Part 5: Criteria for IRB to approve research

Part 6: Quick review

The main responsibilities of IRB include:

I. Provide an infrastructure to support the ethical review of proposed and ongoing research. ? The infrastructure includes the following IRB processes:

? Perform its functions according to written operating procedures.

? Keep written records of its activities and meeting minutes.

? Iii. Comply with all applicable federal and state regulatory requirements.

? Iv. The proposed clinical trial should be reviewed within a reasonable time.

? Make a decision at a meeting with a quorum present.

? Vi. Keep all relevant records (for example, written procedures, membership list, membership occupation/affiliation list, submitted documents, meeting minutes and correspondence) for at least 3 years and provide them when required by any regulatory body.

? Vii. Inform the investigators of their decisions in a timely manner in writing, explain the reasons for making these decisions, and indicate the appeal procedures.

1. Provide infrastructure to support ethical review of proposed and ongoing research. Includes the following IRB processes:

(1) performs its functions according to written operating procedures.

(2) Keep written records of its activities and meeting minutes.

(3) Comply with all applicable federal and state regulatory requirements.

(4) The proposed clinical trial should be reviewed within a reasonable time.

(5) Make a decision at an announcement meeting attended by a quorum.

(6) After completing the research, keep all relevant records (such as written procedures, membership list, membership occupation/affiliation list, submitted documents, meeting minutes and letters) for at least 3 years, and provide them when required by any regulatory agency.

(7) immediately notify the investigators of their decisions in writing, explain the reasons for these decisions, and explain the appeal procedure.

II. Review and understand the complete study plan. In order to conduct a comprehensive review, IRB should obtain the following documents (examples of information contained in the complete research plan):

? I. research plan and amendments to the plan.

? Ii. Written informed consent and consent update suggested by the researcher.

? Iii. Documents and other media (such as advertisements) related to the participant recruitment procedure.

? Provide written information to participants, including questionnaires and explanatory materials.

? 5. Payment and compensation information available to participants.

? Sixth, the researcher's handbook.

? Vii. Available safety information, including references of relevant documents.

? Viii. The current resume of the researcher and/or other documents proving the qualification of the researcher.

? 9. Other documents required to perform the duties of the Internal Review Committee.

2. Review and understand the whole study plan. In order to provide a comprehensive review, IRB should obtain the following documents (examples of information included in the complete research plan):

( 1)? Research plan and plan revision.

(2) Updated the written informed consent and consent to be used by researchers.

(3) Documents and other media (such as advertisements) related to the participant recruitment procedure.

(4) Written information provided to participants, including questionnaires and explanatory materials.

(5) Payment and reward information available to participants.

(6) the researcher's handbook.

(7) Available safety information, including references to relevant documents.

(8) The current resume of the researcher and/or other documents providing the qualification certificate of the researcher.

(9) Any other documents required to perform IRB duties.

Iii. Keep written records of IRB decisions. ? The following written records related to IRB's review of the proposed study shall be kept:

? First, the identification of research.

? Second, review the list of documents.

? Decisions reached: approval, disapproval and reasons for disapproval.

? 4. Termination or suspension of pre-approval.

? 5. Date of reaching a resolution.

? 6. Communication with researchers.

3. Keep a written record of IRB decisions. Regarding IRB's review of the proposed study, the following written records shall be kept:

(1) research and identification.

(2) Review the list of documents.

(3)? Decisions reached: approval, disapproval and reasons for disapproval.

(4)? Pre-approved termination or suspension.

(5)? The date of the decision.

(6)? Correspondence with investigators.

Fourth, consider the qualifications of researchers

IRB shall consider the qualifications of the researcher for the proposed study as recorded in the current resume or other relevant documents.

4. Consider the qualifications of researchers.

IRB should consider the qualifications of the researcher who proposed the study, as recorded in the current resume or other relevant documents.

ⅴ. Continuously review the ongoing research.

IRB continuously reviews each ongoing study at appropriate intervals according to the risk level of human participants. According to the regulations, this interval must be at least once a year.

5. Keep the ongoing research under review.

IRB continuously reviews each ongoing study at appropriate intervals according to the risk level of human participants. According to the regulations, this interval should be at least once a year.

ⅵ. Ask for more information when necessary.

IRB may ask for more information to help them with the review. One of the reasons for making such a request is that IRB believes that additional information will be meaningful for the protection of the rights, safety or well-being of participants.

6. Ask for more information if necessary

IRB may request more information to assist its review. One of the reasons for this requirement is that IRB believes that supplementary information will help protect the rights, safety or well-being of participants.

Seven, review the participation award

The amount paid to the participants in the study or the distribution method must not be mandatory. (The informed consent unit also discussed this issue. )。 )

IRB should review the amount and method of payment to the participants to ensure that neither party will exert undue influence on the research participants. The remuneration paid to the participants should be distributed in proportion (proportional distribution), not entirely depending on the participants' completion of the research (there is no large comprehensive payment in the end).

IRB shall confirm the information about the payment to the participants, including the method, amount and schedule of payment to the research participants, which meet the requirements of the scheme and are specified in the written informed consent form and any other written information provided to the participants. You should specify the method of prorating payment.

Some IRBs have written requirements for appropriate compensation for research participants. Researchers should be familiar with these requirements before submitting the scheme to IRB for approval.

7. Review the motivation for participation.

No matter in the amount or distribution, the payment to the research participants can not be mandatory. (This issue will also be discussed in the informed consent module. )。 )

IRB shall review the amount and method of payment to the subjects to ensure that neither party will have undue influence on the research subjects. The payment to the participants should be distributed in proportion (proportional distribution), and it does not depend entirely on the completion of the research by the participants (no large consolidated payment will be made in the end).

IRB shall confirm that the information paid to the participants, including the method, amount and schedule of payment to the research participants, conforms to this Agreement and is specified in the written informed consent form and any other written information provided to the participants. The method of proportional payment shall be specified.

Some IRBs have written requirements for the appropriate remuneration of research participants. Researchers should be familiar with these requirements before submitting the plan to IRB for approval.

The Belmont Report, the report of the National Committee for the Protection of Human Subjects in Biomedical and Behavioral Research, established three key principles of the current human research protection system: respect for human beings, charity (not harming/maximizing possible benefits and minimizing possible harm) and justice. These principles are the basis of the criteria for IRB to approve research (see Belmont Report).

Belmont Report is a report of the National Committee for the Protection of Human Subjects in Biomedical and Behavioral Research in the United States, which establishes three key principles of the current human research protection system: respect for people, charity (harmless/benefit as much as possible, harm as little as possible) and justice. These principles are the basis for IRB to approve research standards (refer to Belmont Report).

The guidance for users is as follows: Choose from three principles related to a given standard and description: respect; Charity? ; Justice. Then, after selecting the relevant principles, we will give you feedback.

Instruct users as follows: Choose from three principles related to a given standard and description: respect? ; Charity; Justice. Then, after selecting the relevant principles, your answers will be fed back.

Standard 1: Minimize the risk of participants.

IRB shall ensure that the procedures used in the proposed research conform to the reasonable research design, and will not expose participants to unnecessary risks, and, where appropriate, include diagnosis or treatment procedures that will not bring further risks.

Standard 1: Minimize the risks faced by participants.

IRB shall ensure that the procedures used in the proposed study conform to the reasonable study design, and will not expose participants to unnecessary risks, and, where appropriate, include diagnosis or treatment procedures that will not cause further risks.

Criterion 2: The risk of the participant is reasonable relative to the expected return.

IRB should only consider the possible risks and benefits of the study, not the risks and benefits of the treatment that participants will receive even if they are not involved in the study. IRB should not consider the possible long-term impact of the knowledge gained in applied research.

Criterion 2: Relative to the expected return, the risk of participants is reasonable.

IRB should only consider the possible risks and benefits of the research results, which is different from the risks and benefits of participants participating in treatment, even if they are not involved in the research. IRB should not consider the possible long-term impact of the knowledge gained in applied research.

Criterion 3: The selection of participants is fair.

No single gender or race, nationality or socio-economic group should bear the burden of research or gain the benefits of research disproportionately. IRB should ensure that the gender, race, nationality and socio-economic status of the participants in the study match those who are expected to benefit from the study as much as possible.

IRB should also pay attention to the special challenges of research involving vulnerable groups, such as children, prisoners, pregnant women, mentally disabled people or economically or educationally disadvantaged groups.

Criterion 3: The choice of participants is fair.

There is no single gender or race, and ethnic or socio-economic groups should bear a disproportionate burden or benefit from research. IRB should ensure that the gender, race, ethnicity and socio-economic status of the research are as close as possible to those who are expected to benefit from the research.

IRB should also pay attention to the special challenges of research involving vulnerable groups, such as children, prisoners, pregnant women, mentally disabled people or economically or educationally disadvantaged groups.

Standard 4: Obtain and record informed consent appropriately.

IRB must review the informed consent and ensure that informed consent is obtained from each prospective participant or the authorized representative office of the participant. IRB must also ensure that the process of obtaining informed consent is properly documented. (This topic will be discussed in detail in the informed consent module. )

Adequate preparations have been made for monitoring the collected data to ensure the safety of participants.

IRB must review plans for data collection, storage and analysis and ensure the safety of participants. This includes plans to capture and report information on adverse events. (Adverse events are included in the Participant Safety and Adverse Events module. )

Complex or high-risk research may require data and safety monitoring plans. Some organizers may require all research to have a data security monitoring plan. For example, in the clinical trial network, all research must have a data and safety monitoring plan, which is monitored by the Data and Safety Monitoring Committee.

Standard 4: Obtaining and recording informed consent correctly.

IRB must review the informed consent form and ensure that the informed consent of each potential participant or legally authorized representative of the participant is sought. IRB must also ensure that the process of obtaining informed consent is properly documented. (This topic will be discussed in detail in the informed consent module. )

Adequate provisions have been made for monitoring the collected data to ensure the safety of participants.

IRB must review the data collection, storage and analysis plan and ensure the safety of participants. This includes plans to obtain and report information on adverse events. (Adverse events are included in the Participant Safety and Adverse Events module)

Complex or high-risk research may require data and security monitoring plans. Some organizers may require all research to have a data security monitoring plan. For example, in the clinical trial network, all research must have a data and safety monitoring plan, which is monitored by the Data and Safety Monitoring Committee.

Standard 5: Adequate provisions are made to protect the privacy of participants and maintain the confidentiality of data.

Protect the privacy of participants. IRB must consider whether the research involves invasion of privacy. Factors to consider include:

I. Privacy or sensitivity of the information sought.

Ii. Participants regard the research as the possibility of invasion of privacy.

Third, the importance of research.

Ⅳ. Whether there are alternative methods to study.

Confidentiality of data. IRB must evaluate whether there are sufficient regulations to protect the confidentiality of the information collected. (See Security Module. )

Feedback: Which of the three principles is related to this standard: respect, kindness or justice? This standard relates to the principle of respecting people in the Belmont Report.

Standard 5: Adequate regulations are made to protect the privacy of participants and maintain the confidentiality of data.

Protect the privacy of participants. IRB must consider whether the research involves invasion of privacy. Factors to consider include:

1. The privacy or sensitive nature of the information sought.

2. Participants think that this research may invade privacy.

3. The importance of research.

4. Is there any alternative method to carry out the research?

Confidentiality of data. IRB must evaluate whether there are sufficient regulations to protect the confidentiality of the collected information. (See Security Module)

Standard 6: Provide additional protection for vulnerable groups.

Some people's willingness to voluntarily participate in clinical trials may be improperly influenced by the expectation of benefits related to participation (whether reasonable or not), or threatened by the actual or perceived situation of people in an authoritative position. Examples of these vulnerable groups include:

I. Children.

Ii. prisoners.

Ⅲ. Pregnant women.

Ⅳ. Mentally disabled persons.

ⅴ. The economically or educationally disadvantaged.

ⅵ. Patients with incurable diseases.

ⅶ. Patients in emergency.

Students majoring in medicine, nursing, dentistry and pharmacy.

Nine, subordinate hospital staff.

X. Members of the armed forces.

When some or all participants in a study may come from disadvantaged groups, IRB must ensure that the study contains appropriate additional safeguards to protect the rights and welfare of these participants. Such additional safeguards may include:

I. Strengthen the monitoring of informed consent process. In some cases, IRB may wish to approve each participant to join the study.

Ii. changes in the composition of IRB. For example, when reviewing research involving prisoners, at least one voting member (or alternate member) in IRB must be a prisoner or a prisoner representative with appropriate background and experience. If a specific research project is under the jurisdiction of more than one IRB, each recorded IRB needs to meet this requirement.

Standard 6: Including additional protection for vulnerable groups.

The willingness of some individuals to voluntarily participate in clinical trials may be excessively influenced by the expectation of benefits related to participation (whether reasonable or not), or threatened by the reality or perception of people in an authoritative position. Examples of such vulnerable groups include:

1, son.

2. prisoners.

3. Pregnant women.

4. People with mental retardation.

5, economically or educationally disadvantaged people.

6. Patients with incurable diseases.

7. Emergency patients.

8. Students majoring in medicine, nursing, dentistry and pharmacy.

9. Hospital staff.

Members of the armed forces.

When some or all participants in the study may come from vulnerable groups, IRB must ensure that the study includes appropriate additional safeguards to protect the rights and welfare of these participants. Such additional safeguards may include:

1. Strengthen the monitoring of informed consent process. In some cases, IRB may wish to approve each participant to participate in the study.

2. Changes in the composition of internal rating agencies. For example, when reviewing research involving prisoners, at least one voting member (or alternate member) of IRB must be a prisoner or a prisoner representative with appropriate background and experience and serve in this capacity. If a specific research project is under the jurisdiction of more than one IRB, each recorded IRB needs to meet this requirement.

Feedback 1- charity; Feedback 2-charity; Feedback 3-Justice; Feedback 4-respect; Feedback 5-respect; Feedback 6- Charity and respect.

IRB can use the fast review procedure for the following studies:

I, involving only minimal risks and

Ii. It belongs to the category that appears in the approved list of research categories eligible for rapid review.

IRB can use the fast review process to conduct the following studies:

1, involving the least risk and danger.

2. It belongs to the category on the approved list of research categories that meet the requirements for emergency review.

IRB can also use quick review to approve minor changes to previously approved studies during the authorization period (1 year or less). IRB must have written procedures on how to conduct quick review.

IRB can also use quick review to approve minor changes to previously approved studies during the authorization approval period (1 year or less). IRB must establish written procedures on how to conduct rapid review.

The IRB Chairman or one or more experienced IRB members designated by the Chairman can conduct a quick review (which may shorten the waiting time for IRB approval). Reviewers can exercise all the powers of IRB except not approving research. Only all members of IRB can veto the proposal to submit a quick review.

The quick review can be conducted by the IRB Chairman or one or more experienced IRB members designated by the Chairman (this may reduce the time waiting for IRB approval). Reviewers can exercise all the rights of IRB, except the right not to approve the research. Proposals submitted for quick review can only be rejected by the complete IRB.

The Department of Health and Human Services has decided that certain types of research do not involve more than a minimum risk and are therefore eligible for accelerated review.

The Department of Health and Human Services (HHS) has determined that certain types of research involve minimal risks and are therefore eligible for rapid review.

The following are examples of research that meet the requirements of rapid review:

I. Collection of hair or deciduous teeth.

Ii. collect external secretions, including sweat and saliva.

Iii. Record the data from adults using non-invasive procedures commonly used in clinical practice (excluding exposure to electromagnetic radiation outside the visible range, such as X-rays or microwaves). )

Ⅳ, venous puncture to collect blood samples.

ⅴ Recording for research purposes, such as speech defect investigation.

ⅵ. Healthy volunteers should exercise moderately.

ⅶ. Research on existing data, documents, records, pathological specimens or diagnostic specimens.

The following are examples of studies that meet the requirements for quick review:

1, collect hair or deciduous teeth.

2. Collect exocrine fluid, including sweat and saliva.

3. Use non-invasive procedures commonly used in clinical practice to record adult data (excluding exposure to electromagnetic radiation outside the visible range, such as X-rays or microwaves).

4, venous puncture to collect blood samples.

5. Phonetic records recorded for research purposes, such as voice defect investigation.

6. Healthy volunteers should exercise moderately.

7, the existing data, documents, records, pathological specimens or diagnostic specimens.

For more information about the types of research eligible for quick review, please visit the website of the Office for the Protection of Human Research.

For more information about the types of research eligible for quick review, please visit the website of the Office for the Protection of Human Research.