Posted: April 25th, 2025

Biology Quantative protocol draft assignment

It’s actually doing the real study, need to be feasible on college, one person level and then pretend that I did the study. 

• APA format. 
• Follow the example on the document attached. 
• Specific what quantative study you gonna use 

How to Create a Research Protocol

The Research Protocol is a statement of the researcher’s project design and a description of

his/her responsibilities toward the human subjects involved in the research.

To ensure an effective review by the Institutional Review Board, a full description of the planned

research must be submitted with the Application for IRB Review. A research protocol provides

the reader with background information of the problem under study, including the study

rationale, a detailed plan for conducting the research involving human research participants, and

a discussion of the potential importance of the research.

1. Objectives

The purpose of the study (research questions and / or study objectives) should be clearly and

succinctly stated. In experimental designs, objectives may be stated as hypotheses to be tested.

2. Background and Rationale

Summarize and synthesize the available research (including published data) to provide

justification for the study. Evaluate prior research for relevance to the research question under

study. Describe the significance of the research including potential benefits for individual

subjects or society at large.

3. Procedures

The procedures should include the following:

a) Research Design

The research design should be identified and should be appropriate to answer the research

question(s) under study. Describe the type of research proposed (e.g. experimental, correlational,

survey, qualitative) and specific study design that will be used.

b) Sample

Describe the sampling approach to be used. Identify the procedures that will be used to recruit,

screen, and follow study volunteers. Specifically define the study sample (number of subjects to

be enrolled, characteristics of subjects to be included in and excluded from the research, and

whether this will be a random or convenience sample).

c) Measurement/Instrumentation

Identify the variables of interest and study endpoints (where applicable). Justify measurement

techniques selected. Provide information regarding the validity and reliability of selected

measures.

d) Detailed study procedures

Methods for collecting data and for avoiding / minimizing subject risks should be included.

Include a timeline for subject participation in the project. Identify how subject confidentiality

will be safeguarded (plans for coding data and for securing written and electronic subject

records). Indicate how long personal information will be stored once the study is completed.

Methods will vary with the research approach used (qualitative, quantitative). The selected

methods should be sufficiently described to justify the use of the approach for answering the

defined research question. Methods should also be described in adequate detail so that IRB

members may assess the potential study risks and benefits.

e) Internal Validity

Threats to internal / external validity should be considered. Describe measures that have been

taken to avoid study bias.

f) Data Analysis

Specify the analytic techniques the researcher will use to answer the study questions. Indicate the

statistical procedures (e.g. specific descriptive or inferential tests) that will be used and why the

procedures are appropriate. For qualitative data, specify the proposed analytic approaches.

4. Bibliography

Include a reference list of literature cited to support the protocol statement.

How to Create an Informed Consent Form
The informed Consent Form must be a separate document from other documents. Except as provided in

sections 4, 5 and 6 below, informed consent shall be documented by the use of a written consent form

approved by the IRB and signed by the subject or the subjects’ legally authorized representative. A copy

shall be given to the person signing the form. The full informed consent form must include:

Content of the written consent form

1. Statement that the activity involves research and a description of where the research activity will

occur.

2. An explanation of the scope, aims, and purposes of the research, and the procedures to be followed

(including identification of any treatments or procedures which are experimental) and the nature of

the expected duration of the subjects’

participation.

3. Description of any reasonably foreseeable benefits, if any, to the subjects or others that may result

from the research.

4. A disclosure of appropriate alternative procedures or course of treatment (in instances where

therapeutic procedures are involved), if any that might be advantageous to the subjects.

5. A statement describing the extent to which confidentiality or records identifying the subjects will be

maintained except in unusual cases.

6. An offer to answer any questions the subjects may have about the research, the subject’s rights or

related matters, and the name of the person (together with address and telephone number) to

whom the subjects may direct questions or must report an injury.

7. A Statement that participation is voluntary, that refusal to participate involves no penalty or loss of

benefit to which the subjects are otherwise entitled, and that the subjects may discontinue

participation at any time without penalty or loss to which the subjects are otherwise entitled if they

had completed their participation in the research.

8. For research which may involve more than minimal risk of injury the subject should be informed of

the following statement which must appear in the consent form: (to be modified for off-campus

research). “In the unlikely event of injury resulting from this research, Andrews University

is not able to offer financial compensation nor to absorb the costs of medical treatment.

However, assistance will be provided to research subjects in obtaining emergency

treatment and professional services that are available to the community generally at

nearby facilities. My signature below acknowledges my consent to voluntarily participate

in this research project. Such participation does not release the investigator(s),

sponsor(s) or granting agency (ies) from their professional and ethical responsibility to

me.”

9. A space for the dated signatures of the subject, the principal investigator, and a witness. In the case

of a minor (the child must also sign if seven years of age or older) or a person unable to sign, a

second authorizing signature is required from the parent, guardian, or other responsible person. The

relationship must be specified.

In addition there is need to pay special attention to the following two definitions in your Informed

Consent, since lack of coercion and confidentiality are required for approval:

a) Coercion

Coercion means to compel or force someone to participate in or perform an action that would not

ordinarily be done of the individual’s own free choice. Coercion may be present when recruiting

subjects for research. Participation should be free and voluntary, with no overriding statements. The

following are ways that coercion can be introduced: The researcher is the supervisor or pastor of the

participants. Telling subjects or their parents (when children are involved) how much they will be

helping the investigator by participating in research can be interpreted as coercive. Mentioning a

relationship that exists between the researcher and the potential subjects may be coercive. Subjects

may feel obligated to participate because they know or have seen the researcher at various times.

In cases of infants and children, mentioning that the researcher cares for or has cared for the child

puts parents in a very awkward and unfair position. Face-to-face recruitment has the potential to be

coercive. It is difficult for individuals to say no to someone who is directly in front of them and

talking about his or her research. Inflection, tone of voice, and nonverbal cues can inadvertently slip

into the recruitment process without the researcher’s awareness. Coercion can be reduced if an

impartial third party presents the request for participation. Subjects should be protected from

coercion. If subjects are not protected, the IRB application must include an explanation of why

coercion is necessary as well as any possible repercussions of the coercion. The methods to be used

for coercing subjects must be detailed in the research proposal. A plan for informing subjects at the

end of the research of how and why they were coerced must be fully explained (see Debriefing).

Potential physical and/or psychological risks that may be incurred by subjects due to the coercion

must be identified, and procedures for addressing the risks must be established as part of the

debriefing procedures.

b) Confidentiality

Confidentiality refers to protection of subjects’ privacy so that information collected about them, as

part of the research process, is not disclosed. Information may be revealed in group form, or as

individual examples, but not in a way that an individual may be identified. If the investigator collects

information on subjects over a period of time, such as in test-retest reliability or in

Pretest-posttest study designs, there must be a mechanism to relate various data to the same

subject. This may be done by using codes or identifiers (e.g., subject ID numbers) on both sets of

data that only the researcher can trace to a master name-number list. Because names and numbers

can be related, this list must be kept confidential by storing it in a private and secure location, such

as a locked file cabinet. If data are recorded in cases where the researcher personally knows

subjects, it must be acknowledged that the researcher knows the subjects personally, and the data

must be treated confidentially, because anonymity is not possible. The data must be collected in

such a way that the identity is not recorded. All data should be stored in a way that the person is

not identified when the identity is not crucial for the research objectives. In other words, the IRB will

require that data be collected in the least intrusive and most confidential way to serve the purpose

of the research. In a focus group situation, it must be acknowledged that there is a lack of

confidentiality due to the group situation. The consequences of this lack of confidentiality must be

outlined. It is important to acknowledge

It is important to acknowledge that subjects may waive the right of confidentiality. This may occur,

for example, when a subject specifically requests to be quoted. In the United States, all confidential

data must be stored by the researcher for 3 years. In Canada, data must be stored for 6 years.

Consider also that ethical research requires that the researcher is qualified to do the research they

are proposing.

Format of the Written Consent Form

1. The consent form should clearly identify the relationship of the researcher to Andrews University.

The name of Andrews University should appear centered at the top of the consent form together

with the name of the department with which the researcher is affiliated. In cases where an

anonymously returned questionnaire substitutes as a form of implied consent, the cover letter

accompanying the questionnaire should clearly identify how the research is connected with Andrews

University and one of its academic departments.

2. The consent from should clearly indicate the name, address, and phone number of the investigator

and an advisor or impartial third party whom the research subject may contact for additional

information if desired.

3. Places for the dated signatures of the subject (and/or parent/guardian, if applicable), investigator,

and witness should be included at the bottom of the consent form.

Retention of the Signed Informed Consent Form

1. A copy of the Informed Consent Form should be returned to the subject or the person legally

appointed to sign the Informed Consent Form to retain for his/her review.

2. The responsibility for retaining signed copies of the Informed Consent Form lies with the principal

investigator(s). These Informed Consent Forms should be kept in a secure depository along with the

researcher’s other records for a reasonable amount of time (not normally to exceed three years).

Use of Alternate and/or Simplified Consent Forms

Certain situations may justify the use of alternate and/or simplified consent forms. However, in all cases the

investigator must demonstrate how the anonymity or confidentiality of the subject and his/her voluntary

participation in the project will be assured and maintained.

1. Oral Instructions Read to a Group. In the case of no risk or minimal risk research where

instructions are read to a group of subjects (e.g. a questionnaire passed out in a classroom setting,

with prior written authorization of the instructor), a short form to document the oral instructions

presented to the subjects may be used. A witness who heard the oral instructions read to the group

must co-sign the short form along with the researcher. A written copy of the oral instructions that

are to be read to the group must be submitted with the protocol. The items listed in Section 1 above

should be included in the oral instructions.

Research using surveys or questionnaires and dealing with sensitive areas of the respondent’s own

behavior (illegal conduct, drug/alcohol use, sexual behavior, etc. See Appendix A, Exempt Review,

item 4) require special consideration. Although the purpose and use of surveys or questionnaires in

such research may be explained in a classroom setting (with prior documented permission of the

instructor(s) involved), requesting respondents to actually complete survey instruments in the

classroom setting is not recommended. Alternative methods of collecting forms completed at the

discretion of the respondent and which thus insure the respondent’s anonymity should be employed.

2. Anonymous Surveys or Questionnaires. In the case of risk or minimal risk research involving

the use of surveys or questionnaires which are distributed individually and returned anonymously,

the cover letter explaining the purposes and procedures of the research project may substitute for

the consent form. Such a cover letter must be submitted with the protocol and should contain

reference to the items mentioned in section 1 above. It should state in the cover letter as well as on

the survey form itself that the return of the survey or questionnaire serves as a form of implied

consent.

3. Simplified Oral Interviews. Investigators conducting simple oral interviews, the content of which

qualifies as exempt from review, may submit an alternate form of written documentation in place of

an informed consent form. Such documentation should describe how the interviewer will explain

his/her research to the interviewee and how the researcher is prepared to insure the interviewee’s

confidentiality and his/her right to refuse participation in the interview.

In all cases, the researcher is responsible for the filing of all proof of compliance with the above

procedures and to keep them for a period of three years

Waiving of Signed Consent Documentation

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all

subjects if it finds that either of the following conditions exists:

1. The only record linking the subject and the research would be the consent document and the

principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be

asked whether he/she wants documentation linking the subject with the research, and the subject’s

wishes will govern.

2. The research presents no more than minimal risk of harm to subjects and involves no procedures for

which written consent is normally required outside of the research context.

Waiving the Consent Process

The IRB may under certain special circumstances approve a consent procedure which does not include or

which alters some or all of the elements motioned above or may waive the requirement to obtain consent

provided the Board verifies and documents each of the following items:

1. The research involves no more than minimal risk to the subjects

2. The waiver or alteration of consent will not adversely affect the rights and welfare of the subjects.

3. The research could not practicably be carried out without the waiver or alteration.

4. Whenever appropriate, the subjects will be provided with additional pertinent information after

participation.

Consent form from Attending Physician and/or Other Health Care Professionals

In situations where an individual is currently being treated/evaluated by a physician and/or other health

care professional for a condition related to the objective of the research study, the researcher is required to

obtain the consent of the physician and/or health care professional prior to involving such research subjects

in the study.

Or faxed to attention IRB: (269) 471-6543

E-mail Letters: Letters may be sent as scanned email attachments to irb@andrews.edu.

mailto:irb@andrews.edu