As a resource for our participants and for caregivers, DHR Health Institute for Research and Development has developed a KNOWLEDGE CENTER with the objective of providing easy and timely access to new knowledge generated in the field of translational and clinical research.
We aim to use this portal to continuously provide our community with up-to-date information and to educate them about the importance of getting engaged in clinical research. Some of the resources are provided below:
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trial database, currently holding registrations from over 230,000 trials from 195 countries in the world.
To access this resource, please visit this website: https://clinicaltrials.gov/
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.
OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP also supports the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues related to protecting human subjects in research.
To access this resource, please visit this website: https://www.hhs.gov/ohrp/
The NIH Clinical Trials and You website is a resource for people who want to learn more about clinical trials. By expanding the below questions, you can read answers to common questions about taking part in a clinical trial.
To access this resource, please visit this website: https://www.nih.gov/health-information/nih-clinical-research-trials-you
Physician investigators at DHR Health Institute for Research & Development understand that parents and caregivers have many questions when they are considering enrolling a child in a clinical study, and that children and adolescents also want to know what they will go through.
DHR Health Institute for Research & Development remains committed to ensuring that families trying to decide whether to enroll their child in a clinical study get all the information they need to feel comfortable and make informed decisions.
The safety of children remains the utmost priority for all research studies conducted under the auspices of DHR Health Institute for Research & Development.
To learn more about the involvement of children in clinical research, please visit these websites:
It is important for clinical trials to have participants of different ages, sexes, races, and ethnicities. When research involves a group of people who are similar, the findings may not apply to or benefit everyone. When clinical trials include diverse participants, the study results may have a much wider applicability.
Researchers need the participation of older people in their clinical trials so that scientists can learn more about how the new drugs, therapies, medical devices, surgical procedures, or tests will work for older people. Many older people have special health needs that are different from those of younger people. For example, as people age, their bodies may react differently to drugs. Older adults may need different dosages (or amounts) of a drug to have the right result. Also, some drugs may have different side effects in older people than younger people. Having seniors enrolled in drug trials helps researchers get the information they need to develop the right treatment for older people.
Researchers know that it may be hard for some older people to join a clinical trial. For example, if you have many health problems, can you participate in a trial that is looking at only one condition? If you are frail or have a disability, will you be strong enough to participate? If you no longer drive, how can you get to the study site? Talk to the clinical trial coordinator about your concerns. The research team may have already thought about some of the obstacles for older people and have a plan to make it easier for you to take part in the trial.
DHR Health Institute for Research & Development is committed to involving older adults in cutting edge clinical trials to ensure diversity and the ascertain the benefit (or risk) in this patient population.
To learn more about the involvement of children in clinical research, please download this publication: Clinical Trial and Older Adults
The Code of Federal Regulations outlines specific requirements to enhance protections for three groups. The vulnerable population includes:
At DHR Health Institute for Research & Development, our investigators understand that risks may vary for particular groups, depending on the nature of the research being conducted. In addition to the groups specified in 45 CFR 46, consider what protections or additional steps may be needed to minimize risk for your study population, such as outlining procedures for consenting individuals with diminished decision-making capacity, or specifying a plan to address incidental findings from your research. Points to consider regarding consent of individuals with reduced decision-making capacity can be found here.
Please note that the existence of additional protections should not discourage research with vulnerable populations or those requiring special considerations. NIH policies state that studies should not be designed to exclude women, minorities, and individuals based on age unless there is a scientific or ethical reason not to include them.
To learn more about the inclusion of vulnerable population in clinical research, please visit these website:
There are well-established differences in incidence of disease between the sexes and among racial or ethnic groups. The most important diseases that disproportionately affect ethnic minorities include type 2 diabetes, cardiovascular disease, stroke, infectious diseases (HIV/AIDS, STDs), and different types of cancer (colon, prostate, cervix, lung).
Some of these variations result from genetic variants that are more common in certain subpopulations than others are, however lifestyle and socioeconomic factors influence risk bias based on sex or race/ethnicity. For instance, women live longer and bear greater disease burden than men, and require extra care for reproductive health and childbearing needs. Ethnic minority groups are disproportionately affected by poverty and low socioeconomic status, which are linked to poorer health outcomes.
Researchers at DHR Health Institute for Research & Development understand the importance of inclusion of diversity in clinical research particularly since >90% of population in the Rio Grande Valley is of Hispanic origin.
To learn more about the importance of inclusion of women and minorities in clinical research, please download this document: https://www.fda.gov/media/84982/download
Precision medicine is “an emerging approach for treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” This approach will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. It is in contrast to a one-size-fits-all approach, in which disease treatment and prevention strategies are developed for the average person, with less consideration for the differences between individuals.
Although the term “precision medicine” is relatively new, the concept has been a part of healthcare for many years. For example, a person who needs a blood transfusion is not given blood from a randomly selected donor; instead, the donor’s blood type is matched to the recipient to reduce the risk of complications. Although examples can be found in several areas of medicine, the role of precision medicine in day-to-day healthcare is relatively limited. Researchers hope that this approach will expand to many areas of health and healthcare in coming years.
To learn more about precision medicine in research, please visit these websites:
Clinical research should be seen as the social good that it is. The first step in tackling this challenge is regularly getting the public to think about participating in clinical research. People need to consider how they can help advance the prevention, diagnosis, and treatment of disease. It is never too early to consider participation whether or not someone ultimately chooses to join a study.
The ethics of promoting greater awareness of clinical research must be considered carefully. The focus of any awareness campaign should be to advocate for consideration of participation, rather than to encourage participation. Providing resources to help individuals make informed decisions about research involvement promotes understanding of the true benefits and risks of participation.
Given that <1% of individuals with Hispanic heritage are involved in clinical research nationally, DHR Health Institute for Research & Development is making concerted efforts to enhance their involvement in clinical research. This is extremely important to ensure that people of different ethnicities are involved in clinical research as new drugs and devices are developed. Let us not assume that a drug and/or device will work across all ethnically diverse groups if that ethnic group has not been involved in its development and testing.