Ethics in Quantitative Research Methods

Transcription

1 Ethics in Quantitative Research Methods Mala Ramanathan AMCHSS, SCTIMST Short Term Training Program Ethics in Social Science Research Related to Health ICMR, New Delhi and CSER, Mumbai 27 Nov 1 Dec 2006, Golden Huts Resorts, Haryana ICMR-CSER 1

2 Potential for Ethical Problems in Quantitative Research Related to the stage of research Formulating the research questions Designing the study: Types of studies and ethics Collecting data: data collection processes Analysis Reporting ICMR-CSER 2

3 Formulating the Research Questions Influenced by: The ideological position of the researcher The political economic context in which the research is taken up The various stakeholders including the funding agencies, the researchers, the nation state as a player, the global situation ICMR-CSER 3

4 The study on the declining sex ratio in India the type of research questions Would be different if you believe: that there is a need to strengthen state regulation of the PNDT Act that there is too much interference into family size decision making and these are matters that are best left to the citizens of the state to decide and that women who are unable to have access to MTPs may rendered vulnerable in the domestic environment ICMR-CSER 4

5 Formulating the Research Questions This in turn influences- The manner in which you review the existing evidence The nature of the data collection process that would be used and the analysis ICMR-CSER 5

6 Data Collection Methods Quantitative data collection methods Qualitative data collection methods ICMR-CSER 6

7 Quantitative data collection methods ICMR-CSER 7

8 Departures Quantitative studies to test hypothesis and determine causality, measure the extent of problems, Nature: method and design determined in advance(apriori) Inappropriate/bad science to change mid-way therefore unethical ICMR-CSER 8

9 Study designs Experiments best for establishing causality Ethical issues in selecting the control group, to use or not use the placebo etc, Observational studies best suited when experiments are not possible eg. Cell phone use and seizures Control confounders, qualify conclusions Sample surveys Types of questionnaires and ethics, sample size estimation -sampling and non-sampling errors ICMR-CSER 9

10 Guidance: Professional Ethics Guidelines ASA (American Statistical Association Guidelines/Sociological Guidelines) AAA (American Anthropological Association) AMMA(American Medical Anthropological Association) ISA (International Statistical Association) Professional Guidelines NCESSRH Guidelines (social scientists working in health) in India ICMR-CSER 10

11 Potential Problems ICMR-CSER 11

12 Potential problems with data gathering Collecting data without appropriate controls Omitting controls that others have pointed out Using inappropriate sample sizes Selecting what to observe Failing to see events or seeing non-existing ones Failing to preserve data for a sufficiently long time ICMR-CSER 12

13 Potential problems with data processing Editing data Making up data Using inappropriate statistical tests Violating the statistical assumptions Performing multiple statistical tests Reporting only positive or significant results ICMR-CSER 13

14 Reporting findings -1 Using other people s words or data(plagiarism) Not reporting contradictory findings Putting your name on work that you did not do Not reporting others related or contradictory findings Writing an abstract with no data Publishing the same evidence many times Failing to submit oneself to review or obtaining permission from authors ICMR-CSER 14

15 Reporting findings - 2 Changing the hypothesis of the paper Gradually changing from far out possibility to established fact Concluding cause and effect when only correlation is found Failing to report negative findings ICMR-CSER 15

16 Ethics of Reviewing Obtaining a secondary citation for one s own publication Pirating the topic of a paper Providing reverse criticism on a second review Quibbling excessively over minor points Blocking publication for invalid or unscientific reasons ICMR-CSER 16

17 Role of scientific judgment Young scientists should understand all the subtle ways in which they can delude themselves in the design of observations and the interpretation of data and statistics. They should understand metrology and should know what tendencies to manipulate information are built into their digital signal processors. They should also get to know the algorithms used in their favourite computers, which may under certain circumstances give strange results. Above all they should be trained in detection and control of systematic errors. -Branscomb, L.M. Integrity in science. American Scientist 73: , 1985 reported in Mann MD - ICMR-CSER 17

18 The role of scientific judgment Develop healthy skepticism Acquire technical skills both analytical skills Learn appropriate design of scientific experiments Be conscious of experimenter bias and limitations of analysis Learn about how to give due credit ICMR-CSER 18

19 Mechanisms for continuing review Data and safety monitoring is the process for reviewing accumulated outcome data from an ongoing study to ensure the continuing safety of current participants and those yet to be enrolled, as well as the continuing validity and scientific merit. (usually used in clinical trials) ICMR-CSER 19

20 Data and Safety Monitoring Plan (DSMP) should be tailored to the nature, size, and complexity of the research protocol, the expected risks of the research, and the type of subject population being studied ICMR-CSER 20

21 What does the DSMP include? The type of events that will be monitored Who will be responsible The methods of reporting unexpected events in the field The frequency of assessments Stopping rules Means of communication with Ethical Review Boards and sponsors ICMR-CSER 21

22 What are the requirements in Social and Behavioural health research for data safety? Identify the implications of loss of confidentiality Include mechanisms for limiting these in the planning stages Inform the participants of the limits to confidentiality List potential identifiers that may have to be masked Do not enter into contractual agreements for data transfer without allowing for masking if required ICMR-CSER 22

23 References: 1. Mann, MD (year not known) The Ethics of Collecting and Processing Data and Publishing Results of Scientific Research, Department of Physiology and Biophysics University of Nebraska Medical Center 2. National Academy of Sciences, 1995 On being a scientist. Responsible conduct in research (2 nd edition), National Adacemy Press, Washington DC 3. Lesser, Lawrence M and Eric Nordenghaug, 2004 Ethical statistics and statistical ethics: making and interdisciplinary module, Journal of Statistics Education, Volume 12 (3), ICMR-CSER 23