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Protocol (science)

In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories.[1][2] Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review.[3] In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias.[2]

Similarly, a protocol may refer to the procedural methods of health organizations, commercial laboratories, manufacturing plants, etc. to ensure their activities (e.g., blood testing at a hospital, testing of certified reference materials at a calibration laboratory, and manufacturing of transmission gears at a facility) are consistent to a specific standard, encouraging safe use and accurate results.[4][5][6]

Finally, in the field of social science, a protocol may also refer to a "descriptive record" of observed events[7][8] or a "sequence of behavior"[9] of one or more organisms, recorded during or immediately after an activity (e.g., how an infant reacts to certain stimuli or how gorillas behave in natural habitat) to better identify "consistent patterns and cause-effect relationships."[7][10] These protocols may take the form of hand-written journals or electronically documented media, including video and audio capture.[7][10]

Experiment and study protocol Edit

Various fields of science, such as environmental science and clinical research, require the coordinated, standardized work of many participants. Additionally, any associated laboratory testing and experiment must be done in a way that is both ethically sound and results can be replicated by others using the same methods and equipment. As such, rigorous and vetted testing and experimental protocols are required. In fact, such predefined protocols are an essential component of Good Laboratory Practice (GLP)[11] and Good Clinical Practice (GCP)[12][13] regulations. Protocols written for use by a specific laboratory may incorporate or reference standard operating procedures (SOP) governing general practices required by the laboratory. A protocol may also reference applicable laws and regulations that are applicable to the procedures described. Formal protocols typically require approval by one or more individuals—including for example a laboratory directory, study director,[11] and/or independent ethics committee[12]: 12 —before they are implemented for general use. Clearly defined protocols are also required by research funded by the National Institutes of Health.[14]

In a clinical trial, the protocol is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.[11][12] Since 1996, clinical trials conducted are widely expected to conform to and report the information called for in the CONSORT Statement, which provides a framework for designing and reporting protocols.[15] Though tailored to health and medicine, ideas in the CONSORT statement are broadly applicable to other fields where experimental research is used.

Protocols will often address:[2][11][12]

  • safety: Safety precautions are a valuable addition to a protocol, and can range from requiring goggles to provisions for containment of microbes, environmental hazards, toxic substances, and volatile solvents. Procedural contingencies in the event of an accident may be included in a protocol or in a referenced SOP.
  • procedures: Procedural information may include not only safety procedures but also procedures for avoiding contamination, calibration of equipment, equipment testing, documentation, and all other relevant issues. These procedural protocols can be used by skeptics to invalidate any claimed results if flaws are found.
  • equipment used: Equipment testing and documentation includes all necessary specifications, calibrations, operating ranges, etc. Environmental factors such as temperature, humidity, barometric pressure, and other factors can often have effects on results. Documenting these factors should be a part of any good procedure.
  • reporting: A protocol may specify reporting requirements. Reporting requirements would include all elements of the experiments design and protocols and any environmental factors or mechanical limitations that might affect the validity of the results.
  • calculations and statistics: Protocols for methods that produce numerical results generally include detailed formulas for calculation of results. A formula may also be included for preparation of reagents and other solutions required for the work. Methods of statistical analysis may be included to guide interpretation of the data.
  • bias: Many protocols include provisions for avoiding bias in the interpretation of results. Approximation error is common to all measurements. These errors can be absolute errors from limitations of the equipment or propagation errors from approximate numbers used in calculations. Sample bias is the most common and sometimes the hardest bias to quantify. Statisticians often go to great lengths to ensure that the sample used is representative. For instance political polls are best when restricted to likely voters and this is one of the reasons why web polls cannot be considered scientific. The sample size is another important concept and can lead to biased data simply due to an unlikely event. A sample size of 10, i.e., polling 10 people, will seldom give valid polling results. Standard deviation and variance are concepts used to quantify the likely relevance of a given sample size. The placebo effect and observer bias often require the blinding of patients and researchers as well as a control group.[12][16]

Best practice recommends publishing the protocol of the review before initiating it to reduce the risk of unplanned research duplication and to enable transparency, and consistency between methodology and protocol.[17]

Blinded protocols Edit

A protocol may require blinding to avoid bias.[16][18] A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constrains.[19]

During the course of an experiment, a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them. Unblinding that occurs before the conclusion of a study is a source of experimental error, as the bias that was eliminated by blinding is re-introduced. Unblinding is common in blind experiments, and must be measured and reported. Reporting guidelines recommend that all studies assess and report unblinding. In practice, very few studies assess unblinding.[20]

An experimenter may have latitude defining procedures for blinding and controls but may be required to justify those choices if the results are published or submitted to a regulatory agency. When it is known during the experiment which data was negative there are often reasons to rationalize why that data shouldn't be included. Positive data are rarely rationalized the same way.

See also Edit

References Edit

  1. ^ Hinkelmann, K.; Kempthorne, O. (1994). Design and Analysis of Experiments: Introduction to Experimental Design. Vol. 1. John Wiley & Sons. p. 11. ISBN 0471551783. Retrieved 22 March 2019.
  2. ^ a b c Selwyn, M.R. (1996). Principles of Experimental Design for the Life Sciences. CRC Press. pp. 12–13. ISBN 0849394619. Retrieved 22 March 2019.
  3. ^ Desposato, S. (2015). Ethics and Experiments: Problems and Solutions for Social Scientists and Policy Professionals. Routledge. p. PT382. ISBN 9781317438663.
  4. ^ American Society for Microbiology (2016). "Laboratory Protocols". Retrieved 22 March 2019.
  5. ^ National Research Council Canada (June 2003). "Recommended practices for calibration laboratories". Retrieved 22 March 2019.
  6. ^ Nash, T. (July 2005). "Automotive Protocols & Standards". Motor. Retrieved 22 March 2019.
  7. ^ a b c Thiagarajan, S. (1980). Protocol Packages. Educational Technology Publications. p. 3. ISBN 0877781516. Retrieved 22 March 2019.
  8. ^ Reading, H.F. (1996). Dictionary of the Social Sciences. Atlantic Publishers and Distributors. p. 164. ISBN 8171566057. Retrieved 23 March 2019.
  9. ^ Fiske, D.W. (1986). Metatheory in Social Science: Pluralisms and Subjectivities. University of Chicago Press. pp. 61–62. ISBN 0226251926. Retrieved 22 March 2019.
  10. ^ a b O'Shaughnessy, J. (2012). Consumer Behaviour: Perspectives, Findings and Explanations. Palgrave Macmillan. pp. 71–2. ISBN 9781137003768.
  11. ^ a b c d UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (2001). "Chapter 2: Good Laboratory Practice Training" (PDF). Handbook: Good laboratory practice (GLP). World Health Organization. pp. 16–18, 29–33. Retrieved 6 October 2023.
  12. ^ a b c d e World Health Organization (2005). "Handbook for good clinical research practice (GCP): Guidance for implementation" (PDF). WHO. pp. 27–34. Retrieved 6 October 2023.
  13. ^ "Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)" (PDF). ich.org. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 9 November 2016. pp. 34–37. Retrieved 6 October 2023.
  14. ^ National center for Complementary and Integrative Health (24 July 2018). "NCCIH Clinical Research Toolbox". NIH. Retrieved 23 March 2019. NCCIH requires that study investigators submit a final protocol document for all funded clinical projects.
  15. ^ "History". CONSORT. Retrieved 23 March 2019.
  16. ^ a b Holman, L.; Head, M.L.; Lanfear, R.; Jennions, M.D. (2015). "Evidence of Experimental Bias in the Life Sciences: Why We Need Blind Data Recording". PLOS Biology. 13 (7): e1002190. doi:10.1371/journal.pbio.1002190. PMC 4496034. PMID 26154287.
  17. ^ PRISMA-P Group; Moher, David; Shamseer, Larissa; Clarke, Mike; Ghersi, Davina; Liberati, Alessandro; Petticrew, Mark; Shekelle, Paul; Stewart, Lesley A (1 January 2015). "Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement". Systematic Reviews. 4 (1): 1. doi:10.1186/2046-4053-4-1. ISSN 2046-4053. PMC 4320440. PMID 25554246.
  18. ^ Salkind, N.J., ed. (2010). "Triple-Blind Study". Trible-Blind Study. Encyclopedia of Research Design. Sage. doi:10.4135/9781412961288.n471. ISBN 9781412961271. Retrieved 23 March 2019.
  19. ^ David, Sharoon; Khandhar, Paras B. (2021), "Double-Blind Study", StatPearls, Treasure Island (FL): StatPearls Publishing, PMID 31536248, retrieved 2021-08-10
  20. ^ Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn (October 2014). "The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications". Journal of Clinical Epidemiology. 67 (10): 1059–1069. doi:10.1016/j.jclinepi.2014.05.007. ISSN 1878-5921. PMID 24973822.

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Protocol at Wikipedia s sister projects Definitions from WiktionaryTextbooks from Wikibooks In natural and social science research a protocol is most commonly a predefined procedural method in the design and implementation of an experiment Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories 1 2 Additionally and by extension protocols have the advantage of facilitating the assessment of experimental results through peer review 3 In addition to detailed procedures equipment and instruments protocols will also contain study objectives reasoning for experimental design reasoning for chosen sample sizes safety precautions and how results were calculated and reported including statistical analysis and any rules for predefining and documenting excluded data to avoid bias 2 Similarly a protocol may refer to the procedural methods of health organizations commercial laboratories manufacturing plants etc to ensure their activities e g blood testing at a hospital testing of certified reference materials at a calibration laboratory and manufacturing of transmission gears at a facility are consistent to a specific standard encouraging safe use and accurate results 4 5 6 Finally in the field of social science a protocol may also refer to a descriptive record of observed events 7 8 or a sequence of behavior 9 of one or more organisms recorded during or immediately after an activity e g how an infant reacts to certain stimuli or how gorillas behave in natural habitat to better identify consistent patterns and cause effect relationships 7 10 These protocols may take the form of hand written journals or electronically documented media including video and audio capture 7 10 Contents 1 Experiment and study protocol 1 1 Blinded protocols 2 See also 3 ReferencesExperiment and study protocol EditVarious fields of science such as environmental science and clinical research require the coordinated standardized work of many participants Additionally any associated laboratory testing and experiment must be done in a way that is both ethically sound and results can be replicated by others using the same methods and equipment As such rigorous and vetted testing and experimental protocols are required In fact such predefined protocols are an essential component of Good Laboratory Practice GLP 11 and Good Clinical Practice GCP 12 13 regulations Protocols written for use by a specific laboratory may incorporate or reference standard operating procedures SOP governing general practices required by the laboratory A protocol may also reference applicable laws and regulations that are applicable to the procedures described Formal protocols typically require approval by one or more individuals including for example a laboratory directory study director 11 and or independent ethics committee 12 12 before they are implemented for general use Clearly defined protocols are also required by research funded by the National Institutes of Health 14 In a clinical trial the protocol is carefully designed to safeguard the health of the participants as well as answer specific research questions A protocol describes what types of people may participate in the trial the schedule of tests procedures medications and dosages and the length of the study While in a clinical trial participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment 11 12 Since 1996 clinical trials conducted are widely expected to conform to and report the information called for in the CONSORT Statement which provides a framework for designing and reporting protocols 15 Though tailored to health and medicine ideas in the CONSORT statement are broadly applicable to other fields where experimental research is used Protocols will often address 2 11 12 safety Safety precautions are a valuable addition to a protocol and can range from requiring goggles to provisions for containment of microbes environmental hazards toxic substances and volatile solvents Procedural contingencies in the event of an accident may be included in a protocol or in a referenced SOP procedures Procedural information may include not only safety procedures but also procedures for avoiding contamination calibration of equipment equipment testing documentation and all other relevant issues These procedural protocols can be used by skeptics to invalidate any claimed results if flaws are found equipment used Equipment testing and documentation includes all necessary specifications calibrations operating ranges etc Environmental factors such as temperature humidity barometric pressure and other factors can often have effects on results Documenting these factors should be a part of any good procedure reporting A protocol may specify reporting requirements Reporting requirements would include all elements of the experiments design and protocols and any environmental factors or mechanical limitations that might affect the validity of the results calculations and statistics Protocols for methods that produce numerical results generally include detailed formulas for calculation of results A formula may also be included for preparation of reagents and other solutions required for the work Methods of statistical analysis may be included to guide interpretation of the data bias Many protocols include provisions for avoiding bias in the interpretation of results Approximation error is common to all measurements These errors can be absolute errors from limitations of the equipment or propagation errors from approximate numbers used in calculations Sample bias is the most common and sometimes the hardest bias to quantify Statisticians often go to great lengths to ensure that the sample used is representative For instance political polls are best when restricted to likely voters and this is one of the reasons why web polls cannot be considered scientific The sample size is another important concept and can lead to biased data simply due to an unlikely event A sample size of 10 i e polling 10 people will seldom give valid polling results Standard deviation and variance are concepts used to quantify the likely relevance of a given sample size The placebo effect and observer bias often require the blinding of patients and researchers as well as a control group 12 16 Best practice recommends publishing the protocol of the review before initiating it to reduce the risk of unplanned research duplication and to enable transparency and consistency between methodology and protocol 17 Blinded protocols Edit A protocol may require blinding to avoid bias 16 18 A blind can be imposed on any participant of an experiment including subjects researchers technicians data analysts and evaluators In some cases while blinding would be useful it is impossible or unethical A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constrains 19 During the course of an experiment a participant becomes unblinded if they deduce or otherwise obtain information that has been masked to them Unblinding that occurs before the conclusion of a study is a source of experimental error as the bias that was eliminated by blinding is re introduced Unblinding is common in blind experiments and must be measured and reported Reporting guidelines recommend that all studies assess and report unblinding In practice very few studies assess unblinding 20 An experimenter may have latitude defining procedures for blinding and controls but may be required to justify those choices if the results are published or submitted to a regulatory agency When it is known during the experiment which data was negative there are often reasons to rationalize why that data shouldn t be included Positive data are rarely rationalized the same way See also EditAdaptive clinical trial Blocking statistics Design of experiments DRAKON Estimation Estimation theory Margin of error Medical guideline Milwaukee protocol Observational error Paradigm experimental Propagation of error Protein methods and Nucleic acid methods Random error Randomized controlled trial Royal Commission on Animal Magnetism Sample statistics Sample size Sampling error Scientific control Standard deviation Statistical population Survey sampling Systematic errorReferences Edit Hinkelmann K Kempthorne O 1994 Design and Analysis of Experiments Introduction to Experimental Design Vol 1 John Wiley amp Sons p 11 ISBN 0471551783 Retrieved 22 March 2019 a b c Selwyn M R 1996 Principles of Experimental Design for the Life Sciences CRC Press pp 12 13 ISBN 0849394619 Retrieved 22 March 2019 Desposato S 2015 Ethics and Experiments Problems and Solutions for Social Scientists and Policy Professionals Routledge p PT382 ISBN 9781317438663 American Society for Microbiology 2016 Laboratory Protocols Retrieved 22 March 2019 National Research Council Canada June 2003 Recommended practices for calibration laboratories Retrieved 22 March 2019 Nash T July 2005 Automotive Protocols amp Standards Motor Retrieved 22 March 2019 a b c Thiagarajan S 1980 Protocol Packages Educational Technology Publications p 3 ISBN 0877781516 Retrieved 22 March 2019 Reading H F 1996 Dictionary of the Social Sciences Atlantic Publishers and Distributors p 164 ISBN 8171566057 Retrieved 23 March 2019 Fiske D W 1986 Metatheory in Social Science Pluralisms and Subjectivities University of Chicago Press pp 61 62 ISBN 0226251926 Retrieved 22 March 2019 a b O Shaughnessy J 2012 Consumer Behaviour Perspectives Findings and Explanations Palgrave Macmillan pp 71 2 ISBN 9781137003768 a b c d UNDP World Bank WHO Special Programme for Research and Training in Tropical Diseases 2001 Chapter 2 Good Laboratory Practice Training PDF Handbook Good laboratory practice GLP World Health Organization pp 16 18 29 33 Retrieved 6 October 2023 a b c d e World Health Organization 2005 Handbook for good clinical research practice GCP Guidance for implementation PDF WHO pp 27 34 Retrieved 6 October 2023 Integrated Addendum to ICH E6 R1 Guideline for Good Clinical Practice E6 R2 PDF ich org International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH 9 November 2016 pp 34 37 Retrieved 6 October 2023 National center for Complementary and Integrative Health 24 July 2018 NCCIH Clinical Research Toolbox NIH Retrieved 23 March 2019 NCCIH requires that study investigators submit a final protocol document for all funded clinical projects History CONSORT Retrieved 23 March 2019 a b Holman L Head M L Lanfear R Jennions M D 2015 Evidence of Experimental Bias in the Life Sciences Why We Need Blind Data Recording PLOS Biology 13 7 e1002190 doi 10 1371 journal pbio 1002190 PMC 4496034 PMID 26154287 PRISMA P Group Moher David Shamseer Larissa Clarke Mike Ghersi Davina Liberati Alessandro Petticrew Mark Shekelle Paul Stewart Lesley A 1 January 2015 Preferred reporting items for systematic review and meta analysis protocols PRISMA P 2015 statement Systematic Reviews 4 1 1 doi 10 1186 2046 4053 4 1 ISSN 2046 4053 PMC 4320440 PMID 25554246 Salkind N J ed 2010 Triple Blind Study Trible Blind Study Encyclopedia of Research Design Sage doi 10 4135 9781412961288 n471 ISBN 9781412961271 Retrieved 23 March 2019 David Sharoon Khandhar Paras B 2021 Double Blind Study StatPearls Treasure Island FL StatPearls Publishing PMID 31536248 retrieved 2021 08 10 Bello Segun Moustgaard Helene Hrobjartsson Asbjorn October 2014 The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications Journal of Clinical Epidemiology 67 10 1059 1069 doi 10 1016 j jclinepi 2014 05 007 ISSN 1878 5921 PMID 24973822 Retrieved from https en wikipedia org w index php title Protocol science amp oldid 1179270571, wikipedia, wiki, book, books, library,

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