How can we protect human research participants?
- Review the Office of Human Research Protections ( OHRP) Web site.
- Consult with your IRB.
- Carefully review the PHS 398.
- Determine your own institutional policy regarding when to submit to your IRB.
- Understand Peer Reviewers' options with regard to human subject protections.
Why do we have to protect people in research?
The regulations we have to protect people in research came about after a series of events in the twentieth century in which doctors and scientists abused the trust that society placed in them.
Why conduct research with human participants?
Research with human participants has proven invaluable, in advancing knowledge in the biomedical, behavioral and social sciences. Such research is strictly regulated, with laws at the federal, state and local levels.
How to protect the privacy of research participants?
In summary, the protection of research participants should be a main focus for all researchers. When applying the concepts of privacy, confidentiality and anonymity in research, researchers must always consider not only what will be best for their research, but what is best for the participants who make the research possible.
Who is responsible for protecting research participants from risks?
Types of Risk Because research involves risks, investigators, Institutional Review Boards (IRBs), and other members of the research team must take responsibility for protecting participants against the risks of participating in research. Protections vary according to the kind of risk:
How can you protect research participants from harm?
In order to minimising the risk of harm you should think about:Obtaining informed consent from participants.Protecting the anonymity and confidentiality of participants.Avoiding deceptive practices when designing your research.Providing participants with the right to withdraw from your research at any time.
What should an ethical researcher do to protect participants?
These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication. Scientists and researchers must always adhere to a certain code of conduct when collecting data from others.
Why is it important to protect human participants?
It is of central importance because we are ethical people, and society has set up regulations to assure minimum ethical standards in protecting subjects. Protecting subjects is also critical to society's research goal, since research subjects will not volunteer if the fear of harm becomes a major issue.
How do you protect research?
What are Some Best Practices for Researchers to Protect Research Data?Remain Current with Cybersecurity Practices. ... Install Anti-virus Software. ... Install a Firewall.Update and Patch Operating System. ... Data Classification. ... System Authentication and Security. ... Data Backup Options. ... Data Encryption.More items...
How do you protect participants anonymously?
There are two main ways to ensure that the privacy of participants is being respected: (1) by conducting anonymous research, and (2) by conducting confidential research.
Which of the following is important in protecting the rights and welfare of research participants?
An Institutional Review Board, also called an Independent Review Board (IRB) is a group of people (or a “board”) who review research to assure that it will be done in a way that protects the rights, safety, and welfare of the research participants.
How do you protect participant data?
Managing participants' personal data during recruitmentBe clear about personal data during recruitment. ... Take care of participants' contact details and other data. ... Treat all research data as personal data. ... Collect only the data you need. ... Agree a retention period. ... Store research data securely at all times.More items...•
What is human subject protection in research?
"Human Subjects Protections" is a collective term for the federal, state, and university policies, procedures, and ethical considerations that protect the rights and welfare of human beings who participate in research as the subjects of that research.
Do researchers have a duty of care to participants?
ethical focus is a duty of care toward their research participants. The individuals who participate in studies, whether interviewees, focus group members, or community-based co-investigators, are researchers' primary concern when it comes to ethical responsibilities.
Why is clinical research important?
Clinical research with human subjects is key to progress in understanding and improving human health. Research of this type that is supported by the U.S. government follows a system of federal rules and regulations that were designed to protect human participants and ensure that clinical research is conducted in an ethical manner.
What is an anprm?
In 2011, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services published an Advanced Notice of Proposed Rulemaking (ANPRM) that presaged the most comprehensive change to the regulations for protecting human subjects since their inception.
Has the oversight system kept pace with changes in research?
In the ensuing years, research has significantly grown and diversified, and although the system of oversight and protection in the United States has also grown, many believe the oversight system has not kept pace with changes in research.
When HHS-supported research takes place outside of the United States, what consideration must be given to justice, as well
When HHS-supported research takes place outside of the United States, careful consideration must be given to justice, as well as beneficence, and respect for persons, particularly in resource-poor settings, to avoid exploiting participants.
What should the relationship between investigators and human subjects be?
The relationship between investigators and human subjects should be based on honesty, trust, and respect. All investigators involved in human subjects research should be knowledgeable about basic research ethics and associated federal regulations and policies.
What is an IRB review?
IRB Review of Research. An IRB (Institutional Review Board) must review all human subjects research activities covered by the HHS regulations. Non-exempt research undergoes either Expedited (subcommittee) review or Full Board review. Protocols cannot be expedited if the research involves more than minimal risk.
Is it acceptable to publish demographic data?
NOTE: Publishing demographic information is only acceptable in situations where the population is large enough, or the condition is common enough, that research participants cannot be identified using the demographic data provided.
What is genetic research?
Human genetic research involves the study of inherited human traits. Much of this research is aimed at identifying DNA mutations that can help cause specific health problems, developing methods of identifying those mutations in patients, and improving the interventions available to help patients address those problems.
When should attention be paid to subjects' rights?
Attention should be paid to subjects' rights when they decide to withdraw from participation in the study. The federal regulations clearly require that subjects be free to withdraw from participation without penalty or loss of benefits to which they are otherwise entitled [Federal Policy §116 (a) (8)].
Why do IRBs need to become familiar with the issues?
Because of the uncertainties involved in genetic research , IRBs may not, for some time, be able to set clear standards for investigators.
What can IRBs do?
What IRBs can do, however, is ensure that investigators have thought through the factors that may affect the rights and welfare of human subjects (e.g., risks to privacy, psychological risks, employment and insurance risks).
What is an exception to requiring explicit authorization for the release of data?
An exception to requiring explicit authorization for the release of data may be secondary research use of the data, where the data are not especially sensitive and where confidentiality can be assured. IRBs should exercise their discretion in reviewing protocols that call for the secondary use of genetic data.
What is the final issue involving consent?
Publication Practices. One final issue involving consent is the publication of research data. The publication of pedigrees can easily result in the identification of study participants. Where a risk of identification exists, participants must consent, in writing, to the release of personal information.
When should consent be obtained for identifying data?
Various authors have noted the problem of obtaining consent for the publication of identifying data, and have recommended that consent to the publication be obtained immediately prior to the publication, rather than as part of the consent to treatment or participation in research.
How to protect against psychological risks?
Possible ways to protect against psychological risks include reminding participants of their right to withdraw from research or limit their participation if they become uncomfortable, providing counseling or psychological support for participants who experience distress, or thoroughly debriefing research participants after research sessions are completed.
Why is the relationship between investigators and human subjects important?
Human subjects are essential to the conduct of research intended to improve human health. As such, the relationship between investigators and human subjects is critical and should be based on honesty, trust, respect.
What is the Universal Declaration of Human Rights?
The United Nations adopted The Universal Declaration of Human Rights, which was inspired by atrocities committed during World War II and states the conviction that human rights needed to be preserved at the international level.
Why was the consent process unethical?
The investigators maintained that hepatitis infection was inevitable for this population; however, critics asserted that the consent process was unethical because coercive tactics were employed as only children whose parents gave permission to participate in the studies were admitted to Willowbrook.
How can physical risks be minimized?
In many situations, physical risks in research can be minimized by carefully and skillfully following protocols, by having trained individuals conduct research procedures, through careful monitoring of research participants’ health status, by recruiting appropriate populations, and by providing clinical care when needed.
Why were Nazis tried separately from other war criminals?
The individuals who conducted Nazi experiments during WWII were tried separately from other war criminals because of their professional status as physicians and the horrendous and unique nature of their crimes. They were found guilty of “crimes against humanity.”
How many experiments did the US government conduct?
The U.S. Government conducted more than 400 experiments to determine the effects of exposure to ionizing radiation on human health or to calibrate instruments designed to detect radiation. Most studies involved minimal risks and most of those involving greater than minimal risks included appropriate informed consent.
When was the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research created?
In the early 1970s , following widely publicized cases of research abuse, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created to study issues surrounding the protection of humans in research.
What is the Belmont report?
In 1979 the Commission issued a report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly called the Belmont Report ), which provided the ethical framework on which current federal regulations for the protection of human participants in research are based. Legislation/Regulations.
Is human research protected?
Human Research Protections. Research with human participants has proven invaluable, in advancing knowledge in the biomedical, behavioral and social sciences. Such research is strictly regulated, with laws at the federal, state and local levels.
Why are rules needed in research?
The Need for Rules to Protect Research Participants. As a result of the public outcry from publicized cases of unethical research, Congress passed a law requiring federal rules to protect people who participate in research.
What are some examples of unethical research?
Examples of Unethical Research in the Past. The Nuremberg Doctors' Trial, in 1946, was an international military tribunal that tried and convicted Nazi doctors who conducted horrific unethical experiments on concentration camp prisoners during the Holocaust.
How have we arrived at the current rules and regulations for protecting human subjects who participate in research?
This exposition of how we have arrived at the current rules and regulations for protecting human subjects who participate in research is lengthy but is at best an outline . Even this abbreviated history should elicit an appreciation of the complexity of the ethics surrounding protection of human subjects in research. A fair question is whether these provisions have significantly altered the landscape since Dr Beecher published his concerns in the New England Journal of Medicine in 1966. A cursory review turns up a few exceptions to the relative safety afforded by the current protections, with three that are particularly instructive.
How has human subjects protection evolved?
Our current approach to human subjects protection has evolved with efforts to understand questionable ethical behavior in research over the course of several hundred years. One might suggest that the jester conscripted to sample the king's food to ensure that it was safe to eat presaged the use of vulnerable populations as subjects for research, but the evolution of the management of smallpox is perhaps a more applicable early perspective on research in humans. Three centuries ago, reports of good outcomes following variolation—inhalation of the scabs from persons infected with smallpox—were circulating in Asia. In 1717, Lady Mary Wortley Montagu, the wife of the British ambassador to Turkey, became an advocate of variolation after learning about it in Constantinople. In 1721, after she returned to England, Lady Montagu and the Princess of Wales urged variolation of “several prisoners and abandoned children” by having smallpox scabs inserted under their skin. Several months later, the children and prisoners were deliberately exposed to smallpox. When none contracted the disease, the procedure was deemed safe, and members of the royal family were treated according to this new protocol. 1
What was the purpose of Beecher's article?
The purpose of Beecher's article was to demonstrate the widespread lapse in ethical issues in medical research and to encourage reform in the ethical approach to human subjects research that inspired Congress to reconsider legislative reforms for human subject s protection.
What is the role of an institutional review board?
Institutional review boards (IRBs) have the federally mandated responsibility to review research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in the study.
What is an IRB?
Background: Institutional review boards (IRBs), duly constituted under the Office of Human Research Protection, have the federally mandated responsibility of reviewing research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in any study.
Why are investigators always in positions of potential conflict?
Others, who are independent of the research, must share this responsibility, because investigators are always in positions of potential conflict by virtue of their concern with the pursuit of knowledge as well as the welfare of the human subjects of their research.
Can a subject be asked to participate in a placebo controlled study?
A research subject may be asked to participate in a study of no benefit and no substantial risk or in a study with the potential for significant benefit but also significant risk. In placebo-controlled studies, subjects may be exposed to significant risk for no benefit to the individual.
Introduction
- Human genetic research involves the study of inherited human traits. Much of this research is aimed at identifying DNA mutations that can help cause specific health problems, developing methods of identifying those mutations in patients, and improving the interventions available to help patients address those problems. The identification of genetic...
Definitions
- Lod Score:An expression of the probability that a gene and a marker are linked. Genotype:The genetic constitution of an individual. Phenotype:The physical manifestation of a gene function. Proband:The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or character…
IRB Considerations
- It may be useful to think of genetic research as being carried out on a continuum comprising four stages: (1) pedigree studies (to discover the pattern of inheritance of a disease and to catalog the range of symptoms involved); (2) positional cloning studies (to localize and identify specific genes); (3) DNA diagnostic studies (to develop techniques for determining the presence of speci…
Points to Consider
- Does the proposed study population comprise family members? Has the appropriateness of various strategies for recruiting subjects (e.g., recruiting by the proband or other family members, by the in...
- Does the investigator plan to use the proband or the proband's clinical medical records as a source of research data about other persons (e.g., other family members)? If so, must their c…
- Does the proposed study population comprise family members? Has the appropriateness of various strategies for recruiting subjects (e.g., recruiting by the proband or other family members, by the in...
- Does the investigator plan to use the proband or the proband's clinical medical records as a source of research data about other persons (e.g., other family members)? If so, must their consent be o...
- Has the investigator established clear guidelines for disclosure of information, including interim or inconclusive research results, to the subjects? Will subjects be informed, in clear language, a...
- Will family members be protected against disclosures of medical or other personal informati…
Applicable Laws and Regulations
- Federal Policy for the Protection of Human Subjects Federal Policy §116 [Informed consent] 45 CFR 46 Subpart D [DHHS: Additional protections for children involved as subjects in research] Federal, state, and local laws or regulations governing confidentiality of information. Federal, state, and local laws or regulations pertaining to insurance. There are currently no laws or regula…