CITI Training Responsible Conduct

Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.

Fabrication involves making up data or results, recording the data in a permanent record, sharing fake data informally or in a written report.

Falsification involves purposefully manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct.

To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.

Falsification

It is a situation where the individual who wrote the manuscript is not listed as an author.

The two main criteria used by NSF to evaluate a grant proposal are the intellectual merit and broader impacts of the proposal.

Management plans are often created to reduce the impact of conflicts of interest. Organizations often create management plans to reduce the impact of conflicts of interest rather than completely eliminating them. However, in some cases, it will be necessary to eliminate a conflict of interest.

Persons with diminished autonomy are entitled to protection.

Respect for Persons, Beneficence, Justice

Respect for Persons

45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".

The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.

Although all of these are related to the problems with the IRB system, the death of a research subject (Jesse Gelsinger) was what received public attention.

The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identification of guidelines, ethical principles and regulations came as a result of the deliberations of the National Commission.

public information

A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

Research is only eligible for exemption if all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption.

Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. Comment The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution.

For a minimum of three years after completion of the study

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Occur at least annually.

Asking women if they have had an abortion

Risks are specific to time, situation, and culture.

Protect identifiable research information from compelled disclosure.

Invasion of privacy, breach of confidentiality, and study procedures

If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the research.

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries

Provide potential subjects with information at the appropriate reading comprehension level.

There was neither a violation of privacy nor a breach of confidentiality

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.

Is there a power differential between researchers and subjects?

Economic vulnerability

Situational cognitive vulnerability

Physical control, coercion, undue influence, and manipulation Comment There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least (Nelson and Merz 2002, V69-80). The other abuses- prejudice, neglect, and disrespect - should still be avoided in research.

must be more detailed for disclosures that involve fewer than 50 subject records.

Identifiable health information that is created or held by covered entities and their business associates.

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity. Comment It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient's healthcare providers. If the contact will be made by someone other than the patient's healthcare provider, permission will be required.

Data that does not cross state lines when disclosed by the covered entity.

To all human subjects research that uses PHI without an authorization from the data subject.

An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.

Supplement those of the Common Rule and FDA.

For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.

Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.