Documents submitted to BMRC (ANNEXURE – D) INFORMED CONSENT FORM

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APPENDIX 5: Documents submitted to BMRC (ANNEXURE – D)

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connection, past experience, and, having any kind of illness etc.

2) Part-B (Cognitive/ Perceptional factors)

There are 13 Psychological factors that are used in the hypothetical model. Every factor will be measured by 3 questionnaire items.

Respondent will read each statement and rate each statement on 5-point Likert scales by putting √ (tick) in the number that best describes she/he. All statements will be measured on a 5-point Likert scale, where 1 = Strongly disagree, 2 = Disagree, 3=

Neither Disagree nor agree, 4 = Agree, and 5 = Strongly agree.

It will take 25-30 minutes to complete the questionnaire and another 20 will need to take the health check-up. Data will be collected in 3 different points in time per year:

First survey (survey 1)- after initial introduction of the PHC system (T1), Second survey (survey 2)- 4 months after the first survey (T2), Third survey (survey 3)- 4 months after the second survey (T3). The same respondent will be interviewed in the post-survey.

• Duration, Procedures of the study and participant’s involvement:

This proposed study plan to implement a longitudinal survey with providing PHC health service for consecutive three years. The survey will be continuously conducted three years after getting the ethical permission one in every 4 months at the both targeted areas. The study will be enrolled of total 300 potential users of PHC service.

Study participants will be those who have used PHC service at least once. It will include initial introduction of the PHC system, Research Protocol Design and research instrument development, pre-testing, field preparation, mapping, Staff Training &

Workshop, PHC health Check-up service, data collection, data entry, Data Cleaning, data processing, data analysis, report writing, Publications and dissemination of survey findings. The study will be implemented immediately after getting the IRB approval from BMRC. The results of the study will raise awareness and actual use of eHealth technology and thereby the finding will reduce morbidity rate in the country.

• Potential benefits:

A participant can receive medical examination and the medical checkup results will be distributed immediately so that participant can be known health status immediately.

After the health check-up, participants can consult with remote doctor by skype based on the medical examination results and receive prescription if necessary. These health check-up and doctor’s consultation will be free of charge. Participants may benefit in the future from the information we find in this study through decision making based on the findings.

At this PHC services, you can receive the following health check-up and doctor’s

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consultations.

• Risks, hazards and discomforts:

There is a possibility of adverse health effects due to health examination. In principle, however, medical equipment used for medical examination was approved by the Pharmaceutical Affairs Law of Japan and Bangladesh. Some medical instruments (pulse oximeter) will remodel the equipment for automatic transmission of data, so it will be out of the approval of the law, but the possibility of affecting health examination is It is considered to be low.

Possible side effects are drugs purchased at a later date by prescription prescribed by remote doctor / consultation by doctor. The prescription is limited to antihypertensive agents against hypertension and minimizes the possibility of side effects. Regarding cardiovascular diseases other than hypertension (arrhythmia etc.) and kidney disease (urine protein positive), complications such as hypoglycemia and medical treatment of the original disease are especially required, so we will not prescribe.

• Reimbursements:

The patients will receive free investigations for their current illness. None of the patients will pay any money for participation in this study. The participants shall be provided best possible, free treatment for any research related injuries.

• Confidentiality:

We shall assure that the privacy, anonymity and confidentiality of data/information identifying the patient will be strictly maintained. We would keep all the medical information, description of treatment, and results of laboratory tests performed confidential, and stored in a safe place, under lock and key under the responsibility of the principal investigator. None other than the investigators of this research study;

possible study monitor; regulatory authorities, such as the Ethical Review Committee (ERC); and any law-enforcing agency in the event of necessity would have access to the information. We want to mention here that data related to the study will not be sent outside the country for analysis. The name or any identification of the patients would not be disclosed while publishing the results of this study.

• Termination of study participation / Rights to withdraw from participation:

The participation in the study is totally voluntary and one has the sole authority to decide for or against the participation into the study. Anyone may refuse enrolment of him/her in the study. The participants would also be able to withdraw their consent at

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any time during the study, without showing any reason and without any prejudice or penalty or loss of care, benefits or attention.

If you agree to our proposal of enrolling you in our study, please indicate that by putting your signature or your left thumb impression at the specified space below:

Thank you for your cooperation.

• Name of the participant: ---

• Signature/Thumb print of the participants:---

• Name of the witness:---

• Signature of the witness:---

• Name of the interviewer:---

• Signature of the interviewer:---

Name and contact phone number of Principal Investigator:

Masuda Begum Sampa

Ph.: +81-80-7989-3966

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