Identifying complication of drinking cinnamon to induce labor - Research Proposal Example

EFFECTS OF USE OF CINNAMON STICKS IN LABOR INDUCTION of Table of Contents EFFECTS OF USE OF CINNAMON STICKS IN LABOR INDUCTION 1 CHAPTER 3: METHODS 3 3.1 Variables 3 3.2 Research Design 4 3.2.1 Study Type 4 3.2.2 Research Setting 4 3.4 Sampling 5 3.5 Ethical Considerations 7 3.6 Procedures 9 3.1 Research Personnel 11 3.2 Procedures for Data Collection 11 CHAPTER 4: PLANNED ANALYSIS 13 4.1 Levels of Analysis 13 4.2 Plans for the Dissemination of Findings 15 4.3 Budget 15 4.4 Funding Sources 16 4.5 Suggestions for Future Research 16 CHAPTER 3: METHODS 3.1 Variables The dependent variables, in this case, are related to the research question as indicated in chapter 1. This means that they are this refers to the complications of drinking cinnamon sticks to induce labor. The study has the objective of determining all the complications associated with the use of the sticks by the expectant mothers. The complication, in this case, is defined as any anomaly that would occur to the baby or the mother immediately or later and directly linked to the use of the cinnamon. The outcomes of use of cinnamon will be measured through an analysis of the subject’s medical charts during the time of use. It is noted that the time of use may not necessarily mean that the baby is mature to be born at nine months. Some use may trigger an early birth process that may be considered a miscarriage (OBrien, 2009). The use of the charts is subject to informed consent. The different results as obtained from the charts will amount to the number of negative aspects associated with the use of the cinnamon. This will be determined from conception to birth as recorded in the charts. Data from all the chats at different times will be consolidated and then standardized for measurement that continually responds to the objectives and the research question. The independent variable in this research will be the socio-economic positions of the mothers. These are extraneous variables and consist of all socio-economic factors. It was noted in Chapter 2 that the economic factors also determine the usability of cinnamon sticks to induce labor. Therefore, age, levels of education, the marital status of the women and their economic ability. These factors may be static, but they may also determine the usability of the cinnamon sticks. They are important because it was determined in Chapter 2 that the women from the high social class are not likely to use the sticks at a higher rate than those from low economic class. 3.2 Research Design 3.2.1 Study Type The study under the proposal does not actively include experimental designs (non-experimental). Given that the interest as per the research question is on the effects of using cinnamon sticks to induce labor, the choice of the method has been restricted to review of the hospital maternity charts used by the mothers during the entire pregnancy period. The viability of this study is based on the fact that that there is the lack of much research linking both the stated independent and dependent variables. 3.2.2 Research Setting Participation in the research will involve women at their prenatal pregnancy stages and postnatal period. This will be at both public and private clinics so that there is no bias of having differing results over single choices of location. Records for the participants will be sought in both urban and rural places so that the data collection is comprehensive enough and supportive of the study questions. A wide search for information will be based on the higher levels of research done in as varied places as possible. The results as per the medical charts are expected to vary from depending on the usability levels of the cinnamon sticks, but that still remains hypothetical. Consideration of reference to the medical charts at the clinics of focus has a collection of advantages over questionnaires or direct interviews (Goswami & Dutta, 2014). Apart from the most important aspect of ethics, the research time is highly reduced; the costs involved are lower, and the available data is easily entered and the immediate task becomes analyzed. The method is also convenient for the researcher. However, the maternity charts of the different mothers may not be viable in showing trends established over a long period of time. They only cover a specified period of time which may not accurately tell whether the effects have been common over the given time. That is, the effects of the cinnamon may have changed over 50 years to the users given changes in dietary characteristics and lifestyle in the Saudi population. Recent research has shown that over the past 50 years, the level of obesity in Saudi Arabia has reached 70% of the population (Awad, 2015). This is bound to affect the body responses to medical attention including the use of cinnamon in childbirth. There are also too many variables under consideration and these may not be effectively determined by use of the maternity charts. Recent research has shown that women in high-class family statuses are least likely to use cinnamon sticks. The reason is that they are able to effectively afford medical care in the best hospitals in the country as opposed to those from relatively low-class family backgrounds (McDonagh, Osterweil, & Guise, 2005). 3.4 Sampling According to the Global Midwifery Council (GMC) (2012), Saudi Arabia has no out-of-hospital birth centers, just like the western nations. There are also no professional midwives attending to women during their maternity period. This therefore means that all the information can be obtained from hospitals. With the concentration of the information, random sampling will be utilized so that effective group samples are obtained. However, the exemption applies to the lower class citizens that cannot afford the very expensive medical care in the country. Though they would still go to hospitals for the sake of cultural pressure, they would go to local hospitals for the medical attention during the period. The sample would also consider citizens attending such clinical attention in such places. The research will, therefore, group the research in two census zones, metropolitan and rural. The metropolitan region will take to account the central region of Riyadh. The rural region will divide the other regions in terms of; the Eastern Province, the Southern Region (Asir and Makkah) and the Northern Region (Medinah and the Northern Borders province). The five regions will act as a representative sample of all regions Saudi Arabia. Medinah and Makkah are also cities that will provide representative information apart from Riyadh (al-Rasheed, 2010). The subjects will, therefore, be culled from records in these two regions that are further subdivided. Since the research is about the effects of cinnamon sticks to the mothers, homogeneous information will be obtained from the effects in the two regions. Differences will be obtained from the levels of effects in the two regions. The research team will, therefore, focus on records from the different hospitals in the two regions; five in the rural and five in the urban centers. The choice of the hospitals will be based on reference to the Ministry of Health (MoH) Portal Information about the availability of the hospitals in the different areas identified. The MoH will also serve to grant permission for carrying out the research in jurisdictive sections. i. Sample Size Having identified the 12 hospitals indicated in Appendix 1, a collection of statistical measures will be taken to determine the number of records to be considered. Based on this, it is projected that 240 records will be considered which constitutes an approximated number of 20 charts per hospital. These are supposed to help determine as much information as possible on the research objective of finding the effects of cinnamon sticks on the pregnancy of women when used to induce labor. Given that there will be the reference to the hospital records about women that give birth, it is noted that the research will directly lead to there being many efforts in establishing the required content from the records. It is therefore hypothetically determined that 90% of the records (216 records or more) will contain information viable for the research. The percentage is bound to be applicable to all the regions. ii. Criteria for Inclusion and Exclusion First, the study is limited to pregnant women in Saudi Arabia only. It considers recorded information from the first prenatal visit to the postnatal period. The choice of pre-natal is based on the fact that some may have used the cinnamon sticks in their previous pregnancies or in other circumstances that may have future effects. For such a group of women, the current pregnancy is considered as the future pregnancy as it is the one under scrutiny. For the purposes of consistency, the study considers that the women must be of age to give birth under the federal laws of the republic of Saudi Arabia. The women must also have given birth in any of the hospitals under consideration as indicated in appendix 1. Therefore, exclusions are imposed on women that are bound to make an out of hospital delivery. 3.5 Ethical Considerations It is important that the study adheres to the highest level standards of humanity grounds. Moreover, it must also not violate government laws. The researcher is still a student and, therefore, there must be permission sought both from the ministry of health and the administration of the respective hospitals under review. Given that the research considers very sensitive matters of female privacy, it is important to note that effective reference on ethics is made to Lavery (2007). It considers all human subject procedures and respective ethical matters in the medical research. a. The right to disclosure of full research information The hospital administration will be required to be fully informed about the research and the type of information that will be required. In this case, the records departments of the hospitals will be required to have full knowledge of the information to be collected. To this cause, a letter will be written, and copies send to all the hospitals under focus. The letter will describe, in simple terms the study significance and its level of necessity. However, the hypothesis of the study and the aims will not be stated for the sake of keeping with finding or failing to find them at the end of the research. The research process will be effectively analyzed, the number of participants in the research whenever possible and any other material that the respective hospitals may require as per the internal policies. The rights and responsibilities of researchers in Saudi Arabia are well documented in the "Research Permissions Management System” in the government portal (Ministry of Health – Kingdom of Saudi Arabia, 2015). The same will also be referred to. b. The Right to Confidentiality This is a research that does not have a one-on-one contact with the respondents. It will only involve medical staff in charge of the records section of the respective hospitals. Therefore, confidentiality will be taken care of with reference to the duties of the research assistant, the main researcher and the hospital staff. The matters of confidentiality will be effectively determined by the following considerations; i. All the participants (research assistants and the respective researcher) will provide their contact details (personal identity, address and effective location) as a sign that they will be responsible for any information that will be disseminated. ii. The research assistant at the hospital will cover the names on the respective maternity hospital documents of the respective women so that the same names are not accessible to the lead researcher. This helps keep the personal information of the women as confident as possible. iii. In concluding the research, the charts will effectively be taken back and kept back to the record files from where they were obtained. This will be done without revealing information as was originally contained c. The Right to Informed Consent The hospitals from which the research will take place reserve the right to be informed about the research. The informed consent document will, therefore, have information regarding the purpose statement. The information on the informed consent will be partly contained in the ‘informed consent form’ indicated in appendix 2. It will be supposed to be filled accordingly with adherence to the relevant information. The letter is efficiently crafted to meet the official standards of the respective hospitals. The sensitivity of the research requires that the entire information in the form be adequately adhered to. 3.6 Procedures The research will consider the reference to a collection of maternity documents (ante-natal charts). It will be limited to the described regions for the purposes of effective sample representation. The procedure will not involve much dealing with people where processes like interviews will be considered. Therefore, the concept will be to get to the respective hospitals at the respective times and then make out ways of reaching out to the documented charts bearing the required information. All plans to visit the respective hospitals will be made at the college of education with the direction of the tutor in charge. There will be one research assistant that will take care of all planned logistics and getting in touch with the relevant authorities to make the research successful. The research period will span a period of four months from August 2015-January 2016. This is because the temperatures at this time of the year are relatively conducive to travel and access many places, taking in mind the sandstorms in the southwest regions (al-Rasheed, 2010). However, it is anticipated that planning is done a month earlier to this so that effective preparations are made, and no section is left out of the planned research. The raw schedule is classified below: Activity Period Pre-testing the entire research 2-3 weeks Obtaining permission 2-3 weeks Data collection in the various hospitals 4-6 months Completion of data analysis 1 month As already indicated earlier, the research will be carried out in six regions. Twelve hospitals will be reviewed, and 20 charts reviewed in each hospital making an approximated number of 240 charts that will be reviewed for this research. At the respective hospitals, the researcher will have obtained authority to view the pregnancy progress maternity charts in the hospitals for which specific attention will be generated towards the subject topic. Ethics will be regarded at the highest level because this is one of the researchers that Liamputtong (2006) classified as one of the ‘very sensitive research’. The information will, therefore, be accessed through the highest levels of confidentiality. 3.1 Research Personnel This research will be carried out through one full-time researcher. A research assistant will be applicable to the cause but very limited for organization purposes. It is important that the main researcher will have sound knowledge of IT and effective statistics. The research assistant will, therefore, require skills at exemplary levels in negotiation and will also need to be of extreme ethical conduct. He must be able to protect effectively the human subjects. 3.2 Procedures for Data Collection The dependent variable has been identified in this case; effects of the cinnamon sticks in the induction of labor. Data for details on the dependent variable as well as all the other extraneous factors will be collected through the chart extraction from the hospital records. Much help will also be needed from the hospital record keeper team so that access is easily made possible. It is noted that there are some hospitals that keep an Electronic Medical Recording (EMR) while others keep it manual. In the case of the electronic system, passwords will be asked from the record keeper to make sure that access is done. For those that keep manual systems, and then the respective patient files will be accessed with the help of the record keeper. In this case, the research assistant will also be required to have signed a confidentiality pledge to have the confidence of the hospital management staff. Extraction of the charts containing information will be done during the main research period. The extraction of the information from the charts will occur at the respective hospitals in the following order: Region Place Time Riyadh Riyadh August Eastern AL huluf September Southern Asir October November Makkah Northern Medinnah December January 2016 Northern Border The researcher will be looking for information as detailed in the research object. Therefore, the following information will be put under consideration from each of the charts; • Gestational age • Methods of labor initiation, previous and present • Presence of any health related complication including the post-natal; period This information will be effectively collected and stored in a spreadsheet with each chart given its number. The prefixes for all data charts from Riyadh will be named RR with the first R depicting region and the second R depicting place. The charts will then be named RR1 up to RR40. This is summarily illustrated below: Region Place Chart Notations Riyadh Riyadh RR1-RR40 Eastern Al Huluf EA1-EA40 Southern Asir SA1-SA40 Makkah SM1-SM40 Northern Medina NM1-NM40 Northern Border NN1-NN40 As can be seen from the table, every place will contribute 40 charts from hospitals reviewed. This will help identify the specific region from which the data was collected so that conclusions can be drawn from the differences in the different regions. CHAPTER 4: PLANNED ANALYSIS 4.1 Levels of Analysis The planned research is quantitative as opposed to qualitative. Moreover, it covers a vast region and, therefore, adequate analysis will remain comparative. In essence, the analysis will take place at three identified levels; predictive, inferential and descriptive. i. Descriptive level The use of descriptive statistical analysis will be significant in the presentation of the sample populations in the different places under research. It will, therefore, have the function of summarizing data in a way that is unifying for understanding purposes. In this case, the mean of the information will be calculated. This means that comparable means for the effects found in each of the six places under research will be determined. Secondly, the standard deviations of the same data will be calculated putting into consideration all the viable information from region to region. This section will also consider the demographic characteristics of the participating women. It was hypothesized that women in low-class demographic zones are bound to consider using cinnamon sticks as opposed to those in higher economic zones. This will take to account their ages, time and level of pregnancy and any other relevant information viable for consideration. The information will be presented in tables so that adequate understanding is realized. At this level, bivariate statistics will applicable be used in the presentation of the use of cinnamon sticks and the possibility of there being an impact. This also applies to any of the other variables considered extraneous. There will also be the use of correlational analysis especially the Pearson’s correlational analysis for the sake of determining the extraneous variables in consideration during the later regression models. It is important that all the variables are considered effectively to make sure that the relationship between use of cinnamon and any of the variables is ascertained. It is noted that there are variables that lead to the high level use of the sticks than others. ii. Inferential Analysis This will be used in ascertaining the fact that the found effects of the use of cinnamon in labor induction are applicable in all the places and regions under review. This will also be compared to other external populations. Regarding the research design, it was noted that the examined characteristics will be considered to be randomly distributed. To this cause, t-tests will be used in comparing the level of adverse effects realized and the normal births in the same samples. It is considered at this level that not all cases of use of the cinnamon sticks lead to consequences that are adverse. iii. Predictive Analysis In this case, there will be the direct use of regression analysis to determine the intensity of the effects of using cinnamon sticks based on the application of the extraneous factors. This will indicate the perceived changes in the either dependent variables as applied to the different extraneous variables. Variations in the extraneous variables will be done to determine the various changes in the effects on the mothers of using cinnamon sticks. 4.2 Plans for the Dissemination of Findings When the study is complete, the compilation of a report will be done. However, adequate consultation will be sought from other colleagues that have done similar researches. This will be to consider the required plan, inclusions, and exclusions and make the quality better. It is noted that very little research has been done on the effects of cinnamon sticks to labor induction in women. Therefore, this research will viably be submitted to a collection of libraries dealing with medical sciences such as Al-Majmaah University, College of Medicine, King Saud bin Abdulaziz University for Health Sciences and others. From these libraries, it is anticipated that the journal will reach to other international academic arena, thanks to the internet and online libraries at the universities in Saudi Arabia and other places. However, there is no limitation to the number of libraries, schools and government agencies that may want to use the information in the journal. It is understood that many university libraries will want to edit the same before adding it to a library collection. That will be done with due consent from my university and lecturer. 4.3 Budget The research involves much traveling. Hiring one research assistant was a way of minimizing the costs of operation. As a student, there are financial limitations and constraints. Category Rate Total of items Cumulative total Personnel One research assistant (only viable for the research period) $1500 per month plus $500 per month benefits ×6 months 12,000 Hospital staff helping in extraction of the charts 2 persons per hospital ×12 hospitals ×$75 per day $1800 $13,800 Effective supplies 2 laptop computers $1100 per laptop ×2 2200 Cabinets for filing One cabinet 250 Space for office 450 per month ×6 2700 Bill for phone calls $120 per month ×6 months 720 $5,870 Miscellaneous $60 per month ×6 360 360 Grand Total 20,030 4.4 Funding Sources The researcher has the objective of sourcing for funding from different sources. The government of Saudi Arabia has been known to support higher education and therefore it is also expected that there will be effective funding from the government. Saudi Arabia tops the world in higher education spending including her students pursuing higher education in other countries (Smith & Abouammoh, 2013). Therefore, expenditure is sure to be partly offset by the government. There is, therefore, every indication that there will be a substantial financial support for the program. Further funds will be obtained from the LHV Persian Gulf Fund, which is a fund for companies in the region to create a consolidated fund for education. The last fund source is the King Faisal Foundation (KFF) which is also a philanthropic education fund. 4.5 Suggestions for Future Research This research is considered basic. It was noted in chapter 1 that there is very little research that has been done on this topic. This maiden research is still general on the effects of cinnamon on induction of labor. However, after identifying the individual impact, more research can be done on the contents of cinnamon that cause the respective impact. Secondly, more research can be done on the effects at different levels of pregnancy and whether there are other health-related effects of using cinnamon by a pregnant woman. Thirdly, it can also be discerned the other impacts of cinnamon on the body of a pregnant woman. This would be related to the fact that cinnamon has components that would be of concern to the health of an individual. REFERENCES Al-Rasheed, M. (2010). A History of Saudi Arabia. Riyadh: Cambridge University Press. Arabia, M. o.–K. (2015). Patient’s Bill of Rights and Responsibilities. Riyadh : Ministry of Health – Kingdom of Saudi Arabia. Awad, A.-Q. (2015). Childhood Obesity in Saudi Arabia. Riyadh: Lap Lambert Academic Publishing GmbH KG. Council, G. M. (2012, March ). Midwifery Today, the Heart and Science of Birth . Retrieved June 21, 2015, from Global Midwifery Council : http://www.midwiferytoday.com/iam/GMC.asp Goswami, A., & Dutta, H. N. (2014). Uses Of Control Charts For Healthcare Practitioners Using Count Data. Far East Journal of Theoretical Statistics, 46(2), 76. Lavery, J. V. (2007). Ethical Issues in International Biomedical Research: A Casebook. Oxford : Oxford University Press. Liamputtong, P. (2006). Researching the Vulnerable: A Guide to Sensitive Research Methods. London: SAGE. McDonagh, M. S., Osterweil, P., & Guise, J.‐M. (2005). The benefits and risks of inducing labour in patients with prior caesarean delivery: a systematic review. BJOG: An International Journal of Obstetrics & Gynaecology, 112(8), 319. OBrien, B. (2009). Use Of Indigenous Explanations And Remedies To Further Understand Nausea And Vomiting. Health Care for Women International, 20(1), 213. Smith, L., & Abouammoh, A. (2013). Higher Education in Saudi Arabia: Achievements, Challenges and Opportunities. London : Springer Science & Business Media. APPENDICES APPENDIX 1 LIST OF HOSPITALS FOR THE RESEARCH Region Province Hospital Riyadh Riyadh Saudi German Hospital King Faisal Specialist Hospital & Research Centre Eastern Eastern Johns Hopkins Aramco Healthcare, Dhahran King Fahad University Hospital-Khobar Southern Asir Asir Central Hospital- Abha Al-Zafer Hospital- Najran Makkah AL-Noor Specialized Hospital – Mecca Northern Medinnah King Abdulaziz Hospital- Medina Prince Mohammed bin Abdulazeez Hospital Northern border Muznib General Hospital – Muznib Buraidah Central Hospital - Buraidah APPENDIX 2 INFORMED CONSENT RELEASE Investigator: “My name is (name of researcher), and I am a/an (undergraduate/graduate student, faculty member, etc.) at (name of institution/facility). I am inviting you to participate in a research study. Involvement in the study is voluntary, so you may choose to participate or not. I am now going to explain the study to you. Please feel free to ask any questions that you may have about the research; I will be happy to explain anything in greater detail. “I am interested in learning more about (state what the research is about). You will be asked to (state what the participant will be asked to do.) This will take approximately ( ) min./hrs. of your time. All information will be kept (either confidential, in the case where subjects identities need to be retained or can be associated with their responses, or anonymous and confidential, in the case where data collection does not allow responses to be connected with a particular subject). If anonymous, this means that your name will not appear anywhere and no one except me will know about your specific answers. If confidential, I will assign a number to your responses, and only I will have the key to indicate which number belongs to which participant. In any articles I write or any presentations that I make, I will use a made-up name for you, and I will not reveal details or I will change details about where you work, where you live, any personal information about you, and so forth. “The benefit of this research is that you will be helping us to understand (topic of research). This information should help us to (benefit of the research, better understanding, etc.). The risks to you for participating in this study are (state the risks to subjects). These risks will be minimized by (state the procedures you will use to minimize the risks). If you do not wish to continue, you have the right to withdraw from the study, without penalty, at any time.” Participant - “All of my questions and concerns about this study have been addressed. I choose, voluntarily, to participate in this research project. I certify that I am at least 18 years of age [or have a signed parental consent form on file with the______________________________ department]. print name of participant signature of participant date print name of investigator signature of investigator date TO THE RESEARCHER: ISSUES TO BE AWARE OF WHEN OBTAINING INFORMED CONSENT Abuse If a researcher is asking about care-taking practices or observing in a childs home, the researcher would need to indicate what his/her reporting responsibility is in the event of child abuse. Another example might be if the researcher determined that subjects were at risk for harming themselves or others. If the researcher felt bound to notify someone about that risk, subjects should be notified of that obligation when asking for their participation. Anonymous and Confidential Data Collection Indicate whether data collection will be (a) anonymous or (b) confidential. The term "anonymous" is used when the investigator collects no identifying information about subjects and, thus, an individual data sheet cannot be connected with a specific subject (by the investigator or anyone else) once the data are collected. As an example, tape-recording, by its very nature, cannot be considered anonymous. Confidentiality, in contrast, refers to collected data that can be linked to an individual subject. For example, assigning subjects numbers, but then keeping a "key" that links the numbers to identifying information, is a procedure one might use in order to preserve confidentiality. Not identifying subjects by name or by any other identifying information in reports and presentations also is a measure taken to preserve confidentiality. If individual subject data are used as illustrative examples, you must assure subjects that this will be done in a way that does not allow identification of the participant. Care must be taken to not only not divulge subjects names, but also other details about them or their experiences that would allow them to be identified. Occasionally, it is important to the research to identify an individual who participated, or subjects themselves may wish to have their contribution attributed to them. In such cases, it would be necessary for a participant to sign a release form indicating their willingness to be so identified. Audio- and Videotaping If you wish to tape subjects, please include a request to tape explaining the type (e.g. videotaping in the classroom, audiotaping, single or group interviews, etc.), and the disposition of the tape(s) when the study is complete. If the tapes will be used for any other purpose, clearly state the who, where, and why of the other use; if there is no other use of the tape, simply stating that it will be erased when the study is complete is sufficient. Benefit to the Participant If it is too strong a statement to say that the subject will benefit from the research, perhaps the better statement would be that the subject may benefit from the research. Contact Information Include contact information - a phone number, and/or e-mail address where subjects may reach you. If a student is conducting the study, the advisors name and phone number should also be provided. Identifying References In the event that potentially identifying references need to be included in publications or presentations in order to maintain the basic integrity of the study, the researcher needs to specifically include that fact in the written informed consent statement. Illegal Activities Researchers must indicate the limits of the confidentiality. If the researcher plans to ask subjects about their or others illegal activities (underage drinking, drug use, etc.), the consent form must indicate that the researchers data can be subpoenaed. The consent forms should include the following sentence: "The researcher is not immune to legal subpoena about illegal activities. Although it is very unlikely, if law enforcement officials asked to see my data, I would have to comply with that request." Problematic Language Language used in the informed consent form should be simple and direct. Consider the following examples: (1) Problematic language: “The purpose of this study is to validate the concept of citizenship and to determine the public’s view on the rights and responsibilities citizenship entails.” (2) Preferred language: “This study is designed to find out about what being a citizen means to you.” Use of Minors The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. Considerations must be taken of the benefits, risks, and discomforts inherent in the proposed research and to assess the justification in light of the expected benefits to the child-subject or to society as a whole. Withdrawal from Study You must state that participation is voluntary and that subjects "may withdraw at any time up until the study has ended." You also must indicate that subjects will not suffer in any way from withdrawing. Wording of this may depend upon the specifics of the study. Examples: (1) If subjects are receiving a service from the agency where the research is occurring, they should be told that they will still continue to receive services even if they decide not to continue participating in the study. (2) If subjects are students in a class or employees in a company, they should be told that their decision to stop participating will not negatively affect a grade or performance evaluation, or participants will be informed on the consent form and by the test administrator that "participation in the study is voluntary and that they can withdraw from participation at any time without penalty." Read More