CAPE PENINSULA UNIVERSITY OF TECHNOLOGY201113015406 by sdsdfqw21

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									         CAPE PENINSULA UNIVERSITY OF TECHNOLOGY
   HEALTH AND WELLNESS SCIENCES RESEARCH ETHICS COMMITTEE

               HUMAN PARTICIPANTS' REVIEW APPLICATION

This application to the Health and Wellness Sciences Research Ethics
Committee (HWS-REC) must be preceded by approval of the research proposal
by the Faculty Research Committee.

Questions to guide this application and Documents required:
  • CPUT application (HWS-REC 4.1)
  • Research proposal
  • Budget/funding information
Do you intend to have a consent form in the 3 regional languages or the language/s
appropriate to your participants?
   •   Provide Consent documents in English with statement of other languages
       it will be translated into.
Do you have approval from or have you applied to any other Ethics Committee/s?
   •   Provide evidence of all other Research Ethics applications/approval.
Has your full proposal been approved by the Faculty Research Committee?
   •   Provide evidence.

The HWS-REC must receive two hard copies of this application form, all
relevant accompanying documentation (i.e. consent forms, questionnaire,
instruments, data collection sheets, etc.) and your research proposal.

Address to :      Ms O Daniels
                  Secretary – Research Ethics Committee
                  Health and Wellness
                  Bellville Campus, CPUT

Also forward an electronic copy of the above to: danielso@cput.ac.za

Ms O Daniels:     Phone:                   Fax:

                   FOR COMMITTEE USE ONLY

                   Application No.: 2011/…………….

Note:
  •      The application should be typed directly onto the electronic version.
  •      The committee will NOT accept hand-written applications.
  •      All information requested must be provided.
  •      Applications will be received at any time but will only be tabled at REC
         meeting as per the schedule of meetings.
   •     Applications too late for any meeting will be held over to the next
         meeting.
                                                                                            HWS-REC 4.1


I.     PRINCIPAL INVERSTIGATOR’S DETAILS
This is the primary researcher/postgraduate student in whose name the application is filed. All
correspondence from the HWS-REC will be directed to this person.

Name:                                                Title:                         Position:

Department:                                   Qualification:

Student No:                            Professional Registration Number:

Postal Address:

Telephone:                             Fax:                   e-mail:


II.      TITLE OF PROJECT:
Provide a concise, descriptive title. Title must be the same as the title of your proposal.
______________________________________________________________

III.     SIGNATURES:
Principal investigator to sign and date the application on Line A., supervisor (in the
case of student research) on Line B, and Head of Department on Line C. One copy
must contain original signatures.

The undersigned acknowledge that: 1. this application represents an accurate and
complete description of the proposed research; 2. the research will be conducted in
compliance with the recommendations of and only after written approval has been
received from the HWS-REC, 3. the principal investigator is responsible for reporting
any serious adverse events or problems to the HWS-REC, 4. HWS-REC approval will be
requested for any modifications and, 5. a status report (HWS-REC 4.2) will be
submitted if an extension is required beyond the period of approval.

A.       Investigator:                 ___________________________________________
                                                     Type Name and Sign                   Date


B.       Supervisor/s:(for student research)____________________________________
                                                     Type Name and Sign                   Date


                                              _______________________________________
                                                     Type Name and Sign                   Date


C.       Head of Department:                  ___________________________________________
                                                    Type Name and Sign                    Date




____________________________________________                  ____________   Approved    Not Approved
       HWS-REC SIGNATURE                                         DATE

Subject to the following conditions:          ________________________________________________________

____________________________________________________________________________________________

Period of approval is one year, from _____________________________ to ___________________________




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      *VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED*

Information included in this box includes the signature of the chair of the HWS-REC who approved the
application, the date it was approved, the period of approval, and any conditions for the approval.
Conditions could include, for example, submission of a letter of approval from the Head of Department of
the research site, minor revisions of the consent form etc. It is the investigator’s responsibility to comply
with the conditions before the proposal is forwarded to the Higher Degrees Committee.

IV.     CO-INVESTIGATORS
Provide all the information requested for each co-investigator. Primarily this means all researchers who will
have contact with human participants and will perform study procedures with them. Add sections as
necessary. This is the place to show if you are part of a larger research project. This is not meant to include
consultants, laboratory technicians, or others who perform consulting or analysis services. Indicate if the
co-investigator/s is/are registered with the Health Professions Council of South Africa (HPCSA), Nursing
Council etc.

Name:                                            Title:                          Position:

Department:                     Faculty:

Professional Registration Number:

Postal Address:



Telephone:                      Fax:                      e-mail:


        RESEARCH ASSISTANTS
Provide all the information requested for research assistants linked to this study. This information is
generic to all research assistants and not necessarily specific to individuals. Primarily this means all
research assistants who will have contact with human participants and will perform study procedures with
them.

Minimum qualifications needed:


Training to be given:


Supervision/Monitoring plan:


V.     INDICATE FUNDING SOURCES OR CONTRACT RELEVANT TO THIS
       APPLICATION.
This section asks for funding sources, which support the research activity. Include as many funding
sources as are relevant to the activity. Explain what kind of funding mechanism is involved, the name of
the principal investigator (this may be different from the listed investigator on the HWS-REC application),
the name of the agency to which the proposal was submitted, the reference number (if the agency has
assigned one), the title of the proposal submitted (this may be different from the title on the HWS-REC
application), the proposed dates of funding.




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                                                                                          HWS-REC 4.1

A.        Type of proposal:         Un-funded Research                       Contract

               CPUT student grant           Subcontract             Other,     Specify ………………………..

     B.        Name of principal investigator:
     C.        Name of funding agency:
     D.        Agency’s number (is assigned):
     E.        Title of proposal:


Researchers with a financial interest in research must go through a disclosure procedure. If this situation
applies to you or members of your research team, please provide the Committee with documentation that
the Faculty Research Committee has cleared all conflicts of interest.

          Does the researcher or any member of the research team have a financial
          interest in the research or its products?
               No                   Yes.
          If: yes”, include documentations that this has been cleared.

_____________________________________________________________________


VI.       SUMMARY OF ACTIVITY.
This selection should include a short description of the research goals and their significance sufficient to
provide Committee members with a context in which to review the activity. Because the Committee
include non-scientists as members, please avoid technical terms and jargon. Do not reference the pages
of an accompanying research proposal since there are only two copies of the proposal and five copies of
the application. A brief version of this section, written in language appropriate for the audience, should be
included in the “Purpose and Benefits” section of the consent form for participants.



A. BACKGROUND AND RATIONALE FOR THIS STUDY.
Provide relevant background information and explain in lay language what research
question(s) this activity is designed to answer.

____________________________________________________________________

B.        METHOD AND METHODOLOGY.
Briefly state the methodology (type of research) and method (specifically the procedure in which human
subjects will be participating). The Committee wants to know how the study procedures compare with
what would usually happen to a participant. This is most relevant when participants are patients, but it
could also be important when participants are students or clients receiving a service

A shortened version of this section, written in language appropriate to the audience, must be included in
the information of the consent form for participants.



          1.      Provide a complete description of: a. the study design, and b. sequence
                  and timing of all study procedures that will be performed, e.g. volume of
                  blood, questionnaire. Provide this information for each phase of the
                  study (pilot, screening, intervention and follow-up). Use lay language.
                  Attach study flow sheet, if available.

___________________________________________________________________



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                                                                                           HWS-REC 4.1

        2.      Would participants undergo these or similar procedures (medical,
                educational, etc.) if they were not taking part in this research?
                     Yes               No
                If “No”, describe how the study procedures differ from what
                 participants would otherwise undergo.

____________________________________________________________________



C.      PARTICIPANTS
Include the total number of participants and the age range of these participants. Committee members will
use this information to consider the risks and benefits of the activity.

1.      How many participants will you need to complete this study?

        Number ______________                Age range ____________

____________________________________________________________________

Provide a statement of the criteria that will be used to select participants for the study (for example,
females with osteoarthritis between ages of 35 and 65.

2.      What are the inclusion criteria for participants in this study? Answer for each
        participant group, if these criteria are different.

_____________________________________________________________________


Provide the criteria that will be used to exclude participants (for example, pregnancy, allergy to specific
medications, blood pressure over or under certain levels etc.).

3.     What are the exclusion criteria for participants who are otherwise eligible from
this study? (Answer for each participant group, if the criteria are different.)

_____________________________________________________________________


Explain how you will recruit each group of participants (for example, from a clinic, from a certain school,
company). Provide examples of the flyers, letters to physicians, etc., that you will use.

4.     Describe the participant recruitment strategies you will use for each group of
       participants.

_____________________________________________________________________

Explain who will be recruiting participants and how participants will be approached to participate in the
study. (For example, a nurse at the research site may approach patients to ask if they will participate in
the study.)
5.    Explain participant recruitment and how this will be done to protect participants’
privacy and identity.

_____________________________________________________________________



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                                                                                             HWS-REC 4.1



Provide a letter from non-University agencies, institutions etc. indicating
permission for the project.
Participants must be free to decline participation and must not be coerced into participating in the study.

6.      Explain what steps you will taken during the recruitment process to minimize
        potential coercion or the appearance of coercion.

_____________________________________________________________________

If participants will receive payments, service, extra course credit etc. for participating, explain why this is
necessary and not coercive and how it will be delivered to the participants. A clear description of
inducements for participation should be included in the “Other Information” section of the consent for
participants.

7.      Will you give participants gifts, payments, services without charge, or extra
course credit?               No                       Yes
      If yes, explain:

_____________________________________________________________________

Explain what charges, if any, participants or third parties (including government agencies) will be asked to
bear. Justify why participants should be asked to psy these costs.

8.      Will any of the participants or third parties be charged for any procedures?
              No                       Yes        If ‘yes’, explain:

_____________________________________________________________________

Include a statement of the site(s) at which the study will take place (for example, University Hospital,
Symphony High School). The site will be assessed for both safety and appropriateness and to determine if
other approvals are necessary.

9.    Where will the study procedures be carried out?
(Attach letters of permission from all sites.)

_____________________________________________________________________


D.      RISKS AND BENEFITS (participants, researchers, public etc.)
It is important for the committee to understand the researcher’s view of the risks due to this study.
Describe the possible risks to the participants e.g. radiation risk, side effects of substances being
administered, the stress of responding to personal questions, the risk of disclosure of sensitive
information, or the discomfort of psychological and physiological research techniques

Note that a clear description of the likely risks involved in the study should be included in the “Risks,
Stress or Discomfort” section of the consent form.



1.      Describe the nature and degree of risk to participants through possible injury,
        stress, discomfort, invasion of privacy from all study procedures. Include
        psycho-social risks as well as physiological risks.




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                                                                                            HWS-REC 4.1

_____________________________________________________________________

2.      Describe the nature and degree of risk to the researcher/s, research
        assistants, member of the public etc. through possible injury, exposure to
        hazardous substances or organisms etc.

The Committee’s charge is to ensure that the researcher has minimized the risks of harm (physical,
emotional, economic, etc.) and taken steps to protect the rights and welfare of participants, researchers
and all persons who may be affected by this research. For vulnerable groups (i.e. minors, prisoners,
fetuses in utero, pregnant woman, decisionally impaired, or economically or educationally disadvantaged
participants etc.) the Committee would like to see evidence that the researcher recognizes the special
needs of these groups and has taken steps to reduce the possibility of damage to their rights and welfare.

3.      Explain what steps you will take to minimize risks of harm and to protect the
        rights and welfare of participants’ and all persons affected by this research.
        Please identify the group(s) and answer this question for each group.

_____________________________________________________________________

Describe concisely and realistically the benefits of the proposed study for participants (if none, state this),
and for society or the community etc. Note that this information should be included in the “Purpose and
Benefits” section of the consent form for participants.

4.      Describe the anticipated benefits of this research for individual participants in
        each participant group. If none, state “None.”

_____________________________________________________________________


The Committee must determine that the risk of harm to individual participants is out-weighted by the
potential benefit, especially if there is little or no potential benefit for the participants themselves. This
information should be included in the “Purpose and Benefits” section of the consent form for participants.

5.     Describe concisely the anticipated benefits of this research for society, and
explain how the benefits outweigh the risks.

_____________________________________________________________________


E.      ADVERSE EVENTS OR EFFECTS

Who will handle adverse events?                   Investigator       Referral         Other, explain:
Provide an explanation of how the investigator will handle adverse events that might result from the study
both immediately and in the future, if relevant. If the investigator will handle all possible adverse events,
the Committee must determine that the investigator has these capabilities. If the research team will
handle some adverse events, and refer others, this should be explained. This information should be
included in the “Risks, Stress, or Discomfort” section of the consent form for participants.

_____________________________________________________________________


F.      CONFIDENTIALTY OF RESEARCH DATA




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                                                                                          HWS-REC 4.1

 Sometimes it is necessary for researchers to retain identifiers in order to conduct longitudinal studies or
to link data from one data set to another. If this is necessary, provide an explanation. Information about
what identifiers will be kept should be included in the consent form for participants.

1.      Will you retain any direct identifiers (names, patient, hospital, addresses,
         telephone numbers, etc)           No                 Yes
        If yes, explain why this is necessary.
_______________________________________________________________________________________________


Data which will be kept confidential should be coded using a study code. Hospital or patient
numbers, and clinic numbers are not sufficient to protect the identity of a participant. If data are coded,
a master list linking the data to individual participants should be maintained securely and separately
from the data. All data should be identified only with the code number, and not with the identifier.

2.      Will you retain a link between study code numbers and direct identifiers?
             No                       Yes
        If yes, explain why this is necessary and for how long you will keep this link.

_____________________________________________________________________

3.   Describe how you will protect data against disclosure to the public or to the
     other researchers or non-researchers. Explain who will have access to data.
      Describe the data protection procedures (password protected computers, locked
      files in locked rooms, etc) that you will put in place to protect the study data
      from inadvertent disclosure. Identify any group, which will have access to
      identifiable data, and explain why the group has such access. This information
      should be included in the “Other Information” section of the consent form.
_____________________________________________________________________

It is necessary to place a copy of the consent form in a personal medical record if the study intervention is
related to a condition for which the participant is being treated/examined. However, placing a consent
form or study information in a participant’s medical record when the study is unrelated to their medical
care simply increases the risks of invasion of privacy and breach of confidentiality. If it is necessary to
place this information in the participant’s medical record, the consent form should include this information.

4.      Will you place a copy of the consent form or other study information in the
        participant’s medical or other personal record?
             No                       Yes.
        If yes, explain why this is necessary.

_____________________________________________________________________

If you anticipate using data collected for this study in the future, include a description of the possible
future uses in the consent form. Depending on the specificity with which you are able to describe future
uses, the degree of similarity between the current and future use, and whether the data will be linkable to
participant identifiers, the Committee may or may not allow the consent obtained for this study to apply to
future studies.

5.     Do you anticipate using any data (information, specimens, etc.) from this study
       for other studies in the future?
             No                       Yes
        If “yes”, explain and include this information in the consent form.



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                                                                                          HWS-REC 4.1



_____________________________________________________________________

6.      Will feedback be given to participants?
             No                       Yes
Briefly describe how feedback will be given.
_____________________________________________________________________

If medical or academic records of participants will be examined to recruit participants, screen participants,
or to provide study data, this information should be included in the consent form as a statement (i.e., “We
would like to review your medical record for information about your health history and treatment”.)

7.      Will you need access to participants’ medical, academic or other personal
        records for screening purposes or during this study?
             No                       Yes.
        If “yes”, specify types of records, what information you will take from the
        records and how you will use them.

_____________________________________________________________________


If audio-visual or tape recordings (videos, photographs or voice recordings) are study procedures, check
“yes.” This information should be included in the consent form for participants. If the recordings will be
shared in any way (through publications, presentations, or classroom use) with anyone who is not a
member of the investigating team, participants should be offered the opportunity to review the recordings
and to delete any portions. The identity of the participants should be obscured in the recording where
possible.

8.      Will you make audio-visual or tape recordings or photographs of participants?
             No                     Yes.
        If yes, explain what type of recordings you will make, how long you will keep
        them, and if anyone other than the researcher will be able to see them.

_____________________________________________________________________



G.      EQUIPMENT

        Will your study involve use of equipment?
            No                      Yes.
        If yes, describe safety testing and quality control procedures you will use to
        ensure participant safety.

_____________________________________________________________________

G.      ADDITIONAL INFORMATION

        Give any additional information relevant to this application.

_____________________________________________________________________



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                                                                                            HWS-REC 4.1



H.      CONSENT FORMS
Standard procedure is that research participants should provide documentation of informed consent
through a written and signed consent form. If there is good reason why this approach should be different
in your study, provide the relevant information and include an example of how consent will be obtained.
For instance, if you are requesting that consent be obtained orally, provide an explanation of why oral
consent is appropriate, and include an example of the statement, which will be read to participants. In
most cases in which consent is obtained orally, participants should be provided with a written
information statement, which includes all of the elements of informed consent except the signature of
the participant. If you are requesting that informed consent be waived, attach an explanation of why this
is appropriate.


Consent documents should be prepared for each group of participants in the study. Assent forms should
be prepared for minors appropriate to their ages, and consent form(s) for parents or legal guardians
should also be prepared. For children too young to comprehend a simple explanation of participation,
parental consent is sufficient only if the research will provide direct benefit to the participant, a member of
the participant’s family, or other children with the same condition as the participant.


Language used in the consent form should be appropriate for the intended group. Avoid medical or
scientific jargon. Use short words and short sentences.



          Written (Attach copies of all consent and assent forms for
        each participant group.)
          Oral (Attach written scripts of oral consent and assent for
        each participant group.)
           Waiver (Attach written justification of waiver of consent)
_____________________________________________________________________


I.      DRUGS, SUBSTANCES AND DEVICES
Provide the name, dose or dose range, source (where obtained or manufactured), route of administration
and side effects for all substances used in the study. Include all substances, even if they would be used in
the course of patient care.

1.      List all drugs or other substances used to conduct this research. Include
        products used for standard clinical care if they are used in this study for
        research purposes.


         Name                        Source                       Dose                How administered


___________________________________________________________________
2.   Provide copies of a concise summary of drug information prepared by the
     investigator with this application.

_____________________________________________________________________

If an investigational device is involved in the activity, provide as much information as is available about
the device. Include the name of the device, who is manufacturing the device, a description of the device




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                                                                                          HWS-REC 4.1

and how it will be used in the study. If the device does not pose a significant risk to participants, state
this and explain why. Include any documentation about the device provided by the manufacturer or
through reprints or description of other studies using the device. Drawings or photographs of the device
are always helpful, if available. The Committee needs enough information to determine whether or not
the device poses a significant risk to participants.

3.     List all investigation devices you will use. Provide the information requested
below.

    a.      Name of the device:
    b.      Name of the manufacturer:
    c.      Description of its purpose and how you will use it in this study:
    d.      Description of previous studies in humans and animals:

_____________________________________________________________________




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