Part 5: Protection of Informants and Defendants

Part 6: Possible penalties for research misconduct

Part 7: Summary of main points

Federal policy stipulates that researchers and research institutions are mainly responsible for reporting and investigating alleged research misconduct. What are the expected tasks of research institutions in dealing with such allegations? 42 CFR Part 50 Subpart A.

Federal policy stipulates that researchers and research institutions are mainly responsible for reporting and investigating suspected research misconduct. The expected tasks of research institutions in dealing with such allegations are detailed in 42 CFR Part 50 Subpart A. ..

Generally speaking, there are three stages in responding to allegations of improper research.

Generally speaking, the response to the allegations of misconduct in the study is divided into three stages.

Investigate and evaluate the alleged facts and the necessity of investigation. The investigation must be completed within 60 calendar days after the start, unless the situation clearly requires a longer time.

The preliminary investigation assessed the facts of the allegations and the necessity of the investigation. The preliminary investigation must be completed within 60 calendar days after the start, unless it is obvious that it takes longer.

People accused of misconduct must be informed of the allegations and investigations. A written investigation report must be prepared to summarize the evidence examined and the conclusions drawn. The defendant must be given a copy of the investigation report.

People accused of misconduct must be informed of the allegations and investigations. A written investigation report must be prepared to summarize the evidence reviewed and the conclusions drawn. A copy of the investigation report must be provided to the defendant.

If the investigation provides sufficient basis for the investigation, the investigation shall be started within 30 days after the completion of the investigation. The decision to start an investigation must be reported in writing to the Director of the Office of Research Integrity (ORI) on or before the date of investigation.

If the investigation provides sufficient basis for the investigation, the (formal) investigation should be started within 30 days after the completion of the (preliminary) investigation. The decision to start an investigation must be reported in writing to the Director of the Office of Research Integrity (ORI) on or before the date of investigation.

The survey usually includes:

Review all documents, including relevant research data, proposals, publications, letters and telephone records.

2. Interview all informants and all people accused of misconduct, as well as others who may have key information about the allegations.

Three, write a report on the results of the investigation, and let all informants and all people accused of misconduct express their opinions on the report.

Ⅳ. Submit the final report of the research funded or supported by NIH to ORI, PI, organizers and NIH.

A formal investigation usually includes:

1. Check all documents, including relevant research data, proposals, publications, letters and telephone records.

2. Interview all informants, all people accused of misconduct and others who may have key information about the allegations.

3. Prepare a report on the investigation results and provide it to all informants and all people accused of misconduct for their comments.

4. Submit the final report of the research funded or supported by NIH to ORI, PI, sponsors and NIH.

In most cases, the investigation should be completed within 120 days after the start. If the agency decides that it cannot complete the investigation within this time, it must submit a written extension request to the ORI.

In most cases, the formal investigation should be completed within 120 days after the start. If the organization decides that it cannot complete the investigation within this time, it must submit a written extension request to the ORI.

The request must explain the reasons for the delay, report the progress of the investigation so far, and estimate when the investigation will be completed and submit the final report.

The request must explain the reasons for the delay, report the progress of the investigation so far, estimate when the investigation will be completed, and submit the final report.

If the investigation finds that the allegations are well-founded, the agency can impose appropriate penalties. In addition, ORI can impose its own punishment on investigators or institutions.

If the investigation concludes that the accusation is well founded, the agency can impose appropriate punishment. In addition, ORI can impose its own punishment on investigators or institutions.

If something is found in the inquiry or investigation of research misconduct allegations, the institution must immediately notify the Research Integrity Office (ORI).

If anything is discovered during the investigation or investigation of misconduct allegations, the institution must immediately notify the Research Integrity Office (ORI).

Click to view the related contents of Clinical Trial Network (CTN).

Each CTN member institution has an official who is responsible for investigating and researching complaints of misconduct, also known as the Research Integrity Officer (RIO). When accusations of scientific misconduct are made in CTN experiments, the research integrity officer of the research institution should be contacted immediately.

Each CTN member institution should have an official who is responsible for investigating and researching misconduct complaints, also known as the Research Integrity Officer (RIO). When allegations of scientific misconduct are made in CTN experiments, the research integrity officer of the research institution should be contacted immediately.

The research integrity officer should immediately assess whether the allegation falls within the federal definition of research misconduct and whether there is sufficient evidence to support the investigation. He or she should alert the network office of NIDA clinical trial center that there are allegations of research misconduct at one or more research sites of CTN. Within the National Development Institute, the responsibility for supervising the inquiry and investigation of research misconduct is assumed by the Office of Extracurricular Affairs.

The Research Integrity Commissioner shall immediately assess whether the allegation falls within the definition of research misconduct by the federal government and whether there is sufficient evidence to support the investigation. He or she should inform the network office of NIDA Clinical Trial Center that someone has accused one or more CTN research institutions of misconduct. Within NIDA, the Office of Extracurricular Affairs is responsible for supervising the investigation and investigation of scientific misconduct.

In addition, if NIDA is the initiator of a new drug (IND) under study, NIDA must immediately report to the FDA that any person involved in human trials has committed research misconduct. If the FDA receives a complaint alleging improper testing, it will conduct an independent investigation in addition to the ORI investigation and take any necessary regulatory measures.

In addition, if NIDA is the sponsor of the research under the new drug research (IND), NIDA must immediately report to the FDA any information about any research misconduct of anyone involved in human trials. If the FDA receives a complaint alleging misconduct in the trial, it will investigate independently of the ORI investigation and take any necessary regulatory measures.

The accusation of improper research behavior may have a significant impact on the whistleblower, the defendant and the institution where the misconduct occurred. Appropriate procedures must be in place to ensure the safety of original documents, computers, biological specimens, laboratory notebooks, research and financial records and other related items that may be altered, lost or destroyed.

Allegations of research misconduct may have a significant impact on whistleblowers, defendants and institutions suspected of misconduct. Procedures must be established to ensure the safety of original documents, computers, biological specimens, laboratory notebooks, research and financial records and other related items that may be changed, lost or destroyed.

In addition, it is necessary to take specific safeguards to ensure that all those involved in the study of allegations of misconduct are protected.

In addition, it is necessary to take specific safeguards to ensure the protection of all personnel involved in the study of allegations of misconduct.

Informant (informer) refers to any member of a research institution, including non-employees, who accuses the research institution or its members of participating in or failing to respond appropriately to the allegations of misconduct in research.

Informer refers to any member of a research institution, including non-employees who claim that the institution or one of its members participated in or failed to fully respond to the allegations of misconduct in the research.

The role of whistleblower is very important to protect the integrity of research. A person who reports misconduct in good faith must be able to report it in confidence without fear of retaliation or retaliation.

The role of whistleblower is very important to protect the integrity of research. Those who report obvious misconduct in good faith must be able to report it secretly without fear of retaliation or reward.

Federal policy requires agencies to provide whistleblowers with the following protection measures:

I. Protect privacy as much as possible. However, informants cannot remain anonymous.

Second, prevent retaliation.

III. Procedures for fairly and objectively examining and resolving allegations of misconduct in scientific research.

Four, due diligence to protect the status and reputation of informants.

Federal policy requires agencies to provide whistleblowers with the following assurances:

1, as much as possible to protect privacy. However, informants cannot remain anonymous.

2. Prevent retaliation.

3. A fair and objective procedure for examining and resolving allegations of misconduct in scientific research.

4, efforts to protect the status and reputation of informants.

Neither research institutions nor individual researchers should punish those who report so-called research misconduct in good faith. Even if the accusation is not established, as long as it is in good faith, informants must be protected because they play a vital role in professional self-discipline.

Neither research institutions nor individual researchers shall punish those who report research misconduct in good faith. Even if the accusation is groundless, as long as the accusation is in good faith, whistleblowers must be protected, because they play a vital role in professional self-discipline.

Most of the allegations of research misconduct have not been proved. People accused of research misconduct must be assured that simply making accusations will not stop their research or become the basis for other disciplinary actions without convincing reasons. Other safeguards for the defendant include:

Most of the allegations of misconduct in scientific research have not been proved. People accused of research misconduct must be assured that without convincing reasons, mere accusations will not stop their research, nor will they become the basis for other disciplinary actions. Other safeguards for the defendant include:

I. Inform them in writing of the charges against them in time.

Ii. description of all charges.

Three, reasonable access to data and other evidence to support the allegations.

Ⅳ. Opportunities to respond to accusations, support evidence and any inappropriate research findings.

ⅴ, maximum confidentiality.

1. Immediately notify him in writing of the charges against him.

2. Description of all allegations.

3. Obtain reasonable data and other evidence to support the accusation.

4. Have the opportunity to respond to allegations, supporting evidence and any findings of misconduct.

5. Keep it as secret as possible.

Personnel selected to investigate allegations of improper research must have appropriate professional knowledge and no unresolved conflicts of interest.

Personnel selected to investigate allegations of misconduct must have appropriate professional knowledge and no unresolved conflicts of interest.

A reasonable time limit must be set for responding to allegations of improper research. The time can be extended if necessary.

A reasonable time limit must be set for responding to allegations of misconduct in research. If necessary, the time can be extended.

If possible, we should strictly grasp the identity information of the subjects and informants who participated in the investigation of research misconduct. However, the defendant has the right to know the identity of the informant.

If possible, we should closely understand the identities of the subjects and informants involved in the investigation and study of misconduct. However, the defendant has the right to know the identity of the informant.

Misconduct in clinical trials that may threaten the health or safety of trial participants must be immediately reported to the trial principal investigator, the federal agency sponsoring the trial (NIDA in CTN research) and the Office of Research Integrity (ORI). The name of the defendant should be kept confidential, but measures must be taken to ensure the safety of the participants in the trial.

Suspicious misconduct in clinical trials that may threaten the health or safety of trial participants must be immediately reported to the trial principal investigator, the federal agency sponsoring the trial (NIDA in the case of CTN research) and the Office of Research Integrity (ORI). The name of the defendant should be kept confidential, but measures must be taken to ensure the safety of the participants in the trial.

Research institutions can punish researchers who are found guilty of improper research behavior by terminating employment or requiring supervision of future research activities.

Research institutions can punish those researchers who are found to have research misconduct by terminating their work or asking for supervision of future research activities.

When the funded institution supports the investigation results of research misconduct of anyone engaged in a research project funded by NIH, the funded institution must evaluate the impact of the investigation results on the person's ability to continue to engage in the research project. In addition, the grantee must obtain the approval of the sponsor and NIH immediately for any change of the principal investigator or other key personnel involved in the research project.

When the research misconduct of anyone working in a research project funded by NIH is discovered with the support of the funded institution, the funded institution must evaluate the impact of the discovery on the person's ability to continue the research project. In addition, the grantee must immediately obtain the approval of the funder and NIH to replace any principal researcher or other key personnel involved in the research project.

The Research Integrity Office (ORI) can also punish research misconduct. The punishment depends on the seriousness of the misconduct. Factors that ORI may consider when choosing punishment include the degree of misconduct:

The Research Integrity Office (ORI) can also punish research misconduct. The punishment depends on the severity of the misconduct. Factors that ORI may consider when choosing punishment include the degree of misconduct:

I. It was carried out in a knowing, intentional or reckless manner.

Ⅱ. Is it an isolated event or a part of the model?

Iii. It has a significant impact on research records, research objects, other researchers, institutions or public welfare.

1, in a knowing, intentional or reckless manner.

2. It is part of an isolated event or pattern.

3. Those who have a significant impact on research records, research objects, other researchers, institutions or public welfare undertakings.

The Office of Research Integrity (ORI) may impose various penalties after discovering research misconduct. These penalties may include:

The Research Integrity Office (ORI) may impose various penalties while maintaining the investigation results of research misconduct. These penalties may include:

I. Revision of research records.

Ii. letter of reprimand.

3. Suspension or termination of research funding.

IV. Suspension or prohibition of receiving federal funds.

1. Correction of research records.

2. A letter of reprimand.

3. Suspension or termination of research funding.

4. Suspension or prohibition of receiving federal funds.

When the ORI (or FDA, which has its own bulletin board for banned and disqualified investigators) takes administrative measures, the names of these people will be made public.

When the ORI (or FDA, which has its own bulletin board for banning and disqualifying researchers) takes administrative measures, the names of these people will be published.

If the ORI believes that the research misconduct may involve criminal or civil fraud, it will immediately refer the matter to an investigation agency, such as the Ministry of Justice or the Inspector General's Office of the Ministry of Health and Human Services.

If the investigation agency believes that misconduct may involve criminal or civil fraud, it will immediately refer the matter to the investigation agency such as the Ministry of Justice or the Inspector General's Office of the Ministry of Health and Human Services.

After the public strongly protested the improper research behavior that occurred for many years, ICH GCP was established and began to operate. Follow ICH GCP guid eline to help prevent fraud and misconduct. Therefore, studying misconduct is also a form that does not conform to ICH GCP.

ICH GCP was established and began to operate after the public strongly protested the scientific misconduct that occurred for many years. Following the ICH GCP guidelines helps to prevent fraud and misconduct. Therefore, the study of misconduct is also a kind of non-compliance with ICH GCP (? )。

I. Federal policy defines research misconduct as "fabrication, forgery or plagiarism when proposing, executing or reviewing research or reporting research results". This definition does not include honest mistakes or differences of opinion or copyright disputes, unless they involve plagiarism.

1. Federal policy defines research misconduct as "fabrication, forgery or plagiarism when proposing, executing or reviewing research or reporting research results." This definition does not include honest mistakes, differences or copyright disputes unless plagiarism is involved.

Second, the federal policy on research misconduct applies to all federally funded research and all proposals submitted to federal agencies for research funding.

2. The federal policy on research misconduct applies to all federally funded research and all research funding proposals submitted to federal agencies.

3. The Office of Research Integrity (ORI) under the Department of Health and Human Services is responsible for supervising the investigation of allegations of research misconduct and making a final ruling on the investigation results of research misconduct in American public health service institutions.

3. The Office of Research Integrity (ORI) of the Department of Health and Public Health Services is responsible for supervising the investigation of allegations of research misconduct, and making a final decision on the findings of the US Public Health Service on research misconduct.

Fourth, federal policy gives researchers and research institutions the main responsibility for reporting and investigating allegations of misconduct.

4. Federal policy shifts the main responsibility of reporting and investigating allegations of scientific misconduct to researchers and research institutions.

ⅴ. Generally speaking, there are three stages in responding to allegations of misconduct in scientific research:

I. investigation (assessment of the alleged facts).

Second, the investigation (if the investigation provides sufficient basis).

Third, the ruling (if the accusation is established, the appropriate punishment will be imposed).

5. Generally speaking, the response to allegations of misconduct can be divided into three stages:

(1) Preliminary investigation (assessment of the alleged facts).

(2) Formal investigation (if the investigation provides sufficient basis).

(3) adjudication (if the accusation is found to be valuable, appropriate punishment will be imposed).

Penalties for research misconduct may include termination of employment, suspension or termination of research funding, suspension or prohibition of receiving federal funds.

6. Penalties for research misconduct may include termination of employment, suspension or termination of research funding, suspension or prohibition of receiving federal funds.