Human Research Handbook

This training is for researchers conducting studies that qualify for Exempt status in the IRB review process. If you already have current CITI certification, you do not need to complete this training. Qualifying faculty, students, and staff must complete the abbreviated training every two years, which includes reviewing materials and completing a Qualtrics quiz. Even for exempt studies, all advisors MUST have full CITI training.

The CITI program, sponsored by the University of Miami, covers several aspects of bioethics and human subjects research in a series of modules. This training is required for all PIs conducting higher-risk research or those serving as research advisors. Each module includes educational material and a brief online test. Completing the basic set of CITI modules typically takes 3-6 hours, and the program can be done at your own pace. Upon completion, you’ll receive a certificate that is valid for three years, after which you’ll need to complete a CITI Refresher course.

All researchers, staff, and students can access the CITI Human Subjects Research Educational Program. This online educational program is sponsored by the University of Miami.

The CITI program, developed by national IRB experts, covers several aspects of bioethics and human subject research in a module format. Each module has educational material that can be read on screen or printed, and a brief online test. The basic cluster of CITI modules takes about 3-6 hours to complete. You can do each module separately — you do not have to complete the entire program in one sitting.

To complete the CITI course you must first register at http://www.citiprogram.org/.

Your UM username and password will not work to login into this system. When you register, you are asked to create a username and password (see #3 below.)

1. At the CITI Login and Registration Page, click Register for the CITI Course.
2. At the Select your Institution or Organization page, scroll down to the category All Others and select University of Mississippi–Oxford, then click the Submit button.
3. At the Select Your Username and Password page, enter the requested information according to the instructions and click the Submit button.
4. At the CITI Registration Page, complete the form as instructed and when finished, click the Submit Information button.
   Note: If you are UM faculty/staff, please enter your employee number in the Employee Number space; if you are a UM student, enter your student ID number. If you are neither of these (e.g., an IRB community member), leave this space blank.
5. At the Select Group page, Step One gives you basic instructions; Step Two asks you to select a group appropriate to your research activities. You should choose one of these:

   Group 1 IRB Members (only if you are a member of the IRB)

   SBR Group 2A Social/Behavioral Faculty/Staff
   SBR Group 3A Social/Behavioral Graduate Students
   SBR Group 4A Social/Behavioral Undergraduate Students

   Biomedical Group 2B Biomedical Faculty/Staff
   Biomedical Group 3B Biomedical Graduate Students
   Biomedical Group 4B Biomedical Undergraduate Students

   Note: Most of the research done on our campus is considered social/behavioral research, including much of the research done in Psychology, Sociology, the School of Education, and the Business School. Examples of research which would be considered biomedical are some of the exercise studies in HESRM, and some studies in the School of Pharmacy. If you are unsure which CITI group to select, contact the IRB at irb@olemiss.edu.

6. After you have completed the modules for one of the above groups, the IRB will get an email and you will get a certificate of completion.
7. After completing one of the core courses above, IF you are conducting research with children, with prisoners, or in another country, you should THEN complete the appropriate supplementary modules. DO NOT complete the supplementary modules before you finish the core course for your group.

Supplementary Modules for SBR Investigators Conducting Research with Children
Supplementary Modules for SBR Investigators Conducting Research with Prisoners
Supplementary Module for SBR Investigators Conducting International Research
Supplementary Modules for Biomedical Investigators Conducting Research with Children
Supplementary Modules for Biomedical Investigators Conducting Research with Prisoners
Supplementary Module for Biomedical Investigators Conducting International Research

University of Mississippi Clinical Trials and FDA Administrator

Daniel M. Riche, Pharm.D., BCPS, CDE
Associate Professor of Pharmacy Practice
The University of Mississippi School of Pharmacy
Assistant Professor of Medicine
Clinic Coordinator, Cardiometabolic Clinic
The University of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216
Phone (601) 984-2640
Fax (601) 984-2751
driche@umc.edu

The FDAAA 801 Requirements page provides summary information on the clinical trial registration and results submission requirements described in Section 801 of the Food and Drug Administration Amendments Act, known as FDAAA 801. It includes information about Responsible Party, Applicable Clinical Trials, deadlines for submitting required information, and penalties. It includes information on:

• Who Is Responsible for Registering Trials and Submitting Results?
• Which Trials Must Be Registered and Have Results Submitted to ClinicalTrials.gov?
• When Do I Need to Register and Submit Results?
• Are There Penalties If I Fail to Register or Submit Results?
• Other FDAAA 801 Requirements: NIH and FDA
• Development of Regulations to Implement FDAAA 801

For details about the data submission process, see How to Register Your Study and How to Submit Your Results. For descriptions of data elements, see the Protocol Data Element Definitions and Basic Results Data Element Definitions.

It is IRB policy that research that only involves secondary analysis of pre-approved public data files does not require IRB approval, as it does not constitute human subject research as defined in 45 CFR 46.102.

Such public use data files must adhere to the following rules:

1. the data file must be publicly available to any researcher through unlimited access or via a member institution or for a fee;
2. the original data collection was gathered in anonymous form or on unknown persons, or the original data collection was gathered on identified subjects but the data file has been stripped of direct identifiers and indirect identifiers that may risk disclosure of subjects' identity; and
3. a formal disclosure analysis was performed to reasonably prevent the identification of individual subjects using variables within the database.

The following databases are recognized as public use databases:

• Inter-University Consortium for Political and Social Research (ICPSR)
• U.S. Bureau of the Census
• National Center for Health Statistics
• National Center for Educational Statistics
• Centers for Disease Control and Prevention
• National Election Studies
• Roper Center for Public Opinion Research

The IRB staff should be consulted if there are any doubts about the applicability of this policy to other databases.

Approved by the IRB January 16, 2008

 In Survey Options

1. Click into the Survey Options.
2. Under Survey Termination, check Anonymize Response. This will automatically remove panel information and IP address from collected responses.

In order to collect information for incentives while keeping a survey anonymous, you can create 2 surveys in Qualtrics and keep them separate. The one with the data will be an anonymous survey. At the end, you would post a link to a second, separate survey that asks for email address or name to collect information for incentives.  

Also, make sure that you not only test the survey by having your lab take the survey, but then to go to where the data is stored to make sure the process generates two different databases - one for data you want to analyze and another for contact data for incentives. Then, delete that preview data before distributing for the actual study. If the databases are not separate, then your survey will not be anonymous!

Make sure to anonymize responses as shown here.

All Ole Miss web pages include an Accessibility Check. Certain types of survey features are considered non-accessible. If you must use these types of features, you will need to contact one of the qualtrics administrators to allow them.

Non-accessible survey features include:

• Slider
• Constant Sum – Slider
• Matrix – Bipolar
• Rank Order – Drag and Drop
• Pick, Group, and Rank
• Heat Map
• Hot Spot
• Graphic Slider
• GAP

UM Qualtrics administrators

Penny Rice, Faculty Technology Development Center; parice@olemiss.edu; (662) 915-7918

Amelia Robbins, Faculty Technology Development Center; amelia@olemiss.edu; (662) 915-7918

See www.qualtrics.com/support/survey-platform/survey-module/survey-tools/check-survey-accessibility for more information.

Allowable & Best Practices for Cash and Gift Card Incentives for Human Subjects Research Participants

Overview: Cash and gift card incentives for human subject research participation are generally permitted from Fund 25 and 30 budgets – IF they are implemented consistent with Mississippi State Law and University policy.

To satisfy law and policies, you must:

• provide sufficient justification documentation to Procurement and
• establish an audit-sufficient paper trail on how the cash or gift cards were distributed

Procedures:

1. Submit a memo of justification to Rachel Bost (rbost@olemiss.edu) that includes:
   • Justification for purchasing gift cards or giving cash        
   • details of internal controls established for the disbursement of the cards / cash (detail how you will select winners, deliver, and track in real-time)
   • a statement that the PI or project personnel and their family members will not be compensated participants, that members of the PI's department or unit will not be compensated participants, and that the study is open to the public and an effort will be made to seek participants beyond University employees (tell how this will be done)
   • a statement that participants will sign for the cards / cash and you will maintain those records for a period of 7 years after the last payment (or you will track as under 3.b. below)
   • your IRB-approved consent form with incentive information highlighted
   • If your study is sponsored by funds external to UM, document sponsor approval of the payments & method with excerpts from your grant or contract (or separate letter from sponsor)
2. Obtaining cash or gift cards from Procurement

   ***Use gift cards instead of cash whenever possible (reduces risk of audit and loss)

   *** Use a Procurement VISA card whenever possible for purchasing incentives

   ***Request funds / gift cards up front instead of paying participants out-of-pocket and requesting subsequent reimbursement (reduces risk of audit; avoids risk you will not be reimbursed)

   • For gift cards:
     • Submit a request for payment to the PI [contact Rachel Bost for form] & purchase gift cards with the payment
     • Better: Use your UM Procurement VISA to purchase the gift cards [contact Shelley Morrison smorriso@olemiss.edu  to raise the monthly purchase limit, if needed]
   • For cash:
     • [contact Rachel Bost for information]
3. Distributing & tracking incentives
   1. Have participants print & sign names showing they received an incentive with the date received and value of the incentive (add ID#s for students).  Keep this documentation separate from your research data and have it available in case you are audited.
   2. If you mail gift cards (e.g., there is no in-person contact with participants), document participant name, date mailed, and incentive value. Keep this documentation separate from your research data and have it available in case you are audited.   
4. Reconciling VISA statements –  submit the following:
   1. Your list from #3.a. or #3.b. above
   2. Your memo of justification from #1 above
   3. ***If all gift cards have not been distributed when the visa document is due, include a statement that you will keep similar records of card distribution. When all cards have been distributed, send the list with your copy of the VISA document to Shelley Morrison smorriso@olemiss.edu. 

If a subject could receive more than $600 in cash + gift cards in a calendar year – from your study or from multiple studies:

UM must report to the IRS payments from UM accounts that exceed $600 per participant per calendar year (IRS considers gift cards/certificates equivalent to cash). This case requires subject name, address, and social security number – which should be disclosed to subjects in the IRB consent form along with the fact that the IRS will receive a 1099 MISC Form and they will likely have to pay tax. A 1099 MISC Form should be completed [contact Rachel Bost for information]. Do not include the study name on any check.

Access the Determination of Intensity of Exercise

OHRP’s “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure” lists under (4)(e) “moderate exercise, muscular strength testing, body composition testing, and flexibility testing where appropriate given the age, weight, and health of the individual.” There is no further detail on how to determine what constitutes moderate exercise (versus vigorous exercise). This guidance aims to meet that need.

Procedure

The “Expedited or Full Board Review Determination Procedure” described above in this policy will be used to decide whether procedures involving exercise meet the definition above. However, for protocols falling into ‘gray areas,’ three sources of information will be used at the discretion of the subcommittee:

• IRB members or others with expertise in medicine and/or exercise science will be consulted.
• Subcommittee members will have investigators run them through exercise procedures.
• Subcommittee members will consult the guideline below from the Centers for Disease Control and Prevention and the American College of Sports Medicine (ACSM).
• The ACSM table** (p.7) will be considered definitive, if specified parameters are measured in a study of apparently healthy adults, as determined by, for example, the PAR-Q or PAR-Q+

ACSM/CDC Guidelines:

Moderate exercise consists of activities that result in a noticeable increase in breathing and heart rate, but can be comfortably sustained for ~45 minutes. The activities are commonly described as “very light” to “light” to “somewhat hard” when the level of perceived exertion is rated. During moderate intensity exercise, participants should be able to easily carry on a conversation.

Examples of common moderate intensity activities include:

• Walking at a moderate or brisk pace on a level surface
• Hiking
• Water aerobics
• Yoga
• Doubles tennis
• Raking the lawn
• Moderate household cleaning (e.g. vacuuming, washing windows, sweeping).

More than moderate exercise (vigorous) results in substantial increases in breathing and heart rate. The activities are commonly described as “hard” to “very hard” when the level of perceived exertion is rated. Carrying on a conversation is difficult during/while performing vigorous intensity exercise.

Examples of common more than moderate intensity activities include:

• Jogging or running
• Step aerobics
• Circuit weight training
• Most competitive sports (basketball, soccer, football, etc.)
• Singles tennis
• Heavy yard work (e.g. digging ditches, swinging an ax, pushing a mower).

Note: Moderate intensity activities may, in fact, be more than moderate if the participants are sedentary, not physically fit, elderly, and/or have a known cardiac, pulmonary, or metabolic disease. 

Reference:

ACSM's Guidelines for Exercise Testing and Prescription (2010). Baltimore, MD: Lippincott, Williams, & Wilkins.

The IRB thanks Dr. Paul Loprinzi for his efforts in compiling this guidance. (Dr. Loprinzi is an Associate Professor of Health, Exercise Science and Recreation Management, and Director of the Exercise & Memory Laboratory in the School of Applied Sciences.)

Section 404 of the regulations allows the IRB to approve research if the IRB finds that the risks of the research are no more than minimal.

Three of the four categories of human research involving children may be approved by an Institutional Review Board (IRB). The four categories differ from one another according to the level of risk involved, the prospect of direct benefit to the research subjects, and the anticipated research findings. For all four categories, the proposed research activity must satisfy the requirements for parental or guardian permission and child assent. Depending on the category, additional conditions must be met in order for the IRB to approve the research activities.

The three categories approvable by an IRB are:

• Section 404 of the regulations allows the IRB to approve research if the IRB finds that the risks of the research are no more than minimal. The regulations rely on the definition of “minimal risk” provided in Subpart A of the regulations, as follows:
  • Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i))
• Section 405 of the regulations allows the IRB to approve research if the IRB finds that:
  • more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject or by a monitoring procedure that is likely to contribute to the subject’s well-being;
  • the risk is justified by the anticipated benefit to the subjects; and,
  • the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.
• Section 406 allows the IRB to approve research if the IRB finds that:
  • more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well being of the child;
  • the risk represents a minor increase over minimal risk;
  • the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations; and,
  • the intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition.
• The fourth category of approvable research involving children is identified in Section 407, and requires the IRB to make certain findings and refer the proposed research activity to the Secretary of HHS for further review and approval.

Background:

The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) governs how student Education Records are protected. FERPA regulates the disclosure of Personally Identifiable Information from Education Records in all public elementary and secondary schools, school districts, intermediate education agencies, state education agencies and any public or private agency or institution that uses funds from the U.S. Department of Education. This guidance provides procedures related to research access for Education Records covered by FERPA.

Education Records include, but are not limited to, course grades and graded coursework, transcripts, class lists, student course schedules, health and athletics records, student financial information, and student discipline files. These records may be recorded in any format such as handwritten, printed, computer media, videotape, audiotape, film, microfilm, microfiche, and e-mail.

Faculty, staff, and administrators have access to student Education Records for the purposes of conducting the duties of their job. Faculty, staff, and administrators cannot use this natural access for other purposes, such as research. When student Education Records are used for research purposes FERPA applies, and written permission is required, unless there is an applicable exception, as outlined below. Many researchers who are also educators are surprised to learn that when conducting research, they no longer have a “legitimate educational interest” in the records they otherwise handle on a regular basis (e.g., tests, journals, written assignments, etc.).

An educational institution has the authority under FERPA to determine what information may be accessed from an Education Record. If a researcher is denied access to information in an Education Record by the University, the IRB cannot overrule the decision.

Researchers are responsible for maintaining compliance with FERPA, human research regulations (Institutional Review Board requirements), and University policy when accessing Education Records for the purpose of research. If a complaint is filed regarding violation of FERPA, an investigation will be conducted by the appropriate federal office. Failure to resolve a FERPA noncompliance can result in loss of federal funding.

Authorization for Release of Records:

FERPA and IRB requirements are typically met if a parent or student 18 years or older signs a consent form to participate in a project, which also authorizes the release of the student Education Records for research purposes.

1. A written, signed, and dated release is required for investigators to obtain student records from the Registrar. The release must a.) specify exactly what student information is to be released; b.) specify the purpose of the disclosure; and identify which investigators will have access. Undergraduate investigators cannot have access to identified student records.
2. An electronic alternative to a signed release, (e.g., using student emails for identity verification), may be allowed in some cases. The email release must comply with the same requirements as a signed paper release.

Release of Records without Authorization Exceptions:

Access to student Education Records without obtaining signed consent for research purposes can occur under certain stipulations.

1. FERPA allows schools to designate and disclose, without consent, certain items of information as “directory information,” such as student names, addresses, telephone numbers, dates and places of birth, honors and awards, and dates of attendance. Each educational institution designates what information is considered directory information. Therefore, the researcher should contact each institution from which they propose to access student Education Records and follow that institution’s FERPA policy and procedures when accessing directory information.
2. A researcher can also gain access to Education Records without consent if a school official with legitimate access (other than the researcher) strips the records of any identifying information prior to release of that information.
3. An institution may grant an exception and disclose personally identifiable information from a student Education Record without written consent if disclosed to an organization conducting research for, or on behalf of, the institution to:
   1. Develop, validate, or administer predictive tests;
   2. Administer student aid programs; and/or,
   3. Improve instruction (34 CFR §99.31)
      1. If the researcher is a school official with legitimate education interest (34 CFR §99.31(a)(1); or,
      2. If the researcher is conducting studies for or on behalf of the school (34 CFR §99.31(a)(6).

Researcher Responsibilities to Protect FERPA data:

Approval to use student Educational Record data in research is contingent on the researcher:

1. Using the information only for purposes of the approved research. New usage of the information will require a new approval.
2. Providing adequate protection for the student Education Record to ensure that it is not compromised or subject to unauthorized access.
3. Ensuring that only research team members who have a legitimate educational interest access student Education Records without signed permission from the parent or eligible student.
4. Ensuring that no one outside of research team members who are specifically listed on the protocol have access to the personally identifiable information.
5. Ensuring that all data shared in aggregate form is properly de-identified to avoid unauthorized disclosure to third parties. The University’s disclosure avoidance procedure is to restrict reporting any cell size (n-number) that is smaller than 10 when paired with restricted data.

Records Retention:

The investigator must retain a copy of the release for 7 years (scanned / electronic copies are acceptable).

Summary/Purpose:

Lists certain types of human subjects research that may not require Institutional Review Board (IRB) review or applications.

• All human subjects research requires an application to the IRB
• Quality assurance / quality improvement (QA/QI) could be considered research by the federal regulations
• The IRB has determined that certain forms of QA/QI activities may not require IRB applications:
  • Teaching, Faculty and Staff evaluations (However, research on such evaluations would require IRB review)
  • Performance evaluations
  • Institutional program review
  • Classroom assessment
  • Curriculum review
  • Strategic planning
  • Performance improvement research conducted exclusively by Athletics Department personnel (However, Athletics Department research that includes faculty as investigators would require IRB review)

Summary/Purpose: Definition of snowball recruiting, its possible complications, and requirements for researchers.

Definition of snowball recruiting: Also called peer or network recruiting, snowball recruiting involves asking currently enrolled or potential research participants to recruit additional participants with similar attributes or qualities as those being studied.

Types of recruitment: Recruitment can happen in one of two ways.

1. A participant in a study can nominate someone by giving information to the investigator (who then contacts the nominee); or
2. A participant in a study can nominate someone by giving him/her information about the study and having the nominee contact the investigator.

Possible complications:

• A participant being recruited by a person in a position of authority may feel undue influence to participate in the research study because of the status of the nominator.
• Recruitment for studies involving sensitive subject matters or potentially embarrassing information may cause more than minimal risk to participants.
• Sensitive subject matters include but are not limited to medical or psychological diagnoses, illegal behavior, or sexual orientation.
• Subject matters such as occupation, leisure activities, or age likely do not involve increased risk to participants. See Third Party Research policy for more information.

Requirements:

• Type 1 recruitment:
  • Researchers should ask participants whether they would be willing to nominate potential participants to complete the study. This script must be included with the IRB application.
  • Researchers should obtain a nominating participant’s consent to reveal the participant’s identity to nominees.
• Type 2 recruitment:
  • Researchers should ask participants whether they would be willing to pass on some information about the study to other potential participants. This script must be included with the IRB application.
  • Researchers should give participants an information sheet that they can pass on to people they think may be qualified and interested in participating in the study. This information sheet must be included with the IRB application.

It is IRB policy that research that only involves secondary analysis of pre-approved public data files does not require IRB approval, as it does not constitute human subject research as defined in 45 CFR 46.102.

Such public use data files must adhere to the following rules:

• the data file must be publicly available to any researcher through unlimited access or via a member institution or for a fee;
• the original data collection was gathered in anonymous form or on unknown persons, or the original data collection was gathered on identified subjects but the data file has been stripped of direct identifiers and indirect identifiers that may risk disclosure of subjects' identity; and
• a formal disclosure analysis was performed to reasonably prevent the identification of individual subjects using variables within the database.

The following databases are recognized as public use databases:

• Inter-University Consortium for Political and Social Research (ICPSR)
• U.S. Bureau of the Census
• National Center for Health Statistics
• National Center for Educational Statistics
• Centers for Disease Control and Prevention
• National Election Studies
• Roper Center for Public Opinion Research

Summary/Purpose: To explain the criteria for the review of research using human tissue and commercially available cell lines.

Studies that do not require IRB Review

Policy: Studies using human tissue where donors cannot be identified or commercially available human cell lines are not human subjects research and do not require IRB review.

Regulations: According to the Office for Human Research Protections (OHRP), “HHS-conducted or supported research that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research. See the NIH Decision Chart for an overview of the determination. Accordingly, in vitro research and research in animals using already derived and established human cell lines, from which the identity of the donor(s) cannot readily be ascertained by the investigator, are not considered human subject research and are not governed by the HHS or FDA human subject protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56. IRB review is not required for such research.”  [Office for Human Research Protections Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles, March 19, 2002.]

Studies that require IRB Review

Policy: Investigators who wish to conduct research using human tissue OR human cell lines where the donor(s) may be identified must submit an IRB application for review and approval prior to beginning their research.

Regulations: OHRP also notes, “HHS-conducted or supported research that uses human cell lines where the donor(s) may be identified, including cells that retain links (such as a code) to identifying information is generally considered human subject research that is governed by 45 CFR Part 46 because the donors are human subjects. IRB review and approval is required for such research.”  [Office for Human Research Protections Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles, March 19, 2002.]

Summary/Purpose: Criteria for requiring Certificates of Confidentiality (CoC) to add protection for sensitive human research where subjects can be identified. CoC cover investigators funded by Public Health Service agencies automatically under Section 2012 of the “21^st Century Cures Act.”  

Background and Applicability

(See content from NIH at http://grants1.nih.gov/grants/policy/coc/faqs.htm and from CDC at https://www.cdc.gov/od/science/integrity/confidentiality/applinst.htm), 

A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research.

Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant.

Any research project that collects personally identifiable, sensitive information and that has been approved by an IRB is eligible for a Certificate. Federal funding is not a prerequisite for a Certificate.

Sensitive information includes (but is not limited to) information relating to sexual attitudes, preferences, or practices; information relating to the use of alcohol, drugs, or other addictive products; information pertaining to illegal conduct; information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination; information pertaining to an individual's psychological well-being or mental health; and genetic information or tissue samples.

Studies eligible for a Certificate (partial list):

• Research on HIV, AIDS, and other STDs;
• Studies that collect information on sexual attitudes, preferences, or practices;
• Studies on the use of alcohol, drugs, or other addictive products;
• Studies that collect information on illegal conduct;
• Studies that gather information that if released could be damaging to a participant's financial standing, employability, or reputation within the community;
• Research involving information that might lead to social stigmatization or discrimination if it were disclosed;
• Research on participants' psychological well being or mental health;
• Genetic studies, including those that collect and store biological samples for future use;
• Research on behavioral interventions and epidemiologic studies.

Studies ineligible for a Certificate:

• not research based,
• not approved by an IRB in accordance with these guidelines,
• not collecting sensitive information or information that might harm the research participants, or
• not collecting personally identifiable information.

Identifying characteristics include things such as: name, address, social security or other identifying number, fingerprints, voiceprints, photographs, genetic information or tissue samples, or any other item or combination of data about a research participant which could reasonably lead, directly or indirectly by reference to other information, to identification of that research subject.

UM Policy

The IRB generally limits requiring researchers to get Certificates to studies where there is a real risk of a subpoena or court order to produce data and where identifying information is retained for a significant period of time.

• The IRB will require a Certificate in studies collecting admissions of criminal activity. These include studies on rape and illicit drug use, for example.
• Certificates will generally not be required for data that could be socially stigmatizing, because these are less likely to be solicited by the legal system.

Researchers may opt to get Certificates without IRB mandate. Because Certificates require altered consent forms, the IRB must be made aware of Certificates obtained by researchers, and consent forms must comply with NIH / CDC requirements before IRB will approve them.

See https://www.cdc.gov/od/science/integrity/confidentiality/CoCProtections.htm

• An incentive must be consistent with the effort of the participants (i.e. non-coercive).
• Extra credit can only be offered as an incentive if all instructors from recruited classes agree to offer extra credit and provide an alternate assignment to students. If all course instructors from recruited classes will not offer extra credit with alternate assignments, extra credit should not be offered as incentives must be offered equally to all participating students.
• The alternate assignment must be comparable to participation in terms of time, effort, stress, and convenience and stated within the consent document. For example, a 5 page paper is not an acceptable alternative to participation in a 4-minute survey.
• Subjects participating in the same study and completing the same tasks should be compensated equitably when appropriate. *
  • *Variation in compensation may occur when it can be justified. For example, it is reasonable that compensation for subject populations in different countries may vary according to cultural customs or if a group in a study is involved in more testing than another, ie control group.
  • When there are different incentives offered for different subject groups in a research protocol, justification will need to be given in the application for different incentives for different groups.
  • All incentives for all groups should be listed on a singular consent form to ensure all participants are fully informed.

Adverse events and unanticipated problems occurring in research studies must be reported to the IRB. Principal investigators or other research personnel should use the Incident report form when reporting issues that occur. Serious adverse events (that result in death, hospitalization, significant disability, life-threatening situations, or concerns about physical health or future health of subjects) should be reported to the IRB within one week of an investigator becoming aware of the event or effect. All other incidents or experiences should be reported to the IRB within two weeks.

Adverse events include unfavorable physical or psychological harm that occurs in a human subject during the course of a research study, whether or not considered related to the subject's participation in the research. Unanticipated problems involve experiences that are unexpected in nature, severity, or frequency, and suggest that the research places subjects or others at a greater risk of harm than was previously noted in the consent form or protocol. The IRB will review the report and take appropriate action, including notifying the investigator of the action(s) taken.

UM Policy on Reporting Adverse Events and Unanticipated Problems