Dr. Elizabeth Hill, ProfessorIRB Chair Voice: 313-578-0405 Fax: 313-578-0507E-mail: hillelm@udmercy.edu

Responsible Research with Human Participants

Cate Caldwell, PhDDirector, OSPRA Voice: 313-992-1544Fax: 313-993-1534E-mail: caldwecr@udmercy.edu

EthicsProfessional ethicsPrivacy and consent issues are concerns in

many contexts outside of research:- E.g., American Medical Association,

American Psychological Association codes- Federal privacy rules

- Health Insurance Portability and Accountability Act (HIPPA)

- Family Educational Rights and Privacy Act (FERPA)

- And othersResearch ethics

Research EthicsWhat is research?

RESEARCH is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”

Research EthicsWhat is research?Publication of results outside the university is

a critical issueDistinct from practice

Individual cases Distinct from teaching assessment

Teaching evaluationsDistinct from student projects in classes

Ethical conduct is still required

Research EthicsWhat is research with human subjects?HUMAN SUBJECT is defined as “a living

individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information

Research with animals also requires ethics review, conducted by Institutional Animal Care and Use Committees

Research EthicsTrigger Events Ethical Milestones

The Nazi Experiments Nuremberg Code, 1947

Tuskegee Syphilis Study National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research, 1974

* Belmont Report, 1978* Common Rule, 1991

The Belmont ReportThe principles of the Belmont Report govern all

research supported by the U.S. Government. The ethical principles outlined in the report are the basis for subsequent regulations designed to ensure protection of human subjects in research.

Respect for Persons Beneficence Justice

The Belmont Report1.Respect for persons

Informed consent

Protection of privacy and maintaining confidentiality

Additional safeguards for protection of vulnerable populations to prevent coercion or undue influence

Protection of individuals with reduced autonomy

The Belmont Report2. Beneficence

maximize benefits and minimize harm

an independent person/board must review all research and assess the risk/benefit ratio

this assessment includes evaluation of the study design and the ability of the researcher

The Belmont Report3. Justice

selection of subjects must be equitable o inclusion of appropriate populations without

unnecessary exclusion of populations-- fairness of inclusion and distribution of results

equitable distribution of research burdens and benefits

Federal RegulationsCurrent regulations were developed to comply with the

principles in the Belmont Report

Title 45 Public Welfare Department Of Health And Human Services National Institutes Of Health Office For Protection From Research Risks

Part 46 Protection Of Human Subjects

Known as 45 CFR Part 46 or the Common Rulewww.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

Federal protection of human subjects is overseen by the Office of Human Research Protections (OHRP) at Health and Human Services (HHS)

www.hhs.gov/ohrp/

Federal Regulations45 CFR 46A set of guidelines-- not meant to be rules

Each institution interprets the guidelines for their types of research

Research facilities may require more than one review board, depending on the variety of research conducted at the facility

UDM PoliciesALL researchers/experimenters working with

human subjects in research investigations are required to obtain clearance from UDM’s IRB PRIOR to running the experiments/studies

See our website: http://www.udmercy.edu/academicaffairs/ospra/irb/index.htm

ALL researchers/experimenters are required to complete the online training course entitled “Program for the Protection of Human Research Subjects” conducted by the Collaborative Institutional Training Initiative

See the website: http://www.citiprogram.org

UDM PoliciesFor all projects, regardless of the level of

review, an application must be submitted to the IRB prior to the initiation of any research involving human subjects.

Most federal agencies have a “Just-in-time” policy. That is, you don’t need to have IRB approval at the time of proposal submission, but you must have IRB approval prior to the acceptance of award funds.

The IRB chairperson is responsible for determining the review status of each project.

Three levels of IRB review / continuing review

UDM PoliciesExempt- minimal risk to participants (risk

equivalent to everyday life)o educational researcho anonymous surveyso secondary/archival data o naturalistic observationo quality control

Please note that exempt research projects still need to be submitted to the IRB. Exemptions are granted by the IRB chair.

UDM PoliciesExpedited

Only research in categories 1-7 in 45 CFR 46.110(b)(1) may be reviewed through an expedited procedure.

This list of categories can be found on our website at http://www.udmercy.edu/academicaffairs/ospra/irb/guidelines/index.htm#ExemptionExpedited

Also, the study musto Be no more than minimal risko Collect no sensitive informationo Not recruit protected populations as participantso Not be classified research

UDM PoliciesFull Committee

o greater than minimal risko intervention/experimental studies which require

investigational new drug applicationso vulnerable subjects (prisoners, children, pregnant

women)

o These decision tables and others can be found on the Health and Human Services (HHS) Office for Human Research Protections (OHRP) website at

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

UDM PoliciesThe Make-Up of UDM’s IRB

At least 5 members with varying backgroundsSufficient diversity (gender, race, expertise) to

represent research facilityAt least one member must be knowledgeable of

all institutional commitments, regulations, and applicable laws

At least one member must be from outside the research facility

At least one member must represent non-scientific interests

For review of any project, the IRB can invite person(s) with particular expertise as a temporary non-voting IRB member

UDM PoliciesGoals of the IRBReview study design and determine

risk/benefit of each projectDetermine if all requirements of Informed

Consent are fulfilledDetermine if additional safeguards are

provided for vulnerable populations

UDM PoliciesAll forms, procedures, and meeting dates are available

at http://www.udmercy.edu/academicaffairs/ospra/irb/index.htm

Proposals must be submitted on the provided form-- a Word file available on the web page

Proposals submitted for exempt or expedited review may be submitted at any time—plan on a 1-2 weeks for review

For consideration at a full committee review, the application must be submitted three weeks prior to the next scheduled IRB meeting

The full committee meets every two monthsExempt and Expedited categories of research are listed

on the website

UDM PoliciesConfidentialityData with personal identification should be

stored in a confidential manner.To assure confidentiality, unless necessary all

identification should be removed from the actual data.

When identification of data is necessary, information that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain should be replaced with a code number.

The key to decipher the code, enabling linkage of the identifying information to the private information or specimens, should be kept secure, separate from the data.

UDM PoliciesInformed Consent: Each subject must be informed ofexpectations of their participation- including time

requirements and procedural detailscontact information for the investigator and the IRB

Chairpersonexpectations of risks and benefits (details of

confidentiality, voluntary nature of participation, with no penalty or loss of benefits for nonparticipation or withdrawal, explicit statement that subject may withdraw at any time, compensation, if any)

details regarding the storage of information, including identification of stored materials and access by others

Required elements of informed consent are listed on the IRB webpage, along with an example consent form

UDM PoliciesThe responsibility for the protection of human subjects

does not rest solely with the IRB. It is shared between the PI, and the IRB, and rests with

the Institutional Official (at UDM this is the Academic Vice President for Academic Affairs).

Institutional Official: AVP Pam ZarkowskiSpecial Assistant to the AVP: Lisa Zessin IRB Chairperson: Elizabeth Hill

This shared responsibility includes appropriate training of all researchers.

Cate Caldwell, Director of OSPRA, may also be able to answer your questions.

UDM PoliciesCITI ethics training course - onlineGo to www.citiprogram.org.Register as a new user (username and

password)Select University of Detroit MercySelect a learner groupe.g., Social/Behavioral, Biomedical, Students

conducting no more than minimal risk research, Archives/Records/Specimens, Educational/Pedagogical Research

Complete the Basic Course (text and quizzes)

FAQsQ: My study participants will be minors. What

additional steps must I take?A: Research with children or adolescents

requires a parental consent form and a child assent form. The assent form must be written to be understandable by the age group of your participants. (Assent forms for children 7-13 are written at the 3rd grade level, forms for adolescents 13-17 are written at the 5th grade level.) If the research is minimal risk, only one parent must consent. If the research is more than minimal risk, both parents must consent.

FAQsQ: If I assign a student research project in one of my

classes, do my students need to go through the IRB?A: It depends. If the student plans to seek

publication, then yes. If it is only to complete the requirements of the course, then no. However, it is important that the student take ethical considerations into account, especially in studies with more than minimal risk to participants. It is advisable that they go through the IRB process in these cases, even though they are not required to submit. (Some universities require student research with more than minimal risk to go through the IRB.)

FAQsQ: My study was approved by another IRB.

Do I still need to go through the UDM IRB?

A: Yes, but it is an abbreviated process. We ask that you complete the Project Summary Form and attach the prior approval.

FAQsQ: I want to recruit UDM students, faculty, or

staff as study participants on the UDM listserv. Do I need IRB approval to do that?

A: Yes. The text of the recruitment script, the context in which the recruitment takes place (e.g. posting a message on a newsgroup, mass emailing, and websites created for recruitment of participants) must be reviewed and approved by the IRB. Please send all such messages to OSPRA and/or the IRB chair for prior review before distribution.

Investigator Responsibilities to obtain IRB approval for all projects prior to recruitment

of subjects and compliance with all IRB determinationsprotecting the rights of subjects according to 45 CFR 46obtaining and documenting the informed consent for all

subjects, as appropriateensuring that each potential participant understands the

nature of the research and their participation fully debrief all subjects, when necessary to inform the IRB of any unanticipated events during the

conduct of the protocol to inform the IRB of any changes in protocol following

committee approval prior to implementation of changes-- must obtain IRB approval for all protocol changes

report to the IRB the status of the protocol one year after approval and, if necessary, submitting an extension