Ethical review committee

Instructions / guidelines for researchers:

  1. Please answer all questions. It is the responsibility of researcher to fill the application form appropriately. Incompletely and inappropriately filled form will not be accepted and considered for review and discussion in the committee. This may result in delay in approval of the proposal.
  2. In case of urgency, a strong justification should be provided for an expedited review and approval such as meeting a dead line for funding etc. Even in case of expedited, review it may take 7-10 days in granting approval if there is no ethical issue.
  3. Application must be signed by PI. In case of student's/ resident's application, it should be signed by supervisor also.
  4. In response to Q.1, please give a brief background of the study indicating the need for the study.
  5. In response to Q.3, please don't give details of laboratory or scientific procedures. Only mention the procedures to be carried out on human subjects such as withdrawal of blood or collection and storage of other samples, treatment to be provided to study subjects, observations, interviews, focus group discussions etc.
  6. In response to Q.8, only direct compensations should be mentioned. Traveling in connection of studies and presentation should not be included here.
  7. In response to Q.9, All possible adverse events likely to occur as a result of the study should be included, with a plan to help the patient get appropriate treatment.
  8. Consent form must be attached. Separate guidelines are given for drafting consent form which should be strictly followed. In case of improperly drafted consent form or its absence on preliminary scrutiny, no application will be considered for discussion in the committee.
  1. Project involves the use of:

(Check all pertinent ones)

  1. Experimental drug(s)
  2. Radioactive agents
  3. Non-therapeutic research
  4. Non-approved use or non-approved dose for approved drugs
  5. Experimental surgical procedures
  6. Fetal research
  7. Behavioral research
  8. Gene molecular cloning
  9. Other (please specify) : Qualitative, Descriptive exploratory

  1. What is the purpose of the study? (Please give a brief background of the study)
  2. In general, women's life expectancy has increased, but their quality of life is questionable. All women in their mid life, experience menopause but it is difficult to determine their perceptions and experiences. Menopause is affecting women's life in various ways. Literature showed that menopause experience depends upon the socio-cultural norms, geographical environment, and personal knowledge. Literature also revealed many key characteristic of menopause experience of women in general however; there is limited information about the experience of women living in Pakistan. In Pakistan, only a few (four) quantitative studies have been conducted on this topic, however no qualitative studies have been conducted in any of the province, neither in urban nor in rural areas. This qualitative study would help to develop in-depth understanding of menopause experience of women living in Karachi and ultimately help them to cope and adjust with their experience and improve their quality of life.

    Purpose of study: The study purpose is to explore menopause experience of women living in Karachi, Pakistan.

  3. Enumerate the objectives of the study
    • To gain insight about the perceptions of women related to menopause.
    • To find out the impact of menopause
    • To explore the challenges menopausal women face.
    • To find out the strategies used to manage the challenges.
  4. Brief description of methods used in protocol.
  5. study Design: The qualitative approach would be used. The method will be exploratory descriptive.

    Study population: All women who are in their menopausal age, coming to Outpatient department of Obstetrics & Gynaecology at Pakistan Naval Ship(PNS) Shifa Hospital Karachi. .

    Setting: Outpatient department of Obstetrics & Gynaecology at Pakistan Naval Ship(PNS) Shifa Hospital Karachi. The permission to conduct the study and collect data has already been obtained from the Army General Head Quarter Rawalpindi.

    Study Sample: Study sample would be purposive.

    Sampling Technique for Recruitment of participants: I will request the Gynaecologist and the RN/RM who are in charge of the department to identify women who meet the inclusion criteria. If they will ready to participate after having complete information about the study I will take the informed consent from them.

    Sample Size: The sample size consists of 8-12 menopausal women until saturation achieved.

    Data Collection Method: Face to face, In-depth interview through interview guide, for 45-60 minutes would be taken it would be audiotape as well as notes will be taken by the researcher regarding the observations.

    Analysis: Qualitative analysis would be done by manual method. Lincoln and Guba's framework of trust worthiness would be utilized for the analysis. Themes would be extracted after transcribing, categorizing and coding the data. Experts would be involved in data analysis (supervisor and committee member).

  6. Criteria for inclusion and exclusion of patients and controls (type separate).
  7. Inclusion criteria include:

    • Women aged 45-65years.
    • Women who are in menopause symptoms.
    • Able to understand and speak Urdu or English.

    Exclusion criteria include:

    1. Women who are having any chronic illness/illnesses.
    2. Women who are having regular periods.
  8. Adverse effects:
    1. Describe adverse effects/risks expected to the subjects involved in the investigation during the study?
    2. No adverse effect expected but there are chances that the participant may become physically or emotionally upset, while reflecting on their experience, Participant may feel embarrassment or uncomfortable.

    3. What is the provision for managing these effects?
    4. Comfort break and support will be provided. Offer a glass of water, tissue paper and as a positive aspect investigator will be there to listen to her and if required refer to the Gynaecologist (one of the committee member at PNS Shifa Hospital.

    5. Who will pay for them?
  9. in cases where therapeutic need of the research subject is identified during the course of the study:
    1. What is the provision for managing these cases?
    2. NA

    3. Who will pay for them?
    4. NA

  10. Laboratory and Radiological studies:
    1. Will any tests be performed which are not routinely included as part of the work-up for these types of patients?
    2. NA

    3. Who or what agency will pay for these tests?
    4. NA

    5. Location of study:
    6. Outpatients units:

  11. What are actual potential benefits if any, to be obtained?
    1. By participants.
    2. Improve the understandings of menopause phenomena. Able to cope in a better way. Sense of relaxation as they will have opportunity to share their feelings and reflect on the experiences which they have encountered.

    3. By society as a result of this study?
    4. Findings of this study will help to identify strategies that will be helpful in improving the quality of life of menopausal women.

    5. Please specify benefit of the study to the funding agency or sponsors.
    6. Enrich the research data and provide the direction for further studies (AKU-SON).

    7. Please specify benefit of the study to institution where study is being conducted.
    8. Helpful in developing the better understanding of the menopausal women's behaviour and attitude and ultimately it will help in improving the quality of care to be provided to them from health care team/

  12. How will confidentiality of the subjects be ensured?
  13. Researcher will not write participants' names, instead a numerical code such as 1, 2 will be used for each write participants' names. Data will be kept under lock and key and only principle investigator have the access to it. No individual person can be identified, and data would be discarded after the completion and publication of the study. The audio taped interview would be destroyed after the conduction of study and the publication.

  14. How will the study findings be shared with?
    1. Study subjects
    2. The study finding/ results would be shared with the participants, through the presentation and discussions.

    3. Community at large
    4. Through publication, a hard copy will be kept in library so people will have an access.

  15. Discuss Ethical Issues involve in the study.
    • The ethical approval from Aga Khan University will be obtained/
    • A permission to collect data and conduct the study has already been obtained from the GHQ Rawalpindi.
    • Participant's autonomy, participants will be approached to consent for voluntary participation and will have freedom to choose to terminate their participation at any time during the study.
    • No potential physical or psychological harm is involved.
    • The data will not be utilized for any other study. Privacy and confidentiality of the subjects will be maintained.
  16. Any other information relevant to the study in context to Pakistan?
  17. Delay in data collection may occur due to Karachi's law and order situation, political situation (terrorism, strikes may be the obstacles)

  18. Has this study conducted elsewhere earlier? If yes where? Please give references

In Canada qualitative study has been done on this topic in one of the rural area. Reference:

  • Price, S.L., Storey, S. & Lake, M. (2007). Menopausal experiences of women in rural areas. Journal of Advance Nursing, 61(5), 503-511.

Guidelines for drafting an informed consent form

Although a sample of informed consent form is attached, additional guidelines are given here in order to help and facilitate the researchers in drafting a proper, acceptable consent form.

  1. All studies involving human subjects should have a properly drafted consent form. No study should be done on human subjects without obtaining informed consent and sufficiently before the start of the study, at an appropriate time, and not at a time when s/he is under stress such as surgical procedure, and is unable to understand the study.
  2. Consent may be written or verbal or telephonic. In case of unwritten consent, it should be signed by the person taking the consent and witnessed by a second person.
  3. In case of children, an assent form from children and consent from guardian / parents is needed.
  4. In case of mentally or physically incapacitated subject, consent should be obtained from immediate guardian or relative such as, wife or husband, father or mother, brother or sister etc.
  5. In case of community studies, community leaders, elders, local political leaders, religious leaders (in certain cases), and governmental officials should be taken into confidence, and a written consent should be obtained.
  6. In case of doing a study in other locations such as other hospitals and clinics, permission from appropriate authority or physicians should also be obtained.
  7. The consent form should be in English, Urdu or other local language if needed. These should be identical in such a way that the translation of one into other is similar. The language should be easy which can be understood by study subjects (uneducated or primary passed). Use of technical terms should be avoided.
  8. It should be written in "second or third person" and not in "first person". For example, "You will be asked to give 10 cc blood" or "you will be asked few questions" etc.
  9. A properly drafted consent form should contain the following important points.
    1. Information sheet. There should be one paragraph or page giving information about the nature of study, its purpose and need, possible benefits of the study, and procedures to be carried out on the study subjects.
    2. Possible risks and benefits to the study subjects
    3. Availability of alternate treatment in case of therapeutic trials
    4. Voluntary participation without any compulsion, moral or otherwise and without any financial incentive or coercion. However, financial assistance or reimbursement for time and traveling may/should be provided to study subjects; which should commensurate with the time spent, and should not be too high.
    5. Right to withdraw from the study at any time without affecting their rights and treatment.
    6. Confidentiality
    7. If any specimen is to be stored, its time of storage and permission to use it in further research.
    8. Name and contact number of the investigator in case the study subject wants further clarification or information about study.
    9. Authorization from study subjects with their signature, thumb impression, signature of witness etc.

Important Notes

  1. Studies shouldn't be done on patient's expenses.
  2. If any new or additional tests are to be done as a requirement of study, their cost should be supported by the study.
  3. If a new treatment is compared with an existing and established one OR two treatment modalities are being evaluated and compared, cost of treatment or difference in cost of treatment should be borne by the study. In addition any expected or unexpected complication arising as a result of new treatment should also be supported by the study.
  4. Studies which are unlikely to produce any significant results because of faulty design are often considered not to be ethical as such studies cause wastage of time and resources. These should be avoided unless there is strong justification.

Sample Informed Consent

This is a generic sample form to help you address most situations. Please adapt as appropriate for your research protocol and institution. Pending rulemaking for classified human subject research will require additional elements of consent.

Consent document must be clearly written and understandable to subjects. The language must be nontechnical (comparable to the language in a newspapers or general circulation magazine), and scientific, technical or medical terms must be plainly defined.

Informed Consent, whether oral or written, may not include language that appears to waive subjects' legal rights or appears to release the investigators or anyone else from liability for negligence.

  1. PURPOSE OF THIS RESEARCH STUDY
    • Include 3-5 sentences written in nontechnical language. "You are being asked to participate in a research study designed to..."
  2. PROCEDURES
    • Describe procedures: "You will be asked to do..."
    • Identify any procedures that are experimental/investigational/non-therapeutic.
    • Define expected duration of subject's participation.
    • Indicate type and frequency of monitoring during and after the study.
  3. POSSIBLE RISKS OR DISCOMFORT
  4. Note that these include not only physical injury, but also possible psychological, social or economic harm, discomfort, or inconvenience.

    • Describe known or possible risks. If unknown, state so.
    • Indicate if there are special risks to women of child bearing age; if relevant, state that study may involve risks that are currently unforeseeable, e.g., to developing fetus
    • If subject's participation will continue over time, state: "any new information developed during the study that may affect your willingness to continue participation will be communicated to you."
    • If applicable, state that a particular treatment or procedure may involve risks that are currently unforeseeable (to the subject, embryo or fetus, for example.)

    POSSIBLE BENEFITS

    • Describe any benefits to the subject that may be reasonably expected. If the research is not of direct benefit to the participant, explain possible benefits to others.

    FINANCIAL CONSIDERATIONS

    • Explain any financial compensation involved or state: "There is no financial compensation for your participation in this research."
    • Describe any additional costs to the subject that might result from participation in this study.
    • Please indicate any financial benefits to the subjects including therapeutic or diagnostic costs being covered by the study.
  5. AVAILABLE TREATMENT ALTERNATIVES
    • If the procedure involves an experimental treatment, indicate whether other non-experimental (conventional) treatments are available and compare the relative risks (if known) of each.
  6. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES
    • "This study involves (minimal risk) (greater than minimal risk)." In the event that greater than minimal risk is involved, provide the subject with the following information.
    • If you are injured as a direct result of taking part in this research study, emergency medical care will be provided by [name] medical staff or by transporting you to your personal doctor or medical center. Indicate who will pay for this treatment.
  7. CONFIDENTIALITY
    • Describe the extent to which confidentiality of records identifying the subject will be maintained.

    "Your identity in this study will be treated as confidential. The results of the study, including laboratory or any other data, may be published for scientific purposes but will not give your name or include any identifiable references to you."

    "However, any records or data obtained as a result of your participation in this study may be inspected by the sponsor, or by AKU ERC members".

    In addition, list steps to protect confidentiality such as codes for identifying data.

    TERMINATION OF RESEARCH STUDY

    You are free to choose whether or not to participate in this study. There will be no penalty or loss of benefits to which you are otherwise entitled if you choose not to participate. You will be provided with any significant new findings developed during the course of this study that may relate to or influence your willingness to continue participation. In the event you decide to discontinue your participation in the study,

    • These are the potential consequences that may result: (list)
    • Please notify (name, telephone no., etc.) of your decision or follow this procedure (describe), so that your participation can be orderly terminated.

    In addition, your participation in the study may be terminated by the investigator without your consent under the following circumstances. (Describe) It may be necessary for the sponsor of the study to terminate the study without prior notice to, or consent of, the participants in the event that (Describe circumstances, such as loss of funding.)

  8. AVAILABLE SOURCES OF INFORMATION
    • Any further questions you have about this study will be answered by the Principal Investigator:
    • Name:

      Phone Number:

    • Any questions you may have about your rights as a research subject will be answered by:
    • Name:

      Phone Number:

    • In case of a research-related emergency, call:

    Day Emergency Number:

    Night Emergency Number:

  9. AUTHORIZATION

I have read and understand this consent form, and I volunteer to participate in this research study. I understand that I will receive a copy of this form. I voluntarily choose to participate, but I understand that my consent does not take away any legal rights in the case of negligence or other legal fault of anyone who is involved in this study. I further understand that nothing in this consent form is intended to replace any applicable Federal, state, or local laws.

Participant Name (Printed or Typed):

Date:

Participant Signature:

Date:

Principal Investigator Signature:

Date:

Signature of Person Obtaining Consent:

Date:

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