BEING PART OF RESEARCH
A note from ECHO about conduct of research.
One of the intended benefits of participation is for learners to have opportunities to be part of research projects that may arise during discussions and planning with other members in the program. Therefore, we provide you with information on the following:
- responsible conduct of research
- conflicts of interest
- responsible authorship
- policies for handling misconduct
- data management and data sharing
- human and animal subjects
- online human subjects protection training (e.g., CITI)
- sample IRB policies
Participants are guided toward learning about and adhering to their institutional guidelines and governing agencies relative to their places of employment or study.
Responsible Conduct of Research
As described by the National Institutes of Health (NIH):
Responsible conduct of research is defined as the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.
From the National Science Foundation (NSF):
The responsible and ethical conduct of research (RECR) is critical for excellence, as well as public trust, in science and engineering. The responsible and ethical conduct of research involves not only a responsibility to generate and disseminate knowledge with rigor and integrity, but also a responsibility to:
- conduct peer review with the highest ethical standards;
- diligently protect proprietary information and intellectual property from inappropriate disclosure; and
- treat students and colleagues fairly and with respect.
For further information and resources, please visit: https://www.nsf.gov/od/recr.jsp and https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html
Conflicts of Interest
From the American Psychology Association (APA):
A conflict of interests occurs when a researcher has to contend with two or more competing concerns, such as honestly reporting research results versus making a profit, achieving publication or retaining outside funding. A conflict of commitments occurs when a researcher engages in competing obligations, such as collaboration on another project, preparing a new grant application, teaching or peer review.
For legislation and guidance, refer to: https://www.apa.org/research/responsible/conflicts
Responsible Authorship
From the American Psychology Association (APA):
Authorship credit should reflect the individual’s contribution to the study. An author is considered anyone involved with initial research design, data collection and analysis, manuscript drafting, or final approval. However, the following do not necessarily qualify for authorship: providing funding or resources, mentorship, or contributing research but not helping with the publication itself. The primary author assumes responsibility for the publication, making sure that the data are accurate, that all deserving authors have been credited, that all authors have given their approval to the final draft; and handles responses to inquiries after the manuscript is published.
For guidance and further resources, please visit: https://www.apa.org/research/responsible/publication
Handling Misconduct
From the National Science Foundation (NSF):
Responding to an allegation of research misconduct tends to be a unique rather than a routine event at most institutions. There is potential, however, for a research misconduct allegation to have a high impact both on the individuals involved as well as on the institution where the alleged misconduct took place.
Factors such as the scope of the misconduct, the length of time the misconduct went undetected, the prestige of the individuals or institutions involved, the possible impact on public health or clinical treatment, retaliation against the complainant or other mishandling of the allegation, as well as the extent of media coverage can all play a role in the impact that a particular case may have on individual researchers or their institutions.
For resources (such as checklists), please refer to: https://ori.hhs.gov/handling-misconduct
Data Management and Data Sharing
From the National Institutes of Health (NIH):
Data management – the process of validating, organizing, protecting, maintaining, and processing scientific data to ensure the accessibility, reliability, and quality of the data for its users. Proper data management helps maintain scientific rigor and research integrity. Keeping good track of data and associated documentation lets researchers and collaborators use data consistently and accurately. Carefully storing and documenting data also allows more people to use the data in the future, potentially leading to more discoveries beyond the initial research.
Data sharing – sharing scientific data accelerates biomedical research discovery, enhances research rigor and reproducibility, provides accessibility to high-value datasets, and promotes data reuse for future research studies
For more information on both data management and sharing, please visit: https://sharing.nih.gov/data-management-and-sharing-policy
Human and Animal Subjects
From the National Institutes of Health (NIH):
Human subject
45 CFR Part 46 defines a human subject as a living person about whom an investigator obtains either 1) data through intervening or interacting with the person or 2) identifiable, private information.
Read definitions of these key terms:
- Human subjects. Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information.
- Individually identifiable. Describes private information regarding the identity of human subjects that an investigator may ascertain directly or through a coding system. If identity is knowable, the study is considered to be human subjects research.
- Private information. Information for which a person can expect that observations or recordings are not taking place, and the information will not be made public. Information must be individually identifiable to constitute human subjects research.
- Research using human specimens or data. Human subjects research involving individually identifiable human specimens or data and subject to federal and state regulatory requirements. For example, this would include research on living persons using:
- Bodily materials such as cells, blood, urine, tissues, organs, hair or nail clippings, even if collected by others.
- Residual diagnostic specimens, including those from routine patient care, that are kept for research rather than discarded.
- Private information, such as medical or genetic information, even if collected for another study.
For more information, visit: https://www.niaid.nih.gov/grants-contracts/human-subjects
Animal Subject
You must follow the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (referred to as PHS policy below) and the Animal Welfare Act.
The PHS policy is summarized in the NIH brochure What Investigators Need to Know About the Use of AnimalsPDF.
The PHS definition of research animal use includes production of custom antibodies and animals obtained for their tissues. Read more at Applicability of the PHS Policy.
Read about NIH animal research, policies, and crisis management at OER Animals in Research.
For more information, visit: https://www.niaid.nih.gov/grants-contracts/research-vertebrate-animals
Human Subjects Protection Training
A training in Human Subject Protection in research is either recommend or mandatory depending on your institution. Therefore, many institutions will offer training options themselves. Here are some examples of online human subject protection trainings:
https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/index.html
https://about.citiprogram.org/series/human-subjects-research-hsr/
https://phrptraining.com/about-phrp-course
https://grants.nih.gov/policy/humansubjects/research/training-and-resources.htm#Training
IRB policies
Some IRB policies may differ between institutions. Here is an example of NYU IRB policies:
For some more general information on the IRB, visit the FDA website: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions#IRBProcedures