New User Special Price Expires in

Let's log you in.

Sign in with Facebook


Don't have a StudySoup account? Create one here!


Create a StudySoup account

Be part of our community, it's free to join!

Sign up with Facebook


Create your account
By creating an account you agree to StudySoup's terms and conditions and privacy policy

Already have a StudySoup account? Login here

Research Design

by: Dayne Reichert

Research Design PSYC 6018

Dayne Reichert

GPA 3.62


Almost Ready


These notes were just uploaded, and will be ready to view shortly.

Purchase these notes here, or revisit this page.

Either way, we'll remind you when they're ready :)

Preview These Notes for FREE

Get a free preview of these Notes, just enter your email below.

Unlock Preview
Unlock Preview

Preview these materials now for free

Why put in your email? Get access to more of this material and other relevant free materials for your school

View Preview

About this Document

Class Notes
25 ?




Popular in Course

Popular in Psychlogy

This 0 page Class Notes was uploaded by Dayne Reichert on Monday November 2, 2015. The Class Notes belongs to PSYC 6018 at Georgia Institute of Technology - Main Campus taught by Staff in Fall. Since its upload, it has received 20 views. For similar materials see /class/234267/psyc-6018-georgia-institute-of-technology-main-campus in Psychlogy at Georgia Institute of Technology - Main Campus.


Reviews for Research Design


Report this Material


What is Karma?


Karma is the currency of StudySoup.

You can buy or earn more Karma at anytime and redeem it for class notes, study guides, flashcards, and more!

Date Created: 11/02/15
Ethics From Belmont Report Psychology 6018 What You Should Learn From Text and Lecture oz De ne research ethics oz What is the role of the IRB oz Why do we need IRB review oz Principles from Belmont Report oz The What and how of submitting to IRB oz What is the principle of informed consent oz Responsibility to participants during data collection oz Explain process of debrie ng oz Ways con dentiality of data can be protected A Little History oz It is important to look at history We learn from our mistakes History can repeat itself oz The Nuremberg Doctors Trial of 1946 oz The Milgram Study oz Thalidomide Tragedy oz Untreated Syphilis Study oz Human Radiation Experiments The Nuremberg Doctors Trial of I 946 oz Due to medical experiments many people died 7 The German Air Force 39 high altitude experiment 7 40 ofthe 200 participants died 39 parachuting into cold Water experiment 7 300 prisonerparticipants sulfered a mortality rate of30 39 Wound bums amputation chemical and biological agent exposure experimen 7 many died or were mined for life 39 Many experiments Went on throughout the W11 7 A mortality rate of25 ms typical The Nuremberg Code 15 of the 23 defendants were found guilty A Code was developed 7 Informed consent of Volunteers must be obtained Without coercion of any kind 7 Human experiments should be based upon prior animal experimentation 7 Anticipated scienti c resulw should justify the experiment 7 Only quali ed scientists should conduct medical research 7 Physical and mental suffering and injury should be avoided 7 There should be no expectation of death or disabling injury from the experiment More Attention Needed While the Nuremberg Code and subsequent ethical guidelines represented the most enlightened thinking of the time many well intentioned researchers did not know about them or did not apply this guidance to their research activities The Milgram Study Obedience to Authority oz This study involved administering electric shocks up to extreme levels oz Deception was used causing some psychological stress oz Informed consent was not obtained oz Federal guidelines now instruct IRBs and investigators to 7 consider not only physical harms but also psychological social legal and economic I observed a mature and initially poised businessman enter the lab smiling and con dent Within 20 minutes he was reduced to a twitching stuttering wreck who was rapidly approaching a point of nervous collapse S Milgram in Obedience to Authority Thalidomide Tragedy oz Thalidomide used in Europe as a sedative not approved in US oz Manufacturers supplied samples to US doctors who were paid to study its safety by giving the experimental drugs to patients oz They found that administering the drug was extremely damaging to the fetus if taken during the first trimester resulting in interference with normal development of arms and legs Impact on the Hearings oz It was found that those taking the drug were not informed that they were being given an experimental substance nor had they been asked to give their consent oz This led to The passage of the Drug Amendments of 1962 to the Food Drug and Cosmetic Act The FDA issued regulations with a consent requirement for documenting consent in writing and informing participants that they might receive a placebo Untreated Syphilis Study oz Known as the Tuskegee Study oz The control group was denied the penicillin treatment even though it was widely available o Study is striking example of many things including 7 Lack of informed consent 7 Lack of follow up and record keeping 7 Lack ofBeneficence and Respect for Persons 7 Deception and coercion 7 Lack of effective oversight r Targeting a vulnerable population 7 Withholding effective treatment Sometimes with the best of intentions scientists and public officials and others involved in working for the benefit of us all forget that people are people They concentrate so totally on plans and programs experiments statistics on abstractions that people become objects symbols on paper figures in a mathematical formula or impersonal subjects in a scientific study From an article in the Atlanta Constitution on July 27 1972 reacting to the revelations concerning the Syphilis Study Prelude to Change ozo Many saw a need to protect people from experiments and scientists who for Whatever reason ignored human values ozo As a result Congress passed the National Research Act this Act created the National Commission for the Protection of Human participants of Biomedical and Behaviorial Research The National Commission established the Belmont Report The Belmont Report The cornerstone statement of ethical principles upon which the federal regulations for the protection of participants are based 0 The Basic Principles 39 Respect for Persons 7 individuals should be treated as autonomous agents a persons with diminished autonomy are entitled to increases protection 39 Beneficence a persons are treated in an ethical manner by respecting their decisions and protecting them form harm r maximize possible bene ts and minimize risks 39 Justice 7 fairness in distribution Respect for Persons oz This principle is captured in the consent process oz We must consider different types of participants Vulnerable participants Prisoners Children Subordinate individuals Decisionally impaired Bene cence oz Obligations of beneficence affect both individuals and society We must weigh the risks and the benefits 0 risk refers to a possibility that harm my occur 0 bene t refers to something of positive value 0 determining the balance constitutes an ethical dilemma in research Even if the the benefit to science and society is great never should we forgo participant protection Justice oz The principle of justice is captured in the selection process oz Justice requires exclusion of those groups unlikely to be among bene ciaries of subsequent applications of the research oz Justice requires inclusion of diverse populations so that they may bene t form the research ndings Human Radiation Experiments oz Under government sponsorship researchers injected plutonium into unknowing participants Nuclear facilities had intentionally released radiation into the environment oz President Clinton created Advisory Committee on Human Radiation Experiments ACHRE to determine What the ethical and scienti c standards were for evaluating these events National Bioethics Advisory Commission NBAC Federal Regulations oz Directly derived from the ethical principles in the Belmont Report oz The common set of regulations is known as the Common Rule Review of research by an IRB Informed consent of participants Institutional assurances of compliance Institutional Review Board IRB oz Purpose 7 review research and determine if the rights and welfare ofhurnan participants involved in research are adequately protected oz The IRB has authority to approve require modi cation or disapprove all research activities IRB Review oz All studies undergo continuing review to ensure that the riskbenefit relationship of the research remains acceptable the informed consent process and documents are still appropriate the enrollment of participants has been equitable oz Any changes in the study must also receive IRB approval before being instituted Considerations in IRB Review of a Study oz The risks to the participants oz The anticipated bene ts to the participants and others oz The importance of the knowledge that may reasonably result oz The informed consent process to be employed Informed Consent oz What does this entail Information 0 Informed consent is a process of information exchange that takes place between the prospective participant and the investigator before during and sometimes after the study Comprehension Investigators are responsible for ascertaining that the participant has comprehended the information Voluntarinesss An agreement to participate in the research constitutes a valid consent only if voluntarily given Protocol oz Protocol is a formal document that establishes the conditions under which research is to be conducted oz The investigator should include the specific scienti c objectives budget personnel and facility considerations research methods and procedures the analytical methods description of data monitoring security measures to protect the data human participant issues Human participant Issues Inclusion criteria o Exclusion criteria Justi cation for any inclusion of vulnerable participants The intended gender distribution of the participants Women of childbearing potential may not be routinely excluded from participating in research The age range of participants The intended racial and ethnic distributions of the participants Any potential bene ts o Alternatives that are available should the participant select not to participate in the study The recruitment methods Human participants Issues cont Who Will obtain consent and how the process of informed consent Will be structured If all participants Will not be capable of giving consent describe additional protections o Assessment of understanding of the information presented o Justi cation of any nondisclosure and description of poststudy debrie ng o Justi cation of any costs that the participants Will incur o Description of any reimbursements or incentives such as cash payments Vulnerable Participants oz Additional protections may be necessary when conducting research with vulnerable participants oz The vulnerable population includes Children Mentally disabled Individuals with cognitive disorders Prisoners Pregnant women Protocol Deviation oz The investigator may only deviate from the protocol to eliminate an immediate hazard to participants Without prior IRB approval oz The deviation is considered an amendment oz The IRB must be noti ed as soon as possible Amendment in a Study oz It must be approved by the IRB before implementing the change oz Changes in a consent form may require reccnsent of those currently participating Multiple Project Assurance oz Multiple Project Assurance MPA is required for federally sponsored research oz A fundamental condition of an Assurance is that the institution must establish and maintain an IRB that oversees the conduct of the research Decision Tree of Review and Approval of Research Involving Human Particpants g g a D332 Q n x m quotwwwmme WWW mm mm 1 mmy whvllymvnlve quot Mum m up A Maramm m WW th A ath 0mm M 1m mm A mums m m meuan quot1 W send u IRE um quotI mud mmqu awning mmhmm wand mmac rmmmmmr m In dzizmmzs u humbling I zx mmhunmenmpl mum m Izqullzs um um uncannymun Violation ofMPA oz If obligations set forth in an Assurance have been violated the Of ce for Protection from Research Risk OPRR has the authority to terminate or suspend the Institution s Assurance suspend or restrict any ongoing studies departmental restrictions individual restrictions Violations of FDA Regulations oz Disquali cationdebarrnent of individuals from clinical research oz Disquali cation of institutions andor IRBs from conducting or approving clinical research oz Other sanctions including seizures injunctions criminal charges and monetary penalties Drug or Device Accountability Records DARS oz DARs are used to provide evidence that all materials are accounted for and that their nal disposition is controlled oz DARs are forms that are customized documents tailored to the individual protocol oz Not only is the investigator s signature required but also any persons who dispenses the drugs or deVices to ensure accountability Form FDA 572 oz A list of commitments in which the investigator is making to the FDA for conduct of the study can be found on the back of this form oz This form is also referred to as the hanging paper Why It is a criminal offense to sign this document if 0 it contains false information o if commitments made Within the signed document are ignored Form FDA 1572 oz Who signs this form This form requires the names of the principal investigator the coprincipal investigators and any subinvestigators oz What does this form mean Signing this form is an agreement to conduct the investigation according to the provisions listed on the Form Adverse Events oz If any adverse events take place the investigator must report them to the sponsor the reviewing IRB Source Documentation oz Source documentation is Where the information is rst recorded original documents oz The investigator is required to prepare as well as maintain adequate and accurate records of all observations and other data pertinent to the study for every participant Source Documentation list oz The documents should include things like demographic information evidence for supporting the condition for which the participant is being studied general informationmedical history physical ndings documentation that informed consent was obtained for each participant prior to participation in the study Judgement oz Professional judgement should be used throughout a study to maintain the integrity of the research process to keep the participant informed of hisher role in the process relationship with the investigators Investigator s Responsibility oz Investigators bear the ultimate ethical responsibility for their work with human participants oz Other responsibilities include compliance with federal state laws and regulations assuming scal management supervising and training of students post docs and residents complying with the terms and conditions of the sponsor s award submission of all technical progress invention and nancial reports on a timely basis Investigator s Responsibility cont oz Violations may result in loss of funding or debarment oz Investigators who also serve as sponsors must comply with the responsibilities of both the sponsor and the investigator Institution s Responsibility oz The institution has responsibility for educating researchers on issues of scienti c integrity as well as the mandated responsibility to investigate cases of scienti c misconduct Scientific Misconduct oz A fabrication falsi cation plagiarism or other practices that seriously deviate form those that are commonly accepted Within the scienti c community for proposing conducting and reporting research oz Does not include honest error of honest differences in interpretations or judgements of data oz These individuals are known as whistleblowers Allegations of Misconduct oz Individuals who in good faith have made an allegation of misconduct should not be the object of retaliation 3 oz Retaliation against a whistleblower who made the allegation of misconduct in good faith may itself be construed as an act of misconduct Recruitment of Participants oz Direct advertising yers posters newspaper ads press release oz Must be reviewed by the IRB oz Not state or imply bene ts beyond that outlined in the protocol oz Not be coercive or use undue pressures oz Not be misleading to participants Ethical Considerations Daring Data Collection ozo Avoidance of harm ozo Withdrawal of consent After Data Collection Debrie ng ozo What is debrie ng ozo What are the components of debrie ng ozo What is effective debrie ng De nition ozo Research ethics are a set of principles or guidelines that will assist the researcher in making dif cult research decisions and in deciding which goals are most important in reconciling con icting values Ethical Issues ozo Science and society Should society dictate What issues are investigated ozo Professional Issues Fraudulent activities Partial and duplicate publication Review the ethics case studies Plan Research Involving Human Subjects Get Wise to IRBWISET39V39 Stnce mtdFebruary Geor gtaTecn39s HSUIUUOHH Review Board ORB has been successtHy recetvtng apphcattons vta RBW SE39M a webeenabted protocot management and tracking system AH 3 lg rMTM A IRBv at tacutty star and students t s kg sma wno propose research or studtes Invotvmg human subjects may now appty vsa lRBW SETMJocated at th sra 3wquot nedar39btnw ran 7 CO 5 RBVVISETM supports protocol preparatton annual renewats reporting of adverse events and more tRB members UUHZE the system to access protocols for rewew and Of ce of Research Comphance staff U39JUZE it for LIECng and management of records AWebWtSE account 5 requtred for access to RBWtSETM You may request access oane at nttasw webwtse gtrrgetecnectK Protocots and renewal apphcattons er SUN be accepted on the paper torm whtcn can be found at t tp39H WWWOSD gater ecuquotcornahancwnuwa tsr umans xtm For assistance contact the Of ce of Research Compitance at 404 89476944 or at trbg3tcth eju


Buy Material

Are you sure you want to buy this material for

25 Karma

Buy Material

BOOM! Enjoy Your Free Notes!

We've added these Notes to your profile, click here to view them now.


You're already Subscribed!

Looks like you've already subscribed to StudySoup, you won't need to purchase another subscription to get this material. To access this material simply click 'View Full Document'

Why people love StudySoup

Bentley McCaw University of Florida

"I was shooting for a perfect 4.0 GPA this semester. Having StudySoup as a study aid was critical to helping me achieve my goal...and I nailed it!"

Kyle Maynard Purdue

"When you're taking detailed notes and trying to help everyone else out in the class, it really helps you learn and understand the I made $280 on my first study guide!"

Jim McGreen Ohio University

"Knowing I can count on the Elite Notetaker in my class allows me to focus on what the professor is saying instead of just scribbling notes the whole time and falling behind."


"Their 'Elite Notetakers' are making over $1,200/month in sales by creating high quality content that helps their classmates in a time of need."

Become an Elite Notetaker and start selling your notes online!

Refund Policy


All subscriptions to StudySoup are paid in full at the time of subscribing. To change your credit card information or to cancel your subscription, go to "Edit Settings". All credit card information will be available there. If you should decide to cancel your subscription, it will continue to be valid until the next payment period, as all payments for the current period were made in advance. For special circumstances, please email


StudySoup has more than 1 million course-specific study resources to help students study smarter. If you’re having trouble finding what you’re looking for, our customer support team can help you find what you need! Feel free to contact them here:

Recurring Subscriptions: If you have canceled your recurring subscription on the day of renewal and have not downloaded any documents, you may request a refund by submitting an email to

Satisfaction Guarantee: If you’re not satisfied with your subscription, you can contact us for further help. Contact must be made within 3 business days of your subscription purchase and your refund request will be subject for review.

Please Note: Refunds can never be provided more than 30 days after the initial purchase date regardless of your activity on the site.