exception i. For human subjects research that does not involve a clinical trial: Your study, although it is not a clinical trial, may have significant risks to participants, and it may be appropriate to include a data and safety monitoring plan.

    If you choose to include a data and safety monitoring plan, you may follow the content criteria listed below, as appropriate.

    Include only the following information in your data and safety monitoring plan i. For any proposed clinical trial, NIH requires a data and safety monitoring plan DSMP that is commensurate with the risks of the trial, its size, and its complexity.

    Provide a description of the DSMP, including:. The attachment may include information on study team composition and key roles e. Do not include study team members' individual professional experiences i. If you answered "Yes" to all the questions in the " Clinical Trial Questionnaire: If you answered "No" to any question in the " Clinical Trial Questionnaire: Inputting information in this section will result in errors and will prevent your application from being accepted.

    Do not provide information in "Section 4 - Protocol Synopsis. At the time of your application, do not provide information in "Section 4 - Protocol Synopsis. Post-award, while you will be required to fill out Study Records, you must still not provide information in "Section 4 - Protocol Synopsis. Fellowship applicants proposing to gain clinical trial research experience under a sponsor's supervision i. Enter a short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.

    The Brief Summary is limited to 5, characters but typically needs only 2, characters.

    Clinical trial

    Download Table | Baseline characteristics of included human studies. from publication: Microsporidiosis in Iran: A systematic review and meta-analysis. Download Table | | Study outcomes measured in included human studies. from publication: Effects of Physical Exercise Combined with Nutritional Supplements . Download Table | Characteristics of included human studies on air pollution and ASD, by publication date and study design. from publication: A Systematic.

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    Download Table | Baseline characteristics of included human studies. from publication: Microsporidiosis in Iran: A systematic review and meta-analysis.


    Download Table | | Study outcomes measured in included human studies. from publication: Effects of Physical Exercise Combined with Nutritional Supplements .


    Download Table | Characteristics of included human studies on air pollution and ASD, by publication date and study design. from publication: A Systematic.


    The PHS Human Subjects and Clinical Trials Information form, together with the rest of your application, should include sufficient information for.

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